Does Antrum Size Matter in Sleeve Gastrectomy?

Influence of the Size of the Gastric Antrum After Sleeve Gastrectomy on Weight Loss in Bariatric Surgery

Laparoscopic sleeve gastrectomy (LSG) is currently the most frequent primary bariatric procedure performed worldwide. LSG is safe and effective in terms of excess weight loss. It is a powerful metabolic operation that activates significant hormonal pathways that lead to changes in eating behaviour, glycemic control and intestinal functions. LSG is easier regarding its technical aspects and does not need any intestinal anastomosis, begin limited to the stomach. The most frequent and sometimes dangerous complications are leaking, haemorrhage, splenic injury, sleeve stenosis and gastroesophageal reflux. Despite its established efficacy and safety, controversy still exists on optimal operative technique for LSG: bougie size, the distance of resection margin from the pylorus, the shape of the section at the gastroesophageal junction, staple line reinforcement and intraoperative leak testing is among the most controversial issues 11[6]. In literature, different authors have adopted a resection distance from the pylorus between 2 and 6-7 cm with various reasons 11[6]. Resections more distant to the pylorus improve gastric emptying, prevent distal stenosis and reduce intraluminal pressure, potentially leading to a lower incidence of fistula and/or reflux. On the other hand, resections close to the pylorus would reduce gastric distensibility and increase intragastric pressure, potentially increasing satiety with less oral intake 11(11,12). The primary aim of this randomized monocentric study is to evaluate %EWL at 1 and 2 years follow-up after LSG in two Groups: Group A with a gastric resection starting from 2 cm from the pylorus with therefore a wide antrectomy and Group B with a gastric resection starting from 6 cm from the pylorus with therefore a small antrectomy.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: Wide antrectomy; Procedure: Smal antrectomy

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples
    • Napoli, Naples, Italy, 80035
      • Francdesco Pizza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• informed consent.
• morbid obesity defined as body mass index (BMI) 40 kg/m2

Exclusion Criteria:

• previous bariatric surgical procedures,
• endocrine disorders causing obesity
• pregnancy or lactation
• psychiatric illness
• inflammatory bowel disease
• Barrett ́s oesophagus
• severe GERD with esophagitis B and C
• a large hiatal hernia (>5 cm)
• GERD-HRQLscore > 25 dietary restriction despite

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A; Resection of antrum proximally 2 cm to the pylorus	Procedure: Wide antrectomy; The starting point of resection of the stomach from the pylorus to begin the gastrectomy is 2 cm.
ACTIVE_COMPARATOR: Group B; Resection of antrum proximally 6 cm to the pylorus	Procedure: Smal antrectomy; The starting point of resection of the stomach from the pylorus to begin the gastrectomy is 6 cm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative weight and height combined to report BMI in kg/m^2	Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2)	3 months
Postoperative weight and height combined to report BMI in kg/m^2	Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2)	6 months
Postoperative weight and height combined to report BMI in kg/m^2	Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2)	12 months
Postoperative weight and height combined to report BMI in kg/m^2	Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2)	24 months
Postoperative percentage excess weigth loss	Change of weight expressed in percentage of excess weight loss postoperatively at follow-up	3 months
Postoperative percentage excess weigth loss	Change of weight expressed in percentage of excess weight loss postoperatively at follow-up	6 months
Postoperative percentage excess weigth loss	Change of weight expressed in percentage of excess weight loss postoperatively at follow-up	12 months
Postoperative percentage excess weigth loss	Change of weight expressed in percentage of excess weight loss postoperatively at follow-up	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastroesophageal reflux disease(GERD)	Esophagitys grading according to Los Angeles classification with Upper endoscopy (Grade A: One or more mucosal breaks < 5 mm in maximal length; Grade B: One or more mucosal breaks > 5mm, but without continuity across mucosal folds; Grade C: Mucosal breaks continuous between ≥ 2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D Mucosal breaks involving more than 75% of esophageal circumference	at 12 months
Gastroesophageal reflux disease(GERD)	Esophagitys grading according to Los Angeles classification with Upper endoscopy (Grade A: One or more mucosal breaks < 5 mm in maximal length; Grade B: One or more mucosal breaks > 5mm, but without continuity across mucosal folds; Grade C: Mucosal breaks continuous between ≥ 2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D Mucosal breaks involving more than 75% of esophageal circumference	at 24 months
Gastroesophageal reflux disease symptoms	All patients were surveyed about the presence of heartburn and/or regurgitation with a specific questionnaire GERD HRQL(Gastroesophageal Reflux Disease Health-Related Quality of Life) questionnaire. Each of the 10 questions were rated from 0 (absence of symptoms) to 5 (severe symptoms) for a total score that may range from 0 to 50. Symptoms were defined as absent when patients reported a GERD-HRQL score of 0, mild from 1 to 15, moderate from 16 to 24, and severe from 25 to 50. Patients with GERD-HRQL score >16 was considered positive for GERD.	at 3 months
Gastroesophageal reflux disease symptoms	All patients were surveyed about the presence of heartburn and/or regurgitation with a specific questionnaire GERD HRQL(Gastroesophageal Reflux Disease Health-Related Quality of Life) questionnaire. Each of the 10 questions were rated from 0 (absence of symptoms) to 5 (severe symptoms) for a total score that may range from 0 to 50. Symptoms were defined as absent when patients reported a GERD-HRQL score of 0, mild from 1 to 15, moderate from 16 to 24, and severe from 25 to 50. Patients with GERD-HRQL score >16 was considered positive for GERD.	at 6 months
Gastroesophageal reflux disease symptoms	All patients were surveyed about the presence of heartburn and/or regurgitation with a specific questionnaire GERD HRQL(Gastroesophageal Reflux Disease Health-Related Quality of Life) questionnaire. Each of the 10 questions were rated from 0 (absence of symptoms) to 5 (severe symptoms) for a total score that may range from 0 to 50. Symptoms were defined as absent when patients reported a GERD-HRQL score of 0, mild from 1 to 15, moderate from 16 to 24, and severe from 25 to 50. Patients with GERD-HRQL score >16 was considered positive for GERD.	at 12 months
Gastroesophageal reflux disease symptoms	All patients were surveyed about the presence of heartburn and/or regurgitation with a specific questionnaire GERD HRQL(Gastroesophageal Reflux Disease Health-Related Quality of Life) questionnaire. Each of the 10 questions were rated from 0 (absence of symptoms) to 5 (severe symptoms) for a total score that may range from 0 to 50. Symptoms were defined as absent when patients reported a GERD-HRQL score of 0, mild from 1 to 15, moderate from 16 to 24, and severe from 25 to 50. Patients with GERD-HRQL score >16 was considered positive for GERD.	at 24 months

Collaborators and Investigators

• Sponsor: Azienda Sanitaria Locale Napoli 2 Nord

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2015
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (ACTUAL): March 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 01032020

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