Comparing hand-sewn and stapled methods for gastric bypass surgery
The Incidence of Gastrojejunostomy Ulceration After MGB-OAGB: Comparison of Hand-Sewn and Stapled Techniques of Anastomosis Formation. Multicenter Prospective Randomized Clinical Trial Study
This study is testing whether using hand-sewn stitches or staples during gastric bypass surgery can help prevent ulcers in patients after the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health Academic / other |
| Locations | 1 site (Saint Petersburg) |
| Trial ID | NCT06077955 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the formation of ulcers in patients undergoing mini-gastric bypass surgery using two different techniques: hand-sewn anastomosis and stapled anastomosis. The study hypothesizes that the geometry of the stapled method may lead to ischemia and increased ulcer risk, while the hand-sewn method may provide a more physiological approach without such risks. Participants will be monitored for ulcer formation post-surgery to determine which technique is more effective in preventing this complication. The trial aims to enhance surgical outcomes and patient safety in bariatric procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with a body mass index over 40 kg/m2 or over 35 kg/m2 with metabolic disorders.
Not a fit: Patients with a history of gastric ulcers, smoking, or certain contraindications to bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that reduce the risk of ulcer formation in patients undergoing gastric bypass surgery.
How similar studies have performed: While there have been studies on various surgical techniques for gastric bypass, this specific comparison of hand-sewn versus stapled anastomosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women aged 18 to 65; * Body mass index over 40 kg/m2 or 35 kg/m2 in the presence of concomitant metabolic disorders (type 2 diabetes mellitus, hypertension, coronary artery disease, atherosclerosis and dyslipidemia); * Preliminary consultation with an endocrinologist; * Voluntary informed consent for surgical treatment; * Voluntary informed consent to participate in a clinical trial; * A negative test for Helicobacter pylori or a full course of eradication therapy. Non-Inclusion Criteria: * smoking; * gastric ulcer disease in history; * earlier abdominal surgery by laparotomy * abdominal wall hernias; * contraindications to planned operative treatment of bariatric profile based on the results of the pre-surgery evaluation of somatic status (see section "Patient's Treatment Protocol"); * for women - pregnancy planning in the next 12 months; * mental health record; * patients with oncological diseases; Exclusion Criteria: * surgical complications in the early post-surgery period related to the disruption of vital functions of organs and systems (respiratory, neurological and cardiological disorders requiring a stay in then the intensive-care unit, long-term position compression syndrome with renal impairment, venous thromboembolism); * surgical complications in the early post-surgery period requiring repeated surgery or minimally invasive surgery (intraabdominal / intraluminal hemorrhage, failure of manual/ hardware suture on gastrointestinal organs etc.); * positive intraoperative test for leak-proof anastomosis (injection of methylene blue solution or "bubble-test"), requiring surgical procedures for color leakage zone removal (see section "Patient's Treatment Protocol"); * poor adherence to the recommendations for gastroprotective therapy and recommendations on diet after surgery by the patient (see section "Interim control"); * patient's refusal to participate in the clinical study at any stage.
Where this trial is running
Saint Petersburg
- Almazov National Medical Research Centre — Saint Petersburg, Russian Federation (Recruiting)
Study contacts
- Principal investigator: Aleksandr Neimark, MD, PhD — Almazov National Medical Research Centre
- Study coordinator: Aleksandr Neimark, MD, PhD
- Email: sas_spb@mail.ru
- Phone: +79217590828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.