We included all patients who developed acute perforated peptic ulcer manifestations and referred to our Emergency department between December 2019 to August 2021 with age more than 18 years old ( onset between clinical manifestations & diagnosis & intervention range from 12 hours to 3 days provided that patients not develop septic shock ) . While patients with age below 18 years old and patients with septic shock were excluded. This prospective randomized controlled clinical trial was approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 11195/20.12.2019) and performed in accordance with the code of ethics of the World Medical Association (Declaration of Helsinki) for studies involving human subjects. This study was retrospectively submitted in clinicaltrials.gov in September 2021 (NCT05051683). Written informed consent was obtained from all participants after explaining to them all the study procedures with its benefits and hazards.
Included patients were randomized at a 1:1 ratio to “Surgery Group, SG” or “Endoscopic Group” via the drawing of sealed envelopes containing computer-generated random numbers prepared by a third party before the start of the intervention. Sample size was calculated using open Epi program using the following data: confidence interval 95%, power of test 80%, ratio of unexposed/exposed 1, percent of patients with successful management of acute perforated peptic ulcer by surgical intervention 50% and those with successful management by endoscopy 99%, odds ratio 99%, and risk ratio 2.
Primary and secondary outcomes were leak and mortality in each group after the intervention during the 3-months follow-up period, respectively.
After full history taking and complete physical examination, acute perforated peptic ulcer was clinically suspected and then confirmed by laboratory investigations (complete blood picture, liver and kidney functions, coagulation profile), radiological imaging ( plain erect chest X-ray abdomen, abdominal US to know amount of contamination, CT abdomen with oral and I.V contrast to know site of perforation ) .
Patients, randomized to the endoscopy group, first assess the site & size of perforation then underwent endoscopic stenting (fully covered self-expanded metallic stent, FCSEMS) this for duodenal ulcer only due to narrow lumen while in gastric ulcer ( due to capacious cavity ) in additional to FCSEMS usage we also used endoscopic Over-The-Scope Clipping (OTSC, Ovesco Endoscopy AG, Tubingen, Germany) in narrow perforation (less than 1 cm) , endoscopic suturing (OverStitch (36), Apollo Endo-surgery, TX, United States) in wide perforation ( from 1cm to 2cm) . At same time a radiologic interventional team worked and drainage of peritoneal collection was done by 2 intra-peritoneal tube drains one was placed sub-hepatic another was placed in the pelvis under sonar gaudiness.
During postoperative day one a methylene blue test was done . and blue color was observed in the drain. Patients, randomized to the SG, underwent surgical exploration & primary repair of perforation supported by Grham's omental patch and putting 2 intra-peritoneal tube drains one was placed sub-hepatic another was placed in the pelvis.
Follow up after endoscopy and discharge from the hospital
All patients were clinically examined, and laboratory checked during the hospital stay. Any suspected leak post repair mandated CT scan with oral and I.V contrast and upper GI endoscopy. Patients were followed-up for at least 3 months post repair.
Analysis of data was performed using SPSS (Statistical Package of Social Services) version 22. Quantitative variables were described as mean (±SD, standard deviation) and median (range) according to Shapiro test of normality. Qualitative variables were described as number and percentage. Chi-square test was used to compare qualitative variables between the 2 groups. Fisher exact test was used when one expected cell or more are less than 5. Unpaired t-test was used to compare quantitative variables, in parametric data (SD < 30% of the mean). Mann Whitney test was used instead of unpaired t-test in non-parametric data (SD > 30% of the mean). The results were considered statistically significant when the significant probability was less than 0.05 (P < 0.05). P-value < 0.001 was considered highly statistically significant (HS), and P-value ≥ 0.05 was considered statistically insignificant (NS).