Urethral StrictureVeSpARNCT03572348
VeSpAR: Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Strictures.
A study testing Transecting anastomotic repair (tAR) and Vessel-sparing anastomotic repair (vsAR) in people with Urethral Stricture and Surgery, run by University Hospital, Ghent at 13 sites in 8 countries.
Trial summary
The investigators want to verify whether the surgical outcome of vessel-sparing anastomotic repair in isolated short bulbar urethral strictures is not inferior to the surgical outcome of transecting anastomotic repair. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urethral Stricture, Surgery, Urologic Diseases
- What is being tested?
- Transecting anastomotic repair (tAR) and Vessel-sparing anastomotic repair (vsAR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 13 sitesin 8 countries
- Study dates
- 26 Sep 2018to 14 Dec 2023
- Phase
- Interventional
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary signed written informed consent (according to the rules of Good Clinical Practice and national regulations)
- Male
- Age >= 18 years
- Fit for operation, based on the surgeon's expert opinion
- Isolated short (=< 3cm) bulbar urethral stricture confirmed by preoperative retrograde urethrography (RUG), voiding cysto-urethrography (VCUG), cystoscopy, ultrasonography or a combination of investigations
- Unique urethral stricture
Show all 9Show fewer
- Urethral stricture =< 3 cm
- Urethral stricture at the bulbar segment
- Patient declares that it will be possible for him to attend the follow-up consultation
Who cannot join
- Absence of signed written informed consent
- Age <18 years
- Female patients
- Transgender patients
- Patients unfit for operation
- Concomitant urethral strictures at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck)
Show all 16Show fewer
- Urethral strictures exceeding 3 cm
- A unique urethral stricture at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck)
- Lichen Sclerosus related strictures
- Strictures after failed hypospadias repair
- Patients with neurogenic bladder
- Shift of technique to augmented urethroplasty due to any circumstance
- History of pelvic radiation therapy
- Active treatment to enhance erectile function (such as PDE5-inhibitors and intracavernous injections) at the moment of prescreening for inclusion in this trial
- Any condition or situation, which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study
- Patient declares that it will be impossible for him to attend the follow-up consultations
Trial locations and contacts
13 sites in 8 countries.
13 sites in 8 countries
United States2 sites
Department of Urology, Eastern Virginia Medical School
Norfolk, Virginia, 23507-1912
Department of Urology, SUNY Upstate Medical University
Syracuse, New York, 13210
Argentina2 sites
Department of Urology, Centro de Educación Médica e Investigaciones Clínicas
Buenos Aires
Department of Urology, Hospital Italiano de Buenos Aires
Buenos Aires
Belgium2 sites
Dept. of Urology, Ghent University Hospital
Ghent, 9000
Dept. of Urology, University Hospital Leuven
Leuven
Mexico2 sites
Centro de Uretra Las Alamedas
Mexico City
Department of Urology, Hospital San José Tecnológico de Monterrey, Universidad de Monterrey
Monterrey
Spain2 sites
Department of Urology, Departamento Clínico, Facultad de Ciencias Biomédicas, Universidad Europea de Madrid, Hospital Universitario de Getafe
Madrid
Dept. of Urology, Hospital Univ. de Valdecilla
Santander
China1 site
Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai
Portugal1 site
Department of Urology, Hospital de Santa María, Universidad de Lisboa
Lisbon
United Kingdom1 site
Department of Urology, University College London Hospital
London
About this study
Official title: VeSpAR: A Randomized Controlled Trial Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Urethral Strictures
The investigators want to verify whether the surgical outcome of vessel-sparing anastomotic repair in isolated short bulbar urethral strictures is not inferior to the surgical outcome of transecting anastomotic repair. Furthermore, the investigators compare the functional outcome of both techniques verifying if there is less erectile dysfunction after vessel-sparing anastomotic repair than after transecting anastomotic repair.
Read the detailed description
A randomized controlled trial comparing vessel-sparing anastomotic repair (vsAR) and transecting anastomotic repair (tAR) in isolated short bulbar urethral strictures (maximum 3 centimeter) for both surgical and functional outcome, to demonstrate that vsAR is not inferior to tAR regarding the surgical outcome, and to demonstrate a benefit for vsAR over tAR regarding postoperative erectile function.
- Conditions
- Urethral Stricture, Surgery, Urologic Diseases
- Being tested
- Transecting anastomotic repair (tAR), Vessel-sparing anastomotic repair (vsAR)
- Keywords
- urethral stricture, urethroplasty, bulbar urethra, reconstructive surgery, lower urinary tract symptoms, erectile function
- Medical subject headings
- Urethral Stricture, Urologic Diseases, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transecting anastomotic repair (tAR)Procedure or surgery
Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply.
Vessel-sparing anastomotic repair (vsAR)Procedure or surgery
Alternative technique, leaving the bulbar arteries intact, only transecting and excising the narrow segment of the urethra and the surrounding spongiofibrosis.
| Study group | Role | What they receive |
|---|---|---|
| Transecting anastomotic repair (tAR) | Active comparator | Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply. Receives: Procedure: Transecting anastomotic repair (tAR) |
| Vessel-sparing anastomotic repair (vsAR) | Active comparator | Alternative technique, leaving the bulbar arteries intact, only transecting and excising the narrow segment of the urethra and the surrounding spongiofibrosis. Receives: Procedure: Vessel-sparing anastomotic repair (vsAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
FFS at 24 months
Failure-free survival at 24 months. Surgical failure is defined as urethroscopic evidence of stricture recurrence, impossible to pass with a 16Fr silicone urethral catheter, independent of whether the stricture is treated or not.
Measured: 24 months
Secondary outcomes (10)
FFS at 3 and 12 months
Failure-free survival at 3 and 12 months. Surgical failure is defined as urethroscopic evidence of stricture recurrence, impossible to pass with a 16Fr silicone urethral catheter, independent of whether the stricture is treated or not.
Measured: 3 and 12 months
Erectile function
Erectile function score assessed by the International Index of Erectile Function (IIEF-5) questionnaire
Measured: 3, 12, and 24 months
Ejaculatory function
Ejaculatory function score assessed by the Male Sexual Health Questionnaire - Ejaculatory Dysfunction short form (MSHQ-EjD short form)
Measured: 3, 12, and 24 months
Voiding function
Lower Urinary Tract symptoms assessed by the Peeling's voiding picture.
Measured: 3, 12, and 24 months
Lower Urinary Tract symptoms
Lower Urinary Tract symptoms assessed by the International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms module (ICIQ-MLUTS)
Measured: 3, 12, and 24 months
Urinary incontinence
Urinary incontinence assessed by the International Consultation on Incontinence Questionnaire - Urinary Incontinence short form (ICIQ-UI)
Measured: 3, 12, and 24 months
Maximum flow rate
Qmax assessed using uroflowmetry
Measured: 3, 12, and 24 months
Residual urinary volumes
Residual urinary volumes examined by suprapubic ultrasonic measurement after voiding
Measured: 3, 12, and 24 months
Quality of life (EQ-5D-3L)
QoL scored by the EQ-5D-3L questionnaire
Measured: 3, 12, and 24 months
Quality of life (EQ-VAS)
QoL scored by the EQ visual analogue scale (EQ-VAS)
Measured: 3, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start26 Sep 2018
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Urethral StrictureStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, interventional, multicentric, single-blinded, randomized, controlled, non-inferiority, phase II trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572348
- Sponsor's protocol ID
- BC-03662
- Acronym
- VeSpAR
- Status last verified
- Jan 2024
- First submitted
- 5 Jun 2018
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Latini JM, McAninch JW, Brandes SB, Chung JY, Rosenstein D. SIU/ICUD Consultation On Urethral Strictures: Epidemiology, etiology, anatomy, and nomenclature of urethral stenoses, strictures, and pelvic fracture urethral disruption injuries. Urology. 2014 Mar;83(3 Suppl):S1-7. doi: 10.1016/j.urology.2013.09.009. Epub 2013 Nov 8.
PubMed 24210733Palminteri E, Berdondini E, Verze P, De Nunzio C, Vitarelli A, Carmignani L. Contemporary urethral stricture characteristics in the developed world. Urology. 2013 Jan;81(1):191-6. doi: 10.1016/j.urology.2012.08.062. Epub 2012 Nov 13.
PubMed 23153951Morey AF, Watkin N, Shenfeld O, Eltahawy E, Giudice C. SIU/ICUD Consultation on Urethral Strictures: Anterior urethra--primary anastomosis. Urology. 2014 Mar;83(3 Suppl):S23-6. doi: 10.1016/j.urology.2013.11.007. Epub 2013 Dec 27.
PubMed 24373726Jordan GH, Eltahawy EA, Virasoro R. The technique of vessel sparing excision and primary anastomosis for proximal bulbous urethral reconstruction. J Urol. 2007 May;177(5):1799-802. doi: 10.1016/j.juro.2007.01.036.
PubMed 17437823Gur U, Jordan GH. Vessel-sparing excision and primary anastomosis (for proximal bulbar urethral strictures). BJU Int. 2008 May;101(9):1183-95. doi: 10.1111/j.1464-410X.2008.07619.x. No abstract available.
PubMed 18399836Lumen N, Poelaert F, Oosterlinck W, Lambert E, Decaestecker K, Tailly T, Hoebeke P, Spinoit AF. Nontransecting Anastomotic Repair in Urethral Reconstruction: Surgical and Functional Outcomes. J Urol. 2016 Dec;196(6):1679-1684. doi: 10.1016/j.juro.2016.06.016. Epub 2016 Jun 12.
PubMed 27307398Andrich DE, Mundy AR. Non-transecting anastomotic bulbar urethroplasty: a preliminary report. BJU Int. 2012 Apr;109(7):1090-4. doi: 10.1111/j.1464-410X.2011.10508.x. Epub 2011 Sep 20.
PubMed 21933325Virasoro R, Zuckerman JM, McCammon KA, DeLong JM, Tonkin JB, Capiel L, Rovegno AR, Favre G, Giudice CR, Eltahawy EA, Gur U, Jordan GH. International multi-institutional experience with the vessel-sparing technique to reconstruct the proximal bulbar urethra: mid-term results. World J Urol. 2015 Dec;33(12):2153-7. doi: 10.1007/s00345-015-1512-9. Epub 2015 Feb 18.
PubMed 25690318Bugeja S, Andrich DE, Mundy AR. Non-transecting bulbar urethroplasty. Transl Androl Urol. 2015 Feb;4(1):41-50. doi: 10.3978/j.issn.2223-4683.2015.01.07.
PubMed 26816808Anderson KM, Blakely SA, O'Donnell CI, Nikolavsky D, Flynn BJ. Primary non-transecting bulbar urethroplasty long-term success rates are similar to transecting urethroplasty. Int Urol Nephrol. 2017 Jan;49(1):83-88. doi: 10.1007/s11255-016-1454-1. Epub 2016 Nov 14.
PubMed 27844407Le W, Li C, Zhang J, Wu D, Liu B. Preliminary clinical study on non-transecting anastomotic bulbomembranous urethroplasty. Front Med. 2017 Jun;11(2):277-283. doi: 10.1007/s11684-017-0515-x. Epub 2017 Apr 22.
PubMed 28432540Andrich DE, Dunglison N, Greenwell TJ, Mundy AR. The long-term results of urethroplasty. J Urol. 2003 Jul;170(1):90-2. doi: 10.1097/01.ju.0000069820.81726.00.
PubMed 12796652Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.
PubMed 15227649Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
PubMed 19638912
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VeSpAR: A Randomized Controlled Trial Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Urethral Strictures
- ClinicalTrials.gov ID
- NCT03572348
- Acronym / sponsor ID
- VeSpAR / BC-03662
- Conditions
- Urethral Stricture, Surgery, Urologic Diseases
- Keywords
- urethral stricture, urethroplasty, bulbar urethra, reconstructive surgery, lower urinary tract symptoms, erectile function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 28 Jun 2018 (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.
The investigators want to verify whether the surgical outcome of vessel-sparing anastomotic repair in isolated short bulbar urethral strictures is not inferior to the surgical outcome of transecting anastomotic repair. Furthermore, the investigators compare the functional outcome of both techniques verifying if there is less erectile dysfunction after vessel-sparing anastomotic repair than after transecting anastomotic repair.
Detailed description
A randomized controlled trial comparing vessel-sparing anastomotic repair (vsAR) and transecting anastomotic repair (tAR) in isolated short bulbar urethral strictures (maximum 3 centimeter) for both surgical and functional outcome, to demonstrate that vsAR is not inferior to tAR regarding the surgical outcome, and to demonstrate a benefit for vsAR over tAR regarding postoperative erectile function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, interventional, multicentric, single-blinded, randomized, controlled, non-inferiority, phase II trial
| Arm | Type | Receives |
|---|---|---|
| Transecting anastomotic repair (tAR) | Active comparator | Procedure: Transecting anastomotic repair (tAR)Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply. |
| Vessel-sparing anastomotic repair (vsAR) | Active comparator | Procedure: Vessel-sparing anastomotic repair (vsAR)Alternative technique, leaving the bulbar arteries intact, only transecting and excising the narrow segment of the urethra and the surrounding spongiofibrosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntary signed written informed consent (according to the rules of Good Clinical Practice and national regulations)
- Male
- Age >= 18 years
- Fit for operation, based on the surgeon's expert opinion
- Isolated short (=< 3cm) bulbar urethral stricture confirmed by preoperative retrograde urethrography (RUG), voiding cysto-urethrography (VCUG), cystoscopy, ultrasonography or a combination of investigations
Key exclusion criteria (16 listed)
- Absence of signed written informed consent
- Age <18 years
- Female patients
- Transgender patients
- Patients unfit for operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transecting anastomotic repair (tAR)Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply. | Procedure or surgery | Transecting anastomotic repair (tAR) |
| Vessel-sparing anastomotic repair (vsAR)Alternative technique, leaving the bulbar arteries intact, only transecting and excising the narrow segment of the urethra and the surrounding spongiofibrosis. | Procedure or surgery | Vessel-sparing anastomotic repair (vsAR) |
Primary outcome
FFS at 24 months
Time frame: 24 months
Failure-free survival at 24 months. Surgical failure is defined as urethroscopic evidence of stricture recurrence, impossible to pass with a 16Fr silicone urethral catheter, independent of whether the stricture is treated or not.
10 secondary outcomes
FFS at 3 and 12 months
Time frame: 3 and 12 months
Erectile function
Time frame: 3, 12, and 24 months
Ejaculatory function
Time frame: 3, 12, and 24 months
Voiding function
Time frame: 3, 12, and 24 months
Lower Urinary Tract symptoms
Time frame: 3, 12, and 24 months
Urinary incontinence
Time frame: 3, 12, and 24 months
Maximum flow rate
Time frame: 3, 12, and 24 months
Residual urinary volumes
Time frame: 3, 12, and 24 months
Quality of life (EQ-5D-3L)
Time frame: 3, 12, and 24 months
Quality of life (EQ-VAS)
Time frame: 3, 12, and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Background: PubMed 24210733Latini JM, McAninch JW, Brandes SB, Chung JY, Rosenstein D. SIU/ICUD Consultation On Urethral Strictures: Epidemiology, etiology, anatomy, and nomenclature of urethral stenoses, strictures, and pelvic fracture urethral disruption injuries. Urology. 2014 Mar;83(3 Suppl):S1-7. doi: 10.1016/j.urology.2013.09.009. Epub 2013 Nov 8.
- Background: PubMed 23153951Palminteri E, Berdondini E, Verze P, De Nunzio C, Vitarelli A, Carmignani L. Contemporary urethral stricture characteristics in the developed world. Urology. 2013 Jan;81(1):191-6. doi: 10.1016/j.urology.2012.08.062. Epub 2012 Nov 13.
- Background: PubMed 24373726Morey AF, Watkin N, Shenfeld O, Eltahawy E, Giudice C. SIU/ICUD Consultation on Urethral Strictures: Anterior urethra--primary anastomosis. Urology. 2014 Mar;83(3 Suppl):S23-6. doi: 10.1016/j.urology.2013.11.007. Epub 2013 Dec 27.
- Background: PubMed 17437823Jordan GH, Eltahawy EA, Virasoro R. The technique of vessel sparing excision and primary anastomosis for proximal bulbous urethral reconstruction. J Urol. 2007 May;177(5):1799-802. doi: 10.1016/j.juro.2007.01.036.
- Background: PubMed 18399836Gur U, Jordan GH. Vessel-sparing excision and primary anastomosis (for proximal bulbar urethral strictures). BJU Int. 2008 May;101(9):1183-95. doi: 10.1111/j.1464-410X.2008.07619.x. No abstract available.
- Background: PubMed 27307398Lumen N, Poelaert F, Oosterlinck W, Lambert E, Decaestecker K, Tailly T, Hoebeke P, Spinoit AF. Nontransecting Anastomotic Repair in Urethral Reconstruction: Surgical and Functional Outcomes. J Urol. 2016 Dec;196(6):1679-1684. doi: 10.1016/j.juro.2016.06.016. Epub 2016 Jun 12.
- Background: PubMed 21933325Andrich DE, Mundy AR. Non-transecting anastomotic bulbar urethroplasty: a preliminary report. BJU Int. 2012 Apr;109(7):1090-4. doi: 10.1111/j.1464-410X.2011.10508.x. Epub 2011 Sep 20.
- Background: PubMed 25690318Virasoro R, Zuckerman JM, McCammon KA, DeLong JM, Tonkin JB, Capiel L, Rovegno AR, Favre G, Giudice CR, Eltahawy EA, Gur U, Jordan GH. International multi-institutional experience with the vessel-sparing technique to reconstruct the proximal bulbar urethra: mid-term results. World J Urol. 2015 Dec;33(12):2153-7. doi: 10.1007/s00345-015-1512-9. Epub 2015 Feb 18.
- Background: PubMed 26816808Bugeja S, Andrich DE, Mundy AR. Non-transecting bulbar urethroplasty. Transl Androl Urol. 2015 Feb;4(1):41-50. doi: 10.3978/j.issn.2223-4683.2015.01.07.
- Background: PubMed 27844407Anderson KM, Blakely SA, O'Donnell CI, Nikolavsky D, Flynn BJ. Primary non-transecting bulbar urethroplasty long-term success rates are similar to transecting urethroplasty. Int Urol Nephrol. 2017 Jan;49(1):83-88. doi: 10.1007/s11255-016-1454-1. Epub 2016 Nov 14.
- Background: PubMed 28432540Le W, Li C, Zhang J, Wu D, Liu B. Preliminary clinical study on non-transecting anastomotic bulbomembranous urethroplasty. Front Med. 2017 Jun;11(2):277-283. doi: 10.1007/s11684-017-0515-x. Epub 2017 Apr 22.
- Background: PubMed 12796652Andrich DE, Dunglison N, Greenwell TJ, Mundy AR. The long-term results of urethroplasty. J Urol. 2003 Jul;170(1):90-2. doi: 10.1097/01.ju.0000069820.81726.00.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transecting anastomotic repair (tAR) and Vessel-sparing anastomotic repair (vsAR) in people with Urethral Stricture and Surgery, run by University Hospital, Ghent at 13 sites in 8 countries.
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 9 inclusion and 16 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: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Argentina, Belgium, Mexico, Spain and 3 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
FFS at 24 months (time frame: 24 months). 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 NCT03572348, which also lists 21 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 8 Jan 2024.