Clinical trial NCT04323072: Does Antrum Size Matter in Sleeve Gastrectomy?
Official title: Influence of the Size of the Gastric Antrum After Sleeve Gastrectomy on Weight Loss in Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Lead sponsor: Azienda Sanitaria Locale Napoli 2 Nord
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Postoperative weight and height combined to report BMI in kg/m^2
timeFrame: 3 months
measure: Postoperative weight and height combined to report BMI in kg/m^2
timeFrame: 6 months
measure: Postoperative weight and height combined to report BMI in kg/m^2
timeFrame: 12 months
measure: Postoperative weight and height combined to report BMI in kg/m^2
timeFrame: 24 months
measure: Postoperative percentage excess weigth loss
timeFrame: 3 months
measure: Postoperative percentage excess weigth loss
timeFrame: 6 months
measure: Postoperative percentage excess weigth loss
timeFrame: 12 months
measure: Postoperative percentage excess weigth loss
timeFrame: 24 months
Secondary outcomes:
measure: Gastroesophageal reflux disease(GERD)
timeFrame: at 12 months
measure: Gastroesophageal reflux disease(GERD)
timeFrame: at 24 months
measure: Gastroesophageal reflux disease symptoms
timeFrame: at 3 months
measure: Gastroesophageal reflux disease symptoms
timeFrame: at 6 months
measure: Gastroesophageal reflux disease symptoms
timeFrame: at 12 months
measure: Gastroesophageal reflux disease symptoms
timeFrame: at 24 months
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Francdesco Pizza
state: Naples
Study officials:
References: