NCT07070908Active, not recruiting
Modifications to Gastric Sleeve: Implications for GRED and Quality of Life
Modifications to Gastric Tube Construction in Vertical Gastrectomy: Implications for Gastroesophageal Reflux Disease and Patient Quality of Life
Source: ClinicalTrials.gov · Last updated 17 Jul 2025
Brief summary (registry, in English)
This is a prospective randomized clinical trial evaluating the impact of antrum and fundus calibration during laparoscopic vertical gastrectomy (VG) on postoperative gastroesophageal reflux disease (GERD), quality of life, and surgical costs. Eligible participants are adults with morbid obesity (BMI ≥35 kg/m²) undergoing LSG. Patients are randomized into four groups based on whether antral and/or fundal calibration is performed. Primary outcomes include the incidence of de novo GERD at 12 months. Secondary outcomes include postoperative quality of life, vomiting , surgical complications, weight loss, and operative costs. The study aims to optimize the LSG technique by identifying anatomical modifications that minimize GERD while improving clinical outcomes
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 27 Jun 2025
- Start date
- 6 Apr 2020
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Hospital San Juan de Dios Tenerife
- Diseases
- Obesity
- NCT number
- NCT07070908
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 6 Apr 2020 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous gastric surgery.
Other illness
- Active gastrointestinal disease (such as esophagitis, peptic ulcer, cancer, or esophageal motility disorder), diagnosed by endoscopy or manometry.
Other
- Obesity of endocrine origin.
- Preoperative GERD (diagnosed by pH-metry or upper endoscopy following a positive GERD-HRQL test).
- Patients not meeting the inclusion criteria
Who the study is looking for
- Patients with morbid obesity on the waiting list for bariatric surgery.
- Both male and female participants.
- Age between 18 and 65 years.
- BMI \> 35 kg/m².
- Availability to attend scheduled follow-up visits.
- Indication for sleeve gastrectomy as the first bariatric procedure.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Regional University Hospital of Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.