UnknownNot Applicable

Hemorrhoids: Options of Traditional Hemorrhoidectomy

Russia70 participantsStarted 2023-12-01

Plain-language summary

The goal of this prospective clinical trial is to compare the outcomes of several technical options of open hemorrhoidectomy in patients with symptomatic hemorrhoids. Randomly allocated participants will undergo surgical treatment for hemorrhoids with one technical option of open hemorrhoidecomy: with 'cold' scalpel or electrosurgical instruments. All information to evaluate outcomes between the groups will be collected before surgery and 1 week and 30 days after surgery.

Who can participate

Age range

18 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 over 18 years old * Diagnosed symptomatic hemorrhoidal disease * Planned surgery - open hemorrhoidectomy * Absence of other anarectal diseases * I, II class of anesthetic risk according to ASA classification * Voluntary signing by the participant of an informed consent for surgical treatment and participation in a clinical trial. Exclusion Criteria: * Chronic or prolonged use of medications, including narcotic drugs, with analgesic effect for other diseases. * Patients who have contraindications or technical impossibility of performing subarachnoid anesthesia or the full standard volume of surgery for the corresponding disease. * Patients who refused to participate at any time before the end of the study, as well as patients who did not pass the final postoperative monitoring (1 month after the intervention). * Pregnant women * Complicated course of the postoperative period due to exacerbation of concomitant diseases

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

Pain at rest and during defecation

Timeframe: during 10 days after surgery

Trial details

NCT IDNCT06132152

SponsorCenter of Endourology "Endocenter"

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-01

Contact for this trial

Tatiana Garmanova, PhD

+79773429249 tatianagarmanova@gmail.com

View on ClinicalTrials.gov More Hemorrhoids trials