Polish Revision Obesity Surgery Study

• Conditions: Metabolic Disease; Obesity, Morbid

• Registration Number: NCT05108532
• Lead Sponsor: Medical University of Gdansk

Brief Summary

Bariatric surgery is well established method of treating patients with obesity. Obesity is well-documented risk factor for many health conditions including some cancer, cardiovascular diseases, pulmonary diseases and type-2 diabetes. Bariatric surgery is associated with improved comorbidities, quality of life and survival in severe obesity. However, the rate of conversion or revisional bariatric surgeries is increasing nowadays. Recent date estimate the rate of revisional procedures between 8-25% of all bariatric surgeries performed worldwide.

Weight recidivism or fail to achieve a significant weight loss (estimated 10-20% of operated patients) remains a challenge for surgeons and patients. This has economic and health implications, leading to reduction in quality of life and increased prevalence of obesity-related comorbid conditions. Therefore, the aim of this study is to identified patients with failure after primary bariatric procedure in population of Poland.

Detailed Description

All participating medical institutions performing metabolic and bariatric surgeries from Poland can register patients via online questionaries. The database will include all patients with full preoperative history regarding the status of comorbidities, maximum weight and BMI. Details regarding initial surgery will be collected: type of procedure, time of procedure, length of the procedure, technical aspects (type of anastomosis, location of the anastomosis, type and amount of staplers used, length of bypassed jejunum, type of gastric band), length of hospital stay, short-term complications. The outcomes of initial surgery will be noticed: %TWL, minimum weight and BMI, remission of comorbidities, improvement of comorbidities, reduction of pharmacological treatment. Long-term postoperative complications in example de novo reflux, stenosis of anastomosis, stricture of gastric pouch will be included in analysis. The cause of revisionary surgery will be analyzed. The secondary bariatric procedure will be analyzed in terms of time, type and its length. Detail information of technical aspects will be collected. The complications and outcomes of revisional surgery will be acquired from hospitals registers, as well as, informations received from clinical follow-up.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-10-25
• Last Update Submitted: 2021-10-25
• Study First Posted: 2021-11-05
• Last Update Posted: 2021-11-05
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Patients after revisional bariatric surgery, male and females over 18 years old, any type of primary bariatric surgery.

Exclusion Criteria

Lack of follow-up, lack of anthropometric details at any point of a study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
indications for revisional bariatric operations,	10 years
type of surgeries most frequently chosen as revisional procedures	10 years
course of perioperative treatment among patients undergoing revisional and secondary revisional bariatric surgery	10 years

Trial Locations

Locations (1)

Medical University of Gdańsk; 🇵🇱 Gdańsk, Poland