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Comparing CO2 Laser and Electrosurgical Treatments for Perianal Condyloma

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University of Illinois

Status

Not yet enrolling

Conditions

Perianal Wart

Treatments

Procedure: Electrosurgical Fulguration
Procedure: CO2 LASER Vaporisation

Study type

Interventional

Funder types

Other

Identifiers

NCT06166290
STUDY2023-1221

Details and patient eligibility

About

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.

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

110 participants in 2 patient groups

CO2 LASER Vaporization Group
Experimental group
Treatment:
Procedure: CO2 LASER Vaporisation
Electrosurgical Fulguration Group
Active Comparator group
Treatment:
Procedure: Electrosurgical Fulguration

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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