Haemorrhoidectomy With vs Without Lateral Internal Sphincterotomy (NCT07360912) | Clinical Trial Compass
CompletedNot Applicable
Haemorrhoidectomy With vs Without Lateral Internal Sphincterotomy
Iraq120 participantsStarted 2024-03-01
Plain-language summary
Hemorrhoids are a common anorectal condition that often require surgical treatment in advanced stages. Open hemorrhoidectomy is effective but is frequently associated with significant postoperative pain and early bleeding. Increased anal sphincter spasm after surgery is believed to be a major contributor to these complications.
This study evaluates whether adding lateral internal sphincterotomy (LIS) to conventional open hemorrhoidectomy reduces postoperative pain and bleeding. A total of 120 adult patients with Grade III or IV hemorrhoids were randomized to undergo either open hemorrhoidectomy with LIS or open hemorrhoidectomy alone. Postoperative pain was assessed using a visual analogue scale, and postoperative bleeding was recorded at 24 hours, 48 hours, one week, and two weeks after surgery.
The results of this trial aim to determine whether the addition of LIS provides better short-term recovery and improved postoperative outcomes compared with standard hemorrhoidectomy.
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:
* Adults aged 18 to 70 years
* Patients diagnosed with grade III or IV hemorrhoids
* Patients scheduled for open hemorrhoidectomy
* Patients able to provide informed consent
Exclusion Criteria:
* Patients with inflammatory bowel disease
* Patients with anal fissure, fistula, or anorectal malignancy
* Patients with previous anorectal surgery
* Patients with bleeding or coagulation disorders
* Patients unfit for surgery or general or spinal anesthesia
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 Pain
Timeframe: Postoperative day 1, day 2, day 7, and day 14