Clinical trial NCT05699616: Management of Perforated Peptic Ulcer
Official title: Laparoscopic Management of Perforated Peptic Ulcer: Multicenter Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perforated Peptic Ulcer
Keywords: Peptic ulcer
Laparoscopic repair
Open repair
Graham Patch
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with perforated peptic ulcer admitted to our hospital in last 4 years and underwent surgical intervention.

Brief summary: Perforated peptic ulcer (PPU) is a common surgical emergency. Exploratory laparotomy and repair with the omental patch are routine surgical intervention till now. In developing counties, laparoscopic repair is still not considered the gold standard in this emergency condition. This study was conducted to evaluate laparoscopic management of PPU in terms of peri-operative outcomes.

Detailed description: Files of all patients admitted to our hospital with perforated peptic ulcer in the last 4 years and underwent operative management.

Demographic, clinical and perioperative outcomes will be collected tabulated and analyzed.

Eligibility criteria: Inclusion Criteria:

- All patients with perforated peptic ulcer admitted to our hospital in last 4 years and underwent surgical intervention.

Exclusion Criteria:

Uncompleted patents files.

Primary outcomes:
measure: Operative time
timeFrame: 2 hours
measure: Leakage
timeFrame: 5 days
measure: Time to return to normal daily activities.
timeFrame: 2 weeks
measure: Perioperative complications
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Qena Faculty of Medicine, South Valley University Hospitals
Study officials:
affiliation: South Valley University
name: Abdallah M Taha, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bertleff MJ, Halm JA, Bemelman WA, van der Ham AC, van der Harst E, Oei HI, Smulders JF, Steyerberg EW, Lange JF. Randomized clinical trial of laparoscopic versus open repair of the perforated peptic ulcer: the LAMA Trial. World J Surg. 2009 Jul;33(7):1368-73. doi: 10.1007/s00268-009-0054-y.
citation: Lunevicius R, Morkevicius M. Management strategies, early results, benefits, and risk factors of laparoscopic repair of perforated peptic ulcer. World J Surg. 2005 Oct;29(10):1299-310. doi: 10.1007/s00268-005-7705-4.
citation: Katkhouda N, Mavor E, Mason RJ, Campos GM, Soroushyari A, Berne TV. Laparoscopic repair of perforated duodenal ulcers: outcome and efficacy in 30 consecutive patients. Arch Surg. 1999 Aug;134(8):845-8; discussion 849-50. doi: 10.1001/archsurg.134.8.845.
citation: Lagoo S, McMahon RL, Kakihara M, Pappas TN, Eubanks S. The sixth decision regarding perforated duodenal ulcer. JSLS. 2002 Oct-Dec;6(4):359-68.
citation: Quah GS, Eslick GD, Cox MR. Laparoscopic Repair for Perforated Peptic Ulcer Disease Has Better Outcomes Than Open Repair. J Gastrointest Surg. 2019 Mar;23(3):618-625. doi: 10.1007/s11605-018-4047-8. Epub 2018 Nov 21.