AzTrials
AzTrials

HaemorrhoidNCT05959577

Traditional Ferguson Hemorrhoidectomy vs Stapled Hemorrhoidopexy

A study testing Stapled hemorrhoidopexy with anoplasty and Ferguson hemorrhoidectomy in people with Haemorrhoid, run by National Taiwan University Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 25 to 75 years
Conditions the study is for
Haemorrhoid
What is being tested?
Stapled hemorrhoidopexy with anoplasty and Ferguson hemorrhoidectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteTaiwan
Study dates
17 Aug 2022to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Severe liver cirrhosis
  • Chronic renal disease
  • Coagulopathy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jin-Tung LIANG, MD contact

+886-972651432

jintung@ntu.edu.tw

Taiwan1 site, 1 recruiting
  • Jin-Tung LIANG

    Taipei, 100

    Jin-Tung LIANG, MD, 0972653916, jintung@ntu.edu.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: 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

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.

Conditions
Haemorrhoid
Being tested
Stapled hemorrhoidopexy with anoplasty, Ferguson hemorrhoidectomy
Keywords
Hemorrhoid, Ferguson hemorrhoidectomy, Stapled hemorrhoidopexy
Medical subject headings
Hemorrhoids

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stapled hemorrhoidopexy with anoplastyProcedure or surgery

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

  • Ferguson hemorrhoidectomyProcedure or surgery

    Ferguson hemorrhoidectomy

Study groups in NCT05959577
Study groupRoleWhat they receive
Ferguson hemorrhoidectomyExperimentalThe patients who meet the inclusion and exclusion criteria in this group will undergo Ferguson hemorrhoidectomy
Receives: Procedure: Ferguson hemorrhoidectomy
Stapled hemorrhoidopexy with anoplastyActive comparatorThe patients who meet the inclusion and exclusion criteria in this group will undergo Stapled hemorrhoidopexy with anoplasty
Receives: Procedure: Stapled hemorrhoidopexy with anoplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-operative pain

    Recorded with visual analogue scale (VAS)

    Measured: 6 months

Secondary outcomes (6)
  1. Time to normal life or work

    The recovery duration before the patient returns to their normal life

    Measured: 6 months

  2. Post-operative anal hemorrhage

    Any bleeding needs medicines or surgical intervention

    Measured: 6 months

  3. Wound dehiscence or discharge

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

    Measured: 6 months

  4. Pruritus

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

    Measured: 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.

    Measured: 6 months

  6. Sphincter damage

    Measured by digital examination

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2023
  2. Study start17 Aug 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05959577
Sponsor's protocol ID
202207069RINB
Status last verified
Sep 2024
First submitted
16 Jul 2023
Last updated
20 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Stapled hemorrhoidopexy with anoplasty and Ferguson hemorrhoidectomy in people with Haemorrhoid, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jin-Tung LIANG, MD (+886-972651432, jintung@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-operative pain (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in