Traditional Ferguson Hemorrhoidectomy vs Stapled Hemorrhoidopexy

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.

Study Overview

• Status: Recruiting
• Conditions: Haemorrhoid
• Intervention / Treatment: Procedure: Ferguson hemorrhoidectomy; Procedure: Stapled hemorrhoidopexy with anoplasty

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jin-Tung LIANG, MD; Phone Number: +886-972651432; Email: jintung@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • Jin-Tung LIANG
    • Contact: Jin-Tung LIANG, MD; Phone Number: 0972653916; Email: jintung@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ferguson hemorrhoidectomy; The patients who meet the inclusion and exclusion criteria in this group will undergo Ferguson hemorrhoidectomy	Procedure: Ferguson hemorrhoidectomy; 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; The patients who meet the inclusion and exclusion criteria in this group will undergo Stapled hemorrhoidopexy with anoplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain	Recorded with visual analogue scale (VAS)	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Director: Jin-Tung LIANG, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Estimated): August 16, 2024
• Study Completion (Estimated): December 16, 2024

Study Registration Dates

• First Submitted: July 16, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Stapled hemorrhoidopexy; Hemorrhoid; Ferguson hemorrhoidectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: 202207069RINB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No