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Impact of Crural Repair and Gastropexy During Laparoscopic Sleeve Gastrectomy

23 april 2026 bijgewerkt door: Berk Topaloğlu, Van Training and Research Hospital

Impact of Concomitant Crural Repair and Gastropexy on Gastroesophageal Reflux and Postoperative Outcomes 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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:

  1. Control Group (n=25): Underwent standard LSG.
  2. 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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Control Group
Standard laparoscopic sleeve gastrectomy (LSG) without crural repair or gastropexy.
Procedure: Standard Laparoscopic Sleeve Gastrectomy
Standard laparoscopic sleeve gastrectomy without hiatal dissection, crural repair, or gastropexy.
Experimenteel: Study Group
Laparoscopic sleeve gastrectomy (LSG) combined with systematic hiatal dissection, posterior crural repair, and posterior gastropexy.
Procedure: Laparoscopic Sleeve Gastrectomy with Crural Repair and Gastropexy
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Gastroesophageal Reflux Symptom Burden Assessed by the Gastrointestinal Symptom Assessment Scale (GSAS)
Tijdsspanne: 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.
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)
Tijdsspanne: 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.
Baseline within 4 weeks before surgery and 12 months postoperatively

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Operative Time
Tijdsspanne: Day 1
Total duration of the surgical procedure in minutes, compared between standard LSG and LSG with crural repair and gastropexy groups.
Day 1
Incidence of Postoperative Complications
Tijdsspanne: Up to 30 days postoperatively
The number of participants experiencing early postoperative complications
Up to 30 days postoperatively
Length of Hospital Stay (LOS)
Tijdsspanne: 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.
Up to 30 days postoperatively
Change in Regular Proton Pump Inhibitor (PPI) Use
Tijdsspanne: 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.
Baseline within 4 weeks before surgery and 12 months postoperatively
Postoperative Weight Loss
Tijdsspanne: 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.
Baseline within 4 weeks before surgery and 12 months postoperatively
Concordance of Hiatal Assessment
Tijdsspanne: 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.
Preoperative endoscopy performed within 4 weeks before surgery, and intraoperative hiatal assessment on Day 1

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Van Training and Research Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 november 2022

Primaire voltooiing (Werkelijk)

31 juli 2024

Studie voltooiing (Werkelijk)

31 juli 2024

Studieregistratiedata

Eerst ingediend

19 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 april 2026

Eerst geplaatst (Werkelijk)

1 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

23 april 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • FSMEAH-KAEK-2022/119

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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