ClinicalTrials.gg
RecruitingNCT06550856Updated Aug 13, 2024

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

An interventional study of SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER and OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER in Perforated Peptic Ulcer, sponsored by Sohag University. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-08-13.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Sex
All
01

Study summary

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.

02

Conditions studied

  • Perforated Peptic Ulcer
03

In context

Peptic Ulcer Perforation

21 studies on the registry are indexed under Peptic Ulcer Perforation; 4 are open to participants now.

This study's planned enrollment of 50 is below the median of 66 across 16 interventional studies indexed under Peptic Ulcer Perforation.

Browse Peptic Ulcer Perforation studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

    1. Patients with associated bleeding ulcer (additional steps are needed to control bleeding).
  1. Patients with associated pathology other than perforated peptic ulcer that needs surgical intervention.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    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).

    Procedure: SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER

  • Active comparator
    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).

    Procedure: OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER

Interventions

  • ProcedureSUTURE-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.

  • ProcedureOMENTOPEXY 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.

06

What researchers measure

Primary outcomes

  1. Early postoperative follow up for repair of perforated peptic ulcer

    resumption of oral intake

    Time frame: Three days after the operation

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Berne TV, Donovan AJ. Nonoperative treatment of perforated duodenal ulcer. Arch Surg. 1989 Jul;124(7):830-2. doi: 10.1001/archsurg.1989.01410070084017. PubMed 2742484 ↗
  • 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. PubMed 3800459 ↗
  • 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. PubMed 28138363 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06550856
Lead sponsor
Sohag University
Responsible party
Adel Ashraf Abdrabou (Resident in the Department of General Surgery, oncological and Laparoscopic Surgery Sohag University Hospital, Sohag University) — Principal investigator
First posted
Aug 13, 2024
Start date
Jul 15, 2024
Primary completion
May 1, 2025 (estimated)
Completion
May 1, 2025 (estimated)
Last update
Aug 13, 2024

Study contacts

Adel A Abdrabou, Resident
Contact
adelosman3399@gmail.com
01014910091
Asem Elsani M Ali, Professor
Contact
0100 2613245

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion