Traditional Ferguson Hemorrhoidectomy vs Stapled Hemorrhoidopexy

Not Applicable

Recruiting

• Conditions: Haemorrhoid
• Interventions: Procedure: Ferguson hemorrhoidectomy; Procedure: Stapled hemorrhoidopexy with anoplasty

• Registration Number: NCT05959577
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

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.

Study Timeline

• Status Verified: 2022-08
• Study Start: 2022-08-17
• Study First Submitted: 2023-07-16
• Study First Submitted QC: 2023-07-24
• Last Update Submitted: 2023-07-24
• Study First Posted: 2023-07-25
• Last Update Posted: 2023-07-25
• Primary Completion: 2024-08-16
• Study Completion: 2024-12-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferguson hemorrhoidectomy	Ferguson hemorrhoidectomy	The patients who meet the inclusion and exclusion criteria in this group will undergo Ferguson hemorrhoidectomy
Stapled hemorrhoidopexy with anoplasty	Stapled hemorrhoidopexy with anoplasty	The patients who meet the inclusion and exclusion criteria in this group will undergo Stapled hemorrhoidopexy with anoplasty

Primary Outcome Measures

Name	Time	Method
Post-operative pain	6 months	Recorded with visual analogue scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Time to normal life or work	6 months	The recovery duration before the patient returns to their normal life
Pruritus	6 months	The presence of pruritus that needs topical ointment or antihistamine to relieve the symptom
Sphincter damage	6 months	Measured by digital examination
Wound dehiscence or discharge	6 months	Diagnosed as the presence of open wound needs oral or intravenous antibiotics treatment or surgical dressing
Urinary retention	6 months	No urination for four hours; urinary retention within bladder \> (body weight ) x 4 hours confirmed by ultrasound; the patient needs catheterization.
Post-operative anal hemorrhage	6 months	Any bleeding needs medicines or surgical intervention

Trial Locations

Locations (1)

Jin-Tung LIANG; 🇨🇳 Taipei, Taiwan