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

NCT05481853 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6722

Last updated 2022-08-02

No results posted yet for this study

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

Interventions

PROCEDURE

One Anastomosis Gastric Bypass

Sponsors & Collaborators

  • Assuta Medical Center

    collaborator OTHER

  • Holy Family Hospital, Nazareth, Israel

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05481853 on ClinicalTrials.gov