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Clinical Trials/NCT05481853
NCT05481853CompletedNot Applicable

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

Holy Family Hospital, Nazareth, Israel1 site in 1 country6,722 target enrollmentStarted: January 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
6,722
Locations
1
Primary Endpoint
≤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.

Study Overview

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%).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

≤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.

Time Frame: 1.1.2017 - 31/12/2021

Secondary Outcomes

  • 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)

Investigators

Sponsor
Holy Family Hospital, Nazareth, Israel
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nasser Sakran

Chef Departemtn of General Surgery

Holy Family Hospital, Nazareth, Israel

Study Sites (1)

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