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Minimal Invasive Laser Hemorrhoidoplasty vs Conventional Excisional Hemorrhoidectomy in II-III Grade Hemorrhoidal Disease

U

University of Campania "Luigi Vanvitelli"

Status

Completed

Conditions

Hemorrhoids

Treatments

Procedure: LHP
Procedure: MM

Study type

Interventional

Funder types

Other

Identifiers

NCT04944407
laser hemorroid

Details and patient eligibility

About

the study aims to evaluate the effectiveness and long term outcomes of laser hemorroidoplasty versus conventional milligan morgan hemorrhoidectomy in II-III degree hemorroidal disease.

Full description

Background Hemorrhoidal disease (HD) is a widespread condition and several surgical techniques have been proposed to date without achieving a definitive consensus. Laser Hemorrhoidoplasty (LHP) is a minimal invasive procedure for HD treatment determining the shrinkage of the hemorrhoidal piles by diode laser limiting the postoperative discomfort and pain. The aim of the current prospective randomized trial is to evaluate the postoperative outcomes of HD patients undergoing LHP vs conventional Milligan-Morgan hemorrhoidectomy (MM).

Methods. Operative time, postoperative pain and complications, resolution of symptoms, patients 'quality of life, patients' evaluation of treatment and length of return to daily activity of II-III grade symptomatic HD patients undergoing LHP vs MM were prospectively evaluated. The patients were followed-up for 24 months looking for recurrence of prolapsed hemorrhoid or symptoms.

Enrollment

220 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • II-III hemorrhoidal disease
  • failure of conservative treatment
  • ASA I-II

Exclusion criteria

  • acutely thrombosed hemorrhoids
  • patients affected by IBD involving rectum or anus
  • patients previously surgically treated for hemorrhoidal disease and the inability to complete study protocol

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

220 participants in 2 patient groups

LHP GROUP
Experimental group
Description:
patients recieved minimal invasive LHP procedure with diode laser
Treatment:
Procedure: LHP
MM GROUP
Active Comparator group
Description:
patients received conventional MM hemorroidectomy
Treatment:
Procedure: MM

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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