|Methods||41 months, RCT parallel design, randomized using computer-generated random numbers by the block method, concealment of allocation using sealed envelopes, outcome assessment was made by assessors independent from the treating team for pain evaluation; by independent surgeons not blinded for discharge and by the treating surgeon not blinded for activity, work return evaluation and complications, intention-to-treat analysis, without losses to follow up|
|Participants||121 patients (63 for the laparoscopic group and 58 for the open surgery group)|
Sex: 98 men/ 23 women
Mean age: 53.8 to 56.1 years
Site of perforation: duodenum (93), pyloric-prepyloric (27), gastric (1)
Size of perforation: 4.7 to 5.2 mm
Age: patients older than 16 years old
Clinical diagnosis of perforated peptic ulcer made by the surgeon and confirmed at the operating room.
Gastric outlet obstruction
Previous abdominal operations
Clinically sealed perforation.
Severity assessed by ASA classification and Boey risk factors scale. 81% of patients classified as ASA I and II and 95% as Boey risk scale 0 and 1 (good prognosis).
|Interventions||Intravenous cefuroxime 750 mg was given at the time of induction and continued for 5 days. |
For postoperative analgesia, patients were prescribed pethidine 1 mg/kg every 4 hours as required.
Upper midline incisions were made in patients assigned to open repair. Perforations were repaired with the Cellan-Jones method.
For laparoscopic repair, pneumoperitoneum was established at 15 mm Hg, and three trocars were introduced and the ulcer was sutured with a piece of omentum and non-absorbable suture.
The number of participating surgeons, the number of cases previously operated by the surgeon and the number of patients operated by each surgeon was not reported.
Time of nasogastric aspiration
Time of intravenous fluid maintenance
Pain assessed with Visual Analogue Scale
Conversion rate for laparoscopic group
Time to resume oral diet
Length of hospital stay
|Notes||Sample size was calculated using the analgesic dose data in a previous study by the authors.|
|Risk of bias|
|Bias||Authors' judgement||Support for judgement|
|Random sequence generation (selection bias)||Low risk||"Randomization was performed after the decision was made for surgery; it took place in the operating room control room by a person not otherwise involved in the clinical setting", "computer-generated random numbers"|
|Allocation concealment (selection bias)||Low risk||"Randomization was undertaken by consecutively numbered opaque sealed envelopes containing the treatment options"|
|Blinding (performance bias and detection bias) |
|High risk||"An independent assessor visited every patient in the morning to record the clinical progress, analgesic requirements, and pain score", "Patients were assessed by independent surgeons for discharge if they could tolerate a normal diet, could fully ambulate, and required only oral analgesics. Both the independent assessor and in-charge surgeons were not blinded with respect to study groups."|
Blinding probably do not affect the assessment of hard outcomes as surgical complications, but it is possible that length of stay and pain assessment could be biased by non blinding evaluation of outcomes.
|Incomplete outcome data (attrition bias) |
|Low risk||There were no losses to follow up|
|Selective reporting (reporting bias)||Unclear risk||Although there is no other information in the report of the trial, analysis of the article offers enough information to assume that any bias due to selective outcome reporting should not greatly affect the results.|
|Other bias||Unclear risk||In surgical trials, there is always a bias related with learning curve for the new surgical methods. However, we believe this bias is not present in this trial because experience of surgeons is similar.|