Plug Occlusion of Anal Fistula Shows Mixed Results

A new study reveals that using a collagen anal fistula plug as a means of obliterating the fistula tract and promoting healing has unexplained variations.

Researchers at the Karolinska Institutet (KI; Stockholm, Sweden), Danderyd Hospital (Stockholm, Sweden), and other institutions conducted a retrospective multicenter study involving 126 patients (mean age 47 years) in four Stockholm hospitals who underwent an anal plug fistula procedure between June 2006 and June 2010. Of these patients, 85% were cryptoglandular, 64% were male, and had a mean 2.9 previous fistula procedures. The outcome after first plug insertion was assessed by chart review performed at a minimum of eight months after insertion, and hazard models were used to assess associations of various factors with fistula healing.


The results showed that after a median time of 13 months, 30 (24%) fistulae were closed without discomfort or secretion; the outcome in the four hospitals varied between 13% and 33% for a similar numbers of patients. Patients with an anterior fistula experienced a success rate of 12% compared with 32% of those with posterior tracks, and 41% of those with a lateral internal opening. Age, sex, and number of previous procedures were not associated with healing. The study was published on February 11, 2014, in Colorectal Disease.

“The Biodesign anal fistula plug was introduced as a means of obliterating the fistula tract and promote healing through biocompatibility,” concluded lead author Johannes Blom, MD, PhD, of the KI Center of Surgical Gastroenterology, and colleagues. “The results demonstrated unexplained variations from good to bad; anterior fistulae were much less likely to heal than fistulae in other locations.”

The Biodesign anal fistula plug used in the study acts as a scaffold, allowing tissue to grow and close the fistula tract. The result is remodeled, vascularized tissue and fistula closure without the muscle damage from surgery that can lead to incontinence. The plug is designed to keep the sphincter intact and restores natural form and function with minimal scar tissue formation. The Biodesign anal fistula plug is a product of Cook Medical (Bloomington, IN, USA), and is available with or without retention button.

Related Links:
Karolinska Institutet
Danderyd Hospital
Cook Medical