Bariatric SurgeryNCT06667284
Gastroduodenal Intussusception: Two Cases of Gastroduodenal Intussusception Following Gastric Plication, Each Managed with a Different Approach.
A study testing Roux en y procedure and Omega brown procedure in people with Bariatric Surgery and Intussusception, run by Ibn Al Nafees Hospital.
Trial summary
The investigators received two female patients in the hospital who developed gastroduodenal intussusception following gastric plication procedure, requiring surgical treatment. Both patients presented with non-specific, atypical abdominal pain several months after the gastric plication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery, Intussusception
- What is being tested?
- Roux en y procedure and Omega brown procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2024to 15 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with gastro-duodenal intussusception following a gastric plication procedure.
Who cannot join
- children
Trial locations and contacts
No sites are listed yet.
About this study
The investigators received two female patients in the hospital who developed gastroduodenal intussusception following gastric plication procedure, requiring surgical treatment. Both patients presented with non-specific, atypical abdominal pain several months after the gastric plication. Both patients required surgical intervention, which included manual reduction of the plication followed by subtotal gastrectomy en bloc with Roux-en-Y reconstruction. In the second case, an Omega Brown anastomosis was performed, and a jejunostomy was created after the anastomosis in both patients.
- Conditions
- Bariatric Surgery, Intussusception
- Being tested
- Roux en y procedure, Omega brown procedure
- Keywords
- case report, gastric plication
- Medical subject headings
- Intussusception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux en y procedureProcedure or surgery
subtotal gastrectomy en bloc with Roux-en-Y reconstruction, using TA 90 and GIA staplers. The length of the biliopancreatic limb was 50 cm, while the alimentary limb was 80 cm
Omega brown procedureProcedure or surgery
Gastrojejunal anastomosis with jejunojejunal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Group a | Active comparator | Roux en y procedure Receives: Procedure: Roux en y procedure |
| Group b | Active comparator | Omega Brown anastomosis Receives: Procedure: Omega brown procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of management strategies for gastro-duodenal intussusception following gastric plication.
The investigators compare the outcomes of managing bowel obstruction and abdominal pain after each surgery. The Investigator use small bowel obstruction prediction score index
Measured: 12 weeks following end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start31 Oct 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- 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
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ibn Al Nafees Hospital
- Sponsor type
- Other government
- Collaborators
- Damascus University
- Responsible party
- Principal investigator, Yamen Madi, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667284
- Sponsor's protocol ID
- Gastroduodenal intussuception
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Coco D, Leanza S, Fiume I. Small bowel obstruction: a prognostic score index for surgery - a review. Prz Gastroenterol. 2022;17(3):177-182. doi: 10.5114/pg.2022.118454. Epub 2022 Aug 3.
PubMed 36127935
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastroduodenal Intussusception: Two Cases of Gastroduodenal Intussusception Following Gastric Plication, Each Managed with a Different Approach.
- ClinicalTrials.gov ID
- NCT06667284
- Acronym / sponsor ID
- Gastroduodenal intussuception
- Conditions
- Bariatric Surgery, Intussusception
- Keywords
- case report, gastric plication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Ibn Al Nafees HospitalOther government
- Collaborators
- Damascus University
- Study start
- 31 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 31 Oct 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 investigators received two female patients in the hospital who developed gastroduodenal intussusception following gastric plication procedure, requiring surgical treatment. Both patients presented with non-specific, atypical abdominal pain several months after the gastric plication. Both patients required surgical intervention, which included manual reduction of the plication followed by subtotal gastrectomy en bloc with Roux-en-Y reconstruction. In the second case, an Omega Brown anastomosis was performed, and a jejunostomy was created after the anastomosis in both patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group a | Active comparator | Procedure: Roux en y procedureRoux en y procedure |
| Group b | Active comparator | Procedure: Omega brown procedureOmega Brown anastomosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with gastro-duodenal intussusception following a gastric plication procedure.
Key exclusion criteria (1 listed)
- children
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 |
|---|---|---|
| Roux en y proceduresubtotal gastrectomy en bloc with Roux-en-Y reconstruction, using TA 90 and GIA staplers. The length of the biliopancreatic limb was 50 cm, while the alimentary limb was 80 cm | Procedure or surgery | Group a |
| Omega brown procedureGastrojejunal anastomosis with jejunojejunal anastomosis | Procedure or surgery | Group b |
Primary outcome
Comparison of management strategies for gastro-duodenal intussusception following gastric plication.
Time frame: 12 weeks following end of treatment.
The investigators compare the outcomes of managing bowel obstruction and abdominal pain after each surgery. The Investigator use small bowel obstruction prediction score index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Background: PubMed 36127935Coco D, Leanza S, Fiume I. Small bowel obstruction: a prognostic score index for surgery - a review. Prz Gastroenterol. 2022;17(3):177-182. doi: 10.5114/pg.2022.118454. Epub 2022 Aug 3.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Roux en y procedure and Omega brown procedure in people with Bariatric Surgery and Intussusception, run by Ibn Al Nafees Hospital.
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 1 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 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Yamen Madi, MD (4915731165547, yamen747@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of management strategies for gastro-duodenal intussusception following gastric plication. (time frame: 12 weeks following end of treatment.). 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 NCT06667284, which also lists 1 linked publication.
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 4 Nov 2024.