Clinical trial NCT05959577: 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
Overall status: RECRUITING
Phase: NA
Conditions: Haemorrhoid
Keywords: Hemorrhoid
Ferguson hemorrhoidectomy
Stapled hemorrhoidopexy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Post-operative pain
timeFrame: 6 months
Secondary outcomes:
measure: Time to normal life or work
timeFrame: 6 months
measure: Post-operative anal hemorrhage
timeFrame: 6 months
measure: Wound dehiscence or discharge
timeFrame: 6 months
measure: Pruritus
timeFrame: 6 months
measure: Urinary retention
timeFrame: 6 months
measure: Sphincter damage
timeFrame: 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Jin-Tung LIANG
Study officials:
affiliation: National Taiwan University Hospital
name: Jin-Tung LIANG, MD
role: STUDY_DIRECTOR
References: