Actively Recruiting
A Randomized Prospective Clinical Trial Comparing the Surgical Outcomes of Traditional Ferguson Hemorrhoidectomy Versus Stapled Hemorrhoidopexy With Anoplasty for Patients With Grade III/IV Hemorrhoids
Led by National Taiwan University Hospital · Updated on 2024-09-20
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two surgical methods for treating patients with severe (grade III or IV) hemorrhoids: stapled hemorrhoidopexy combined with anoplasty, and the traditional Ferguson hemorrhoidectomy. Hemorrhoidal disease affects about 5% of people, and surgery is often needed for advanced cases. While the Ferguson method is common, it may leave behind hemorrhoid tissue causing symptoms. Stapled hemorrhoidopexy with anoplasty aims to address some limitations of previous techniques but has its own risks. Participants will be randomly assigned to receive either the Ferguson hemorrhoidectomy or the stapled hemorrhoidopexy with anoplasty procedure. Both are surgical treatments performed to remove or reduce hemorrhoidal tissue. The study carefully compares short-term and long-term outcomes for these two approaches, focusing on aspects like pain and recovery after surgery. During the study, participants will be monitored for various outcomes including post-operative pain, time to return to normal life or work, anal bleeding, wound healing issues, itching, urinary retention, and any damage to the anal sphincter. These measures will be tracked for up to six months after surgery to understand differences between the treatments. The total participation period includes surgery and follow-up assessments to evaluate recovery and complications.
CONDITIONS
Brief Title
Traditional Ferguson Hemorrhoidectomy vs Stapled Hemorrhoidopexy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 25 and 75 years with subjective, severe hemorrhoidal symptoms
- Diagnosed with grade III or IV hemorrhoids
- Suitable condition to undergo hemorrhoidectomy surgery
- ASA physical status classification of 3 or less
You will not qualify if you...
- Severe liver cirrhosis
- Chronic renal disease
- Coagulopathy
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week or until discharge
Participants undergo either Stapled hemorrhoidopexy with anoplasty or Ferguson hemorrhoidectomy surgery followed by immediate post-operative care.
1 surgical visit and daily post-operative assessments during hospital stay
Duration - 6 months
Participants are monitored for recovery, pain, wound healing, and potential complications after surgery.
Approximately 6 post-operative visits
Trial Site Locations
Total: 1 location
1
Jin-Tung LIANG
Taipei, Taiwan, 100
Actively Recruiting
Research Team
J
Jin-Tung LIANG, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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