Polish Revision Obesity Surgery Study

NCT05108532 | Unknown

• 1 other identifier: PROSS
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Disease; Obesity, Morbid

Keywords

bariatric surgery failure; revisional bariatric surgery; secondary bariatric procedure

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Patients after revisional bariatric surgery.

This cohort will include patients, who underwent revisional bariatric surgery.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients after revisionary bariatric and metabolic surgery. Operated in Poland.m

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Gdansk: lead
• University of Warmia and Mazury in Olsztyn: collaborator
• Jagiellonian University: collaborator
• Medical University in Białystok: collaborator
• Nicolaus Copernicus University: collaborator
• Military Institute od Medicine National Research Institute: collaborator

Study Sites (1)

Medical University of Gdańsk

Gdansk, Poland

Location

Related Publications (5)

• 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.

  PMID: 27473804 BACKGROUND

• 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.

  PMID: 31209611 BACKGROUND

• 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.

  PMID: 34002289 BACKGROUND

• Dowgiallo-Gornowicz N, Janik M, Lech P, Kowalski G, Major P; PROSS -Collaborative Study Group. Revisional bariatric surgery after adjustable gastric band: a multicenter Polish Revision Obesity Surgery Study (PROSS). BMC Surg. 2023 Apr 20;23(1):94. doi: 10.1186/s12893-023-02002-w.

  PMID: 37081459 DERIVED

• Labul M, Wysocki M, Bartosiak K, Orlowski M, Katkowski B, Jaworski P, Malczak P, Major P; PROSS-Collaborative Study Group. Analysis of the Factors Contributing to Bariatric Success After Laparoscopic Redo Bariatric Procedures: Results from Multicenter Polish Revision Obesity Surgery Study (PROSS). Obes Surg. 2022 Dec;32(12):3879-3890. doi: 10.1007/s11695-022-06306-3. Epub 2022 Oct 15.

  PMID: 36242680 DERIVED

MeSH Terms

Conditions

Metabolic Diseases; Obesity, Morbid

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Monika Proczko-Stepaniak, Prof

  Medical University of Gdansk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 5, 2021
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 5, 2021

Record last verified: 2021-10

Locations

PL (1)