RecruitingNot ApplicableNCT07598630

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


Sponsor

Cairo University

Enrollment

68 participants

Start Date

May 24, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria1

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

Exclusion Criteria4

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURESkin 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.

PROCEDUREMilligan-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.


Locations(1)

Faculty of medicine, Cairo University

Cairo, Al-Manial, Cairo, Egypt, Egypt

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07598630


Related Trials