Clinical trial NCT05108532: Polish Revision Obesity Surgery Study
Official title: Polish Revision Obesity Surgery Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Disease
Obesity, Morbid
Keywords: bariatric surgery failure
revisional bariatric surgery
secondary bariatric procedure
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
Collaborators: name: University of Warmia and Mazury in Olsztyn
name: Jagiellonian University
name: Medical University in Białystok
name: Nicolaus Copernicus University
name: Military Institute od Medicine National Research Institute
First posted: 2021-11-05
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after revisionary bariatric and metabolic surgery. Operated in Poland.m

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.

Eligibility criteria: 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.

Primary outcomes:
measure: indications for revisional bariatric operations,
timeFrame: 10 years
measure: type of surgeries most frequently chosen as revisional procedures
timeFrame: 10 years
measure: course of perioperative treatment among patients undergoing revisional and secondary revisional bariatric surgery
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdańsk
Study officials:
affiliation: Medical University of Gdansk
name: Monika Proczko-Stepaniak, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Switzer NJ, Karmali S, Gill RS, Sherman V. Revisional Bariatric Surgery. Surg Clin North Am. 2016 Aug;96(4):827-42. doi: 10.1016/j.suc.2016.03.004.
citation: Acevedo E, Mazzei M, Zhao H, Lu X, Edwards MA. Outcomes in conventional laparoscopic versus robotic-assisted revisional bariatric surgery: a retrospective, case-controlled study of the MBSAQIP database. Surg Endosc. 2020 Apr;34(4):1573-1584. doi: 10.1007/s00464-019-06917-5. Epub 2019 Jun 17.
citation: van Rijswijk AS, van Olst N, Schats W, van der Peet DL, van de Laar AW. What Is Weight Loss After Bariatric Surgery Expressed in Percentage Total Weight Loss (%TWL)? A Systematic Review. Obes Surg. 2021 Aug;31(8):3833-3847. doi: 10.1007/s11695-021-05394-x. Epub 2021 May 17.