Preserving the Pre-cardial Fat Pad During Sleeve Gastrectomy on Postoperative Gastroesophageal Reflux

NCT06732661 | Active Not Recruiting DMC

• 2 other identifiers: Fat pad-SG82070685
• Study Type: interventional
• Target: 50
• 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%. The angle of His is important for the maintenance of esophageal anti-reflux ability, and prevent GERD. Most SG operating consensus recommends surgeons should stay at least 1 cm away from the angle of His. However, on consensus was reached about the pre-cardial fat pad should be routinely dissected or not to avoid leaving behind a large fundus consensus. The investigators propose to perform a prospective randomized controlled study to dissect the pre-cardial fat pad or not in obese patients followig sleeve gastrectomy to prevent GERD.

Conditions

Sleeve Gastrectomy; Pre-cardial Fat Pad; Excessive Weight Loss; Total Weight Loss; Gastroesophageal Reflux Disease

Keywords

sleeve gastrectomy; pre-cardial fat pad; Gastroesophageal Reflux Disease; 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 postoperativel

• total weight loss

  3 months, 6 months, 1 year postoperatively

Study Arms (2)

Preserve pre-cardial fat pad

NO INTERVENTION

For this group, 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 10 mm lateral to the esophagus is respected without dissection of pre-cardial fat pad.

Dissect pre-cardial fat pad

EXPERIMENTAL

For this group, a sleeve was fashioned starting 4 cm proximal to the pylorus using serial applications of an 60 stapler over a 36Fr oro-gastric bougie. Dissect the pre-cardial fat pad, and a security distance of 10 mm lateral to the esophagus is respected.

Procedure: Preserve pre-cardial fat pad; Procedure: Dissect pre-cardial fat pad

Interventions

Preserve pre-cardial fat pad PROCEDURE

For this group, 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 10 mm lateral to the esophagus is respected without dissection of pre-cardial fat pad.

Dissect pre-cardial fat pad

Dissect pre-cardial fat pad PROCEDURE

For this group, a sleeve was fashioned starting 4 cm proximal to the pylorus using serial applications of an 60 stapler over a 36Fr oro-gastric bougie. Dissect the pre-cardial fat pad, and a security distance of 10 mm lateral to the esophagus is respected.

Dissect pre-cardial fat pad

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

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

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 Design

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

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: July 1, 2024
• Primary Completion: July 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)