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

NCT06077955 | Recruiting

• 1 other identifier: 0210-22-MGB-OAGB
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Ulcer Peptic

Keywords

bariatric; morbid obesity; ulcer of gastrojejunostomy; mini-gastric bypass; one-anastomosis gastric bypass; hand-sewn anastomosis; stapled anastomosis

Outcome Measures

Primary Outcomes (1)

• The presence of a gastrojejunostomy ulcer

  Video endoscopy of the upper gastrointestinal tract

  6 months

Secondary Outcomes (3)

• Erosive anastomositis

  6 months

• Time of surgery

  Intraoperative indicator

• The amount of foreign non-absorbable material remaining in the body

  Intraoperative indicator

Study Arms (2)

Group A (control) - with stapled anastomosis

ACTIVE COMPARATOR

A variant of the surgery with the stapled formation of a gastrojejunostomy.

Procedure: Mini-gastric bypass with stapled anastomosis

Group B (study) - with hand-sewn anastomosis

EXPERIMENTAL

A variant with a hand-sewn formation of a gastrojejunostomy.

Procedure: Mini-gastric bypass with hand-sewn anastomosis

Interventions

Mini-gastric bypass with stapled anastomosis PROCEDURE

the stomach is transected using linear endoscopic staplers in such a way as to create an isolated narrow gastric tube ("small ventricle") at least 17-18 cm long and 15-20 mm wide (diameter of gastric tube used 36-39 Fr). • A gastroenterostomy is performed at a distance of 150-200 cm from the ligament of Treitz using a linear stapler.

Group A (control) - with stapled anastomosis

Mini-gastric bypass with hand-sewn anastomosis PROCEDURE

the stomach is transected using linear endoscopic staplers in such a way as to create an isolated narrow gastric tube ("small ventricle") at least 17-18 cm long and 15-20 mm wide (diameter of gastric tube used 36-39 Fr). • A gastroenterostomy is performed at a distance of 150-200 cm from the ligament of Treitz using a fully manual suture.

Group B (study) - with hand-sewn anastomosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Almazov National Medical Research Centre

Saint Petersburg, Russia

RECRUITING

Related Publications (8)

• Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001 Jun;11(3):276-80. doi: 10.1381/096089201321336584.

  PMID: 11433900 BACKGROUND

• Ramos AC, Chevallier JM, Mahawar K, Brown W, Kow L, White KP, Shikora S; IFSO Consensus Conference Contributors. IFSO (International Federation for Surgery of Obesity and Metabolic Disorders) Consensus Conference Statement on One-Anastomosis Gastric Bypass (OAGB-MGB): Results of a Modified Delphi Study. Obes Surg. 2020 May;30(5):1625-1634. doi: 10.1007/s11695-020-04519-y.

  PMID: 32152841 BACKGROUND

• Welbourn R, Hollyman M, Kinsman R, Dixon J, Liem R, Ottosson J, Ramos A, Vage V, Al-Sabah S, Brown W, Cohen R, Walton P, Himpens J. Bariatric Surgery Worldwide: Baseline Demographic Description and One-Year Outcomes from the Fourth IFSO Global Registry Report 2018. Obes Surg. 2019 Mar;29(3):782-795. doi: 10.1007/s11695-018-3593-1. Epub 2018 Nov 12.

  PMID: 30421326 BACKGROUND

• National Bariatric Registry. URL: https://bareoreg.ru (Accessed: 01.08.2023).

  BACKGROUND

• Ruiz-Tovar J, Carbajo MA, Jimenez JM, Castro MJ, Gonzalez G, Ortiz-de-Solorzano J, Zubiaga L. Long-term follow-up after sleeve gastrectomy versus Roux-en-Y gastric bypass versus one-anastomosis gastric bypass: a prospective randomized comparative study of weight loss and remission of comorbidities. Surg Endosc. 2019 Feb;33(2):401-410. doi: 10.1007/s00464-018-6307-9. Epub 2018 Jun 25.

  PMID: 29943058 BACKGROUND

• Wang FG, Yan WM, Yan M, Song MM. Outcomes of Mini vs Roux-en-Y gastric bypass: A meta-analysis and systematic review. Int J Surg. 2018 Aug;56:7-14. doi: 10.1016/j.ijsu.2018.05.009. Epub 2018 May 16.

  PMID: 29753952 BACKGROUND

• Mahawar KK, Reed AN, Graham YNH. Marginal ulcers after one anastomosis (mini) gastric bypass: a survey of surgeons. Clin Obes. 2017 Jun;7(3):151-156. doi: 10.1111/cob.12186. Epub 2017 Mar 20.

  PMID: 28320077 BACKGROUND

• Baksi A, Kamtam DNH, Aggarwal S, Ahuja V, Kashyap L, Shende DR. Should Surveillance Endoscopy Be Routine After One Anastomosis Gastric Bypass to Detect Marginal Ulcers: Initial Outcomes in a Tertiary Referral Centre. Obes Surg. 2020 Dec;30(12):4974-4980. doi: 10.1007/s11695-020-04864-y. Epub 2020 Jul 27.

  PMID: 32720263 BACKGROUND

MeSH Terms

Conditions

Peptic Ulcer; Obesity, Morbid

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aleksandr Neimark, MD, PhD

  Almazov National Medical Research Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandr Neimark, MD, PhD

CONTACT

+79217590828; sas_spb@mail.ru

Artem Stepanenko

CONTACT

+79601194009; stepanenko.vsmu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leading researcher

Model Details: Two groups: group A, a variant of the surgery with the stapled formation of a GJS, and group B, a variant with a hand-sewn formation of a GJS.

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 11, 2023
• Study Start: November 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2025
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)