search
Back to results

Traditional Ferguson Hemorrhoidectomy vs Stapled Hemorrhoidopexy

Primary Purpose

Haemorrhoid

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Stapled hemorrhoidopexy with anoplasty
Ferguson hemorrhoidectomy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Haemorrhoid focused on measuring Hemorrhoid, Ferguson hemorrhoidectomy, Stapled hemorrhoidopexy

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Jin-Tung LIANGRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ferguson hemorrhoidectomy

Stapled hemorrhoidopexy with anoplasty

Arm Description

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

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

Outcomes

Primary Outcome Measures

Post-operative pain
Recorded with visual analogue scale (VAS)

Secondary Outcome Measures

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

Full Information

First Posted
July 16, 2023
Last Updated
July 24, 2023
Sponsor
National Taiwan University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05959577
Brief Title
Traditional Ferguson Hemorrhoidectomy vs Stapled Hemorrhoidopexy
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
August 16, 2024 (Anticipated)
Study Completion Date
December 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemorrhoid
Keywords
Hemorrhoid, Ferguson hemorrhoidectomy, Stapled hemorrhoidopexy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ferguson hemorrhoidectomy
Arm Type
Experimental
Arm Description
The patients who meet the inclusion and exclusion criteria in this group will undergo Ferguson hemorrhoidectomy
Arm Title
Stapled hemorrhoidopexy with anoplasty
Arm Type
Active Comparator
Arm Description
The patients who meet the inclusion and exclusion criteria in this group will undergo Stapled hemorrhoidopexy with anoplasty
Intervention Type
Procedure
Intervention Name(s)
Stapled hemorrhoidopexy with anoplasty
Intervention Description
The patients who meet the inclusion and exclusion criteria in this group will undergo Stapled hemorrhoidopexy with anoplasty.
Intervention Type
Procedure
Intervention Name(s)
Ferguson hemorrhoidectomy
Intervention Description
Ferguson hemorrhoidectomy
Primary Outcome Measure Information:
Title
Post-operative pain
Description
Recorded with visual analogue scale (VAS)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Time to normal life or work
Description
The recovery duration before the patient returns to their normal life
Time Frame
6 months
Title
Post-operative anal hemorrhage
Description
Any bleeding needs medicines or surgical intervention
Time Frame
6 months
Title
Wound dehiscence or discharge
Description
Diagnosed as the presence of open wound needs oral or intravenous antibiotics treatment or surgical dressing
Time Frame
6 months
Title
Pruritus
Description
The presence of pruritus that needs topical ointment or antihistamine to relieve the symptom
Time Frame
6 months
Title
Urinary retention
Description
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
Title
Sphincter damage
Description
Measured by digital examination
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Tung LIANG, MD
Phone
+886-972651432
Email
jintung@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tung LIANG, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Jin-Tung LIANG
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Tung LIANG, MD
Phone
0972653916
Email
jintung@ntu.edu.tw

12. IPD Sharing Statement

Learn more about this trial

Traditional Ferguson Hemorrhoidectomy vs Stapled Hemorrhoidopexy

We'll reach out to this number within 24 hrs