Status:
NOT_YET_RECRUITING
Comparison of the Clinical Effects of Open, Closed, and Semi-close Hemorrhoidectomy: Study Protocol for a Single-center, Prospective, Open-label and Randomized Clinical Trial.
Lead Sponsor:
The Affiliated Hospital of Putian University
Conditions:
Hemorrhoids
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study compares three different ways surgeons close the wound after removing hemorrhoids (piles): leaving it completely open, stitching it completely closed, or stitching only half of it closed (s...
Detailed Description
Hemorrhoids are a very common condition, and when surgery is needed, there is no consensus on the best way to manage the surgical wound afterward. This single-center, prospective, randomized clinical ...
Eligibility Criteria
Inclusion
- Patients aged 18 to 75 years.
- Clinical diagnosis of mixed hemorrhoids requiring surgical intervention.
- Scheduled to undergo hemorrhoidectomy with ligation of internal hemorrhoids and excision of external hemorrhoids.
- Willing and able to provide written informed consent.
Exclusion
- History of mental illness or cognitive impairment that may affect the ability to provide informed consent or comply with the study protocol.
- Diagnosis of diabetes mellitus.
- Planned concomitant procedures (e.g., radiofrequency ablation, sclerotherapy) in addition to hemorrhoidectomy.
- Inability or unwillingness to comply with scheduled follow-up visits.
- Presence of severe perioperative comorbidities that render the patient unsuitable for the planned surgical protocol or anesthesia (as determined by the attending anesthesiologist or surgeon).
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
378 Patients enrolled
Trial Details
Trial ID
NCT07196865
Start Date
October 1 2025
End Date
June 1 2026
Last Update
September 29 2025
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