Perianal WartNCT06166290
Comparing CO2 Laser and Electrosurgical Treatments for Perianal Condyloma
A study testing CO2 LASER Vaporisation and Electrosurgical Fulguration in people with Perianal Wart, run by University of Illinois Chicago.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perianal Wart
- What is being tested?
- CO2 LASER Vaporisation and Electrosurgical Fulguration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: CO2 LASER Vaporization vs Electrosurgical Fulguration for the Surgical Management of Perianal Condyloma: a Randomized Controlled Trial.
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.
- Conditions
- Perianal Wart
- Being tested
- CO2 LASER Vaporisation, Electrosurgical Fulguration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 LASER VaporisationProcedure or surgery
The CO2 LASER vaporization procedure is described as follows. Patient positioning will be done, and patient will be anesthetized. Local infiltration with 2% lidocaine, nerve block or general anesthesia will be given. The surgical field will be disinfected and draped. The perianal and anal area will be investigated for lesion. CO2 LASER from 20 cm distance in a continuous wave mode and 20 W power will be applied. After warts melts, necrotic tissue will be removed. After the operation was completed, residual debris will be wiped away with a piece of moist gauze. Bacitracin cream applied over the treated areas. Upon discharge acetaminophen 1-gram q8 and Ibuprofen 600 q8 for pain.
Electrosurgical FulgurationProcedure or surgery
The procedure is described as follows. Patient will be administered regional or general anesthesia, placed in prone jack-knife position. Prepping and draping will be done. The perianal and anal area will be investigated for lesion. The lesions will be excised, and the bases will be fulgurated. Electrosurgery device will be used in monopolar setting (30 Cut mode, 30 Coag mode). After procedure local analgesics total MERCAINE/EPI 0.25% 20 ml on both sides of the lesion. Bacitracin cream applied over the treated areas. Upon discharge 1000 mg of Tylenol every 8 hours along with 600 mg of ibuprofen every 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| CO2 LASER Vaporization Group | Experimental | Not described Receives: Procedure: CO2 LASER Vaporisation |
| Electrosurgical Fulguration Group | Active comparator | Not described Receives: Procedure: Electrosurgical Fulguration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Anal Condyloma
Comparison of recurrence of anal condyloma within 6 months among LASER group and ESF group.
Measured: 6 months
Secondary outcomes (2)
Comparison of Postoperative Pain and associated outcomes
Comparison of postoperative outcomes among LASER group and ESF group. The outcomes of interest are postoperative pain, healing time, and cosmesis.
Measured: 6 months
Incidence of Treatment-Emergent complications
Major complications including soft tissue infection and hemorrhage.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal WartStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerald Gantt, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166290
- Sponsor's protocol ID
- STUDY2023-1221
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CO2 LASER Vaporization vs Electrosurgical Fulguration for the Surgical Management of Perianal Condyloma: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06166290
- Acronym / sponsor ID
- STUDY2023-1221
- Conditions
- Perianal Wart
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2 LASER Vaporization Group | Experimental | Procedure: CO2 LASER Vaporisation |
| Electrosurgical Fulguration Group | Active comparator | Procedure: Electrosurgical Fulguration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2 LASER VaporisationThe CO2 LASER vaporization procedure is described as follows. Patient positioning will be done, and patient will be anesthetized. Local infiltration with 2% lidocaine, nerve block or general anesthesia will be given. The surgical field will be disinfected and draped. The perianal and anal area will be investigated for lesion. CO2 LASER from 20 cm distance in a continuous wave mode and 20 W power will be applied. After warts melts, necrotic tissue will be removed. After the operation was completed, residual debris will be wiped away with a piece of moist gauze. Bacitracin cream applied over the treated areas. Upon discharge acetaminophen 1-gram q8 and Ibuprofen 600 q8 for pain. | Procedure or surgery | CO2 LASER Vaporization Group |
| Electrosurgical FulgurationThe procedure is described as follows. Patient will be administered regional or general anesthesia, placed in prone jack-knife position. Prepping and draping will be done. The perianal and anal area will be investigated for lesion. The lesions will be excised, and the bases will be fulgurated. Electrosurgery device will be used in monopolar setting (30 Cut mode, 30 Coag mode). After procedure local analgesics total MERCAINE/EPI 0.25% 20 ml on both sides of the lesion. Bacitracin cream applied over the treated areas. Upon discharge 1000 mg of Tylenol every 8 hours along with 600 mg of ibuprofen every 8 hours. | Procedure or surgery | Electrosurgical Fulguration Group |
Primary outcome
Recurrence of Anal Condyloma
Time frame: 6 months
Comparison of recurrence of anal condyloma within 6 months among LASER group and ESF group.
2 secondary outcomes
Comparison of Postoperative Pain and associated outcomes
Time frame: 6 months
Incidence of Treatment-Emergent complications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
Related trials for Perianal Wart
Active, not recruitingPhase 3
A Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) in Chinese Males
Penile/Perineal /Perianal Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 LASER Vaporisation and Electrosurgical Fulguration in people with Perianal Wart, run by University of Illinois Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Anal Condyloma (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.