Laser Assisted Treatment of Fistula In Ano

Launched by UNIVERSITY HOSPITAL, ANTWERP · May 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for a condition called "fistula in ano," which is an abnormal connection between the rectum and the skin around the anus. The trial compares two different methods of closing these fistulas: one uses a laser to assist in the closure, and the other uses a surgical technique called a rectal advancement flap. The goal is to see which method works better for patients.

To be eligible for the trial, participants need to be at least 18 years old and have a specific type of fistula that affects more than one-third of the external anal sphincter. They should also have had a loose seton (a type of drainage tube) in place for at least two months. However, certain individuals, such as those with complex fistulas, certain diseases, or who are pregnant, cannot participate. If someone joins the study, they will receive one of the two treatments and will be monitored throughout the process to see how well the treatment works. This trial is currently looking for participants, so it could be a good opportunity for those who meet the criteria and are seeking relief from their condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with fistula involving more than one-third of the external anal sphincter
• • Single, continuous fistula tract at time of inclusion
• • Loose seton present in fistula tract for 2 months or more at time of inclusion
• • Age ≥ 18
• • Able to complete an informed written consent, understand its implications and contents, and participate in follow-up
• Exclusion Criteria:
• • Fistula tract \< 1 cm
• • Complex fistula tract system (branching of fistula tract inside the sphincter complex)
• • Pregnancy
• • HIV-positive
• • Crohn´s disease, Ulcerative colitis
• • Fistula due to malignancy
• • Tuberculosis
• • Hidradenitis Suppurativa
• • No internal opening
• • Unable to undergo or contraindications to MRI