Polish Revision Obesity Surgery Study

Obesity, Morbid Clinical Trial

— PROSS  

Official title:

Polish Revision Obesity Surgery Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05108532
• Other study ID #: PROSS
• Status: Active, not recruiting
• Start date: January 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: October 2021
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases
• Obesity
• Obesity, Morbid

Locations

Country	Name	City	State
Poland	Medical University of Gdansk	Gdansk

Sponsors (6)

Lead Sponsor	Collaborator
Medical University of Gdansk	Jagiellonian University, Medical University in Bialystok, Military Institute of Medicine, Poland, Nicolaus Copernicus University, University of Warmia and Mazury in Olsztyn

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	indications for revisional bariatric operations,		10 years
Primary	type of surgeries most frequently chosen as revisional procedures		10 years
Primary	course of perioperative treatment among patients undergoing revisional and secondary revisional bariatric surgery		10 years