Bladder DysfunctionNCT06472193
The Utility of Shanfield Implantation Technique During Creation of Mitrofanoff Procedure in Pediatric Age Group
A study testing Shanfield implantation technique in Mitroffanof procedure in people with Bladder Dysfunction, run by Sohag University at 1 site in Egypt.
Trial summary
Management of bladder dysfunction was revolutionized by the introduction of intermittent catheterization by Lapides. Later, Mitrofanoff described a trans-appendicular continent cystostomy, launching a new concept whereby the bladder could be emptied by a route other than the urethra. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Bladder Dysfunction
- What is being tested?
- Shanfield implantation technique in Mitroffanof procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Aug 2025
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children with neurogenic bladder dysfunction, as an alternative route for catheterization for those who are unable or unwilling to utilize the native route being sensate urethra.
- in cases where bladder neck closure or reconstruction is necessary to achieve continence.
- Patients with urethral valves, prune belly syndrome and bladder exstrophy, performed either as an isolated procedure enabling patients to perform clean intermittent catheterization (CIC) or in relation with concomitant bladder augmentation
Who cannot join
- patients clinically unfit for surgery patients underwent previous traditional Mitroffanof procedure
- -
Trial locations and contacts
1 site in 1 country.
ahmed A Gafar, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
Management of bladder dysfunction was revolutionized by the introduction of intermittent catheterization by Lapides. Later, Mitrofanoff described a trans-appendicular continent cystostomy, launching a new concept whereby the bladder could be emptied by a route other than the urethra.
Clean intermittent catheterization (CIC) is one of the main tools for neurogenic lower urinary tract dysfunction management, as it provides adequate bladder emptying and protects the upper urinary tract from high pressures, hence preventing progressive renal damage.
Read more
Despite its important role, CIC is difficult to perform in various situations: lack of manual dexterity, female wheelchair patients, body habitus, anatomical morbidity due to extensive surgery or psychological problems. For such patients, continent urinary diversion (CUD) is a viable option for bladder emptying optimization.
Various techniques have been described to create an anti-reflux appendicovesical anastomosis in pediatric lower urinary tract reconstruction, whether performed via an extravesical or an intravesical route, all share a common denominator of creating a submucosal tunnel in an attempt to replicate the physiological anti-reflux mechanism.
- Conditions
- Bladder Dysfunction
- Being tested
- Shanfield implantation technique in Mitroffanof procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shanfield implantation technique in Mitroffanof procedureProcedure or surgery
a stab incision of the bladder wall 1-2 cm above the trigone is deepened down to the mucosa without penetrating it. The prolapsed mucosa is grasped through this window and incised. The spatulated appendix-Mitrofanoff is advanced through the window to the interior of the bladder and its lower lip is anchored to the trigone 1-2 cm distal to the stab wound with an appropriate size (4/0-6/0) vicryle suture using a U-stich. The stitch passes initially through the bladder wall to its interior, looping full thickness through posterior lip of the appendix, then back through the full thickness of the bladder wall to be knotted outside. Supplementary stitches are added externally between the adventitia of the conduit and the detrusor to stabilise the tube-bladder intersection. The detrusorotomy is closed over loosely forming a short subdetrusor tunnel. This technique will be done by open lower midline incision or by laparoscopy using 3 or 4-port access.
| Study group | Role | What they receive |
|---|---|---|
| cases | Experimental | Not described Receives: Procedure: Shanfield implantation technique in Mitroffanof procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
antireflux competence of stomal end of the Mitrofanoff conduit
The percentage of patients with whom leakage of urine occured in between CICs
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Feb 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bladder DysfunctionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Saad Gad, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472193
- Sponsor's protocol ID
- Soh-Med-24-05-07MD
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paludo AO, Castro LFC, Gorgen ARH, Schwengber VHV, Dos Santos EB, Tavares P, Rosito TE, Corbetta JP. Garrahan U-Stitch laparoscopic appendicovesicostomy - Making surgery easier. J Pediatr Urol. 2020 Oct;16(5):719-720. doi: 10.1016/j.jpurol.2020.07.046. Epub 2020 Aug 10.
PubMed 32828684Gander R, Asensio M, Royo GF, Lopez M. Pediatric laparoscopic mitrofanoff procedure- preliminary results of a simplified technique. J Pediatr Urol. 2022 Apr;18(2):112.e1-112.e7. doi: 10.1016/j.jpurol.2021.12.018. Epub 2022 Jan 7.
PubMed 35063366Gundeti MS, Petravick ME, Pariser JJ, Pearce SM, Anderson BB, Grimsby GM, Akhavan A, Dangle PP, Shukla AR, Lendvay TS, Cannon GM Jr, Gargollo PC. A multi-institutional study of perioperative and functional outcomes for pediatric robotic-assisted laparoscopic Mitrofanoff appendicovesicostomy. J Pediatr Urol. 2016 Dec;12(6):386.e1-386.e5. doi: 10.1016/j.jpurol.2016.05.031. Epub 2016 Jun 15.
PubMed 27349147Shanfield I. New experimental methods for implantation of the ureter in bladder and conduit. Transplant Proc. 1972 Dec;4(4):637-8. No abstract available.
PubMed 4566812
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Shanfield Implantation Technique During Creation of Mitrofanoff Procedure in Pediatric Age Group
- ClinicalTrials.gov ID
- NCT06472193
- Acronym / sponsor ID
- Soh-Med-24-05-07MD
- Conditions
- Bladder Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 25 Jun 2024 (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.
Management of bladder dysfunction was revolutionized by the introduction of intermittent catheterization by Lapides. Later, Mitrofanoff described a trans-appendicular continent cystostomy, launching a new concept whereby the bladder could be emptied by a route other than the urethra.
Clean intermittent catheterization (CIC) is one of the main tools for neurogenic lower urinary tract dysfunction management, as it provides adequate bladder emptying and protects the upper urinary tract from high pressures, hence preventing progressive renal damage.
Despite its important role, CIC is difficult to perform in various situations: lack of manual dexterity, female wheelchair patients, body habitus, anatomical morbidity due to extensive surgery or psychological problems. For such patients, continent urinary diversion (CUD) is a viable option for bladder emptying optimization.
Various techniques have been described to create an anti-reflux appendicovesical anastomosis in pediatric lower urinary tract reconstruction, whether performed via an extravesical or an intravesical route, all share a common denominator of creating a submucosal tunnel in an attempt to replicate the physiological anti-reflux mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cases | Experimental | Procedure: Shanfield implantation technique in Mitroffanof procedure |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- children with neurogenic bladder dysfunction, as an alternative route for catheterization for those who are unable or unwilling to utilize the native route being sensate urethra.
- in cases where bladder neck closure or reconstruction is necessary to achieve continence.
- Patients with urethral valves, prune belly syndrome and bladder exstrophy, performed either as an isolated procedure enabling patients to perform clean intermittent catheterization (CIC) or in relation with concomitant bladder augmentation
Key exclusion criteria (2 listed)
- patients clinically unfit for surgery patients underwent previous traditional Mitroffanof procedure
- -
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 |
|---|---|---|
| Shanfield implantation technique in Mitroffanof procedurea stab incision of the bladder wall 1-2 cm above the trigone is deepened down to the mucosa without penetrating it. The prolapsed mucosa is grasped through this window and incised. The spatulated appendix-Mitrofanoff is advanced through the window to the interior of the bladder and its lower lip is anchored to the trigone 1-2 cm distal to the stab wound with an appropriate size (4/0-6/0) vicryle suture using a U-stich. The stitch passes initially through the bladder wall to its interior, looping full thickness through posterior lip of the appendix, then back through the full thickness of the bladder wall to be knotted outside. Supplementary stitches are added externally between the adventitia of the conduit and the detrusor to stabilise the tube-bladder intersection. The detrusorotomy is closed over loosely forming a short subdetrusor tunnel. This technique will be done by open lower midline incision or by laparoscopy using 3 or 4-port access. | Procedure or surgery | cases |
Primary outcome
antireflux competence of stomal end of the Mitrofanoff conduit
Time frame: 18 months
The percentage of patients with whom leakage of urine occured in between CICs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Background: PubMed 32828684Paludo AO, Castro LFC, Gorgen ARH, Schwengber VHV, Dos Santos EB, Tavares P, Rosito TE, Corbetta JP. Garrahan U-Stitch laparoscopic appendicovesicostomy - Making surgery easier. J Pediatr Urol. 2020 Oct;16(5):719-720. doi: 10.1016/j.jpurol.2020.07.046. Epub 2020 Aug 10.
- Background: PubMed 35063366Gander R, Asensio M, Royo GF, Lopez M. Pediatric laparoscopic mitrofanoff procedure- preliminary results of a simplified technique. J Pediatr Urol. 2022 Apr;18(2):112.e1-112.e7. doi: 10.1016/j.jpurol.2021.12.018. Epub 2022 Jan 7.
- Background: PubMed 27349147Gundeti MS, Petravick ME, Pariser JJ, Pearce SM, Anderson BB, Grimsby GM, Akhavan A, Dangle PP, Shukla AR, Lendvay TS, Cannon GM Jr, Gargollo PC. A multi-institutional study of perioperative and functional outcomes for pediatric robotic-assisted laparoscopic Mitrofanoff appendicovesicostomy. J Pediatr Urol. 2016 Dec;12(6):386.e1-386.e5. doi: 10.1016/j.jpurol.2016.05.031. Epub 2016 Jun 15.
- Background: PubMed 4566812Shanfield I. New experimental methods for implantation of the ureter in bladder and conduit. Transplant Proc. 1972 Dec;4(4):637-8. No abstract available.
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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.
ahmed A Gafar, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shanfield implantation technique in Mitroffanof procedure in people with Bladder Dysfunction, run by Sohag University at 1 site in Egypt.
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 3 inclusion and 2 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 26 Jun 2024. 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 Egypt. 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?
Contact mahmoud s gad, assistant lecutrer (01010674328, mahmoud_abdelraheem@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antireflux competence of stomal end of the Mitrofanoff conduit (time frame: 18 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 NCT06472193, which also lists 4 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 26 Jun 2024.