Definition and Validation of HeQAS for the Assessment of Technical Quality in Excisional Hemorrho… (NCT07719881) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Definition and Validation of HeQAS for the Assessment of Technical Quality in Excisional Hemorrhoidectomy
Spain80 participantsStarted 2026-01-01
Plain-language summary
This observational multicenter study aims to develop and validate the Hemorrhoidectomy Quality Assessment Scale (HeQAS), a histopathological tool designed to assess the technical quality of excisional hemorrhoidectomy. The project includes a methodological validation phase using blinded assessment of surgical specimens by expert pathologists, followed by a clinical cohort phase comparing micro-open excisional hemorrhoidectomy (microOEH) and conventional open excisional hemorrhoidectomy (OEH) in real-world practice. The study will evaluate the reproducibility and applicability of HeQAS and explore whether microOEH is associated with lower histological tissue damage than conventional OEH.
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:
* Adult patients undergoing excisional hemorrhoidectomy (micro-open excisional hemorrhoidectomy or conventional open excisional hemorrhoidectomy) at the participating centers.
Availability of the surgical specimen with adequate histopathological preservation for standardized processing and HeQAS assessment.
Availability of routine clinical follow-up data required for outcome assessment (pain, complications, and 12-month clinical status).
Exclusion Criteria:
Surgical specimens with inadequate fixation, autolysis, or fragmentation that preclude reliable histopathological assessment according to the protocol.
Incidental diagnosis of malignancy (carcinoma) in the surgical specimen.
Intraoperative change of surgical technique that prevents clear assignment to one cohort (micro-open excisional hemorrhoidectomy or conventional open excisional hemorrhoidectomy).
Prior use of the same specimen in the methodological validation study (Study 1) of HeQAS.
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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
1
HeQAS total histopathological score
Timeframe: At the time of histopathological assessment of the surgical specimen (within routine pathology processing after surgery).