Impact of Crural Repair and Gastropexy During Laparoscopic Sleeve Gastrectomy (NCT07560787) | Clinical Trial Compass
CompletedNot Applicable
Impact of Crural Repair and Gastropexy During Laparoscopic Sleeve Gastrectomy
Turkey (Türkiye)50 participantsStarted 2022-11-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Gastroesophageal Reflux Symptom Burden Assessed by the Gastrointestinal Symptom Assessment Scale (GSAS)
Timeframe: Baseline within 4 weeks before surgery and 12 months postoperatively
2
Change in Gastroesophageal Reflux Symptom Burden Assessed by the Frequency Scale for the Symptoms of GERD (F-Scale)
Timeframe: Baseline within 4 weeks before surgery and 12 months postoperatively