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Traditional Ferguson Hemorrhoidectomy vs Stapled Hemorrhoidopexy

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National Taiwan University

Status

Enrolling

Conditions

Haemorrhoid

Treatments

Procedure: Stapled hemorrhoidopexy with anoplasty
Procedure: Ferguson hemorrhoidectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05959577
202207069RINB

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

25 to 75 years old

Volunteers

No Healthy Volunteers

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

  • Severe liver cirrhosis
  • Chronic renal disease
  • Coagulopathy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Ferguson hemorrhoidectomy
Experimental group
Description:
The patients who meet the inclusion and exclusion criteria in this group will undergo Ferguson hemorrhoidectomy
Treatment:
Procedure: Ferguson hemorrhoidectomy
Stapled hemorrhoidopexy with anoplasty
Active Comparator group
Description:
The patients who meet the inclusion and exclusion criteria in this group will undergo Stapled hemorrhoidopexy with anoplasty
Treatment:
Procedure: Stapled hemorrhoidopexy with anoplasty

Trial contacts and locations

1

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Central trial contact

Jin-Tung LIANG, MD

Data sourced from clinicaltrials.gov

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