Does Antrum Size Matter in Sleeve Gastrectomy?

NCT04323072 | Completed DMC

• 1 other identifier: 01032020
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• Gastroesophageal reflux disease(GERD)

  at 12 months

• Gastroesophageal reflux disease(GERD)

  at 24 months

• Gastroesophageal reflux disease symptoms

  at 3 months

• Gastroesophageal reflux disease symptoms

  at 6 months

• Gastroesophageal reflux disease symptoms

  at 12 months

Study Arms (2)

Group A

EXPERIMENTAL

Resection of antrum proximally 2 cm to the pylorus

Procedure: Wide antrectomy

Group B

ACTIVE COMPARATOR

Resection of antrum proximally 6 cm to the pylorus

Procedure: Smal antrectomy

Interventions

Wide antrectomy PROCEDURE

The starting point of resection of the stomach from the pylorus to begin the gastrectomy is 2 cm.

Group A

Smal antrectomy PROCEDURE

The starting point of resection of the stomach from the pylorus to begin the gastrectomy is 6 cm.

Group B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria Locale Napoli 2 Nord: lead

Study Sites (1)

Francdesco Pizza

Napoli, Naples, 80035, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the bariatric and metabolic surgery unit

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 26, 2020
• Study Start: March 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)