- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07491003
Laparoscopic Hiatal Hernia Repair With Mesh Cruroplasty
Laparoscopic Hiatal Hernia Repair With Mesh Cruroplasty Following Sleeve Gastrectomy: A Prospective Study
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zagazig, Egypt
- Zagazig Univeesity Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults (≥18 years), Patients underwent laparoscopic sleeve gastrectomy, Intraoperative confirmation of hiatal hernia, no prior history of esophageal or gastric surgery and Patient fit for general anesthesia
Exclusion Criteria:
- Patients with severe esophageal motility disorders, Patients with contraindications to laparoscopic surgery, Previous hiatal hernia repair, Esophageal stricture and perforation, Pregnancy or uncontrolled comorbidities, Presence of large paraesophageal hernias (>4 cm) with volvulus, Contraindications to laparoscopic surgery, such as severe cardiopulmonary disease and Contraindication for general anesthesia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: hernia arm represent patients with hiatal hernia
A single group of 20 adult patients undergoing intraoperative Hiatal Hernia (HH) repair using mesh cruroplasty during a Laparoscopic Sleeve Gastrectomy (LSG)
|
The procedure was performed laparoscopically under general anesthesia with the patient in a 30° reverse Trendelenburg position. Following pneumoperitoneum and five-trocar insertion, any adhesions from the previous Sleeve Gastrectomy (LSG) were released to expose the hiatus. Dissection: The gastrohepatic ligament was divided, and the hernia sac and gastroesophageal fat pad were fully reduced into the abdomen while preserving the hepatic branch of the vagus nerve. Repair: The crural defect was closed using 2-3 interrupted non-absorbable sutures to achieve a tension-free repair. Mesh Augmentation: A shaped polypropylene mesh was placed in an "onlay" fashion over the posterior crural repair, secured with endoscopic metal fixators, and covered with the remaining hernia sac flaps to protect the esophagus. Closure: After confirming hemostasis, trocars were removed and ports closed. Postoperative Management: Patients followed a standardized protocol involving gradua |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of Hiatal Hernia (HH) Recurrence Rate
Time Frame: 6 months after the surgical procedure.
|
The primary objective is to determine the incidence of hiatal hernia recurrence following Laparoscopic Sleeve Gastrectomy (LSG) with concurrent mesh cruroplasty
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6 months after the surgical procedure.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Laparoscopic hiatal hernia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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