Methods

77 months, multicenter RCT parallel design, randomized using computer generated random numbers, concealment of allocation using sealed envelopes, outcome assessment was carried out by the treating team, lost to follow‐up not reported, intention‐to‐treat analysis

Participants

101 patients (52 for laparoscopic group and 49 for open surgery group).
Sex: 61 men/ 40 women
Mean age 61
Site of perforation: duodenum (34), juxtapyloric (61)
Size of perforation 10 mm
Age of inclusion not reported, but probably adults.
Inclusion criteria: clinical diagnosis of perforated peptic ulcer made by the surgeon and confirmed at the operation room.
Exclusions criteria:
Inability to read the Dutch language patient information booklet

Inability to complete informed consent

Prior upper abdominal surgery

Current pregnancy.
Severity assessed by ASA score (mean 1) and Mannheim Peritonitis Index. (mean 16‐19‐5)

Interventions

Intravenous antibiotics at the diagnosis, type ant time not specified. All patients were allocated for Helicobacter pylori eradication therapy.
For postoperative analgesia, patients were prescribed opiates. Dose and frequency not specified.
Upper midline incisions were made in patients assigned to open repair. Perforations were repaired with sutures alone or in combination with omental patch.
For laparoscopic repair, pneumoperitoneum was established (pressure not stated) and three trocars were introduced and the ulcer was closed with sutures alone or in combination with omental patch.
The number of participating surgeons, the number of cases previously operated by the surgeon and the number of patients operated by each surgeon or center was not reported.

Outcomes

Postoperative complications
Time of nasogastric aspiration
Pain assessed with visual analogue scale
Conversion rate for laparoscopic group
Operation time
Time of analgesic use
Length of hospital stay

Notes

Sample size was not calculated.

Risk of bias

Bias

Authors' judgement

Support for judgement

Adequate sequence generation?

Low risk

"Surgeons contacted the study coordinator" "The envelope randomisation was based on a computer‐generated list provided by the trial statistician"

Allocation concealment?

Low risk

"randomisation took place by opening a sealed envelope."

Blinding?
All outcomes

High risk

"this was an unblinded trial."

Incomplete outcome data addressed?
All outcomes

Low risk

No missing outcome data

Free of selective reporting?

Low risk

Protocol published at the Clinicaltrials.gov web site

Free of 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 the experience of surgeons is similar.

In multicenter trials, a bias related with high volume and low volume centers is possible. There is no information about the number of patients by center.

Methods

28 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 two assessors (not stated if independent from the treating team and blind) for pain evaluation and by the treating team for activity, work return evaluation and complications, available to follow‐up at 4 weeks: 73% for laparoscopic group vs 69% for open surgery group but all live patients available at 8 weeks for gastroscopy, to intention‐to‐treat analysis

Participants

93 patients (48 for laparoscopic group and 45 for open surgery group).
Sex: 79 men/14 women
Mean age 47.8 to 52.3
Site of perforation: duodenum (76), juxtapyloric (11), gastric (6)
Size of perforation 1‐25 mm
Age of inclusion not reported, but probably adults.
Inclusion criteria:
clinical diagnosis of perforated peptic ulcer made by the surgeon and confirmed at the operation room.
Exclusions criteria:
Complicated ulcers that required definitive surgery (criteria not stated)
Bleeding ulcer
Previous abdominal operations
Serious associated cardiopulmonary diseases
Clinically sealed perforation
Severity assessed by APACHE II score. Median 6.

Interventions

Intravenous cefuroxime 750 mg and metronidazole 500 mg was given at the time of induction and for the first postoperative day.
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 or using a rolled piece of gelatin sponge placed in the perforation and secured with fibrin sealant.
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 or using a gelatin and fibrin sealant.
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.
The study divided laparoscopic and open surgery groups in two groups: one repaired with suture and the other repaired with fibrin sealant. We did not consider this distinction to be important and we re‐aggregated the data.

Outcomes

Complications
Time of nasogastric aspiration
Time of intravenous fluid maintenance
Pain assessed with Visual Analogue Scale
Conversion rate for laparoscopic group
Operation time
Analgesic use
Time to resume oral diet
Length of hospital stay

Notes

Sample size was calculated using the analgesic doses using a previous study made by the same authors.

Risk of bias

Bias

Authors' judgement

Support for judgement

Adequate sequence generation?

Low risk

"Computer‐generated blocked random numbers were used"

Allocation concealment?

Low risk

"to assign the type of surgery, which was written on a card sealed in a completely opaque envelope. Envelopes were drawn randomly by the senior duty nurse in the operating department"

Blinding?
All outcomes

High risk

"All patients were assessed by the treating team approximately 4 weeks postoperatively in the outpatient clinic"

Incomplete outcome data addressed?
All outcomes

Low risk

"At the end of 6 to 8 weeks after surgery, gastroscopy showed that the ulcers had healed for all patients", "Similar proportions of patients with laparoscopic repair (group 1 and 2) and open repair (groups 3 and 4) were available at follow‐up (73% vs. 69%), respectively", "The data for patients who did not attend this first follow‐up visit but who were called back for a check‐up gastroscopy were not included in this analysis because there was a delay of at least 1 month in the recording of these data, which made it less reliable"

We believe that lost to follow up at four weeks for measuring returning to work do no affect results of important outcomes for this systematic review.

Free of selective reporting?

Low risk

Authors reported a second study in 1998 that is consistent with data from this study.

Free of 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.

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
Site of perforation: duodenum (93), pyloric‐prepiloric (27), gastric (1)
Size of perforation: 4.7 to 5.2 mm
Age: Patients older than 16 years old
Inclusion criteria:
Clinical diagnosis of perforated peptic ulcer made by the surgeon and confirmed at the operating room.
Exclusion criteria:
Gastric outlet obstruction
Bleeding ulcer
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.

Outcomes

Complications
Analgesic use
Time of nasogastric aspiration
Time of intravenous fluid maintenance
Pain assessed with Visual Analog Scale
Conversion rate for laparoscopic group
Operation time
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

Adequate sequence generation?

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?

Low risk

"Randomization was undertaken by consecutively numbered opaque sealed envelopes containing the treatment options,

Blinding?
All outcomes

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 addressed?
All outcomes

Low risk

There were no losses to follow up

Free of selective reporting?

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.

Free of 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.