Perforated Peptic UlcerNCT06550856
SUTURE-CLOSURE OMENTOPEXY VERSUS OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER
A study testing SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER and OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER in people with Perforated Peptic Ulcer, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Perforated Peptic Ulcer
- What is being tested?
- SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER and OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All adult patients of both sexes with a clinical diagnosis of perforated peptic ulcer (gastric or duodenal) that are fit to undergo surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Asem Elsani M Ali, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, Professor
About this study
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.
- Conditions
- Perforated Peptic Ulcer
- Being tested
- SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER, OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER
- Medical subject headings
- Peptic Ulcer Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCERProcedure or surgery
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 ULCERProcedure or surgery
Patients presented with perforated peptic ulcer will be repaired by using omental patch without any attempt for primary closure of perforation.
| Study group | Role | What they receive |
|---|---|---|
| SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER | Active comparator | 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). Receives: Procedure: SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER |
| OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER | Active comparator | 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). Receives: Procedure: OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early postoperative follow up for repair of perforated peptic ulcer
resumption of oral intake
Measured: Three days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start15 Jul 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Perforated Peptic UlcerStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Ashraf Abdrabou, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550856
- Sponsor's protocol ID
- Soh-Med-24-07-07MS
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 2742484Boey 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 3800459Chung 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUTURE-CLOSURE OMENTOPEXY VERSUS OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER
- ClinicalTrials.gov ID
- NCT06550856
- Acronym / sponsor ID
- Soh-Med-24-07-07MS
- Conditions
- Perforated Peptic Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER | Active comparator | Procedure: SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCERGroup (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). |
| OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER | Active comparator | Procedure: OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCERGroup (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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients of both sexes with a clinical diagnosis of perforated peptic ulcer (gastric or duodenal) that are fit to undergo surgery.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCERPatients 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. | Procedure or surgery | SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER |
| OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCERPatients presented with perforated peptic ulcer will be repaired by using omental patch without any attempt for primary closure of perforation. | Procedure or surgery | OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER |
Primary outcome
Early postoperative follow up for repair of perforated peptic ulcer
Time frame: Three days after the operation
resumption of oral intake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Background: PubMed 2742484Berne TV, Donovan AJ. Nonoperative treatment of perforated duodenal ulcer. Arch Surg. 1989 Jul;124(7):830-2. doi: 10.1001/archsurg.1989.01410070084017.
- Background: PubMed 3800459Boey 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.
- Background: PubMed 28138363Chung 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.
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Falciformopexy for Treatment Perforated Peptic Ulcer.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asem Elsani M Ali, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER and OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER in people with Perforated Peptic Ulcer, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adel A Abdrabou, Resident (01014910091, adelosman3399@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early postoperative follow up for repair of perforated peptic ulcer (time frame: Three days after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06550856, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.