Does Antrum Size Matter in Sleeve Gastrectomy?

Azienda Sanitaria Locale Napoli 2 Nord

Status: Completed

Conditions: Bariatric Surgery Candidate

Treatments: Procedure: Smal antrectomy; Procedure: Wide antrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04323072

01032020

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Group A

Experimental group

Description:

Resection of antrum proximally 2 cm to the pylorus

Treatment:

Procedure: Wide antrectomy

Group B

Active Comparator group

Description:

Resection of antrum proximally 6 cm to the pylorus

Treatment:

Procedure: Smal antrectomy