One Anastomosis Gastric Bypass After Sleeve Gastrectomy Failure

Bariatric Surgery Candidate Clinical Trial

Official title:

One Anastomosis Gastric Bypass After Sleeve Gastrectomy Failure: Does a Single Procedure Fit for All?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04450082
• Other study ID #: 22062020
• Secondary ID: 22062020
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: June 21, 2020

Study information

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

Clinical Trial 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

Description:

This study is a retrospective analysis of prospectively collected data on 582 obese patients. It was conducted according to the ethical principles stated in the Declaration of Helsinki. Written informed consent was obtained from all subjects. The study protocol was approved by the Regional Ethics Committee. From January 2014 to February 2019, morbid obesity patients who failed previous treatment with SG and referred to our bariatric center in the Department of General and Emergency Surgery of "A. Rizzoli" Hospital in Lacco Ameno (Naples, Italy) for a new bariatric procedure, were considered in the study. Redo surgery was only considered if patients still met the criteria for primary bariatric surgery according to guidelines [body mass index (BMI) >35 kg/m2 with co-morbidities, BMI >40 kg/m2] at the time clinical and anthropometrical revision8. A postoperative follow-up of at least 24 months was also considered inclusion criteria. Exclusion criteria were as follows: patients in whom Sleeve Gastrectomy was already performed as revision surgery; patients underwent any other abdominal surgical procedure after One Anastomosis Gastric Bypass not correlated to the bariatric procedure, the presence at baseline of esophagitis B according to the Los Angeles scale, Hiatal Hernia (HH) > 5 cm and history of GERD-related symptoms (i.e., heartburn, pyrosis, regurgitation) not responsive to proton pump inhibitors and/or severe Lower Esophageal Sfinter incontinence. All procedures were performed by the same experienced bariatric surgeons.

Pre-operative evaluation All patients underwent a multidisciplinary preoperative evaluation including anthropometric measurements (height in cm, weight in kg, Body Mass Index in kg/m2), comorbidity evaluation, preoperative Upper Endoscopy with Helicobacter Pylori test, abdomen ultrasound, chest x-ray and nutritional status evaluation.

Radiographic barium swallow test was performed for the diagnosis of HH or presence of gastric fundus. Barium swallow X-ray protocol consisted of five swallows of barium always using the same amount of liquid; anteroposterior and oblique views were obtained in upright and supine positions. Measurements were done using a standardized protocol: a distance of more than 2 cm between the gastroesophageal junction and the diaphragmatic hiatus was defined as a sliding Hiatal Hernia. Preoperative assessments of patient eligibility for bariatric surgery included consultation with the multidisciplinary committee (surgeon, radiologist, diabetologist and psychiatrist) to exclude patients with non-adjusted eating patterns or eating disorders.

Failure of Sleeve Gastrectomy was defined as a consequence of Insufficient Weight Loss or Weight Regain. Insufficient Weight Loss or Weight Regain were analyzed considering the modifications of the percentage of excess weight loss <50% and/or the percentage of total weight loss <25%. A failure of Sleeve Gastrectomy was recognized if the subject was not able to reduce the Body Mass Index <35 with the persistence of co-morbidity or Body Mass Index <40 at least 2-year after the primary surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 21, 2020
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

• informed consent.

• morbid obesity defined as body mass index (BMI) 40 kg/m2

• Sleeve Gastrectomy failure

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Procedure:
• One anastomosis gastric bypass
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale Napoli 2 Nord

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index (kg/m2)	Body Mass Index (kg/m2) at follow-up after OAGB in subjects previously underwent Sleeve Gastrectomy	24 months
Secondary	Gastroesophageal reflux disease(GERD)	Esophagitis 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