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Traditional Ferguson Hemorrhoidectomy vs Stapled Hemorrhoidopexy

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ClinicalTrials.gov Identifier: NCT05959577
Recruitment Status : Recruiting
First Posted : July 25, 2023
Last Update Posted : July 25, 2023
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Haemorrhoid Procedure: Stapled hemorrhoidopexy with anoplasty Procedure: Ferguson hemorrhoidectomy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 17, 2022
Estimated Primary Completion Date : August 16, 2024
Estimated Study Completion Date : December 16, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Post-operative pain [ Time Frame: 6 months ]
    Recorded with visual analogue scale (VAS)


Secondary Outcome Measures :
  1. Time to normal life or work [ Time Frame: 6 months ]
    The recovery duration before the patient returns to their normal life

  2. Post-operative anal hemorrhage [ Time Frame: 6 months ]
    Any bleeding needs medicines or surgical intervention

  3. Wound dehiscence or discharge [ Time Frame: 6 months ]
    Diagnosed as the presence of open wound needs oral or intravenous antibiotics treatment or surgical dressing

  4. Pruritus [ Time Frame: 6 months ]
    The presence of pruritus that needs topical ointment or antihistamine to relieve the symptom

  5. Urinary retention [ Time Frame: 6 months ]
    No urination for four hours; urinary retention within bladder > (body weight ) x 4 hours confirmed by ultrasound; the patient needs catheterization.

  6. Sphincter damage [ Time Frame: 6 months ]
    Measured by digital examination


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05959577


Contacts
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Contact: Jin-Tung LIANG, MD +886-972651432 jintung@ntu.edu.tw

Locations
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Taiwan
Jin-Tung LIANG Recruiting
Taipei, Taiwan, 100
Contact: Jin-Tung LIANG, MD    0972653916    jintung@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Director: Jin-Tung LIANG, MD National Taiwan University Hospital
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT05959577    
Other Study ID Numbers: 202207069RINB
First Posted: July 25, 2023    Key Record Dates
Last Update Posted: July 25, 2023
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
Hemorrhoid
Ferguson hemorrhoidectomy
Stapled hemorrhoidopexy
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases