- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05699616
Management of Perforated Peptic Ulcer
October 21, 2023 updated by: Abdallah Mohamed Taha Aly, South Valley University
Laparoscopic Management of Perforated Peptic Ulcer: Multicenter Experience
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Qinā, Egypt
- Qena Faculty of Medicine, South Valley University Hospitals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Operative time
Time Frame: 2 hours
|
Time from skin incision to skin closure
|
2 hours
|
|
Leakage
Time Frame: 5 days
|
Leakage from the repair
|
5 days
|
|
Time to return to normal daily activities.
Time Frame: 2 weeks
|
Time to return to normal daily activities after surgery.
|
2 weeks
|
|
Perioperative complications
Time Frame: 1 month
|
Any encountered perioperative complications related to surgical intervention..
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Abdallah M Taha, MD, South Valley University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2023
Primary Completion (Actual)
April 20, 2023
Study Completion (Actual)
April 30, 2023
Study Registration Dates
First Submitted
January 17, 2023
First Submitted That Met QC Criteria
January 17, 2023
First Posted (Actual)
January 26, 2023
Study Record Updates
Last Update Posted (Actual)
October 24, 2023
Last Update Submitted That Met QC Criteria
October 21, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SVU-MED-SUR011-4-22-10-466
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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