NCT05699616

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

January 17, 2023

Last Update Submit

October 21, 2023

Conditions

Perforated Peptic Ulcer

Keywords

Peptic ulcerLaparoscopic repairOpen repairGraham Patch

Outcome Measures

Primary Outcomes (4)

  • Operative time

    Time from skin incision to skin closure

    2 hours

  • Leakage

    Leakage from the repair

    5 days

  • Time to return to normal daily activities.

    Time to return to normal daily activities after surgery.

    2 weeks

  • Perioperative complications

    Any encountered perioperative complications related to surgical intervention..

    1 month

Interventions

Repair of perforated peptic ulcerPROCEDURE

Repair of perforated peptic ulcer either open or laparoscopic.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Uncompleted patents files.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qena Faculty of Medicine, South Valley University Hospitals

Qina, Egypt

Location

Related 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.

    PMID: 19430829BACKGROUND

  • 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.

    PMID: 16132404BACKGROUND

  • 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.

    PMID: 10443807BACKGROUND

  • 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.

    PMID: 12500837BACKGROUND

  • 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.

    PMID: 30465190BACKGROUND

MeSH Terms

Conditions

Peptic Ulcer PerforationPeptic Ulcer

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Officials

  • Abdallah M Taha, MD

    South Valley University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 17, 2023

First Posted

January 26, 2023

Study Start

January 30, 2023

Primary Completion

April 20, 2023

Study Completion

April 30, 2023

Last Updated

October 24, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)