Does Antrum Size Matter in Sleeve Gastrectomy?

NCT ID: NCT04323072

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2017-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

Resection of antrum proximally 2 cm to the pylorus

Group Type: EXPERIMENTAL

Wide antrectomy

Intervention Type: PROCEDURE

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

Group B

Resection of antrum proximally 6 cm to the pylorus

Group Type: ACTIVE_COMPARATOR

Smal antrectomy

Intervention Type: PROCEDURE

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

Interventions

Wide antrectomy

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

Intervention Type: PROCEDURE

Smal antrectomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda Sanitaria Locale Napoli 2 Nord

OTHER

Sponsor Role: lead

Responsible Party

Francesco Pizza

Head of the bariatric and metabolic surgery unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Francdesco Pizza

Napoli, Naples, Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

01032020

Identifier Type: -

Identifier Source: org_study_id