Efficacy of Stapled Hemorrhoidopexy for the Treatment of Obstructive Defecation Syndrome (NCT06294470) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Stapled Hemorrhoidopexy for the Treatment of Obstructive Defecation Syndrome
Venezuela34 participantsStarted 2023-05-01
Plain-language summary
The objective of this study is to assess the efficiency of the procedure for hemorrhoidal prolapse and pexia in alleviating symptoms of defecatory obstruction among patients with grade II to IV mucohemorrhoidal prolapse.
Who can participate
Age range
18 Years – 70 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 between 18 and 70 years old.
* Patients diagnosed with grade II to IV mucohemorrhoidal disease and suffering from symptoms of obstructed defecation, which require a procedure for prolapse and hemorrhoidal pexia.
* Patients with a minimum Altomare Score of 3pts and Agachan Score Wexner of at least 12pts.
Exclusion Criteria:
* Patients who, after undergoing a colonic transit time study, are found to have a different type of constipation (such as slow transit or colonic inertia).
* Patients who undergo PPH technique along with another anorectal procedure.
* Patients with any other anorectal conditions, including fistula, anal fissure, inflammatory bowel disease, chronic diarrhea, or malignant lesions.
* Patients diagnosed with mucohemorrhoidal disease and experiencing acute complications.
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
Postoperative improvement of symptoms of defecatory obstruction