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NCT Number: NCT07560787

Impact of Crural Repair and Gastropexy During Laparoscopic Sleeve Gastrectomy

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Training and Research Hospital

Van, Turkey (Türkiye)

About this study

Laparoscopic sleeve gastrectomy (LSG) is a highly effective and widely performed bariatric procedure; however, postoperative gastroesophageal reflux disease (GERD) remains a significant and challenging complication. The mechanisms underlying reflux post-LSG are multifactorial, including disruption of the gastroesophageal junction, decreased lower esophageal sphincter pressure, and intrathoracic migration of the gastric sleeve.

This prospective, randomized, comparative controlled study aims to evaluate the efficacy of incorporating systematic hiatal dissection, posterior crural repair, and posterior gastropexy into the standard LSG procedure to mitigate postoperative reflux. A total of 50 patients with severe obesity completed the study, with 25 patients in each of the following groups:

  • Control Group (n=25): Underwent standard LSG.
  • Study Group (n=25): Underwent standard LSG combined with systematic intraoperative hiatal dissection, posterior crural repair to approximate the crura, and posterior gastropexy by anchoring the gastric corpus to the prepancreatic fascia.

These additional steps aim to preserve normal gastric anatomy, maintain the anatomical position of the sleeve, and prevent intrathoracic migration. Patients were evaluated preoperatively and at a one-year postoperative follow-up. The primary outcome is the assessment of postoperative reflux symptom burden using two questionnaires: the Frequency Scale for the Symptoms of GERD (F-Scale) and the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS). Secondary outcomes include a comparison of operative time, 30-day postoperative complications, length of hospital stay, postoperative weight loss (%EWL and %TWL), and changes in proton pump inhibitor (PPI) use. Additionally, the study assesses the concordance between preoperative endoscopic findings and intraoperative hiatal assessments in the study group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Standard Laparoscopic Sleeve Gastrectomy

Procedure

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

Primary outcomes

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

    Time frame: Baseline within 4 weeks before surgery and 12 months postoperatively

    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.

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

    Time frame: Baseline within 4 weeks before surgery and 12 months postoperatively

    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.

Secondary outcomes

  1. Operative Time

    Time frame: Day 1

    Total duration of the surgical procedure in minutes, compared between standard LSG and LSG with crural repair and gastropexy groups.

  2. Incidence of Postoperative Complications

    Time frame: Up to 30 days postoperatively

    The number of participants experiencing early postoperative complications

  3. Length of Hospital Stay (LOS)

    Time frame: Up to 30 days postoperatively

    The total number of days the patient remained in the hospital following surgery, measured from the day of surgery to the day of hospital discharge.

  4. Change in Regular Proton Pump Inhibitor (PPI) Use

    Time frame: Baseline within 4 weeks before surgery and 12 months postoperatively

    The number of patients reporting regular use of PPI medication, comparing their preoperative status to their postoperative status.

  5. Postoperative Weight Loss

    Time frame: Baseline within 4 weeks before surgery and 12 months postoperatively

    The magnitude of weight reduction, evaluated by calculating the percent excess weight loss (%EWL) and percent total weight loss (%TWL) from baseline to 12 months postoperatively. Higher values indicate greater weight reduction.

  6. Concordance of Hiatal Assessment

    Time frame: Preoperative endoscopy performed within 4 weeks before surgery, and intraoperative hiatal assessment on Day 1

    The percentage of agreement between the findings of the preoperative upper gastrointestinal endoscopy and the actual intraoperative assessment regarding the presence or absence of a hiatal hernia.

Sponsors and collaborators

Lead sponsor

Van Training and Research Hospital

Other Gov

Registry information

Official study title

Impact of Concomitant Crural Repair and Gastropexy on Gastroesophageal Reflux and Postoperative Outcomes During Laparoscopic Sleeve Gastrectomy

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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