Status:
RECRUITING
Ulcers Formation After Hand-Sewn vs Stapled Gastrojejunal Anastomosis In MGB.
Lead Sponsor:
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Conditions:
Ulcer Peptic
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
We assume that the frequency of gastrojejunostomy ulcers after MGB-OAGB is associated with the peculiarities of the side-to-side gastrojejunostomy (GJS) formation, which is currently the "gold standar...
Detailed Description
Today, MGB-OAGB, a mini-gastric bypass or one anastomosis gastric bypass, is one of the most widely used bariatric procedures. This surgery was first performed by Professor R. Rutledge in 1997, having...
Eligibility Criteria
Inclusion
- 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-
- 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
- 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.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06077955
Start Date
November 1 2023
End Date
April 1 2025
Last Update
April 2 2024
Active Locations (1)
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1
Almazov National Medical Research Centre
Saint Petersburg, Russia