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Impact of Crural Repair and Gastropexy During Laparoscopic Sleeve Gastrectomy

23. April 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Control Group
Standard laparoscopic sleeve gastrectomy (LSG) without crural repair or gastropexy.
Verfahren: Standard Laparoscopic Sleeve Gastrectomy
Standard laparoscopic sleeve gastrectomy without hiatal dissection, crural repair, or gastropexy.
Experimental: Study Group
Laparoscopic sleeve gastrectomy (LSG) combined with systematic hiatal dissection, posterior crural repair, and posterior gastropexy.
Verfahren: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Gastroesophageal Reflux Symptom Burden Assessed by the Gastrointestinal Symptom Assessment Scale (GSAS)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Operative Time
Zeitfenster: 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
Zeitfenster: Up to 30 days postoperatively
The number of participants experiencing early postoperative complications
Up to 30 days postoperatively
Length of Hospital Stay (LOS)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Van Training and Research Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. November 2022

Primärer Abschluss (Tatsächlich)

31. Juli 2024

Studienabschluss (Tatsächlich)

31. Juli 2024

Studienanmeldedaten

Zuerst eingereicht

19. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. April 2026

Zuerst gepostet (Tatsächlich)

1. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • FSMEAH-KAEK-2022/119

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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