Comparing CO2 Laser and Electrosurgical Treatments for Perianal Condyloma

Not Applicable

Not yet recruiting

• Conditions: Perianal Wart
• Interventions: Procedure: CO2 LASER Vaporisation; Procedure: Electrosurgical Fulguration

• Registration Number: NCT06166290
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

Perianal condyloma are skin- colored and fleshy lesions caused by various variants of Human Papilloma Virus (HPV), most commonly 6 and 11. The treatment modalities available include topical options like podophyllin, imiquimod cream, trichloroacetic acid and cryotherapy, injectable options like interferon and 5-fluoroucil, and surgical options like excision, fulguration, cryotherapy, and laser removal. However, the treatment is usually short-lived, and the patients are subjected to multiple repeat procedures because of high recurrence and low clearance rates. Surgical management has the highest clearance rate. There are several surgical modalities including excision, electrosurgical fulguration (ESF), and LASER vaporization. LASER techniques work directly to destroy/transect the lesion, cause necrosis of infected keratinocytes and induce local inflammation. LASER treatment is also reported to have minimal local surrounding tissue injury and sphincter injury, and less pain and discomfort. For this reason, LASER therapy has been increasingly used to remove anogenital warts, and is a standard of care treatment of condyloma. We hypothesize that LASER vaporization is effective to treat perianal condyloma and may have clinical benefits over ESF. We will compare postoperative outcomes such as pain, healing, cosmesis and recurrence following either treatment method.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-22
• Study Start: 2024-01
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Adults (>18) treated in our CRS department for perianal condyloma, not previously treated surgically, English speaking patients.

Exclusion Criteria

<18, intra-anal condyloma, previously treated for condyloma, other skin diseases in the perianal region, limited English proficiency.

• Adults unable to consent- exclude
• Individuals who are not yet adults (infants, children, teenagers)- exclude
• Pregnant women- exclude
• Prisoners- exclude

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CO2 LASER Vaporization Group	CO2 LASER Vaporisation	-
Electrosurgical Fulguration Group	Electrosurgical Fulguration	-

Primary Outcome Measures

Name	Time	Method
Recurrence of Anal Condyloma	6 months	Comparison of recurrence of anal condyloma within 6 months among LASER group and ESF group.

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent complications	6 months	Major complications including soft tissue infection and hemorrhage.
Comparison of Postoperative Pain and associated outcomes	6 months	Comparison of postoperative outcomes among LASER group and ESF group. The outcomes of interest are postoperative pain, healing time, and cosmesis.