AzTrials
AzTrials

Bariatric Surgery CandidateNCT04450082

One Anastomosis Gastric Bypass After Sleeve Gastrectomy Failure

An observational study of Bariatric Surgery Candidate, run by Azienda Sanitaria Locale Napoli 2 Nord.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bariatric Surgery Candidate
What is being tested?
One anastomosis gastric bypass
Type of treatment
Surgery or procedure
How many people
59 participants
Where
No sites listed yet
Study dates
1 Jan 2014to 21 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients underwent to One anastomosis gastric bypass after sleeve gastrectomy failure

Who may be able to join

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

Who cannot join

  • 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)

About this study

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

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

Read the detailed 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.

Being tested
One anastomosis gastric bypass
Keywords
Sleeve gastrectomy, One Anastomosis gastric bypass

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • One anastomosis gastric bypassProcedure or surgery

    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.

Study groups in NCT04450082
Study groupRoleWhat they receive
One anastomosis gastric bypassOne anastomosis gastric bypass in Sleeve Gastrectomy failure
Receives: Procedure: One anastomosis gastric bypass

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Mass Index (kg/m2)

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

    Measured: 24 months

Secondary outcomes (1)
  1. 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

    Measured: at 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2020
  2. Study start1 Jan 2014
  3. Primary completion28 Feb 2019
  4. Study completion21 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04450082
Sponsor's protocol ID
22062020
Other IDs
22062020
Status last verified
Jun 2020
First submitted
24 Jun 2020
Last updated
29 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bariatric Surgery Candidate, run by Azienda Sanitaria Locale Napoli 2 Nord.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass Index (kg/m2) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in