SUTURE-CLOSURE OMENTOPEXY VERSUS OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER

NCT ID: NCT06550856

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-05-01

Brief Summary

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The present study will be conducted to assess whether there is a direct benefit associated with modified-Graham's omentopexy (MGO), above and beyond the benefit associated with Graham's omentopexy (GO) in the treatment of perforated duodenal ulcers. We attempted to answer the question whether primary closure of the perforation in MGO will affect the outcome of surgery. Complication rates will be compared for the two alternative surgical procedures.

Detailed Description

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Conditions

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Perforated Peptic Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER

Group (A ) includes modification of the Graham's patch will be used in this group, where suitable sutures are passed between the edges of perforation and tied to close the perforation. A pedicle of omentum based on right omental artery is brought between these sutures, and these sutures are tied again with pedicle of omentum between knots over the perforation (thus the omentum remains sandwiched between the two levels of secured knots).

Group Type ACTIVE_COMPARATOR

SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER

Intervention Type PROCEDURE

Patients presented with perforated peptic ulcer will be repaired using full thickness suture closure using 3/0 vicryl suture then omental patch laied over the sutures.

OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER

Group (B) includes Grahm's technique of omentopexy will be performed by closing the perforation by placing interrupted full thickness suitable sutures along the margins of the ulcer with a patch of pedicled omentum laid over these sutures, which are then tied (without any attempt for primary closure of the perforation before placing the omentum as a plug).

Group Type ACTIVE_COMPARATOR

OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER

Intervention Type PROCEDURE

Patients presented with perforated peptic ulcer will be repaired by using omental patch without any attempt for primary closure of perforation.

Interventions

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SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER

Patients presented with perforated peptic ulcer will be repaired using full thickness suture closure using 3/0 vicryl suture then omental patch laied over the sutures.

Intervention Type PROCEDURE

OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER

Patients presented with perforated peptic ulcer will be repaired by using omental patch without any attempt for primary closure of perforation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\- All adult patients of both sexes with a clinical diagnosis of perforated peptic ulcer (gastric or duodenal) that are fit to undergo surgery.

Exclusion Criteria

\- 1. Patients with associated bleeding ulcer (additional steps are needed to control bleeding).

2\. Patients with associated pathology other than perforated peptic ulcer that needs surgical intervention.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Adel Ashraf Abdrabou

Resident in the Department of General Surgery, oncological and Laparoscopic Surgery Sohag University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Adel A Abdrabou, Resident

Role: CONTACT

01014910091

Asem Elsani M Ali, Professor

Role: CONTACT

0100 2613245

Facility Contacts

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Magdy M Amin, Professor

Role: primary

References

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Berne TV, Donovan AJ. Nonoperative treatment of perforated duodenal ulcer. Arch Surg. 1989 Jul;124(7):830-2. doi: 10.1001/archsurg.1989.01410070084017.

Reference Type BACKGROUND
PMID: 2742484 (View on PubMed)

Boey J, Choi SK, Poon A, Alagaratnam TT. Risk stratification in perforated duodenal ulcers. A prospective validation of predictive factors. Ann Surg. 1987 Jan;205(1):22-6. doi: 10.1097/00000658-198701000-00005.

Reference Type BACKGROUND
PMID: 3800459 (View on PubMed)

Chung KT, Shelat VG. Perforated peptic ulcer - an update. World J Gastrointest Surg. 2017 Jan 27;9(1):1-12. doi: 10.4240/wjgs.v9.i1.1.

Reference Type BACKGROUND
PMID: 28138363 (View on PubMed)

Other Identifiers

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Soh-Med-24-07-07MS

Identifier Type: -

Identifier Source: org_study_id

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