Metabolic DiseasePROSSNCT05108532
Polish Revision Obesity Surgery Study
An observational study of Metabolic Disease and Obesity, Morbid, run by Medical University of Gdansk at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Metabolic Disease, Obesity, Morbid
- How many people
- 700 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2021to 1 Dec 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after revisionary bariatric and metabolic surgery. Operated in Poland.m
Who may be able to join
- Patients after revisional bariatric surgery, male and females over 18 years old, any type of primary bariatric surgery.
Who cannot join
- Lack of follow-up, lack of anthropometric details at any point of a study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Metabolic Disease, Obesity, Morbid
- Keywords
- bariatric surgery failure, revisional bariatric surgery, secondary bariatric procedure
- Medical subject headings
- Metabolic Diseases, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients after revisional bariatric surgery. | This cohort will include patients, who underwent revisional bariatric surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
indications for revisional bariatric operations,
Measured: 10 years
type of surgeries most frequently chosen as revisional procedures
Measured: 10 years
course of perioperative treatment among patients undergoing revisional and secondary revisional bariatric surgery
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start1 Jan 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 700 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warmia and Mazury in Olsztyn, Jagiellonian University, Medical University in Białystok, Nicolaus Copernicus University, Military Institute od Medicine National Research Institute
- Responsible party
- Sponsor
- Investigators
- Monika Proczko-Stepaniak, Prof, Principal investigator, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108532
- Sponsor's protocol ID
- PROSS
- Acronym
- PROSS
- Status last verified
- Oct 2021
- First submitted
- 25 Oct 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27473804Acevedo 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.
PubMed 31209611van 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.
PubMed 34002289Dowgiallo-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.
PubMed 37081459Labul 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.
PubMed 36242680
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polish Revision Obesity Surgery Study
- ClinicalTrials.gov ID
- NCT05108532
- Acronym / sponsor ID
- PROSS / PROSS
- Conditions
- Metabolic Disease, Obesity, Morbid
- Keywords
- bariatric surgery failure, revisional bariatric surgery, secondary bariatric procedure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Collaborators
- University of Warmia and Mazury in Olsztyn, Jagiellonian University, Medical University in Białystok, Nicolaus Copernicus University, Military Institute od Medicine National Research Institute
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients after revisional bariatric surgery. | – | –This cohort will include patients, who underwent revisional bariatric surgery. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after revisionary bariatric and metabolic surgery. Operated in Poland.m
Key inclusion criteria (1 listed)
- Patients after revisional bariatric surgery, male and females over 18 years old, any type of primary bariatric surgery.
Key exclusion criteria (1 listed)
- Lack of follow-up, lack of anthropometric details at any point of a study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
indications for revisional bariatric operations,
Time frame: 10 years
type of surgeries most frequently chosen as revisional procedures
Time frame: 10 years
course of perioperative treatment among patients undergoing revisional and secondary revisional bariatric surgery
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Background: PubMed 27473804Switzer 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.
- Background: PubMed 31209611Acevedo 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.
- Background: PubMed 34002289van 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.
- Derived from this study: PubMed 37081459Dowgiallo-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.
- Derived from this study: PubMed 36242680Labul 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Proczko-Stepaniak, Prof principal investigator
Medical University of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Disease and Obesity, Morbid, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
indications for revisional bariatric operations, (time frame: 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05108532, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.