Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT04063293
Eligibility Criteria:
Inclusion Criteria:
* incontinent patients after low anterior resection for rectal cancer
Exclusion Criteria:
* There are 2 types of exclusion criteria
A. Patients who will not be suitable for initial tests:
1. Patients younger than 18 or older than 80
2. Pregnant or lactating women
3. Patients received pelvic radiation after the initial cancer surgery
4. Patients with local recurrence
5. 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)
6. Patients under chemotherapy
7. Patients confess incontinence prior to initial cancer surgery
8. Contraindication for PRP injection: active infection, thrombocytopenia, anemia (Hgb \<10 gr/dl), allergy for buffalo thrombin
9. If the interval after the final surgery less than 12 months
10. 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:
1. If manometer reveals normal resting (59-74 mm) and squeeze (124-152 mm) pressure (No clue for decreased sphincter strength)
2. If manometer reveals higher than normal volume (17-23 cc) for the first sensation, since it shows reduction of rectal sensitivity
3. 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 \[28\]).
4. 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 \[29,30\].
5. Endoanal ultrasound examination revealing full-thickness tear in external sphincter.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04063293
Study Brief:
Protocol Section:
NCT04063293