Active — Not RecruitingNot Applicable

Argon Plasma Coagulation in Open Excisional Hemorrhoidectomy

Russia100 participantsStarted 2023-08-01

Plain-language summary

This prospective single-center randomized clinical trial evaluates whether the use of argon plasma coagulation (APC) during open excisional hemorrhoidectomy reduces postoperative pain and perioperative morbidity compared with conventional monopolar coagulation in adults with symptomatic grade III-IV hemorrhoids requiring surgical treatment. A total of 100 participants will be randomized in a 1:1 ratio to open hemorrhoidectomy performed with APC or open hemorrhoidectomy performed with monopolar coagulation. In two arms, the severity of pain will be assessed from day 1 to day 7 postoperatively, both before and after taking analgesics. Additional assessments will be conducted on days 14 and 28 post-surgery, as well as during the first and second defecation using a visual analog scale (VAS). Early postoperative complications, including intraoperative and postoperative bleeding, burning sensation and itching will be evaluated. Long-term complications such as anal canal stenosis, perianal scar deformation, and disease recurrence will be assessed six months after surgery using digital examination performed by consultant proctologist. The goal of this clinical trial is to discover the safety and efficacy of open excisional hemorrhoidectomy for hemorrhoids III-IV grade using argon plasma coagulation.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged ≥18 years with symptomatic grade III -IV hemorrhoids refractory to conservative treatment will eligible for inclusion. Exclusion Criteria: * external hemorrhoids thrombosis * patients with grade I-II hemorrhoids * acute and chronic anal fissures * requiring combined interventions * previous surgical interventions for hemorrhoids like a rubber band ligation * sclerotherapy or laser hemorrhoidplasty (LHP) * pregnancy * Any known anorectal malignancy or suspicion of malignancy * Significant systemic diseases (severe cardiovascular disease, severe hepatic dysfunction)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative pain intensity before taking analgesics on postoperative day 4

Timeframe: Assessment on the fourth postoperative day

Trial details

NCT IDNCT07587892

SponsorI.M. Sechenov First Moscow State Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-01

View on ClinicalTrials.gov More Hemorrhoidal Disease trials