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

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05481853
• Other study ID #: 43-20-ASMC
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2022
• Source: Holy Family Hospital, Nazareth, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6722
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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. Exclusion Criteria: Age = 18 years old -

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• One Anastomosis Gastric Bypass

Locations

Country	Name	City	State
Israel	Assuta Medical Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Holy Family Hospital, Nazareth, Israel	Assuta Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	=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	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