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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
介入
入学 (実際)
50
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Van
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Van、Van、トルコ（Türkiye）
- Van Training and Research Hospital
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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実験的：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Gastroesophageal Reflux Symptom Burden Assessed by the Gastrointestinal Symptom Assessment Scale (GSAS)
時間枠：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)
時間枠：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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Operative Time
時間枠：Day 1
|
Total duration of the surgical procedure in minutes, compared between standard LSG and LSG with crural repair and gastropexy groups.
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Day 1
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Incidence of Postoperative Complications
時間枠：Up to 30 days postoperatively
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The number of participants experiencing early postoperative complications
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Up to 30 days postoperatively
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Length of Hospital Stay (LOS)
時間枠：Up to 30 days postoperatively
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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.
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Up to 30 days postoperatively
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Change in Regular Proton Pump Inhibitor (PPI) Use
時間枠：Baseline within 4 weeks before surgery and 12 months postoperatively
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The number of patients reporting regular use of PPI medication, comparing their preoperative status to their postoperative status.
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Baseline within 4 weeks before surgery and 12 months postoperatively
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Postoperative Weight Loss
時間枠：Baseline within 4 weeks before surgery and 12 months postoperatively
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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
時間枠：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.
|
Preoperative endoscopy performed within 4 weeks before surgery, and intraoperative hiatal assessment on Day 1
|
協力者と研究者
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2022年11月1日
一次修了 (実際)
2024年7月31日
研究の完了 (実際)
2024年7月31日
試験登録日
最初に提出
2026年4月19日
QC基準を満たした最初の提出物
2026年4月23日
最初の投稿 (実際)
2026年5月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月1日
QC基準を満たした最後の更新が送信されました
2026年4月23日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- FSMEAH-KAEK-2022/119
個々の参加者データ (IPD) の計画
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いいえ
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いいえ
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