Preserving the Pre-cardial Fat Pad During Sleeve Gastrectomy on Postoperative Gastroesophageal Reflux (Pad and SG)

A Prospective Randomized Controlled Study on the Impact of Preserving the Pre-cardial Fat Pad During Sleeve Gastrectomy on Postoperative Gastroesophageal Reflux

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gastroesophageal Reflux Disease; Sleeve Gastrectomy; Excessive Weight Loss; Total Weight Loss; Pre-cardial Fat Pad
• Intervention / Treatment: Procedure: Preserve pre-cardial fat pad; Procedure: Dissect pre-cardial fat pad

Detailed Description

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 dissection of pre-cardial fat pad is helpful to fully expose the gastric fundus, to accurately judge the distance between the incision line and the esophagus, and to help the suture embedding of the incision line. However, the disadvantages might increase the rate of GERD. While retaining the pre-cardial fat pad may contribute to the reduction of GERD rate. However, it might not be conducive to the judgment of cutting distance to the esophagus and the procedure of suture embedding. Futhermore, there may be gastric fundus residue during SG.

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Beijing Chaoyang Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• BMI ≥ 32.5 kg/m2 with or without T2DM;
• 27.5 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Preserve pre-cardial fat pad; 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.
Experimental: Dissect pre-cardial fat pad; 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; 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.; Procedure: Dissect pre-cardial fat pad; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of gastroesophageal reflux disease	The rate of gastroesophageal reflux disease following sleeve gastrectomy at 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Complications within 30 days postoperatively	30 days postoperatively
Operating time	Time from opeing of the operation to the end of the operation	During the operation
excessive weight loss	Percentage of excess weight loss (EWL) at any time postoperative was calculated as the amount of weight loss divided by the amount of excess weight times 100%.	3 months, 6 months, 1 year postoperativel
total weight loss	total weight loss compared with preoperative weight	3 months, 6 months, 1 year postoperatively

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Estimated): December 13, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Weight Loss; Gastroesophageal Reflux Disease; sleeve gastrectomy; pre-cardial fat pad
• Additional Relevant MeSH Terms: Intestinal Diseases; Body Weight Changes; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Esophageal Diseases; Gastroenteritis; Duodenal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophagitis; Peptic Ulcer; Weight Loss; Body Weight; Gastroesophageal Reflux; Esophagitis, Peptic
• Other Study ID Numbers: Fat pad-SG; 82070685 (Other Grant/Funding Number: National Natural Science Foundation of China (General Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No