Impact of Crural Repair and Gastropexy During Laparoscopic Sleeve Gastrectomy
23 aprile 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
50
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Van
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Van, Van, Turchia (Türkiye)
- Van Training and Research Hospital
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Control Group
Standard laparoscopic sleeve gastrectomy (LSG) without crural repair or gastropexy.
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Standard laparoscopic sleeve gastrectomy without hiatal dissection, crural repair, or gastropexy.
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Sperimentale: Study Group
Laparoscopic sleeve gastrectomy (LSG) combined with systematic hiatal dissection, posterior crural repair, and posterior gastropexy.
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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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Gastroesophageal Reflux Symptom Burden Assessed by the Gastrointestinal Symptom Assessment Scale (GSAS)
Lasso di tempo: 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.
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Baseline within 4 weeks before surgery and 12 months postoperatively
|
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Change in Gastroesophageal Reflux Symptom Burden Assessed by the Frequency Scale for the Symptoms of GERD (F-Scale)
Lasso di tempo: 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.
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Baseline within 4 weeks before surgery and 12 months postoperatively
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Operative Time
Lasso di tempo: Day 1
|
Total duration of the surgical procedure in minutes, compared between standard LSG and LSG with crural repair and gastropexy groups.
|
Day 1
|
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Incidence of Postoperative Complications
Lasso di tempo: Up to 30 days postoperatively
|
The number of participants experiencing early postoperative complications
|
Up to 30 days postoperatively
|
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Length of Hospital Stay (LOS)
Lasso di tempo: 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
|
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Change in Regular Proton Pump Inhibitor (PPI) Use
Lasso di tempo: 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
|
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Postoperative Weight Loss
Lasso di tempo: 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.
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Baseline within 4 weeks before surgery and 12 months postoperatively
|
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Concordance of Hiatal Assessment
Lasso di tempo: Preoperative endoscopy performed within 4 weeks before surgery, and intraoperative hiatal assessment on Day 1
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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.
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Preoperative endoscopy performed within 4 weeks before surgery, and intraoperative hiatal assessment on Day 1
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 novembre 2022
Completamento primario (Effettivo)
31 luglio 2024
Completamento dello studio (Effettivo)
31 luglio 2024
Date di iscrizione allo studio
Primo inviato
19 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
23 aprile 2026
Primo Inserito (Effettivo)
1 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
1 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
23 aprile 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Disturbi della nutrizione
- Ipernutrizione
- Peso corporeo
- Malattie dell'apparato digerente
- Malattie gastrointestinali
- Malattie esofagee
- Sovrappeso
- Obesità
- Disturbi della motilità esofagea
- Disturbi della deglutizione
- Condizioni patologiche, segni e sintomi
- Malattie nutrizionali e metaboliche
- Segni e sintomi
- Obesità, morboso
- Reflusso gastroesofageo
- Procedure chirurgiche, operative
- Procedure chirurgiche del sistema digestivo
- Gastropexy
Altri numeri di identificazione dello studio
- FSMEAH-KAEK-2022/119
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .