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T-tube drainage versus primary closure after open common bile duct exploration

  1. Kurinchi Selvan Gurusamy*,
  2. Rahul Koti,
  3. Brian R Davidson

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 21 JUN 2013

DOI: 10.1002/14651858.CD005640.pub3


How to Cite

Gurusamy KS, Koti R, Davidson BR. T-tube drainage versus primary closure after open common bile duct exploration. Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD005640. DOI: 10.1002/14651858.CD005640.pub3.

Author Information

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

*Kurinchi Selvan Gurusamy, Department of Surgery, Royal Free Campus, UCL Medical School, Royal Free Hospital,, Rowland Hill Street, London, NW3 2PF, UK. kurinchi2k@hotmail.com.

Publication History

  1. Publication Status: New search for studies and content updated (conclusions changed)
  2. Published Online: 21 JUN 2013

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Characteristics of included studies [ordered by study ID]

MethodsRandomised clinical trial


ParticipantsCountry: Pakistan.

Number randomised: 35.Post-randomisation dropouts: not stated.

Revised sample size: 35.

Average age: 44 years.

Females: 30 (85.7%).

Inclusion criteria

Patients undergoing open choledochotomy.

Exclusion criteria

  1. Patients with pancreatitis.
  2. Supparative cholangitis.
  3. Cholangitis.


InterventionsParticipants were randomly assigned to two groups.
Group 1: T-tube (n = 19).

Group 2: primary closure (n = 16).

Other information:

  1. T-tube material: not stated.
  2. Antibiotics: given (further details are not available).
  3. Abdominal drains: yes.
  4. T-tube cholangiogram: 7th post-operative day.
  5. T-tube removal: 12th day.


OutcomesThe outcomes reported were mortality, morbidity, and hospital stay.


NotesAttempts were made to contact the authors in February 2012.


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 of participants and personnel (performance bias)
All outcomes
Unclear riskComment: This information was not available.

Blinding of outcome assessment (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: The mortality and serious morbidity were reported.

Vested interest biasUnclear riskComment: This information was not available.


MethodsRandomised clinical trial


ParticipantsCountry: Greece.
Number randomised: 117.
Mean age: 55 years.
Females: 19 (16.2%).

Inclusion criteria:
Patients who underwent open CBD exploration.


InterventionsParticipants were randomly assigned to two groups.

Group 1: T-tube drain (n = 57).

Group 2: primary closure (n = 60).
Other information:

  1. T-tube material: not stated..
  2. Antibiotics: preoperative + 5 days post-operatively.
  3. Abdominal drains: not mentioned.
  4. T-tube cholangiogram: performed. day not mentioned.
  5. T-tube removal: 14th or 15th day.


OutcomesThe outcomes reported were mortality and morbidity.


NotesAttempts were made to contact the authors in February 2012.


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 of participants and personnel (performance bias)
All outcomes
Unclear riskComment: This information was not available.

Blinding of outcome assessment (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 dropouts.

Selective reporting (reporting bias)High riskComment: Some important outcomes which will generally be assessed were not reported.

Vested interest biasUnclear riskComment: This information was not available.


MethodsRandomised clinical trial


ParticipantsCountry: Finland.
Number randomised: 24.
Mean age: 60 years.
Females: 17 (70.8%).

Inclusion criteria:
Patients who underwent open CBD exploration. All had gall bladder in situ at the time of surgery.

Exclusion criteria:
Suggestion of bile drainage failure due to pancreatic process of spastic sphincter of Oddi.


InterventionsParticipants were randomly assigned to two groups.

Group 1: T-tube drain (n = 16).

Group 2: primary closure (n = 8).
Other information:

  1. T-tube material: not stated.
  2. Antibiotics: only those with acute cholecystitis for 3 days (longer if infective complications were detected).
  3. Abdominal drains: yes.
  4. T-tube cholangiogram: performed on 7th or 8th day.
  5. T-tube removal: 7th or 8th day.


OutcomesThe outcomes reported were mortality, morbidity, and hospital stay.


NotesAttempts were made to contact the authors in February 2012.


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskQuote: "The randomization was performed with a sealed envelope technique".

Comment: Further details of the sealed envelope technique were not available.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: This information was not available.

Blinding of outcome assessment (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)High riskComment: The severity of the morbidity was not reported.

Vested interest biasUnclear riskComment: This information was not available.


MethodsRandomised clinical trial


ParticipantsCountry: India.
Number randomised: 40.
Mean age: 48 years.
Females: 30 (75.0%).

Inclusion criteria:
Patients who underwent open CBD exploration for ultrasound proven CBD stones.

Exclusion criteria:

  1. Previous biliary surgery.
  2. Acute cholangitis.
  3. Acute pancreatitis.
  4. CBD diameter > 2.5 cm.
  5. Papillary stenosis.
  6. Retained stone in completion cholangiography.


InterventionsParticipants were randomly assigned to two groups.

Group 1: T-tube drain (n = 20).

Group 2: primary closure (n = 20).
Other information:

  1. T-tube material: not stated.
  2. Antibiotics: on induction and 3 days post-operatively unless infection supervened.
  3. Abdominal drains: yes.
  4. T-tube cholangiogram: performed on 12th day.
  5. T-tube removal: 12th day.


OutcomesThe outcomes reported were mortality, morbidity, operating time, and hospital stay.


NotesAuthors provided additional information in April 2006. Further information was sought in February 2012. We are awaiting this information.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComment: Slips of paper with the two treatments in the box, drawn by a third party (author replies). 

Allocation concealment (selection bias)Low riskQuote: Slips of paper with the two treatments in the box, drawn by a third party (author replies). 

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskQuote: The patients and health care providers were blinded (author replies).

Comment: Further details were not available.

Blinding of outcome assessment (detection bias)
All outcomes
High riskQuote: The outcome assessors were not blinded (author replies).

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

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

Vested interest biasLow riskQuote: The study was not funded by anybody since it was conducted as a research project in a Government run institute (author replies).


MethodsRandomised clinical trial


ParticipantsCountry: United Kingdom.
Number randomised: 80.
Mean age: not available.
Females: 53 (66.3%).

Inclusion criteria:

  1. Patients who underwent open CBD exploration for
  2. Stones in common bile duct ± dilatation.
  3. Radiological (failure of entry of dye into duodenum).


InterventionsParticipants were randomly assigned to two groups.

Group 1: T-tube drain (n = 40).

Group 2: primary closure (n = 40).
Other information:

  1. T-tube material: not stated.
  2. Antibiotics: not mentioned.
  3. Abdominal drains: not mentioned.
  4. T-tube cholangiogram: performed on 6th to 7th day.
  5. T-tube removal: 6th to 7th day.


OutcomesThe outcomes reported were mortality, morbidity, and hospital stay.


NotesThe corresponding author does not work in this hospital. We did not expect any reliable information from co-authors after more than 25 years of the trial.

Hospital stay was reported in 39 patients in each group. The reason for the lack of hospital stay information for 1 patient in each group is not known.


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 of participants and personnel (performance bias)
All outcomes
Unclear riskComment: This information was not available.

Blinding of outcome assessment (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)High riskComment: The severity of the morbidity was not reported.

Vested interest biasUnclear riskComment: This information was not available.


MethodsRandomised clinical trial


ParticipantsCountry: Australia.
Number randomised: 63.
Mean age: 67 years.
Females: Not mentioned.

Inclusion criteria:

  1. Patients who underwent open CBD exploration for filling defect on cholangiogram.
  2. Pre-operative demonstration of a stone within the CBD by ultrasound.
  3. ERCP, where that stone had not been removed at ERCP.
  4. Stone palpable within the CBD.
  5. Dilatation of the CBD.


Exclusion criteria:

  1. Non-standard duct exploration.
  2. Significant inflammation or swelling of the bile duct or pancreas.
  3. Prior cholecystectomy was not an exclusion criteria (4 in each group).


InterventionsParticipants were randomly assigned to two groups.

Group 1: T-tube drain (n = 26).

Group 2: primary closure (n = 37).
Other information:

  1. T-tube material: not stated.
  2. Antibiotics: peri-operative antibiotic prophylaxis.
  3. Abdominal drains: yes.
  4. T-tube cholangiogram: performed on 7th or 8th day.
  5. T-tube removal: 10th day.


OutcomesThe outcomes reported were mortality, morbidity, and hospital stay. The morbidity was not reported separately in the two groups. So this data could not be used.


NotesThe corresponding author does not work in this hospital . We did not expect any reliable information from the co-authors after 18 years of publication of the trial.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: Randomization was achieved by drawing one pre-sealed envelope (that contained a card designating type of duct closure) from a batch of 100 envelopes, half designated primary closure and half designated T-tube closure, randomly ordered.

Comment: Further details were not available.

Allocation concealment (selection bias)Unclear riskQuote: Randomization was achieved by drawing one pre-sealed envelope (that contained a card designating type of duct closure) from a batch of 100 envelopes, half designated primary closure and half designated T-tube closure, randomly ordered.

Comment: Further details were not available.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: This information was not available.

Blinding of outcome assessment (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)High riskComment: The morbidity was not reported separately for each group.

Vested interest biasUnclear riskComment: This information was not available.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

De Roover 1989Patients allocated alternatively to T-tube drainage and primary closure (ie, not a randomised trial).

Joshi 2010Not a randomised clinical trial.

Lygidakis 1982T-tube with sphincteroplasty versus choledochoduodenostomy for recurrent choledocholithiasis (ie, not primary closure).

Norrby 1988Early versus late removal of T-tube (ie, both groups had T-tube drainage after common bile duct exploration).

Perez 2005Patients in the primary closure group received a biliary stent.

Piecuch 2004Not a randomised clinical trial.

Sheen 1990Patients allocated alternatively to T-tube drainage and primary closure (ie, not a randomised trial).

Sorensen 1994Not a randomised clinical trial.

Xu 2002Not a randomised clinical trial.

 
Comparison 1. T-tube drainage versus primary closure

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

 1 Peri-operative mortality6359Risk Ratio (M-H, Fixed, 95% CI)2.25 [0.55, 9.25]

   1.1 Routine antibiotic prophylaxis
4255Risk Ratio (M-H, Fixed, 95% CI)2.08 [0.43, 10.14]

   1.2 Selective antibiotic prophylaxis
124Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

   1.3 Antibiotic prophylaxis unknown
180Risk Ratio (M-H, Fixed, 95% CI)3.0 [0.13, 71.51]

 2 Serious morbidity4Rate Ratio (Fixed, 95% CI)2.19 [0.98, 4.91]

   2.1 Routine antibiotic prophylaxis
3Rate Ratio (Fixed, 95% CI)3.26 [1.21, 8.79]

   2.2 Antibiotic prophylaxis unknown
1Rate Ratio (Fixed, 95% CI)1.0 [0.25, 4.02]

 3 Morbidity (severity unknown)3221Rate Ratio (Fixed, 95% CI)2.43 [1.14, 5.18]

 4 Serious morbidityOther dataNo numeric data

 5 Operating timeOther dataNo numeric data

 6 Hospital stay5333Mean Difference (IV, Random, 95% CI)4.72 [0.83, 8.60]

   6.1 Routine antibiotic prophylaxis
3138Mean Difference (IV, Random, 95% CI)7.51 [3.36, 11.66]

   6.2 Selective antibiotic prophylaxis
1117Mean Difference (IV, Random, 95% CI)-3.10 [-8.85, 2.65]

   6.3 Antibiotic prophylaxis unknown
178Mean Difference (IV, Random, 95% CI)1.70 [-0.39, 3.79]

 
Analysis 1.4 Comparison 1 T-tube drainage versus primary closure, Outcome 4 Serious morbidity.
Serious morbidity

StudyT-tubePrimary closureFisher's exact test P-value

Ambreen 20093/19 (15.8%)1/16 (6.3%)P = 0.6081

 
Analysis 1.5 Comparison 1 T-tube drainage versus primary closure, Outcome 5 Operating time.
Operating time

StudyT-tube mean (standard deviation) minutes(number of patients = 20)Primary closure mean (standard deviation) minutes (number of patients = 20)Mean difference (95% confidence intervals)P

value

Marwah 2004116.65 (20.53)87.75 (17.12)28.90 minutes (17.18 to 40.62)< 0.00001

 
Summary of findings for the main comparison. T-tube drainage compared with primary closure for patients undergoing open common bile duct exploration

T-tube drainage compared with primary closure for patients undergoing open common bile duct exploration

Patient or population: patients undergoing open common bile duct exploration.
Settings: secondary or tertiary hospital.
Intervention: T-tube drainage.
Comparison: primary closure.

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

Assumed riskCorresponding risk

Primary closureT-tube drainage

Peri-operative mortality6 per 100012 per 1000
(3 to 51)
RR 2.25
(0.55 to 9.25)
359
(6 studies)
⊕⊝⊝⊝
very low1,2,3,4

Serious morbidity (rate)66 per 1000145 per 1000
(65 to 325)
Rate ratio 2.19
(0.98 to 4.91)
272
(4 studies)
⊕⊝⊝⊝
very low4,5

Serious morbidity (proportion)62 per 1000158 per 1000
(18 to 1000)
RR 2.53
(0.29 to 21.98)
35
(1 study)
⊕⊝⊝⊝
very low2,3,4,5,6

Operating timeThe mean operating time in the control groups was
87.75 minutes
The mean operating time in the intervention groups was
28.9 minutes higher
(17.18 to 40.62 higher)
40
(1 study)
⊕⊝⊝⊝
very low4,5,6

Hospital stayThe mean hospital stay in the control groups was
9.12 days
The mean hospital stay in the intervention groups was
4.72 days higher
(0.83 to 8.6 higher)
333
(5 studies)
⊕⊝⊝⊝
very low1,4,7

*The basis for the assumed risk was the overall control group risk across studies. 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 Most trials were at high risk of bias.
2 The confidence intervals include 1 and either 0.75 or 1.25 or both.
3 The number of events in both groups was less than 300.
4 There were few trials included in this review and reporting bias could not be assessed.
5 This trial was at high risk of bias.
6 There was only one trial. So, inconsistency could not be assessed.
7 There was high heterogeneity between the trials.