Clinical Trials Directory

Trials / Completed

CompletedNCT04323072

Does Antrum Size Matter in Sleeve Gastrectomy?

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
150 (actual)
Sponsor
Azienda Sanitaria Locale Napoli 2 Nord · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
PROCEDUREWide antrectomyThe starting point of resection of the stomach from the pylorus to begin the gastrectomy is 2 cm.
PROCEDURESmal antrectomyThe starting point of resection of the stomach from the pylorus to begin the gastrectomy is 6 cm.

Timeline

Start date
2015-03-01
Primary completion
2017-01-01
Completion
2017-01-01
First posted
2020-03-26
Last updated
2020-03-26

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04323072. Inclusion in this directory is not an endorsement.