Comparative Outcomes of One-Anastomosis Gastric Bypass and Roux-en-Y Gastric Bypass As Revisional Procedures Following Failed Restrictive Bariatric Surgery

NCT06794892 | Completed

• 1 other identifier: 2025010188
• Study Type: observational
• Target: 328
• Locations: 1 country
• Sites: 1

Brief Summary

Study Description This prospective, multicenter study aims to compare the outcomes of One-Anastomosis Gastric Bypass (OAGB) and Roux-en-Y Gastric Bypass (RYGB) as revisional procedures for patients experiencing insufficient weight loss or weight regain following restrictive bariatric surgeries, such as laparoscopic sleeve gastrectomy (LSG) or laparoscopic adjustable gastric banding (LAGB). Conducted between January 2019 and December 2021, the study involves a three-year follow-up of 328 patients across high-volume bariatric centers. The primary objective is to evaluate the effectiveness of these revisional procedures in achieving additional weight loss. Secondary objectives include analyzing differences in operative times, complication rates (short- and long-term), reduction of obesity-related comorbidities, mortality, and overall patient outcomes. This study uniquely integrates comprehensive pre- and postoperative assessments, including radiological evaluations, to better understand predictors of success and provide evidence for optimal surgical strategies in revisional bariatric care.

Conditions

Obesity, Morbid; Type 2 Diabetes Mellitus (T2DM); Hypertension; Dyslipidemia

Keywords

obesity; One anastomosis gastric bypass; Roux and Y gastric Bypass

Outcome Measures

Primary Outcomes (3)

• Percentage Total Weight Loss (%TWL)

  The percentage of total body weight lost from the pre-revisional weight to the weight at 36 months post-revision.

  Measured at 12 months post-surgery.

• Percentage Total Weight Loss (%TWL)

  The percentage of total body weight lost from the pre-revisional weight to the weight at 36 months post-revision.

  Measured at 24, months post-surgery.

• Percentage Total Weight Loss (%TWL)

  The percentage of total body weight lost from the pre-revisional weight to the weight at 36 months post-revision.

  Measured at 36 months post-surgery.

Secondary Outcomes (21)

• Percentage Excess BMI Loss (%EBMIL)

  Measured at 12 months post-surgery

• Percentage Excess BMI Loss (%EBMIL)

  Measured at 24 months post-surgery

• Percentage Excess BMI Loss (%EBMIL)

  Measured at 36 months post-surgery

• Reduction in Obesity-Related Comorbidities

  36 months

• Complication Rates

  until 30 days follow-up period.

Study Arms (2)

OAGB Cohort - Patients undergoing One-Anastomosis Gastric Bypass as a revisional procedure.

OAGB Cohort: This group consists of patients who underwent One-Anastomosis Gastric Bypass (OAGB) as a revisional bariatric procedure following insufficient weight loss or weight regain after primary restrictive surgeries, such as laparoscopic sleeve gastrectomy (LSG) or laparoscopic adjustable gastric banding (LAGB). These patients were monitored over three years to evaluate outcomes, including weight loss, complication rates, and improvement in obesity-related comorbidities.

RYGB Cohort - Patients undergoing Roux-en-Y Gastric Bypass as a revisional procedure.

RYGB Cohort: This group includes patients who underwent Roux-en-Y Gastric Bypass (RYGB) as a revisional bariatric procedure due to insufficient weight loss or significant weight regain after primary restrictive surgeries, such as laparoscopic sleeve gastrectomy (LSG) or laparoscopic adjustable gastric banding (LAGB). The cohort was followed prospectively over three years to assess outcomes, including weight loss, resolution of obesity-related comorbidities, complication rates, and overall surgical success.

Eligibility Criteria

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

Study Population

Study participants will be selected from a population of adults aged 18 to 65 years who have undergone primary restrictive bariatric surgery, such as laparoscopic sleeve gastrectomy (LSG) or laparoscopic adjustable gastric banding (LAGB), and have experienced insufficient weight loss or significant weight regain. This population will include individuals from multiple high-volume bariatric centers, ensuring a diverse cohort representing a range of demographic, clinical, and surgical characteristics. Eligible participants must meet specific criteria, such as a body mass index (BMI) ≤ 40 kg/m² and stable comorbid conditions. The study will focus on patients who require revisional bariatric surgery and are deemed suitable candidates for One-Anastomosis Gastric Bypass (OAGB) or Roux-en-Y Gastric Bypass (RYGB). Patients with specific contraindications, such as ongoing acute medical conditions or inability to provide informed consent, will be excluded to maintain the integrity and safety of

You may qualify if:

• Adults aged 18-65 years.
• Experienced insufficient weight loss, defined as:
• Excess weight loss (EWL) \< 50%.
• Total weight loss (TWL) \< 25%.
• BMI \> 40 kg/m² at least two years after primary restrictive surgery.
• Previously underwent laparoscopic sleeve gastrectomy (LSG) or laparoscopic adjustable gastric banding (LAGB).
• Undergoing revisional surgery specifically for inadequate weight loss or weight regain.

You may not qualify if:

• Revisional surgery performed for indications other than inadequate weight loss or weight regain (e.g., complications of the primary procedure such as stenosis or refractory gastroesophageal reflux, or for comorbidity management).
• Known psychiatric illness or untreated eating disorders.
• Pregnancy.
• History of prior gastric surgery unrelated to bariatric interventions.

Sponsors & Collaborators

• Azienda Sanitaria Locale Napoli 2 Nord: lead
• University of Campania Luigi Vanvitelli: collaborator

Study Sites (1)

Lacco Ameno Via Fundera 2

Naples, Italy, 80131, Italy

Location

MeSH Terms

Conditions

Obesity, Morbid; Diabetes Mellitus, Type 2; Hypertension; Dyslipidemias; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD. MD,

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: January 30, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)