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

NCT05452980 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-07-12

No results posted yet for this study

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

Interventions

PROCEDURE

reestablishment of the acute angle of His

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

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.

Sponsors & Collaborators

  • Zhen Jun Wang

    lead OTHER

Principal Investigators

  • Zhen Jun Wang · Beijing Chao Yang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-12-30
Completion
2025-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05452980 on ClinicalTrials.gov