Low Excision and High Suspension Hemorrhoidectomy Versus Conventional Milligan-Morgan Hemorrhoidectomy for Grade III-IV Mixed Hemorrhoids

NCT07495046 | Not Yet Recruiting

• 2 other identifiers: HF-2024-KY-036202427b10020009
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Low Excision and High Suspension Hemorrhoidectomy versus Conventional Milligan-Morgan Hemorrhoidectomy for Mixed Hemorrhoids

Conditions

Mixed Hemorrhoids

Keywords

Mixed Hemorrhoids; low excision and high suspension hemorrhoidectomy; Milligan-Morgan hemorrhoidectomy;

Outcome Measures

Primary Outcomes (2)

• Clinical effective rate at 12 weeks postoperatively

  Cured (complete resolution of symptoms and hemorrhoid prolapse) + improved (obvious relief of clinical symptoms) / total number of patients; an effective rate ≥90% was defined as clinically effective.

  12 weeks postoperatively

• Hemorrhoid recurrence rate at 12 months postoperatively

  Recurrence was defined as the reappearance of hemorrhoid prolapse or rectal bleeding requiring clinical reintervention during the follow-up period.

  12 months postoperatively

Study Arms (2)

Study Group

EXPERIMENTAL

Low Excision and High Suspension Hemorrhoidectomy

Procedure: Low Excision and High Suspension Hemorrhoidectomy

control Group

ACTIVE COMPARATOR

Conventional Milligan-Morgan Hemorrhoidectomy

Procedure: Conventional Milligan-Morgan Hemorrhoidectomy

Interventions

Low Excision and High Suspension Hemorrhoidectomy PROCEDURE

Low Excision and High Suspension Hemorrhoidectomy

Study Group

Conventional Milligan-Morgan Hemorrhoidectomy PROCEDURE

Conventional Milligan-Morgan Hemorrhoidectomy

control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Goligher grade III-IV mixed hemorrhoids via anorectal examination;
• Failed conservative treatment for at least 3 months;
• Voluntarily participated in the study and agreed to complete the 12-month follow-up.

You may not qualify if:

• History of previous anorectal surgery;
• Severe coagulation dysfunction, cardiopulmonary insufficiency, hepatic/renal failure, or mental disorders;
• Pregnancy or lactation;
• Inability to cooperate with postoperative follow-up and evaluation.

Sponsors & Collaborators

• The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Principal Investigator

Model Details: Patients were randomly assigned 1:1 to the LEHS group or MM group using a computer-generated random number table with block randomization (block size=4). Allocation concealment was achieved using sealed, opaque envelopes, which were opened only on the day of surgery. Outcome assessors (responsible for pain scoring, complication recording, and manometry testing) and statistical analysts were blinded to group assignments to minimize bias.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion: June 1, 2026
• Study Completion: July 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share