Status:
UNKNOWN
PRP Injection Into Anal Sphincters for Fecal Incontinence
Lead Sponsor:
Istanbul Medipol University Hospital
Conditions:
Fecal Incontinence
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief Summary
The treatment of fecal incontinence after low anterior resection is problematic, and not always able to increase quality of life. Biofeedback and rehabilitation therapies are harmless and easy to use;...
Detailed Description
Rectal cancer is a common problem worldwide and the standard potentially curative treatment for locally advanced disease includes radical surgery appreciating oncological principals. Sphincter-saving ...
Eligibility Criteria
Inclusion
- incontinent patients after low anterior resection for rectal cancer
Exclusion
- There are 2 types of exclusion criteria
- A. Patients who will not be suitable for initial tests:
- Patients younger than 18 or older than 80
- Pregnant or lactating women
- Patients received pelvic radiation after the initial cancer surgery
- Patients with local recurrence
- Patients with irresectable metastasis (patients with resectable liver and/or lung metastasis will be included after metastasectomy, but patients with peritoneal metastasis who will be candidate for peritonectomy will not be included)
- Patients under chemotherapy
- Patients confess incontinence prior to initial cancer surgery
- Contraindication for PRP injection: active infection, thrombocytopenia, anemia (Hgb \<10 gr/dl), allergy for buffalo thrombin
- If the interval after the final surgery less than 12 months
- Patient refusal
- B. Patients who will be excluded according to manometer and/or endoanal ultrasound findings. Only the patients with an acceptable volume of healthy anal sphincters, an adequate reservoir capacity of neorectum and decreased sphincter strength will be included to the study after ruling out a full-thickness external sphincter tear will be the subjects of the evaluation. These patients will be excluded prior to PRP injection:
- If manometer reveals normal resting (59-74 mm) and squeeze (124-152 mm) pressure (No clue for decreased sphincter strength)
- If manometer reveals higher than normal volume (17-23 cc) for the first sensation, since it shows reduction of rectal sensitivity
- If manometer reveals lessened maximum tolerable volume (MTV), since the continence may be related to the reduced volume of neorectum (For healthy volunteers the normal level of MTV is between 216 cc and 266 cc. Although normal level for neorectum after low anterior resection is not known, in a study it is accepted to be more than 60 cc as the current study \[28\]).
- No or minimal external sphincter volume during: for inclusion the length, wide and volume of the external sphincter should be at least 16.1 mm, 6.8 mm and 6.3 cc, respectively (for inclusion all 3 measures should fulfilled). Although the actual minimal volume of external sphincter preventing incontinence is not indicated, in this study the minimal volume in healthy volunteers has been accepted \[29,30\].
- Endoanal ultrasound examination revealing full-thickness tear in external sphincter.
Key Trial Info
Start Date :
May 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04063293
Start Date
May 15 2019
End Date
February 15 2021
Last Update
August 21 2019
Active Locations (1)
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1
Istanbul Medipol University Medical School
Istanbul, Turkey (Türkiye), 34214