One Anastomosis Gastric Bypass for Severe Obesity in 6,722 Patients: Early Outcomes From the Assuta Surgery Registry

NCT05481853 | Completed

• 1 other identifier: 43-20-ASMC
• Study Type: observational
• Target: 6,722
• Locations: 1 country
• Sites: 1

Brief Summary

Background: One-anastomosis gastric bypass (OAGB) is an emerging type of bariatric metabolic surgery (BMS). Our study aimed to evaluate the short-term (≤30-day) postoperative safety of OAGB. Methods: Electronic medical records of all OAGBs performed between January 2017 and December 2021 at a high-volume bariatric center in Israel were scanned using the MDClone software. Data regarding patients' characteristics, surgical procedure, ≤30-day postoperative complications, and their classification according to Clavien-Dindo grade were gathered. Moreover, multivariate logistic regression analysis was used to identify factors related to early postoperative complications after OAGB. Results: A total of 6,722 patients underwent a primary (74.1%) or revisional (25.9%) OAGB procedure at our institution during the study period. Their preoperative mean age and body mass index (BMI) were 40.6±11.5 years and 41.2±4.6 kg/m2, respectively, and 75.0% were females. Respective mean operating time and length of stay were 67.3±26.6 minutes and 2.2±1.4 days. Complications occurred in 258 patients (3.8%), and include mainly bleeding (n=133, 2.0%), leaks (n=32, 0.5%), and obstruction/strictures (n=19, 0.3%). According to Clavien-Dindo classification, complication rate for grades 1-2 and grades 3a-5 were 1.6%; and 1.4%, respectively. The mortality rate was 0.03% (n=2). The rate of readmission and reoperation were 1.9% and 0.9%, respectively. Age ≥60 years, ≥3 hours of operating room time, and cholecystectomy concomitant with OAGB were independent predictors of early post-OAGB complications. Conclusions: OAGB was found to be a safe primary and revisional BMS procedure in the ≤30-day postoperative term. The most common early complications were gastrointestinal bleeding (2.0%), leak (0.5%), and stricture (0.3%).

Conditions

Morbid Obesity

Keywords

Severe obesity, Bariatric surgery, One anastomosis gastric bypass, Early postoperative complications

Outcome Measures

Primary Outcomes (1)

• ≤30-day postoperative safety of OAGB based on electronic medical records of 6,722 consecutive adult patients who underwent standardized OAGB surgery at a high-volume bariatric center in Israel.

  1.1.2017 - 31/12/2021

Secondary Outcomes (1)

• The causes and management of complications, which are potentially difficult clinical scenarios that can be faced by any bariatric surgeon.

  1.1.2017 - 31/12/2021

Interventions

One Anastomosis Gastric Bypass PROCEDURE

Eligibility Criteria

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

Study Population

Using the MDClone software, the electronic medical records of all patients who underwent primary or revisional OAGB at the Assuta Bariatric Centers (ABCs) between January 2017 and December 2021 were retrospectively scanned. The study was approved by the Assuta Medical Centers' ethics committee (approval number 43-20-ASMC). Informed consent was waived due to the retrospective and anonymous nature of data collected.

You may qualify if:

• Age ≥18 years old, patients who received approval to undergo Bariatric and Metabolic Surgery by Assuta Medical Centers' bariatric committee, patients who have undergone primary or revisional OAGB surgery at ABCs, and patients who had complete follow-up data of 30-day post-procedure.

Sponsors & Collaborators

• Holy Family Hospital, Nazareth, Israel: lead
• Assuta Medical Center: collaborator

Study Sites (1)

Assuta Medical Center

Tel Aviv, 1641100, Israel

Location

MeSH Terms

Conditions

Obesity, Morbid; Postoperative Complications

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chef Departemtn of General Surgery

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: January 1, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)