An interventional study of Stapled hemorrhoidopexy with anoplasty and Ferguson hemorrhoidectomy in Haemorrhoid, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-20.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
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.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion Criteria:
The patients who meet the inclusion and exclusion criteria in this group will undergo Ferguson hemorrhoidectomy
Procedure: Ferguson hemorrhoidectomy
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.
Ferguson hemorrhoidectomy
Post-operative pain
Recorded with visual analogue scale (VAS)
Time frame: 6 months
Time to normal life or work
The recovery duration before the patient returns to their normal life
Time frame: 6 months
Post-operative anal hemorrhage
Any bleeding needs medicines or surgical intervention
Time frame: 6 months
Wound dehiscence or discharge
Diagnosed as the presence of open wound needs oral or intravenous antibiotics treatment or surgical dressing
Time frame: 6 months
Pruritus
The presence of pruritus that needs topical ointment or antihistamine to relieve the symptom
Time frame: 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.
Time frame: 6 months
Sphincter damage
Measured by digital examination
Time frame: 6 months
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