NCT07491003

Brief Summary

The study you're referring to explores a surgical strategy for patients undergoing Laparoscopic Sleeve Gastrectomy (LSG) who also have a Hiatal Hernia (HH). Because obesity is a major risk factor for hiatal hernias, surgeons often find these defects during bariatric procedures

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 18, 2026

Last Update Submit

March 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Hiatal Hernia (HH) Recurrence Rate

    The primary objective is to determine the incidence of hiatal hernia recurrence following Laparoscopic Sleeve Gastrectomy (LSG) with concurrent mesh cruroplasty

    6 months after the surgical procedure.

Study Arms (1)

hernia arm represent patients with hiatal hernia

EXPERIMENTAL

A single group of 20 adult patients undergoing intraoperative Hiatal Hernia (HH) repair using mesh cruroplasty during a Laparoscopic Sleeve Gastrectomy (LSG)

Procedure: Hiatal Hernia (HH) repair using mesh cruroplasty during a Laparoscopic Sleeve Gastrectomy (LSG)

Interventions

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

hernia arm represent patients with hiatal hernia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig Univeesity Hospitals

Zagazig, Egypt

Location

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start

June 26, 2025

Primary Completion

February 26, 2026

Study Completion

February 26, 2026

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations