Clinical Trial: A Novel Method for Chronic Anal Fissure Treatment
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Novel Method for Chronic Anal Fissure Treatment: Adipose Derived Regenerative Cells - A Pilot Study
Brief Summary:
Investigators performed a prospective pilot study to test the feasibility and safety of autologous adipose derived regenerative cell (ADRC) transplantation in treatment of anal fissures. The study included 6 patients with chronic anal fissures with symptoms that had an average duration of 24 months. All patients were candidates for surgical treatment as all previous conservative treatments were unsuccessful. The pain level was measured using the VAS scale and was recorded before the treatment and on every consultation following the treatment.
The initial hypothesis is that application of ADRCs may be an alternative to lateral sphincterotomy and a reliable procedure to avoid fecal incontinence.
Detailed Summary:
This prospective pilot study includes 6 patients suffering from chronic anal fissure. All patients were previously treated with different local applications of glyceryl trinitrate or topical Xylocaine gel. Some patients took oral analgesics as a concomitant therapy for additional pain control. None of the patient received neither topical calcium channel blockers nor Botulinum toxin injection due to the unavailability.
The primary outcome measured is "time to complete cessation of anal pain". The secondary outcome includes the healing of chronic anal fissure defined as "time to complete epithelization".
The study was approved by the Ethics Committee of the First Surgical Clinic, Faculty of Medicine, and University of Belgrade. The study was performed in accordance with the Declaration of Helsinki and current Good Clinical Practices. All patients gave the written informed consent prior to the participation.
Physical examination and the detail medical history has been taken by an experienced colorectal surgeon. Pain assessment is quantified using the visual analog scale (VAS) before the treatment and during each postoperative outpatient visit. Bowel continence has been also assessed using Wexner fecal incontinence score prior to the treatment and during each postoperative outpatient visit. The liposuction procedure has been performed performed under the combination of local anesthesia and moderate sedation/general anesthesia. The mixture of 180 mL saline solution, 1mL Epinephrine (1:10,000) and 20 mL of 2% lidocaine is injected in the subcutaneous layer of the abdominal wall to allow the tumescence and to decrease the blood loss. The manual liposuction procedure has been carried out through two or three small incisions using Sforza harvester (Tulip® me
Sponsor: Clinical Centre of Serbia
Current Primary Outcome: Time to complete cessation of anal pain [ Time Frame: 33 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Time to complete epithelization [ Time Frame: 3 months ]
Original Secondary Outcome: Same as current
Information By: Clinical Centre of Serbia
Dates:
Date Received: December 2, 2015
Date Started: December 2014
Date Completion:
Last Updated: December 10, 2015
Last Verified: December 2015
