- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06667284
Gastroduodenal Intussusception: Two Cases of Gastroduodenal Intussusception Following Gastric Plication, Each Managed with a Different Approach.
October 31, 2024 updated by: Yamen Madi, Ibn Al Nafees Hospital
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yamen Madi, MD
- Phone Number: 4915731165547
- Email: yamen747@gmail.com
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with gastro-duodenal intussusception following a gastric plication procedure.
Exclusion Criteria:
- children
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group a
Roux en y procedure
|
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
|
|
Active Comparator: Group b
Omega Brown anastomosis
|
Gastrojejunal anastomosis with jejunojejunal anastomosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
12 weeks following end of treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
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 (Estimated)
October 31, 2024
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
January 15, 2025
Study Registration Dates
First Submitted
October 28, 2024
First Submitted That Met QC Criteria
October 29, 2024
First Posted (Actual)
October 31, 2024
Study Record Updates
Last Update Posted (Estimated)
November 4, 2024
Last Update Submitted That Met QC Criteria
October 31, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gastroduodenal intussuception
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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