Does Antrum Size Matter in Sleeve Gastrectomy?

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04323072
• Other study ID #: 01032020
• Status: Completed
• Phase: N/A
• Start date: March 1, 2015
• Est. completion date: January 1, 2017

Study information

• Verified date: March 2020
• Source: Azienda Sanitaria Locale Napoli 2 Nord
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Procedure:
• Wide antrectomy
The starting point of resection of the stomach from the pylorus to begin the gastrectomy is 2 cm.
• Smal antrectomy
The starting point of resection of the stomach from the pylorus to begin the gastrectomy is 6 cm.

Locations

Country	Name	City	State
Italy	Francdesco Pizza	Napoli	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale Napoli 2 Nord

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative weight and height combined to report BMI in kg/m^2	Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2)	3 months
Primary	Postoperative weight and height combined to report BMI in kg/m^2	Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2)	6 months
Primary	Postoperative weight and height combined to report BMI in kg/m^2	Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2)	12 months
Primary	Postoperative weight and height combined to report BMI in kg/m^2	Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2)	24 months
Primary	Postoperative percentage excess weigth loss	Change of weight expressed in percentage of excess weight loss postoperatively at follow-up	3 months
Primary	Postoperative percentage excess weigth loss	Change of weight expressed in percentage of excess weight loss postoperatively at follow-up	6 months
Primary	Postoperative percentage excess weigth loss	Change of weight expressed in percentage of excess weight loss postoperatively at follow-up	12 months
Primary	Postoperative percentage excess weigth loss	Change of weight expressed in percentage of excess weight loss postoperatively at follow-up	24 months
Secondary	Gastroesophageal reflux disease(GERD)	Esophagitys grading according to Los Angeles classification with Upper endoscopy (Grade A: One or more mucosal breaks < 5 mm in maximal length; Grade B: One or more mucosal breaks > 5mm, but without continuity across mucosal folds; Grade C: Mucosal breaks continuous between = 2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D Mucosal breaks involving more than 75% of esophageal circumference	at 12 months
Secondary	Gastroesophageal reflux disease(GERD)	Esophagitys grading according to Los Angeles classification with Upper endoscopy (Grade A: One or more mucosal breaks < 5 mm in maximal length; Grade B: One or more mucosal breaks > 5mm, but without continuity across mucosal folds; Grade C: Mucosal breaks continuous between = 2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D Mucosal breaks involving more than 75% of esophageal circumference	at 24 months
Secondary	Gastroesophageal reflux disease symptoms	All patients were surveyed about the presence of heartburn and/or regurgitation with a specific questionnaire GERD HRQL(Gastroesophageal Reflux Disease Health-Related Quality of Life) questionnaire. Each of the 10 questions were rated from 0 (absence of symptoms) to 5 (severe symptoms) for a total score that may range from 0 to 50. Symptoms were defined as absent when patients reported a GERD-HRQL score of 0, mild from 1 to 15, moderate from 16 to 24, and severe from 25 to 50.; Patients with GERD-HRQL score >16 was considered positive for GERD.	at 3 months
Secondary	Gastroesophageal reflux disease symptoms	All patients were surveyed about the presence of heartburn and/or regurgitation with a specific questionnaire GERD HRQL(Gastroesophageal Reflux Disease Health-Related Quality of Life) questionnaire. Each of the 10 questions were rated from 0 (absence of symptoms) to 5 (severe symptoms) for a total score that may range from 0 to 50. Symptoms were defined as absent when patients reported a GERD-HRQL score of 0, mild from 1 to 15, moderate from 16 to 24, and severe from 25 to 50.; Patients with GERD-HRQL score >16 was considered positive for GERD.	at 6 months
Secondary	Gastroesophageal reflux disease symptoms	All patients were surveyed about the presence of heartburn and/or regurgitation with a specific questionnaire GERD HRQL(Gastroesophageal Reflux Disease Health-Related Quality of Life) questionnaire. Each of the 10 questions were rated from 0 (absence of symptoms) to 5 (severe symptoms) for a total score that may range from 0 to 50. Symptoms were defined as absent when patients reported a GERD-HRQL score of 0, mild from 1 to 15, moderate from 16 to 24, and severe from 25 to 50.; Patients with GERD-HRQL score >16 was considered positive for GERD.	at 12 months
Secondary	Gastroesophageal reflux disease symptoms	All patients were surveyed about the presence of heartburn and/or regurgitation with a specific questionnaire GERD HRQL(Gastroesophageal Reflux Disease Health-Related Quality of Life) questionnaire. Each of the 10 questions were rated from 0 (absence of symptoms) to 5 (severe symptoms) for a total score that may range from 0 to 50. Symptoms were defined as absent when patients reported a GERD-HRQL score of 0, mild from 1 to 15, moderate from 16 to 24, and severe from 25 to 50.; Patients with GERD-HRQL score >16 was considered positive for GERD.	at 24 months