Clinical trial NCT05481853: One Anastomosis Gastric Bypass for Severe Obesity in 6,722 Patients: Early Outcomes From the Assuta Surgery Registry
Official title: One Anastomosis Gastric Bypass for Severe Obesity in 6,722 Patients: Early Outcomes From the Assuta Surgery Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Keywords: Severe obesity, Bariatric surgery, One anastomosis gastric bypass, Early postoperative complications
Lead sponsor: Holy Family Hospital, Nazareth, Israel
Sponsor class: OTHER
Collaborators: name: Assuta Medical Center
First posted: 2022-08-01
Enrollment: 6722
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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%).


Eligibility criteria: 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

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Primary outcomes:
measure: ≤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.
timeFrame: 1.1.2017 - 31/12/2021
Secondary outcomes:
measure: The causes and management of complications, which are potentially difficult clinical scenarios that can be faced by any bariatric surgeon.
timeFrame: 1.1.2017 - 31/12/2021
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Assuta Medical Center
Study officials:
References: