SHAPE Versus Milligan-Morgan Hemorrhoidectomy for Hemorrhoidal Disease

NCT07598630 | Recruiting

• 1 other identifier: MS-625-2025
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemorrhoid

Keywords

Hemorrhoidal Disease; SHAPE; Milligan-Morgan Hemorrhoidectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Operative time

  During surgery]

• Number of participants with surgical site infection

  Up to 3 months postoperatively

• Post operative urine retention

  Within 48 hours postoperatively

• Post operative anal stenosis in both groups

  Up to 3 months postoperatively

• Recurrence of hemorrhoids in Both groups

  Up to 3 months postoperatively

Study Arms (2)

Skin-Sparing Hemorrhoidectomy and PExy (SHAPE)

EXPERIMENTAL

Patients will be conducted to skin sparing hemorrhoidectomy and PExy (SHAPE)

Procedure: Skin Sparing Hemorrhoidectomy and PExy (SHAPE)

Milligan-Morgan Hemorrhoidectomy

ACTIVE COMPARATOR

Patients will be conducted to Milligan-Morgan Hemorrhoidectomy

Procedure: Milligan-Morgan Hemorrhoidectomy

Interventions

Skin Sparing Hemorrhoidectomy and PExy (SHAPE) PROCEDURE

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.

Skin-Sparing Hemorrhoidectomy and PExy (SHAPE)

Milligan-Morgan Hemorrhoidectomy PROCEDURE

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.

Milligan-Morgan Hemorrhoidectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine, Cairo University

Cairo, Al-Manial, Cairo, Egypt, 11451, Egypt

RECRUITING

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mostafa Sedky, MD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Ahmed Mohamed Abdelaal, MD

CONTACT

+201118732767; drabdelaal90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): May 24, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)