Sleeve Gastrectomy With Reestablishment of the Acute Angle of His (SG-REACH) in Obese Patients

NCT05452980 | Unknown DMC

• 1 other identifier: SG-REACH
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Gastroesophageal reflux disease (GERD) is one of the most common chronic conditions that can affect one's quality of life. Laparoscopic sleeve gastrectomy (LSG) has become a popular technique and currently is the most frequently practiced surgical operation to treat obesity today. However, the prevalence of GERD following SG can be fairly high. Several studies have noted an incidence between 6% and 47%. To preserve this natural barrier during SG, a careful dissection at the angle of His must be maintained in order to spare the sling fibers and avoid blunting the angle of His. During creation of the sleeve, the gastric sling fibers are frequently transected near the angle of His, particularly if the transection line is very close to this anatomic landmark. These sling fibers contribute significantly to the function of the LES. The investigators suggest that after the finishing of SG, the anatomical structure of His horn was destroyed or partly destroyed, and the acute angle of His become obtuse angle. The investigators propose to perform a prospective randomized controlled study to reestablish the acute angle of His in obese patients followig sleeve gastrectomy to prevent GERD.

Conditions

Gastroesophageal Reflux Disease; Excessive Weight Loss; Total Weight Loss; Sleeve Gastrectomy; Angle of His

Keywords

Gastroesophageal Reflux Disease; Sleeve Gastrectomy; Angle of His; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Rate of gastroesophageal reflux disease

  The rate of gastroesophageal reflux disease following sleeve gastrectomy at 1 year

  1 year

Secondary Outcomes (4)

• Complications

  30 days postoperatively]

• Operating time

  During the operation

• excessive weight loss

  3 months, 6 months, 1 year, 3 years and 5 years postoperatively

• total weight loss

  3 months, 6 months, 1 year, 3 years and 5 years postoperatively

Study Arms (2)

sleeve gastrectomy

ACTIVE COMPARATOR

For standard sleeve gastrectomy (SG), a sleeve was fashioned starting 4 cm proximal to the pylorus using serial applications of an 60 stapler over a 36Fr oro-gastric bougie. A security distance of 15 mm lateral to the esophagus is respected to reduce the risk of high leak.

Procedure: sleeve gastrectomy

SG with reestablishment of the acute angle of His

EXPERIMENTAL

A sleeve was fashioned starting 4 cm proximal to the pylorus using serial applications of an 60 stapler over a 36Fr oro-gastric bougie. A security distance of 15 mm lateral to the esophagus is respected to reduce the risk of high leak. Three stitches using nonabsorbable 2-0 Prolone were performed to reestablish the acute angle of His: anterior gastric fundus with esophagus, gastric fundus with left crural diaphragm, posterior gastric fundus with left crural diaphragm.

Procedure: reestablishment of the acute angle of His

Interventions

reestablishment of the acute angle of His PROCEDURE

A sleeve was fashioned starting 4 cm proximal to the pylorus using serial applications of an 60 stapler over a 36Fr oro-gastric bougie. A security distance of 15 mm lateral to the esophagus is respected to reduce the risk of high leak.

Also known as: sleeve gastrectomy

SG with reestablishment of the acute angle of His

sleeve gastrectomy PROCEDURE

A sleeve was fashioned starting 4 cm proximal to the pylorus using serial applications of an 60 stapler over a 36Fr oro-gastric bougie. A security distance of 15 mm lateral to the esophagus is respected to reduce the risk of high leak.

sleeve gastrectomy

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≥ 32.5 kg/m2 with or without T2DM;
• kg/ m2 \< BMI \< 32.5 kg/m2 with T2DM but failed conservative treatment and combined with at least two metabolic diseases or comorbidities;
• Duration of T2DM ≤15 years with fasting Cpeptide ≥ 50% of normal lower limit
• Waist circumference: male ≥ 90 cm, female ≥ 85 cm
• Age within 16\~65 years old

You may not qualify if:

• GERD preoperatively
• Hiatus hernia approved by gastroscopy preoperatively
• Pregnancy;
• A history of mental illness and neurological disease;
• The patient refuses surgery;
• Combined with pituitary tumor;
• Long-term use of antidepressant drugs;
• Long-term use of immunosuppressants;
• Situations in which the investigator or other examiner considers from the enrolled study that there are good reasons for nonconformity: if there are potential inconsistencies with the clinical protocol

Sponsors & Collaborators

• Zhen Jun Wang: lead

Study Sites (1)

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux; Weight Loss

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhen Jun Wang

  Beijing Chao Yang Hospital

  STUDY CHAIR

Central Study Contacts

Jia Gang Han

CONTACT

+861085231604; hanjiagang@ccmu.edu.cn

Zhi Wei Zhai

CONTACT

+861085231328; zhaizhiwei@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 12, 2022
• Study Start: June 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2025
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)