Ulcers Formation After Hand-Sewn vs Stapled Gastrojejunal Anastomosis In MGB.

Launched by FEDERAL STATE BUDGETARY INSTITUTION, V. A. ALMAZOV FEDERAL NORTH-WEST MEDICAL RESEARCH CENTRE, OF THE MINISTRY OF HEALTH · Oct 5, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the formation of ulcers in the stomach after a specific type of weight-loss surgery called MGB-OAGB. Researchers are comparing two methods of connecting the stomach to the small intestine: one that uses staples and another that is done entirely by hand. They believe that the hand-sewn method may reduce the risk of ulcers because it creates a more natural connection and avoids areas of the stomach that may not get enough blood flow, which can lead to ulcer formation.

To participate in this study, you need to be between 18 and 65 years old and have a high body mass index (BMI) of over 40 or over 35 if you have certain health conditions like diabetes or high blood pressure. You'll also need to have a negative test for a bacteria called Helicobacter pylori. If you join the study, you will be closely monitored after your surgery to see if the type of connection made affects the development of ulcers. It's important to know that the study is currently recruiting participants and aims to improve outcomes for people undergoing this type of surgery.

Gender

ALL

Eligibility 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.