Impact of Crural Repair and Gastropexy During Laparoscopic Sleeve Gastrectomy
23 de abril de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Real)
50
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Van
-
Van, Van, Turquia (Türkiye)
- Van Training and Research Hospital
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Control Group
Standard laparoscopic sleeve gastrectomy (LSG) without crural repair or gastropexy.
|
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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Gastroesophageal Reflux Symptom Burden Assessed by the Gastrointestinal Symptom Assessment Scale (GSAS)
Prazo: 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)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Operative Time
Prazo: 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
Prazo: Up to 30 days postoperatively
|
The number of participants experiencing early postoperative complications
|
Up to 30 days postoperatively
|
|
Length of Hospital Stay (LOS)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de novembro de 2022
Conclusão Primária (Real)
31 de julho de 2024
Conclusão do estudo (Real)
31 de julho de 2024
Datas de inscrição no estudo
Enviado pela primeira vez
19 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de abril de 2026
Primeira postagem (Real)
1 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de abril de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Distúrbios Nutricionais
- Supernutrição
- Peso corporal
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Doenças Esofágicas
- Excesso de peso
- Obesidade
- Distúrbios da Motilidade Esofágica
- Distúrbios da Deglutição
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Obesidade Mórbida
- Refluxo gastroesofágico
- Procedimentos cirúrgicos, operatórios
- Procedimentos cirúrgicos do sistema digestivo
- Gastropexy
Outros números de identificação do estudo
- FSMEAH-KAEK-2022/119
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .