Impact of Crural Repair and Gastropexy During Laparoscopic Sleeve Gastrectomy

NCT07560787 | Completed

• 1 other identifier: FSMEAH-KAEK-2022/119
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized comparative controlled study evaluated the impact of concomitant posterior crural repair and posterior gastropexy on postoperative reflux outcomes in patients undergoing laparoscopic sleeve gastrectomy (LSG). The study was completed with a total of 50 patients, with 25 patients in each group. Participants were allocated to either the control group, which received standard LSG, or the study group, which underwent LSG combined with systematic hiatal dissection, posterior crural repair, and posterior gastropexy. No patient had evidence of hiatal hernia on preoperative upper gastrointestinal endoscopy. The primary endpoint was postoperative reflux symptom burden at one-year follow-up, assessed using the Frequency Scale for the Symptoms of GERD (F-Scale) and the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS). Secondary endpoints included operative time, postoperative complications, length of hospital stay, proton pump inhibitor use, postoperative weight loss, and concordance between preoperative endoscopy and intraoperative hiatal assessment.

Conditions

Obesity, Morbid; Gastroesophageal Reflux Disease

Keywords

Laparoscopic sleeve gastrectomy; Gastropexy; Crural repair; Bariatric surgery; GERD

Outcome Measures

Primary Outcomes (2)

• Change in Gastroesophageal Reflux Symptom Burden Assessed by the Gastrointestinal Symptom Assessment Scale (GSAS)

  The Gastrointestinal Symptom Assessment Scale (GSAS) is a validated self-administered questionnaire that assesses the severity and frequency of upper gastrointestinal symptoms over the preceding week. Each item is rated on a 4-point Likert scale, and reflux, dyspepsia, and total domain scores are calculated as the mean of their respective items, yielding scores ranging from 0 to 3. Higher scores indicate a greater symptom burden and a worse outcome; lower scores indicate a better outcome. The outcome is the change in GSAS reflux, dyspepsia, and total scores from the preoperative baseline to one year postoperatively, calculated as (postoperative score - preoperative score). Negative change values indicate symptomatic improvement.

  Baseline within 4 weeks before surgery and 12 months postoperatively

• Change in Gastroesophageal Reflux Symptom Burden Assessed by the Frequency Scale for the Symptoms of GERD (F-Scale)

  The Frequency Scale for the Symptoms of GERD (F-Scale; also known as the FSSG) is a validated 12-item self-administered questionnaire that evaluates the frequency of gastroesophageal reflux disease symptoms. Each item is scored on a 5-point Likert scale ranging from 0 (never) to 4 (always). The instrument yields three scores: a reflux subscale score (7 items; range 0-28), a dyspepsia/dysmotility subscale score (5 items; range 0-20), and a total score (range 0-48). Higher scores indicate a greater symptom burden and a worse outcome; lower scores indicate a better outcome. The outcome is the change in F-Scale total, reflux subscale, and dyspepsia subscale scores from the preoperative baseline to one year postoperatively, calculated as (postoperative score - preoperative score). Negative change values indicate symptomatic improvement.

  Baseline within 4 weeks before surgery and 12 months postoperatively

Secondary Outcomes (6)

• Operative Time

  Day 1

• Incidence of Postoperative Complications

  Up to 30 days postoperatively

• Length of Hospital Stay (LOS)

  Up to 30 days postoperatively

• Change in Regular Proton Pump Inhibitor (PPI) Use

  Baseline within 4 weeks before surgery and 12 months postoperatively

• Postoperative Weight Loss

  Baseline within 4 weeks before surgery and 12 months postoperatively

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Standard laparoscopic sleeve gastrectomy (LSG) without crural repair or gastropexy.

Procedure: Standard Laparoscopic Sleeve Gastrectomy

Study Group

EXPERIMENTAL

Laparoscopic sleeve gastrectomy (LSG) combined with systematic hiatal dissection, posterior crural repair, and posterior gastropexy.

Procedure: Laparoscopic Sleeve Gastrectomy with Crural Repair and Gastropexy

Interventions

Laparoscopic Sleeve Gastrectomy with Crural Repair and Gastropexy PROCEDURE

Laparoscopic sleeve gastrectomy (LSG) with systematic hiatal dissection, posterior crural repair using two interrupted 2-0 polypropylene sutures, and posterior gastropexy anchoring the gastric corpus to the prepancreatic fascia at two points using 3-0 V-Loc sutures.

Study Group

Standard Laparoscopic Sleeve Gastrectomy PROCEDURE

Standard laparoscopic sleeve gastrectomy without hiatal dissection, crural repair, or gastropexy.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years
• Diagnosis of severe obesity for at least five years, defined as body mass index (BMI) \> 40 kg/m², or BMI \> 35 kg/m² in the presence of obesity-related comorbidities
• Temporary or inadequate weight-loss response to a dietitian-supervised medical weight-management programme
• Absence of hiatal hernia on preoperative upper gastrointestinal endoscopy
• Willingness to participate and ability to provide written informed consent

You may not qualify if:

• Refusal to provide informed consent
• History of upper gastrointestinal surgery
• Presence of gastric ulcer, esophagitis, or hiatal hernia on preoperative upper gastrointestinal endoscopy
• Known allergy to any of the planned postoperative medications (proton pump inhibitors, H2-receptor antagonists, paracetamol, or tramadol)
• Known coagulopathy
• Peripheral vascular disease
• History of cerebrovascular accident
• Intraoperative conversion to a bariatric procedure other than laparoscopic sleeve gastrectomy (LSG)

Sponsors & Collaborators

• Van Training and Research Hospital: lead

Study Sites (1)

Van Training and Research Hospital

Van, Van, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity, Morbid; Gastroesophageal Reflux

Interventions

Gastropexy

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgeon

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: May 1, 2026
• Study Start: November 1, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)