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临床试验/NCT06077955
NCT06077955Unknown不适用

The Incidence of Gastrojejunostomy Ulceration After MGB-OAGB: Comparison of Hand-Sewn and Stapled Techniques of Anastomosis Formation. Multicenter Prospective Randomized Clinical Trial Study

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health2 个研究点 分布在 2 个国家目标入组 300 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
2
主要终点
The presence of a gastrojejunostomy ulcer

研究概览

简要总结

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.

详细描述

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 published the first data in 2001 on a sample of 1274 patients [1]. In 2014, the first consensus conference was held, at which recommendations for application and generalization of experience were adopted [2]. By 2018, the share of MGB-OAGB surgeries in the world was already 7.7% [3]. In the Russian Federation, this index for 2021 was 12%, which indicates a significant prevalence of mini-gastric bypass surgery in the Russian Federation [4]. This is facilitated by the simplicity, safety and high efficiency of this procedure in relation to obesity and metabolic disorders. Comparative studies and subsequent meta-analyses show a number of advantages over the classic Roux-en-Y gastric bypass [5, 6]. Reduction in the duration of the surgery and the reduction in the number of surgical complications are attractive for surgeons.

However, with the increase in the number of surgeries and the accumulation of experience, a number of problems associated with this surgery become apparent. Malabsorption risks are minimized by measuring the length of the common loop and cutting off a strictly defined percentage of the small intestine from digestion. Research on bile reflux effects is currently ongoing, but in order to reduce it, the surgical technique has been modified by lengthening the gastric tube [2]. One of the most serious problems is the appearance of gastrojejunostomy (GJS) ulcers. As a rule, they are difficult to treat and can cause bleeding. Their number seriously varies in different publications from 2% to 13% [7, 8]. These figures, despite the attractiveness of the new surgery, make many surgeons refrain from performing MGB-OAGB in their routine practice. The causes of ulcers are not fully understood and require further study, and it is also possible to change the technique of anastomosis.

Working Hypothesis We assume that the frequency of gastrojejunostomy ulcers after MGB-OAGB is associated with the peculiarities of the side-to-side 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 Hand-sewn technique for the GJS formation when performing MGB-OAGB.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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:
  • 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;

排除标准

  • 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.

结局指标

主要结局

The presence of a gastrojejunostomy ulcer

时间窗: 6 months

Video endoscopy of the upper gastrointestinal tract

次要结局

  • The amount of foreign non-absorbable material remaining in the body(Intraoperative indicator)
  • Erosive anastomositis(6 months)
  • Time of surgery(Intraoperative indicator)

研究者

发起方
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleksandr E. Neimark

Leading researcher

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

研究点 (2)

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