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Traditional Ferguson Hemorrhoidectomy vs Stapled Hemorrhoidopexy

ConditionHaemorrhoid
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-75
SponsorNational Taiwan University Hospital

About this trial

This study aimed to compare the short- and long-term outcomes of stapled hemorrhoidopexy (the procedure for prolapsed hemorrhoids, PPH) with anoplasty versus traditional Ferguson method for the treatment of patients with grade III /IV hemorrhoids.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged between 25~75 years with subjective, severe hemorrhoidal symptoms

Graded III-IV hemorrhoid

The patients' condition can undergo hemorrhoidectomy

ASA status ≤ 3

Disqualifiers

Severe liver cirrhosis

Chronic renal disease

Coagulopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stapled hemorrhoidopexy with anoplasty

    Procedure/Surgery

    The patients who meet the inclusion and exclusion criteria in this group will undergo Stapled hemorrhoidopexy with anoplasty.

  • Ferguson hemorrhoidectomy

    Procedure/Surgery

    Ferguson hemorrhoidectomy

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Ferguson hemorrhoidectomyExperimental treatment 1 intervention
Group B: Stapled hemorrhoidopexy with anoplastyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Post-operative pain

Recorded with visual analogue scale (VAS)

Time frame
6 months

Secondary outcomes

1

Time to normal life or work

The recovery duration before the patient returns to their normal life

Time frame
6 months
2

Post-operative anal hemorrhage

Any bleeding needs medicines or surgical intervention

Time frame
6 months
3

Wound dehiscence or discharge

Diagnosed as the presence of open wound needs oral or intravenous antibiotics treatment or surgical dressing

Time frame
6 months
4

Pruritus

The presence of pruritus that needs topical ointment or antihistamine to relieve the symptom

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov
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