Ulcers Formation After Hand-Sewn vs Stapled Gastrojejunal Anastomosis In MGB. (NCT06077955) | Clinical Trial Compass
UnknownNot Applicable
Ulcers Formation After Hand-Sewn vs Stapled Gastrojejunal Anastomosis In MGB.
Russia300 participantsStarted 2023-11-01
Plain-language 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 standard" for this procedure. The geometry of such anastomosis leads to the formation of a narrow strip of the gastric wall between two stapler lines (between the suture from the 2nd cassette during the formation of the "small ventricle" and directly from the suture from the cassette during the GJS formation). Perhaps this section of the stomach wall is prone to ischemia, which can certainly increase the risk of ulcer formation. It is also possible that a zone with impaired blood supply may also form in the "blind pocket" above the anastomosis.
When forming a Hand-Sewn GJS of the end-to-side type, ischemia zones do not occur. The anastomosis has a more physiological geometry, there is no conflict between the lines of stapled sutures.
Thus, we put forward the assumption that a serious risk factor for the development of a GJS ulcer was eliminated when switching to a completely manual technique for the GJS formation when performing MGB-OAGB.
The study is aimed at the compare the incidence of GJS ulcers during MGB-OAGB, depending on the techniques of anastomosis formation.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
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
The presence of a gastrojejunostomy ulcer
Timeframe: 6 months
Trial details
NCT IDNCT06077955
SponsorFederal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health