Management of Perforated Peptic Ulcer

Perforated Peptic Ulcer Clinical Trial

Official title:

Laparoscopic Management of Perforated Peptic Ulcer: Multicenter Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05699616
• Other study ID #: SVU-MED-SUR011-4-22-10-466
• Status: Completed
• Start date: January 30, 2023
• Est. completion date: April 30, 2023

Study information

• Verified date: October 2023
• Source: South Valley University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 30, 2023
• Est. primary completion date: April 20, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Peptic Ulcer
• Peptic Ulcer Perforation
• Perforated Peptic Ulcer
• Ulcer

Intervention

Procedure:
• Repair of perforated peptic ulcer
Repair of perforated peptic ulcer either open or laparoscopic.

Locations

Country	Name	City	State
Egypt	Qena Faculty of Medicine, South Valley University Hospitals	Qina

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Time from skin incision to skin closure	2 hours
Primary	Leakage	Leakage from the repair	5 days
Primary	Time to return to normal daily activities.	Time to return to normal daily activities after surgery.	2 weeks
Primary	Perioperative complications	Any encountered perioperative complications related to surgical intervention..	1 month