PRP Injection Into Anal Sphincters for Fecal Incontinence

NCT04063293 | Unknown Early Phase 1 DMC

• 1 other identifier: IMU260702
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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; thus, generally selected as the initial treatment modalities, however may be effective in a small portion of patients. More complex treatment techniques including sacral nerve stimulation decrease the severity of symptoms, however the implantation of the device is a costly, staged procedure. Little is known about the effectiveness of other techniques such as injectable substances on incontinence observed after low anterior resection. There is no study evaluating the safety and effectiveness of platelet rich plasma (PRP) injection for incontinent patients after low anterior resection.

Conditions

Fecal Incontinence

Keywords

fecal incontinence; platelet rich plasma; PRP; injection

Outcome Measures

Primary Outcomes (1)

• Wexner fecal incontinence score change

  This scoring system cross-tabulates frequencies and different anal incontinence presentations (Gas/Liquid/Solid/Pad use/Need for lifestyle alterations) and sums the returned score to a total of 0-20 (where 0 = perfect continence and 20 = complete incontinence). Each of the incontinence presentations is graded equally.

  baseline and 6 months after PRP injection

Secondary Outcomes (11)

• St Mark's (Vaizey) score

  baseline and 6 months after PRP injection

• Pescatori incontinence score

  baseline and 6 months after PRP injection

• Fecal Incontinence Quality of Life Questionnaires

  baseline and 6 months after PRP injection

• SF-36 Questionnairy

  baseline and 6 months after PRP injection

• Anal resting pressure

  baseline and 6 months after PRP injection

Study Arms (1)

PRP injection

EXPERIMENTAL

PRP is prepared using a special device (VS-400, Genesis Comp, Korea). For each application a kit (e+ PRP, Genesis Comp, Korea) will be used. 18 cc of venous blood will be collected from the patient into the syringe with 2 cc of anticoagulant, and will be gently inverted. The sample will be slowly injected into the e+ PRP kit. The kit will be centrifuged under 1,500G for 4 minutes, which will separate the blood components into 3 different layers. The rot at the top of the kit will be pressed until the bottom of the piston will touch the red blood cell layer, and the rot will be turned clockwise to close it. The cap will be opened and the small syringe will be connected to the cap for extracting PRP. The injection will be performed in operation room under general anesthesia with either IV sedation of laryngeal mask airway (LMA) sedation. 10 cc of PRP will be directly injected in external muscles at 8 locations under the guidance of endoanal ultrasound

Biological: Platelet Rich Plasma

Interventions

Platelet Rich Plasma BIOLOGICAL

PRP injection into tha anal canal in patients underwent low anterior resection for rectal cancer

Also known as: PRP

PRP injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• incontinent patients after low anterior resection for rectal cancer

You may not qualify if:

• 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 \[28\]).

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University Medical School

Istanbul, 34214, Turkey (Türkiye)

RECRUITING

Related Publications (31)

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MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Mustafa C Haksal, MD

  Istanbul Medipol University Medical School

  PRINCIPAL INVESTIGATOR

• Mustafa Oncel, Prof

  Istanbul Medipol University Medical School

  STUDY CHAIR

Central Study Contacts

Mustafa C Haksal

CONTACT

905059231965; drmustafahaksal@yahoo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The injection will be performed in operation room under general anesthesia with either IV sedation of laryngeal mask airway (LMA) sedation. In case a perfect relaxation will not be achieved, then the patient will be intubated. The patient will be positioned as gynecological position. 10 cc of PRP will be directly injected in external muscles at 8 locations under the guidance of endoanal ultrasound. The final condition of the sphincters will be pictured with the device. The same surgeon (MCH) will perform all procedures. No antibiotics will be used. Local anesthetics will not be injected. If the patient will feel pain after the operation, he/she will be free to use oral painkillers. The patient will be discharged from the hospital on the same night or the day after according to the patient's desire. Patients will be questioned for possible PRP complications during the hospitalization period, and they will be asked to report anytime during the study period.

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 21, 2019
• Study Start: May 15, 2019
• Primary Completion: August 15, 2020
• Study Completion: February 15, 2021
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after the final date of the study, for 1 year
• Access Criteria: related data will be shared with interested clinicians to use the info in their studies and to re-analyse our findings. Contact will be via e-mail of the PI

Locations

TU (1)