Traditional Ferguson Hemorrhoidectomy vs Stapled Hemorrhoidopexy

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

Tracking Information

• First Submitted Date: July 16, 2023
• First Posted Date: July 25, 2023
• Last Update Posted Date: July 25, 2023
• Actual Study Start Date: August 17, 2022
• Estimated Primary Completion Date: August 16, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 24, 2023)

Post-operative pain [ Time Frame: 6 months ]

Recorded with visual analogue scale (VAS)

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 24, 2023)

• Time to normal life or work [ Time Frame: 6 months ]
  The recovery duration before the patient returns to their normal life
• Post-operative anal hemorrhage [ Time Frame: 6 months ]
  Any bleeding needs medicines or surgical intervention
• Wound dehiscence or discharge [ Time Frame: 6 months ]
  Diagnosed as the presence of open wound needs oral or intravenous antibiotics treatment or surgical dressing
• Pruritus [ Time Frame: 6 months ]
  The presence of pruritus that needs topical ointment or antihistamine to relieve the symptom
• 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.
• Sphincter damage [ Time Frame: 6 months ]
  Measured by digital examination

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Haemorrhoid

Intervention

• Procedure: Stapled hemorrhoidopexy with anoplasty
  The patients who meet the inclusion and exclusion criteria in this group will undergo Stapled hemorrhoidopexy with anoplasty.
• Procedure: Ferguson hemorrhoidectomy
  Ferguson hemorrhoidectomy

Study Arms

• Experimental: Ferguson hemorrhoidectomy
  The patients who meet the inclusion and exclusion criteria in this group will undergo Ferguson hemorrhoidectomy
  Intervention: Procedure: 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
  Intervention: Procedure: Stapled hemorrhoidopexy with anoplasty

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 24, 2023): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 16, 2024
• Estimated Primary Completion Date: August 16, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT05959577
• Other Study ID Numbers: 202207069RINB
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: National Taiwan University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: National Taiwan University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: National Taiwan University Hospital
• Verification Date: August 2022