SHAPE Versus Milligan-Morgan Hemorrhoidectomy for Hemorrhoidal Disease

Early Outcomes of Skin-Sparing Hemorrhoidectomy and PExy (SHAPE) Versus Milligan-Morgan Hemorrhoidectomy for Hemorrhoidal Disease: A Randomized Controlled Trial

This study will be conducted at the General Surgery Department, Kasr Al-Ainy Teaching Hospital, Cairo University, on patients presenting with third- and fourth-degree hemorrhoids. Adult patients older than 18 years who fulfill the inclusion criteria and provide informed consent will be enrolled. Patients with inflammatory bowel disease, anal stenosis, colorectal malignancy, or fecal incontinence will be excluded.

All patients will undergo detailed preoperative assessment including medical and surgical history, evaluation of anal symptoms, local anorectal examination, digital rectal examination, and routine laboratory investigations.

Participants will be randomized into two groups: Group A will undergo Skin-Sparing Hemorrhoidectomy and PExy (SHAPE), while Group B will undergo conventional Milligan-Morgan hemorrhoidectomy.

Postoperatively, oral fluids will be allowed after 2 hours and normal diet resumed as tolerated. Patients will be discharged on the first postoperative day unless otherwise indicated. Follow-up visits will assess postoperative pain, complications, and surgical outcome

Study Overview

• Status: Recruiting
• Conditions: Hemorrhoid
• Intervention / Treatment: Procedure: Skin Sparing Hemorrhoidectomy and PExy (SHAPE); Procedure: Milligan-Morgan Hemorrhoidectomy

Detailed Description

This randomized controlled study will be conducted at the General Surgery Department, Kasr Al-Ainy Teaching Hospital, Cairo University, on patients presenting with third- and fourth-degree hemorrhoids. Adult patients older than 18 years who fulfill the inclusion criteria and provide informed consent will be included in the study. Patients with inflammatory bowel disease, anal stenosis, colorectal malignancy, or pre-existing fecal incontinence will be excluded.

Patients attending the outpatient clinic with symptoms suggestive of hemorrhoidal disease will be assessed according to the study criteria. After explaining the purpose and nature of the study, informed written consent will be obtained. All patients will undergo detailed preoperative evaluation including complete medical and surgical history, assessment of symptoms such as pain, bleeding, prolapse, discharge, and pruritus ani, in addition to local anorectal examination and digital rectal examination. Routine preoperative laboratory investigations will be performed for all patients, while colonoscopy will be requested in selected cases to exclude colorectal malignancy or other causes of lower gastrointestinal bleeding.

Participants will be randomly allocated into two groups. Group A will undergo Skin-Sparing Hemorrhoidectomy and PExy (SHAPE), which involves selective excision of hemorrhoidal tissue above the dentate line with preservation of anoderm followed by mucopexy using Vicryl sutures. Group B will undergo conventional Milligan-Morgan hemorrhoidectomy with excision of hemorrhoidal tissue, pedicle ligation, and preservation of skin bridges.

Postoperatively, oral fluids will be initiated after 2 hours and regular diet resumed as tolerated. Most patients will be discharged on the first postoperative day unless otherwise indicated. Patients will be reviewed twice weekly during the first postoperative week, weekly for the first month, and monthly thereafter to assess pain using the Visual Analog Scale (VAS), wound healing, postoperative complications, and surgical outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Mohamed Abdelaal, MD; Phone Number: +201118732767; Email: drabdelaal90@gmail.com

Study Locations

• Egypt
  • Al-Manial, Cairo, Egypt
    • Cairo, Al-Manial, Cairo, Egypt, Egypt, 11451
      • Recruiting
      • Faculty of medicine, Cairo University
      • Contact: Ahmed Mohamed Abdelaal, MD; Phone Number: +201118732767; Email: drabdelaal90@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patients with third- and fourth-degree piles, and their age greater than 18 years old

Exclusion Criteria:

• Patients with inflammatory bowel disease.
• Patients with anal stenosis
• Patients with colorectal malignancy
• Patient with fecal incontinence

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Skin-Sparing Hemorrhoidectomy and PExy (SHAPE); Patients will be conducted to skin sparing hemorrhoidectomy and PExy (SHAPE)	Procedure: Skin Sparing Hemorrhoidectomy and PExy (SHAPE); The procedure involves the selective excision of the hemorrhoidal columns ensuring that the dissection will be initiated cranial to the dentate line, with a preserved margin of at least 5 mm from it. This approach aims to maintain anoderm integrity while effectively addressing both internal and external hemorrhoidal components Following the line of dissection, a mucopexy will be performed using Vicryl 2/0 (polyglactin 910) . This step not only ensured adequate fixation of the prolapsed mucosa but also facilitated a lifting and smoothing effect on the external cutaneous component.
Active Comparator: Milligan-Morgan Hemorrhoidectomy; Patients will be conducted to Milligan-Morgan Hemorrhoidectomy	Procedure: Milligan-Morgan Hemorrhoidectomy; A V-shaped incision is made using a cutting cautery device in the skin surrounding the base of the hemorrhoid. Then dissection in the submucousal plane will be done by cautery to strip the hemorrhoid from its bed. The dissection will be continued in the cranial direction up to the pedicle. The pedicle will be then double ligated with a 2/0 vicryl suture, and the distal part of the hemorrhoid will be excised. The same steps will be carried out regarding the other hemorrhoids ( if present), leaving a skin bridge at least one centimeter between them to avoid anal stenosis. The wound will be left open, and an external pack of gauze will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pain intensity in both groups	Assessment of Post operative pain in both groups. (Compare Pain intensity measured using Visual Analogue Scale between both groups (Visual Analogue Scale for Pain: ranges from 0 to 10 . Higher scores indicate a worse outcome {greater pain intensity}).	At day 1, day 7 and day 30 postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Compare time of operation between both procedure	During surgery]
Number of participants with surgical site infection	compare surgical site infection in both groups (surgical site infection: infection at or near a surgical incision within 30 days post-surgery, marked by redness, swelling, or pus.)	Up to 3 months postoperatively
Post operative urine retention	compare incidence of postoperative urine retention in both groups	Within 48 hours postoperatively
Post operative anal stenosis in both groups	Postoperative anal stenosis will be assessed by digital rectal examination and graded clinically as follows: Mild: anal canal admits a well lubricated index finger. Moderate: Forceful dilatation required to admit a well lubricated index finger. Severe: Little finger cannot be admitted without forceful dilatation	Up to 3 months postoperatively
Recurrence of hemorrhoids in Both groups	Recurrence of hemorrhoids was defined as the reappearance of hemorrhoidal symptoms (bleeding, pain, or prolapse) and/or clinical evidence of hemorrhoids after initial postoperative resolution during the follow-up period	Up to 3 months postoperatively
Time to return to normal activity	Compare Time to return to normal activity in both groups	Up to 3 months postoperatively
Number of participants with Postoperative bleeding	Postoperative Bleeding will be assessed clinically and categorized as mild (self-limited), moderate (requiring medical treatment), or severe (requiring surgical intervention or blood transfusion).	Up to 3 months postoperatively

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Mostafa Sedky, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): May 24, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 16, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 16, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: SHAPE; Hemorrhoidal Disease; Milligan-Morgan Hemorrhoidectomy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: MS-625-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because this is a small surgical trial with a limited number of participants, and sharing raw data could lead to identification of participants

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No