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Polish Revision Obesity Surgery Study

Polish Revision Obesity Surgery Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05108532
Acronym
PROSS
Enrollment
700
Registered
2021-11-05
Start date
2021-01-01
Completion date
2021-12-01
Last updated
2021-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Disease, Obesity, Morbid

Keywords

bariatric surgery failure, revisional bariatric surgery, secondary bariatric procedure

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.

Interventions

None listed

Sponsors

University of Warmia and Mazury in Olsztyn
CollaboratorOTHER
Jagiellonian University
CollaboratorOTHER
Medical University in Białystok
CollaboratorUNKNOWN
Nicolaus Copernicus University
CollaboratorOTHER
Military Institute od Medicine National Research Institute
CollaboratorOTHER
Medical University of Gdansk
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
indications for revisional bariatric operations,10 years
type of surgeries most frequently chosen as revisional procedures10 years
course of perioperative treatment among patients undergoing revisional and secondary revisional bariatric surgery10 years

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026