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RecruitingNCT05959577Updated Sep 20, 2024

Traditional Ferguson Hemorrhoidectomy vs Stapled Hemorrhoidopexy

An interventional study of Stapled hemorrhoidopexy with anoplasty and Ferguson hemorrhoidectomy in Haemorrhoid, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-20.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Aug 2022, registered Jul 2023).
  • Started Aug 2022; still recruiting 4 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
25 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

Hemorrhoidal disease is a common pathology affecting 5 percent of the general population. Hemorrhoidectomy is the most effective approach for hemorrhoidal disease, especially for Grade III and IV hemorrhoids, and is one of the most frequently performed general surgeries. For patients with circumferential prolapsed hemorrhoids, the standard three-quadrant hemorrhoidectomy (Milligan-Morgan or Ferguson method) may leave behind too much hemorrhoid-bearing mucosa and skin tags, which are the main complaints of patients as incomplete resection or recurrence. Since its first description in 1882, the Whitehead hemorrhoidectomy has earned a reputation as a radical procedure for circumferential prolapsed hemorrhoids. However, this procedure has been criticized because it is time-consuming and causes considerable blood loss, disturbed continence, ectropion of the rectal mucosa, and stricture formation, and it has been used rarely by surgeons. More recent modifications, such as a circular incision, anodermal flap graft, or sliding skin flap graft, reduce the risk of complications associated with the primary method, but the results remain unsatisfactory. Some colorectal surgeons have used a modified Ferguson method with various degrees of anoplasty and an anodermal flap to treat circumferential hemorrhoids during the past 20 years,8 but unsatisfactory results were still experienced, including occasional flap necrosis, which causes skin defects and anal stenosis. Furthermore, the loss of most cushioning effect of the anus, which results in varying degrees of incontinence, also is a problem. Stapled hemorrhoidopexy was presented as a procedure for prolapsed hemorrhoids (PPH) in 1998 by Longo. From the viewpoints of lesser post operative pain and short recuperation period after PPH, it was later adapted for grade III and grade IV hemorrhoids gradually. However, PPH had several drawbacks and long-term sequelae, such as residual skin tags, anal stenosis and even chronic anal pain after surgery. Therefore, the Milligan- Morgan hemorrhoidectomy (MMH) or modified Ferguson method is still the most popular method for hemorrhoids. The explanation for residual skin tags is probably that the external components remained untreated by stapling in most of the studies. Therefore, we have been routinely adding an anoplasty for the prominent skin tag after the stapling hemorrhoidopexy procedure. Moreover, previous studies have demonstrated a reduction of rectal distensibility and volume thresholds for sensations in patients treated with stapled hemorrhoidopexy, and a possible correlation between rectal functional alterations and postoperative disorders was postulated. The present study aimed to compare the short- and long-term outcomes of PPH with anoplasty and traditional Ferguson hemorrhoidectomy.

02

Conditions studied

  • Haemorrhoid

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Keywords

  • Hemorrhoid
  • Ferguson hemorrhoidectomy
  • Stapled hemorrhoidopexy
03

In context

Hemorrhoids

238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 183 interventional studies indexed under Hemorrhoids.

Browse Hemorrhoids studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged between 25\~75 years with subjective, severe hemorrhoidal symptoms
  • Graded III-IV hemorrhoid
  • The patients' condition can undergo hemorrhoidectomy
  • ASA status ≤ 3

Exclusion criteria

Exclusion Criteria:

  • Severe liver cirrhosis
  • Chronic renal disease
  • Coagulopathy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Ferguson hemorrhoidectomy

    The patients who meet the inclusion and exclusion criteria in this group will undergo Ferguson hemorrhoidectomy

    Procedure: Ferguson hemorrhoidectomy

  • Active comparator
    Stapled hemorrhoidopexy with anoplasty

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

    Procedure: Stapled hemorrhoidopexy with anoplasty

Interventions

  • ProcedureStapled hemorrhoidopexy with anoplasty

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

  • ProcedureFerguson hemorrhoidectomy

    Ferguson hemorrhoidectomy

06

What researchers measure

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

  5. Urinary retention

    No urination for four hours; urinary retention within bladder \> (body weight ) x 4 hours confirmed by ultrasound; the patient needs catheterization.

    Time frame: 6 months

  6. Sphincter damage

    Measured by digital examination

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05959577
Responsible party
Sponsor
First posted
Jul 25, 2023
Start date
Aug 17, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 20, 2024

Study contacts

Jin-Tung LIANG, MD
Contact
jintung@ntu.edu.tw
+886-972651432
Jin-Tung LIANG, MD
study director · National Taiwan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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