One Anastomosis Gastric Bypass After Sleeve Gastrectomy Failure

NCT04450082 | Completed

• 1 other identifier: 22062020
• Study Type: observational
• Target: 59
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a retrospective analysis of prospectively collected data on 582 obese patients. The primary aim of the study was to evaluate %Excess Weight Loss, Body Mass Index (BMI) and remission of comorbidity at mid- and long-term follow-up after One Anastomosis Gastric Bypass in subjects previously underwent Sleeve Gastrectomy. The secondary aim was to investigate the onset of esophagitis and gastritis at Upper Endoscopy (UE) and the presence of nutritional deficiencies in patients undergoing One Anastomosis Gastric Bypass as a redo surgery

Conditions

Bariatric Surgery Candidate

Keywords

Sleeve gastrectomy; One Anastomosis gastric bypass

Outcome Measures

Primary Outcomes (1)

• Body Mass Index (kg/m2)

  Body Mass Index (kg/m2) at follow-up after OAGB in subjects previously underwent Sleeve Gastrectomy

  24 months

Secondary Outcomes (1)

• Gastroesophageal reflux disease(GERD)

  at 24 months

Study Arms (1)

One anastomosis gastric bypass

One anastomosis gastric bypass in Sleeve Gastrectomy failure

Procedure: One anastomosis gastric bypass

Interventions

One anastomosis gastric bypass PROCEDURE

The linear stapler divides the stomach horizontally at the junction of the corpus and antrum at the level of crow's foot. In cases where the pre-operative study has shown the presence of the gastric fundus, if possible the fundus was dissected and a long, narrow gastric pouch was designed starting from beyond the crow's foot to just lateral the angle of His over a 42-Fr orogastric tube. Gastrojejunostomy was then performed between 200-220 cm distally to the ligament of Treitz using a 45-mm.

One anastomosis gastric bypass

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients underwent to One anastomosis gastric bypass after sleeve gastrectomy failure

You may qualify if:

• informed consent.
• morbid obesity defined as body mass index (BMI) 40 kg/m2
• Sleeve Gastrectomy failure

You may not qualify if:

• previous bariatric surgical procedures other than Sleeve Gastrectomy
• endocrine disorders causing obesity
• pregnancy or lactation
• psychiatric illness
• inflammatory bowel disease
• Barrett ́s oesophagus
• severe gastro-oesophageal Reflux Disease with esophagitis B and C
• a large hiatal hernia (\>5 cm)

Sponsors & Collaborators

• Azienda Sanitaria Locale Napoli 2 Nord: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Bariatric Unit

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 29, 2020
• Study Start: January 1, 2014
• Primary Completion: February 28, 2019
• Study Completion: June 21, 2020
• Last Updated: June 29, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share