Impact of Crural Repair and Gastropexy During Laparoscopic Sleeve Gastrectomy
2026年4月23日 更新者：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.
研究概览
地位
完全的
详细说明
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.
研究类型
介入性
注册 (实际的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Van
-
Van、Van、土耳其（türkiye）
- Van Training and Research Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Control Group
Standard laparoscopic sleeve gastrectomy (LSG) without crural repair or gastropexy.
|
Standard laparoscopic sleeve gastrectomy without hiatal dissection, crural repair, or gastropexy.
|
|
实验性的：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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Gastroesophageal Reflux Symptom Burden Assessed by the Gastrointestinal Symptom Assessment Scale (GSAS)
大体时间：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)
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Operative Time
大体时间：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
大体时间：Up to 30 days postoperatively
|
The number of participants experiencing early postoperative complications
|
Up to 30 days postoperatively
|
|
Length of Hospital Stay (LOS)
大体时间：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
大体时间：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
大体时间：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
|
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Concordance of Hiatal Assessment
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年11月1日
初级完成 (实际的)
2024年7月31日
研究完成 (实际的)
2024年7月31日
研究注册日期
首次提交
2026年4月19日
首先提交符合 QC 标准的
2026年4月23日
首次发布 (实际的)
2026年5月1日
研究记录更新
最后更新发布 (实际的)
2026年5月1日
上次提交的符合 QC 标准的更新
2026年4月23日
最后验证
2026年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.