Actively Recruiting

Phase Not Applicable
Age: 25Years - 75Years
All Genders
ID05959577

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

Age: 25Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Severe liver cirrhosis
  • Chronic renal disease
  • Coagulopathy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

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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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