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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Wide antrectomy | The starting point of resection of the stomach from the pylorus to begin the gastrectomy is 2 cm. |
| PROCEDURE | Smal antrectomy | The 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.