Clinical Trials Logo
  1. Home
  2. Fistula in Ano
  3. NCT03381365

Efficacy of an Anorectal Fistula Plug With Sealing of the Internal Opening as a Treatment for Perianal Fistula

Fistula in Ano Clinical Trial

Official title:
A Pilot Study to Assess the Efficacy of an Anorectal Fistula Plug With Sealing of the Internal Opening (Curaseal AF) as a Treatment for Perianal Fistula

Clinical Trial Summary

The investigators aim to assess the efficacy of the Curaseal anal plug in patients with idiopathic uncomplicated fistulous tracts. Healing of the fistula tract will be assessed both clinically and radiologically with MR imaging.

Clinical Trial Description

Perianal fistula is a challenging condition for colorectal surgeons. Achieving a favourable balance between healing and incontinence is the key to success. Surgeons have adopted many methods to close off this abnormal tract, which include laying opening, use of setons, advancement flaps and permanent stoma. A more recent approach has been the use of devices or substances to block the tract in the hope that it will seal off. Most of the devices that have been used to close the tract have not proved to be as effective in healing as a lay open with high rates of fistula persistence. A major failure of the devices has been their early expulsion and their inability to seal off the internal opening.

The new Curaseal plug may be able to overcome these shortcomings. This plug has a disc to seal the internal opening, with a suture to be placed at the external opening, which may prevent it falling out and ensure internal opening closure.

The investigators aim to assess the efficacy of the Curaseal anal plug in patients with idiopathic uncomplicated fistulous tracts. Healing of the fistula tract will be assessed both clinically and radiologically with MR imaging. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03381365
Study type Interventional
Source London North West Healthcare NHS Trust
Contact
Status Terminated
Phase N/A
Start date September 1, 2016
Completion date December 31, 2018
View Details
See also
  Status Clinical Trial Phase
Terminated NCT02423330 - A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula Early Phase 1
Suspended NCT04660903 - Treatment of Fistula in Ano With Autologous Fatty Tissue Cells Transplantation N/A
Recruiting NCT04187651 - PRP Use in Treatment of Fistula Ano N/A
Completed NCT04069728 - The Impact of 3D Anal Fistula Models on Patient Understanding and Decision Making N/A
Recruiting NCT05039411 - Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas Patients With Crohn's Disease Phase 1
Recruiting NCT05390151 - Laser Assisted Treatment of Fistula In Ano N/A
Completed NCT01880398 - Management of Fistula in Ano by Kshar Sutra, Para Surgical Procedure. N/A
Completed NCT03449069 - Pediatric MSC-AFP Sub-study for Crohn's Fistula Phase 1
Completed NCT04588701 - Long Term Outcomes After Surgery for Anal Fistula
Recruiting NCT05666609 - Fistula-in-ano in Infants and Children N/A
Completed NCT06212739 - Post-op Pain After Fistula Laser Closure or Ligation of the Intersphincteric Tract for Anal Fistula N/A
Completed NCT01954225 - Role of Udumbara Sutra in the Management of Fistula in Ano a Rare Case Study N/A
Completed NCT05223309 - High Type Fistula in Ano, Use Staged Seton, Loose Thick Sutures
Terminated NCT02686580 - Feasibility Study to Assess the Early Use of Porcine Cross-linked Collagen Paste in Cryptoglandular Anorectal Fistulas Phase 3
Completed NCT05660876 - Fistulotomy Versus Fistulotomy With Marsupialization N/A
Recruiting NCT04161469 - Laser Closure of Anal Fistula (FiLaC) N/A
Completed NCT04215718 - Fistulotomy With Marsupialization Versus Fistulectomy With Wound Sutures in Simple Anal Fistula N/A