Actively Recruiting
Early Outcomes of Skin-Sparing Hemorrhoidectomy and PExy (SHAPE) Versus Milligan-Morgan Hemorrhoidectomy for Hemorrhoidal Disease: A Randomized Controlled Trial
Led by Cairo University · Updated on 2026-05-20
68
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two surgical methods for treating third- and fourth-degree hemorrhoids in adults over 18 years old. This randomized controlled trial takes place at the General Surgery Department of Kasr Al-Ainy Teaching Hospital, Cairo University. It compares Skin-Sparing Hemorrhoidectomy and PExy (SHAPE) with conventional Milligan-Morgan hemorrhoidectomy, aiming to understand differences in outcomes such as pain and recovery. Patients with inflammatory bowel disease, anal stenosis, colorectal cancer, or fecal incontinence are not eligible. Participants are randomly assigned to one of two groups. Group A undergoes the SHAPE procedure, which selectively removes hemorrhoidal tissue above the dentate line, preserving anoderm and including mucopexy using Vicryl sutures to lift prolapsed mucosa. Group B has the Milligan-Morgan hemorrhoidectomy, involving excision and ligation of hemorrhoids with skin bridges left to prevent stenosis. After surgery, patients start oral fluids after 2 hours and resume normal diet as tolerated, typically discharged the next day unless complications arise. During the study, patients receive detailed preoperative assessments including history, symptom evaluation, anorectal and digital rectal exams, and routine labs. Follow-up visits occur twice weekly in the first week, weekly for a month, then monthly to monitor pain using a Visual Analog Scale, wound healing, complications, and surgical outcomes. Main outcomes include postoperative pain intensity measured on days 1, 7, and 30. Secondary outcomes include operative time, infection rates, urine retention, anal stenosis, hemorrhoid recurrence, bleeding, and return to normal activity, all followed up to 3 months after surgery.
CONDITIONS
Brief Title
SHAPE Versus Milligan-Morgan Hemorrhoidectomy for Hemorrhoidal Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with third- and fourth-degree hemorrhoids
- Age greater than 18 years old
- Able to provide informed consent
You will not qualify if you...
- Patients with inflammatory bowel disease
- Patients with anal stenosis
- Patients with colorectal malignancy
- Patients with fecal incontinence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo either Skin-Sparing Hemorrhoidectomy and PExy (SHAPE) or Milligan-Morgan Hemorrhoidectomy procedures to treat hemorrhoidal disease.
1 surgical visit (in-person)
Duration - Up to 3 months postoperatively
Participants are monitored for pain, wound healing, postoperative complications, and surgical outcomes after surgery.
Twice weekly visits during the first postoperative week, weekly visits for the first month, and monthly visits thereafter
Trial Site Locations
Total: 1 location
1
Faculty of medicine, Cairo University
Cairo, Al-Manial, Cairo, Egypt, Egypt, 11451
Actively Recruiting
Research Team
A
Ahmed Mohamed Abdelaal, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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