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Polish Revision Obesity Surgery Study

NCT ID: NCT05108532

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-12-01

Brief Summary

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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

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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.

Conditions

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Metabolic Disease Obesity, Morbid

Keywords

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bariatric surgery failure revisional bariatric surgery secondary bariatric procedure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients after revisional bariatric surgery.

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Warmia and Mazury in Olsztyn

OTHER

Sponsor Role collaborator

Jagiellonian University

OTHER

Sponsor Role collaborator

Medical University in Białystok

UNKNOWN

Sponsor Role collaborator

Nicolaus Copernicus University

OTHER

Sponsor Role collaborator

Military Institute od Medicine National Research Institute

OTHER

Sponsor Role collaborator

Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Monika Proczko-Stepaniak, Prof

Role: PRINCIPAL_INVESTIGATOR

Medical University of Gdansk

Locations

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Medical University of Gdańsk

Gdansk, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type BACKGROUND
PMID: 27473804 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31209611 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34002289 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37081459 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36242680 (View on PubMed)

Other Identifiers

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PROSS

Identifier Type: -

Identifier Source: org_study_id