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Fewer-than-four ports versus four ports for laparoscopic cholecystectomy

  1. Kurinchi Selvan Gurusamy1,*,
  2. Jessica Vaughan1,
  3. Michele Rossi2,
  4. Brian R Davidson1

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 20 FEB 2014

DOI: 10.1002/14651858.CD007109.pub2


How to Cite

Gurusamy KS, Vaughan J, Rossi M, Davidson BR. Fewer-than-four ports versus four ports for laparoscopic cholecystectomy. Cochrane Database of Systematic Reviews 2014, Issue 2. Art. No.: CD007109. DOI: 10.1002/14651858.CD007109.pub2.

Author Information

  1. 1

    Royal Free Campus, UCL Medical School, Department of Surgery, London, UK

  2. 2

    Azienda Ospedaliero-Universitaria Careggi, Endoscopia Chirurgica, Firenze, Firenze, Italy

*Kurinchi Selvan Gurusamy, Department of Surgery, Royal Free Campus, UCL Medical School, Royal Free Hospital, Rowland Hill Street, London, NW3 2PF, UK. k.gurusamy@ucl.ac.uk.

Publication History

  1. Publication Status: New
  2. Published Online: 20 FEB 2014

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Characteristics of included studies [ordered by study ID]

MethodsRandomised clinical trial.


ParticipantsCountry: Egypt.

Number randomised: 250.

Post-randomisation drop-outs: 0 (0%).

Revised sample size: 250.

Mean age: 47 years.

Females: 183 (73.2%).

Inclusion criteria

  1. People with symptomatic cholelithiasis, verified by abdominal ultrasonography.
  2. Scheduled for elective cholecystectomy.
  3. ASA classification 1 or 2.


Exclusion criteria

  1. Pregnancy.
  2. Acute cholecystitis (clinical or radiological).
  3. A preoperative indication for a cholangiogram.
  4. BMI > 35 kg/m2.
  5. Previous upper laparotomy.
  6. Previous umbilical hernia repair.
  7. History of peptic ulcer or bronchial asthma.
  8. Allergy to non-steroidal anti-inflammatory drugs.
  9. Long-term use of analgesia.


InterventionsParticipants were randomly assigned to 1 of 2 groups.
Group 1: fewer-than-four-ports laparoscopic cholecystectomy (n = 125).
Further details: single port: 2 cannulas were inserted (1 × 10 mm and 1 × 5 mm).
Successful completion of less-port laparoscopic cholecystectomy: 121/125 (96.8%).
Group 2: four-port laparoscopic cholecystectomy (n = 125).
Further details: size of port in mm: 10 + 10 + 5 + 5.

Other details:

intra-operative cholangiogram: no.


OutcomesMortality, morbidity, quality of life, conversion to open cholecystectomy, operating time, hospital stay, and return to normal activity.


NotesAuthors contacted in September 2013. Authors provided replies.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Randomization was achieved using a computer-generated schedule, and the results were sealed into envelopes (either SALC [single-access laparoscopic cholecystectomy] or CLC groups)".

Allocation concealment (selection bias)Low riskQuote: "An envelope was fetched and opened in the operating room by an operating room nurse not otherwise engaged in the study".

Blinding (performance bias and detection bias)
All outcomes
Unclear riskComment: this information was not available.

Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: there were no post-randomisation drop-outs.

Selective reporting (reporting bias)Low riskComment: mortality and morbidity were reported.

Free from vested interest bias?Low riskQuote: "Our hospital is a governmental university hospital, there was no fund" (author replies).


MethodsRandomised clinical trial.


ParticipantsCountry: Switzerland.

Number randomised: 150.

Post-randomisation drop-outs: 0 (0%).

Revised sample size: 150.

Mean age: 43 years.

Females: not stated.

Inclusion criteria

  1. Elective patients with symptomatic gallbladder stones (history of cholecystitis, history of common bile duct stone migration, biliary pancreatitis, or a combination of these).
  2. Aged > 18 years.


Exclusion criteria

  1. People presenting as an emergency with acute gallbladder disease.
  2. Contraindications to pneumoperitoneum.
  3. Cirrhosis or mental impairment. 


InterventionsParticipants were randomly assigned to 1 of 2 groups.
Group 1: fewer-than-four-ports laparoscopic cholecystectomy (n = 75).
Further details: single port: 1.5-cm umbilical TriPort (multiport trocar).
Successful completion of fewer-than-four-ports laparoscopic cholecystectomy: 73/75 (97.3%).
Group 2: four-port laparoscopic cholecystectomy (n = 75).
Further details: size of port in mm: 10 + 10 + 5 + 5.

Other details: intra-operative cholangiogram: attempted in all participants and successful in 57/75 in single-port group and 62/75 operations in four-port group.


OutcomesMortality, morbidity, quality of life, operating time, hospital stay, and return to work.


NotesAuthors contacted in February 2013. No replies were received.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Patients were allocated to LESS or CL cholecystectomy using a randomization table after their preoperative visit by the surgeon".

Allocation concealment (selection bias)Unclear riskComment: this information was not available.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskComment: this information was not available.

Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: there were no post-randomisation drop-outs.

Selective reporting (reporting bias)Low riskComment: mortality and morbidity were reported.

Free from vested interest bias?Unclear riskComment: this information was not available.


MethodsRandomised clinical trial.


ParticipantsCountry: Turkey.

Sample size: 146.

Post-randomisation drop-out(s): 0 (0%).

Revised sample size: 146.

Mean age: 50 years.

Females: 109 (74.7%).

Inclusion criteria:

  1. People undergoing laparoscopic cholecystectomy for gallstones.


Exclusion criteria:

  1. People with upper abdominal scars.


InterventionsParticipants were randomly assigned to 1 of 2 groups.
Group 1: fewer-than-four-ports laparoscopic cholecystectomy (n = 73).
Further details: size of port in mm: 10 + 10 + 5.
Successful completion of fewer-than-four-ports laparoscopic cholecystectomy: not stated.
Group 2: four-port laparoscopic cholecystectomy (n = 73).
Further details: size of port in mm: 10 + 10 + 5 + 5.

Other details: intra-operative cholangiogram: not stated.


OutcomesOperating time and hospital stay.


NotesAuthors contacted in September 2010. No replies were received.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskComment: this information was not available.

Allocation concealment (selection bias)Unclear riskComment: this information was not available.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskComment: this information was not available.

Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: there were no post-randomisation drop-outs.

Selective reporting (reporting bias)High riskComment: mortality and morbidity were not reported. 

Free from vested interest bias?Unclear riskComment: this information was not available.


MethodsRandomised clinical trial.


ParticipantsCountry: Spain.

Number randomised: 50.

Post-randomisation drop-outs: not stated.

Revised sample size: 50.

Mean age: 47 years.

Females: 34 (68%).

Inclusion criteria

  1. People undergoing day-surgery laparoscopic cholecystectomy for symptomatic cholelithiasis.


Exclusion criteria

  1. Obesity with BMI > 35 kg/m2.
  2. Hepatitis.
  3. Alcoholism.
  4. Pregnancy.
  5. Previous acute pancreatitis.
  6. Cholecystitis.
  7. Choledocholithiasis.
  8. Previous upper abdominal surgery.


InterventionsParticipants were randomly assigned to 1 of 2 groups.
Group 1: fewer-than-four-ports laparoscopic cholecystectomy (n = 26).
Further details: single port: 2-cm umbilical SILSTM Port (Covidien) with 3 openings (allowing the use of 3 × 5-mm trocars).
Successful completion of fewer-than-four-ports laparoscopic cholecystectomy: 25/26 (96.1%).
Group 2: four-port laparoscopic cholecystectomy (n = 24).
Further details: size of port in mm: 10 + 10 + 5 + 5.

Other details: intra-operative cholangiogram: not stated.


OutcomesMortality, morbidity, operating time, and proportion discharged as day surgery.


NotesAuthors contacted in February 2013. Authors replied in February 2013.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Patients were randomized to SILS in LC or surgery on the same day of the procedure using a random table generated by a computer program".

Allocation concealment (selection bias)Unclear riskQuote: "The random allocation of patients to the single port or group of conventional laparoscopic cholecystectomy was performed in the operating room minutes before starting the intervention by the surgical team" (author replies).

Comment: further details about how the allocation concealment was performed were not available.

Blinding (performance bias and detection bias)
All outcomes
High riskQuote: "Neither the patients nor the health professionals were blinded. The outcome assessors were blinded. The results in terms of pain and analgesic requirements were made through telephone calls by nurses who did not know the method used in each case" (author replies).

Incomplete outcome data (attrition bias)
All outcomes
Low riskQuote: "There were no post-randomisation drop-outs" (author replies).

Selective reporting (reporting bias)Low riskComment: mortality and morbidity were reported.

Free from vested interest bias?Low riskQuote: "The study did not receive any funding" (author replies).


MethodsRandomised clinical trial.


ParticipantsCountry: Nepal.

Sample size: 75.

Post-randomisation drop-out(s): 0 (0%).

Revised sample size: 75.

Mean age: 39 years.

Females: 62 (82.7%).

Inclusion criteria:

  1. Elective laparoscopic cholecystectomy.
  2. Aged 18 to 75 years.
  3. Fit for cholecystectomy on anaesthetic grounds.


InterventionsParticipants were randomly assigned to 1 of 2 groups.
Group 1: fewer-than-four-ports laparoscopic cholecystectomy (n = 36).
Further details: size of port in mm: 11 + 10 + 5.
Successful completion of fewer-than-four-ports laparoscopic cholecystectomy: 36/36 (100%).
Group 2: four-port laparoscopic cholecystectomy (n = 39).
Further details: size of port in mm: 11 + 10 + 5 + 5.

Other details: intra-operative cholangiogram: not stated.


OutcomesConversion to open cholecystectomy, hospital stay, and operating time.


NotesAuthors contacted in September 2010. No replies were received.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskComment: this information was not available.

Allocation concealment (selection bias)Unclear riskComment: this information was not available.

Blinding (performance bias and detection bias)
All outcomes
High riskQuote: "All patient dressings were kept for one week. Thus, all patients were blinded to the type of operation they underwent".
Comment: blinding of observers was not reported.

Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: there were no post-randomisation drop-outs.

Selective reporting (reporting bias)High riskComment: mortality and morbidity were not reported. 

Free from vested interest bias?Low riskQuote: "This study was supported by the research grant issued to the Department of Surgery by BP Koirala Institute of Health Sciences, Nepal".


MethodsRandomised clinical trial.


ParticipantsCountry: Italy.

Number randomised: 40.

Post-randomisation drop-outs: 0 (0%).

Revised sample size: 40.

Mean age: 48 years.

Females: 28 (70%).

Inclusion criteria

  1. Aged 18 to 75 years.
  2. BMI < 30 kg/m2.
  3. Presence of Gallstones.
  4. ASA classification I to III.
  5. Nassar grade I to III.


Exclusion criteria

  1. Previous upper abdominal or right colonic surgery.
  2. Acute cholecystitis, bile duct stones, pancreatitis.


InterventionsParticipants were randomly assigned to 1 of 2 groups.
Group 1: fewer-than-four-ports laparoscopic cholecystectomy (n = 20).
Further details: single port: 2-cm umbilical TriPort with 3 legs (allowing the use of 1 × 12 mm and 2 × 5-mm instruments).
Successful completion of fewer-than-four-ports laparoscopic cholecystectomy: 18/20 (90%).
Group 2: four-port laparoscopic cholecystectomy (n = 20).
Further details: size of port in mm: 12 + 12 + 5 + 5.

Other details: intra-operative cholangiogram: not stated.


OutcomesMortality, morbidity, conversion to open cholecystectomy, operating time, hospital stay, and quality of life.


NotesAuthors contacted in February 2013. No replies were received.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskComment: this information was not available.

Allocation concealment (selection bias)Low riskQuote: "Randomization was performed preparing 2 sets of 20 numbered, opaque, sealed envelopes, with the envelopes of each set containing indications for 10 LESS cholecystectomy procedures and 10 standard LC procedures. One set of envelopes was kept at Bianchi Melacrino Morelli Hospital and the other at Monaldi Hospital. The envelopes were opened in numeric order for each patient by an assistant not involved in the surgical operations, right before surgery".

Blinding (performance bias and detection bias)
All outcomes
Unclear riskQuote: "Patients did not know the treatment received until their discharge. A large drape was used to cover the abdomen after surgery, thus hiding the surgical wounds".
Comment: it is not clear whether the healthcare providers involved in the care of the participants were blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: there were no post-randomisation drop-outs.

Selective reporting (reporting bias)Low riskComment: mortality and morbidity were reported

Free from vested interest bias?Unclear riskComment: this information was not available.


MethodsRandomised clinical trial.


ParticipantsCountry: Brazil.

Number randomised: 40.

Post-randomisation drop-outs: not stated.

Revised sample size: 40.

Mean age: not stated.

Females: not stated.

Inclusion criteria

  1. People with symptomatic cholelithiasis, diagnosed based on clinical symptoms and confirmed with abdominal ultrasound scan.
  2. BMI ≤ 35 kg/m2.


InterventionsParticipants were randomly assigned to 1 of 2 groups.
Group 1: fewer-than-four-ports laparoscopic cholecystectomy (n = 20).
Further details: single port: four channels (SITRACC device; 1 × 10 mm and 3 × 5 mm).

Successful completion of less-port laparoscopic cholecystectomy: 18/20 (90%).
Group 2: four-port laparoscopic cholecystectomy (n = 20).
Further details: size of port in mm: 10 + 10 + 5 + 5.

Other details: intra-operative cholangiogram: no.


OutcomesMortality, morbidity, and operating time.


NotesAuthors contacted in September 2013. No replies were received.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskComment: this information was not available.

Allocation concealment (selection bias)Unclear riskComment: this information was not available.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskComment: this information was not available.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskComment: this information was not available.

Selective reporting (reporting bias)Low riskComment: mortality and morbidity were reported.

Free from vested interest bias?High riskQuote: "Funding: All single-port devices were provided without cost by EDLO S/A Produtos Medicos".


MethodsRandomised clinical trial.


ParticipantsCountry: Germany.

Number randomised: 70.

Post-randomisation drop-outs: 0 (0%).

Revised sample size: 70.

Mean age: 47 years.

Females: 16 (22.9%).

Inclusion criteria

  1. Aged ≥ 18 years.
  2. Indication for elective cholecystectomy.
  3. Uncomplicated, symptomatic cholecystolithiasis.


Exclusion criteria

  1. Aged > 80 years.
  2. BMI > 30 kg/m2.
  3. Acute cholecystitis.
  4. Gallbladder empyema.
  5. Pancreatitis or other complications.
  6. ASA grade IV or V.
  7. Previous upper abdominal laparotomy with suspicion of peritoneal adhesions.
  8. Allergy to paracetamol or piritramide.
  9. History of pain medication or alcohol abuse.
  10. Neuromuscular disease.
  11. Pregnancy or lactation. 


InterventionsParticipants were randomly assigned to 1 of 2 groups.
Group 1: fewer-than-four-ports laparoscopic cholecystectomy (n = 35).
Further details: single port: 2-cm umbilical SILS Port (Covidien, Norwalk, Connecticut, USA) with 3 openings (allowing the use of 3 × 5-mm trocars or 2 × 5-mm and 1 × 10-mm trocar).
Successful completion of fewer-than-four-ports laparoscopic cholecystectomy: 34/35 (97.1%).
Group 2: four-port laparoscopic cholecystectomy (n = 35).
Further details: size of port in mm: 10 + 10 + 5 + 5.

Other details: intra-operative cholangiogram: not stated.


OutcomesMortality, morbidity, quality of life, conversion to open cholecystectomy, operating time, hospital stay, and cosmetic scores.


NotesReasons for post-randomisation drop-outs: 1 participant was lost to follow-up on day 7 and 2 participants by 1 year in the single-port group. These participants were included for operative outcomes but not for quality of life (1 participant) and cosmesis (3 participants).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "A sequence with block sizes of three and six in random order was generated by computer (http://www.randomization. com)".

Allocation concealment (selection bias)Low riskQuote: "Patients were randomized to CL, ML [mini-laparoscopic] or SP [single port] cholecystectomy by drawing sequentially numbered, opaque, sealed envelopes that had been prepared earlier by a third party".

Blinding (performance bias and detection bias)
All outcomes
Low riskQuote: "After completion of cholecystectomy, all patients received non-transparent waterproof dressings at four sites on the abdomen, reflecting the incisions necessary for CL cholecystectomy. This ensured that patients, ward doctors and nurses responsible for the postoperative evaluation and care of patients were unaware of which procedure had actually been performed. The operating surgeons and operating room staff were excluded from postoperative treatment and evaluation".

Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: all participants were included for operative outcomes. 2 participants were lost to follow-up and so the quality of life and cosmetic scores may be at high risk of bias. However, mortality and morbidity are at low risk of bias.

Selective reporting (reporting bias)Low riskComment: mortality and morbidity were reported.

Free from vested interest bias?Low riskQuote: "This study was funded partly by the German Federal Ministry of Education and Research: grant numbers 01GH0605 and 01GH1001E (CHIR-Net)".


MethodsRandomised clinical trial.


ParticipantsCountry: Turkey.

Number randomised: 34.

Post-randomisation drop-outs: not stated.

Revised sample size: 34.

Mean age: 49 years.

Females: 22 (64.7%).

Inclusion criteria

  1. Symptomatic or asymptomatic gallbladder pathology such as gallstones, mud, or polyps.
  2. No previous history of upper gastrointestinal surgery.
  3. BMI < 40 kg/m2.


Exclusion criteria

  1. Patient's refusal to participate.
  2. Acute cholecystitis or pancreatitis.
  3. Umbilical hernia.


InterventionsParticipants were randomly assigned to 1 of 2 groups.
Group 1: fewer-than-four-ports laparoscopic cholecystectomy (n = 17).
Further details: single port: 2.5-cm Singleport (allowing the use of 5-mm instruments).

Successful completion of less-port laparoscopic cholecystectomy: not stated.
Group 2: four-port laparoscopic cholecystectomy (n = 17).
Further details: size of port in mm: 10 + 10 + 5 + 5.

Other details: intra-operative cholangiogram: no.


OutcomesMortality, morbidity, and operating time.


NotesAuthors contacted in September 2013. No replies were received.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskComment: this information was not available.

Allocation concealment (selection bias)Unclear riskComment: this information was not available.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskQuote: "Postoperative abdominal pain and shoulder pain were assessed and noted by nurses who were blinded to the study".
Comment: unclear whether the participants and surgeons involved in management of participants were blinded.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskQuote: "Postoperative abdominal pain and shoulder pain were assessed and noted by nurses who were blinded to the study".
Comment: unclear whether the complications were assessed by a blinded observer.

Selective reporting (reporting bias)Low riskComment: mortality and morbidity were reported.

Free from vested interest bias?Unclear riskComment: this information was not available.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Allemann 2012In this ongoing trial, the control group was not standard laparoscopic cholecystectomy as defined in this review.

Asakuma 2011It is not clear whether the control group was standard laparoscopic cholecystectomy as defined in this review.

Bansal 2012In this ongoing trial, it is not clear whether the control group was standard laparoscopic cholecystectomy as defined in this review.

Barugola 2011In this ongoing trial, it is not clear whether the control group was standard laparoscopic cholecystectomy as defined in this review.

Bingener-Casey 2012In this ongoing trial, it is not clear whether the control group was standard laparoscopic cholecystectomy as defined in this review.

Bresadola 1999It is not clear whether the control group was standard laparoscopic cholecystectomy as defined in this review.

Broeders 2010The control group was not standard laparoscopic cholecystectomy as defined in this review.

Brown 2013The control group was not standard laparoscopic cholecystectomy as defined in this review.

Cao 2011The control group was not standard laparoscopic cholecystectomy as defined in this review.

Chang 2013The control group was not standard laparoscopic cholecystectomy as defined in this review.

Chen 2002There is no information as whether the difference between the groups was only in the number of ports or in the size of the ports also.

Cockbain 2013Comment on an included trial (Saad 2013).

Dam 2011In this ongoing trial, it is not clear whether the control group was standard laparoscopic cholecystectomy as defined in this review.

de Carvalho 2013The intervention group also had four ports.

Garg 2012Not a randomised clinical trial.

Gupta 2005The intervention involves a combination of smaller ports and fewer ports.

Hansen 2011In this ongoing trial, it is not clear whether the control group was standard laparoscopic cholecystectomy as defined in this review.

Hauters 2013Not a randomised clinical trial

Hu 2005The control group was not standard laparoscopic cholecystectomy as defined in this review.

Hu 2010The control group was not standard laparoscopic cholecystectomy as defined in this review.

Jorgensen 2010In this ongoing trial, it is not clear whether the control group was standard laparoscopic cholecystectomy as defined in this review.

Khorgami 2011The control group was not standard laparoscopic cholecystectomy as defined in this review.

Kim 2009The control group was not standard laparoscopic cholecystectomy as defined in this review.

Lai 2011The control group was not standard laparoscopic cholecystectomy as defined in this review.

Lee 2010The control group was not standard laparoscopic cholecystectomy as defined in this review.

Leung 2011It is not clear whether the control group was standard laparoscopic cholecystectomy as defined in this review.

Limberger 2005The control group was not standard laparoscopic cholecystectomy as defined in this review.

Ma 2011The control group was not standard laparoscopic cholecystectomy as defined in this review.

Madureira 2013It is not clear whether the control group was standard laparoscopic cholecystectomy as defined in this review.

Marks 2011The control group was not standard laparoscopic cholecystectomy as defined in this review.

Marks 2012It is not clear whether the participants are being randomly allocated. It is also not clear whether the control group is standard laparoscopic cholecystectomy as defined in this review.

Marks 2013The control group was not standard laparoscopic cholecystectomy as defined in this review.

McGregor 2011The control group was not standard laparoscopic cholecystectomy as defined in this review.

Moran 2011It is not clear whether the control group was standard laparoscopic cholecystectomy as defined in this review.

Mosca 2012In this ongoing trial, it is not clear whether the control group was standard laparoscopic cholecystectomy as defined in this review.

Ng 1999Letter to editor not involving a randomised clinical trial.

Noguera 2012The control group was not standard laparoscopic cholecystectomy as defined in this review.

Ospanov 2013It is not clear whether the control group was standard laparoscopic cholecystectomy as defined in this review.

Ostlie 2013The control group was not standard laparoscopic cholecystectomy as defined in this review.

Pappas-Gogos 2010It is not clear whether the control group is standard laparoscopic cholecystectomy as defined in this review.

Pathania 2013It is not clear whether the control group was standard laparoscopic cholecystectomy as defined in this review.

Patricia 2010In this ongoing trial, the control group was not standard laparoscopic cholecystectomy as defined in this review.

Phillips 2012The control group was not standard laparoscopic cholecystectomy as defined in this review.

Poon 2003The control group was not standard laparoscopic cholecystectomy as defined in this review.

Sasaki 2012The control group was not standard laparoscopic cholecystectomy as defined in this review.

Soroush 2011In this ongoing study, it is not clear whether the participants are being randomly allocated. It is also not clear whether the control group is standard laparoscopic cholecystectomy as defined in this review.

Steinemann 2011Protocol of an ongoing trial. This trial will meet the inclusion criteria once completed.

Tacchino 2011It is not clear whether the control group is standard laparoscopic cholecystectomy as defined in this review.

Trichak 2003The intervention involves a combination of smaller ports and fewer ports.

Tsimogiannis 2010It is not clear whether the control group was standard laparoscopic cholecystectomy as defined in this review.

Tsimoyiannis 2010The control group was not standard laparoscopic cholecystectomy as defined in this review.

Umit Ugurlu 2013It is not clear whether the control group was standard laparoscopic cholecystectomy as defined in this review.

Vezakis 2010In this ongoing trial, it is not clear whether the control group was standard laparoscopic cholecystectomy as defined in this review.

Vilallonga 2012It is not clear whether the control group is standard laparoscopic cholecystectomy as defined in this review.

 
Characteristics of ongoing studies [ordered by study ID]

Trial name or titleEndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach.

MethodsRandomised clinical trial.

ParticipantsPeople undergoing laparoscopic cholecystectomy.

InterventionsSingle-port versus conventional multi-port laparoscopic cholecystectomy.

OutcomesMortality, morbidity, conversion to open cholecystectomy, and hospital stay.

Starting dateApril 2013.

Contact informationFranco Mosca (email: f.mosca@med.unipi.it).

Notes


Trial name or titleThe Comparison Between Result of Single Port Laparoscopic Cholecystectomy with 4 Ports Cholecystectomy.

MethodsRandomised clinical trial.

Participants
  1. People with symptomatic cholelithiasis without complications.
  2. Aged 14 to 70 years.
  3. Body mass index < 35 kg/m2.
  4. No history of other diseases.
  5. No history of previous abdominal surgery.

InterventionsSingle-port versus four-ports.

OutcomesMorbidity.

Starting dateAugust 2011.

Contact informationMohammad Soroush (email: soroushm@tbzmed.ac.ir).

Notes


Trial name or titleRandomized Study Comparing Quality of Life after Single-Port Versus Conventional 4-Port Laparoscopic Cholecystectomy.

MethodsRandomised clinical trial.

Participants
  1. Symptomatic cholelithiasis.
  2. Gallbladder polyp.
  3. Adenomyomatosis.

InterventionsSingle-port versus four-port laparoscopic cholecystectomy.

OutcomesMorbidity, quality of life, operating time, and hospital stay.

Starting date26 April 2013 (anticipated).

Contact informationY Takada (telephone: +81899605327).

Notes

 
Comparison 1. Fewer-than-four ports versus four ports

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Serious adverse events7634Risk Ratio (M-H, Fixed, 95% CI)3.93 [0.86, 18.04]

   1.1 One port
7634Risk Ratio (M-H, Fixed, 95% CI)3.93 [0.86, 18.04]

 2 Quality of life4510Std. Mean Difference (IV, Random, 95% CI)0.18 [-0.05, 0.42]

   2.1 One port
4510Std. Mean Difference (IV, Random, 95% CI)0.18 [-0.05, 0.42]

 3 Conversion to open cholecystectomy5581Risk Ratio (M-H, Fixed, 95% CI)0.68 [0.19, 2.35]

   3.1 One port
3360Risk Ratio (M-H, Fixed, 95% CI)0.33 [0.01, 7.72]

   3.2 Three ports
2221Risk Ratio (M-H, Fixed, 95% CI)0.79 [0.20, 3.14]

 4 Operating time9855Mean Difference (IV, Random, 95% CI)14.44 [5.95, 22.93]

   4.1 One port
7634Mean Difference (IV, Random, 95% CI)21.04 [10.45, 31.62]

   4.2 Three ports
2221Mean Difference (IV, Random, 95% CI)-5.32 [-17.38, 6.73]

 5 Hospital stay6731Mean Difference (IV, Random, 95% CI)-0.01 [-0.28, 0.26]

   5.1 One port
4510Mean Difference (IV, Random, 95% CI)0.02 [-0.32, 0.37]

   5.2 Three ports
2221Mean Difference (IV, Random, 95% CI)-0.09 [-0.47, 0.30]

 6 Proportion discharged as day-surgery150Risk Ratio (M-H, Fixed, 95% CI)0.92 [0.70, 1.22]

   6.1 One port
150Risk Ratio (M-H, Fixed, 95% CI)0.92 [0.70, 1.22]

 7 Return to normal activity2325Mean Difference (IV, Fixed, 95% CI)-1.20 [-1.58, -0.81]

   7.1 One port
1250Mean Difference (IV, Fixed, 95% CI)-1.20 [-1.59, -0.81]

   7.2 Three ports
175Mean Difference (IV, Fixed, 95% CI)-0.90 [-5.08, 3.28]

 8 Return to work1150Mean Difference (IV, Random, 95% CI)-2.0 [-3.31, -0.69]

   8.1 One port
1150Mean Difference (IV, Random, 95% CI)-2.0 [-3.31, -0.69]

 9 Cosmetic score2317Std. Mean Difference (IV, Random, 95% CI)0.37 [-0.10, 0.84]

   9.1 One port
2317Std. Mean Difference (IV, Random, 95% CI)0.37 [-0.10, 0.84]

 
Comparison 2. Fewer-than-four ports versus four ports (sensitivity analysis)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Quality of life2320Std. Mean Difference (IV, Fixed, 95% CI)0.14 [-0.08, 0.36]

   1.1 One port
2320Std. Mean Difference (IV, Fixed, 95% CI)0.14 [-0.08, 0.36]

 2 Operating time7665Mean Difference (IV, Fixed, 95% CI)7.40 [5.48, 9.31]

   2.1 One port
5444Mean Difference (IV, Fixed, 95% CI)9.45 [7.34, 11.57]

   2.2 Three ports
2221Mean Difference (IV, Fixed, 95% CI)-2.03 [-6.56, 2.50]

 3 Hospital stay3466Mean Difference (IV, Random, 95% CI)0.21 [0.08, 0.35]

   3.1 One port
2320Mean Difference (IV, Random, 95% CI)0.21 [0.02, 0.41]

   3.2 Three ports
1146Mean Difference (IV, Random, 95% CI)0.15 [-0.34, 0.64]

 4 Return to normal activity1250Mean Difference (IV, Fixed, 95% CI)-1.20 [-1.59, -0.81]

   4.1 One port
1250Mean Difference (IV, Fixed, 95% CI)-1.20 [-1.59, -0.81]

 
Summary of findings for the main comparison. Fewer-than-four ports compared with four ports for laparoscopic cholecystectomy

Fewer-than-four ports compared with four ports for laparoscopic cholecystectomy

Patient or population: people undergoing laparoscopic cholecystectomy.
Settings: secondary.
Intervention: fewer-than-four ports.
Comparison: four ports.

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)

Assumed riskCorresponding risk

Four portsFewer-than-four ports

MortalityThere was no mortality in either groupNot estimable634

(7 studies)
⊕⊝⊝⊝
very low1,2,3





Serious adverse eventsLowRR 3.93
(0.86 to 18.04)
634
(7 studies)
⊕⊝⊝⊝
very low1,2,3

10 per 100039 per 1000
(9 to 180)

Moderate

30 per 1000118 per 1000
(26 to 541)

Quality of life-The mean quality of life in the intervention groups was
0.18 standard deviations higher
(0.05 lower to 0.42 higher)
-510
(4 studies)
⊕⊝⊝⊝
very low1,3,4

Conversion to open cholecystectomy17 per 100012 per 1000
(3 to 40)
RR 0.68
(0.19 to 2.35)
581
(5 studies)
⊕⊝⊝⊝
very low1,2,3

Operating timeThe mean operating time in the control groups was
56 minutes
The mean operating time in the intervention groups was
14.44 higher
(5.95 to 22.93 higher)
-855
(9 studies)
⊕⊝⊝⊝
very low1,5

Hospital stayThe mean hospital stay in the control groups was
2 days
The mean hospital stay in the intervention groups was
0.01 lower
(0.28 lower to 0.26 higher)
-731
(6 studies)
⊕⊝⊝⊝
very low1,3,5

Proportion discharged as day surgery833 per 1000767 per 1000
(583 to 1000)
RR 0.92
(0.7 to 1.22)
50
(1 study)
⊕⊝⊝⊝
very low1,2,3

Return to normal activityThe mean return to normal activity in the control groups was
6.1 days
The mean return to normal activity in the intervention groups was
1.2 lower
(1.58 lower to 0.81 lower)
-325
(2 studies)
⊕⊝⊝⊝
very low1,3,4

Return to workThe mean return to work in the control groups was
12 days
The mean return to work in the intervention groups was
2 lower
(3.31 to 0.69 lower)
-150
(1 study)
⊕⊝⊝⊝
very low1,3

Cosmetic score-The mean cosmetic score in the intervention groups was
0.37 standard deviations higher
(0.1 lower to 0.84 higher)
-317
(2 studies)
⊕⊝⊝⊝
very low3,4

*The basis for the assumed risk was the control group risk across studies in all outcomes other serious adverse events. There were no serious adverse events in the control group and so the information is presented for different control group risks.

The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RR: risk ratio.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 The trial(s) was (were) of high risk of bias.
2 The confidence intervals overlapped 1 and either 0.75 or 1.25, or both. The number of events in the intervention and control group was fewer than 300.
3 It was not possible to explore reporting bias because of the few trials included.
4 The confidence intervals overlapped 0 and minimal clinically important difference (one day for hospital stay, return to activity, and return to work; 15 minutes for operating time; and 0.25 standard deviations for quality of life and cosmesis). The total number of participants in the intervention and control group was fewer than 400.
5 There was severe heterogeneity as noted by the I2 statistic and the lack of overlap of confidence intervals.