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Completed

NCT Number: NCT04323072

Does Antrum Size Matter in Sleeve Gastrectomy?

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.

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Key information

Conditions

Bariatric Surgery Candidate

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Francdesco Pizza

Naples, 80035, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wide antrectomy

Procedure

The starting point of resection of the stomach from the pylorus to begin the gastrectomy is 2 cm.

Smal antrectomy

Procedure

The starting point of resection of the stomach from the pylorus to begin the gastrectomy is 6 cm.

Primary outcomes

  1. Postoperative weight and height combined to report BMI in kg/m^2

    Time frame: 3 months

    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)

  2. Postoperative weight and height combined to report BMI in kg/m^2

    Time frame: 6 months

    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. Postoperative weight and height combined to report BMI in kg/m^2

    Time frame: 12 months

    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)

  4. Postoperative weight and height combined to report BMI in kg/m^2

    Time frame: 24 months

    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)

  5. Postoperative percentage excess weigth loss

    Time frame: 3 months

    Change of weight expressed in percentage of excess weight loss postoperatively at follow-up

  6. Postoperative percentage excess weigth loss

    Time frame: 6 months

    Change of weight expressed in percentage of excess weight loss postoperatively at follow-up

  7. Postoperative percentage excess weigth loss

    Time frame: 12 months

    Change of weight expressed in percentage of excess weight loss postoperatively at follow-up

  8. Postoperative percentage excess weigth loss

    Time frame: 24 months

    Change of weight expressed in percentage of excess weight loss postoperatively at follow-up

Secondary outcomes

  1. Gastroesophageal reflux disease(GERD)

    Time frame: at 12 months

    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

  2. Gastroesophageal reflux disease(GERD)

    Time frame: at 24 months

    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

  3. Gastroesophageal reflux disease symptoms

    Time frame: at 3 months

    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.

  4. Gastroesophageal reflux disease symptoms

    Time frame: at 6 months

    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.

  5. Gastroesophageal reflux disease symptoms

    Time frame: at 12 months

    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.

  6. Gastroesophageal reflux disease symptoms

    Time frame: at 24 months

    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.

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale Napoli 2 Nord

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 26, 2020
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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