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

Primary Purpose

Hemorrhoids

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
LHP
MM
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhoids

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Campania Luigi Vanvitelli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LHP GROUP

MM GROUP

Arm Description

patients recieved minimal invasive LHP procedure with diode laser

patients received conventional MM hemorroidectomy

Outcomes

Primary Outcome Measures

Pain evaluation
postoperative pain assessment with Visual Analogue Scale Score
Analgesic use
use of analgesic drugs in the postopertive days

Secondary Outcome Measures

Presence of recurrence
Patients were considered to have recurrent hemorrhoidal symptoms when any of the following were recorded: bleeding, itching, pain or discomfort affecting patient's perception of quality of life, which could either be associated or not to prolapse recurrence. The Rovrik' score was adopted to assess this issue.

Full Information

First Posted
June 15, 2021
Last Updated
June 21, 2021
Sponsor
University of Campania "Luigi Vanvitelli"
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1. Study Identification

Unique Protocol Identification Number
NCT04944407
Brief Title
Minimal Invasive Laser Hemorrhoidoplasty vs Conventional Excisional Hemorrhoidectomy in II-III Grade Hemorrhoidal Disease
Official Title
Minimal Invasive Laser Hemorrhoidoplasty vs Conventional Excisional Hemorrhoidectomy in II-III Grade Hemorrhoidal Disease: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LHP GROUP
Arm Type
Experimental
Arm Description
patients recieved minimal invasive LHP procedure with diode laser
Arm Title
MM GROUP
Arm Type
Active Comparator
Arm Description
patients received conventional MM hemorroidectomy
Intervention Type
Procedure
Intervention Name(s)
LHP
Intervention Description
A skin microincision of 3 mm was made about 1 to 1.5 cm of distance from the anal verge at the base of each hemorrhoidal node. The probe (1.85 mm of diameter) was driven through the incision in the submucosal tissue until reaching the area underneath the distal rectal mucosa. Then, ten to twelve effective pulses (adjusted to respective node dimensions), 8 watt per 3 seconds each, of approximately 24 Joule using a 1470-nm diode laser generator (LEONARDO® DUAL 45 Biolitec® Jena, Germany) were fired. Half of them were fired in the submucosal tissue, the others in the intra-nodal compartment determining the shrinkage of the hemorrhoidal piles. The anal wounds were left open. At the end of the procedure an anal tampon was positioned.
Intervention Type
Procedure
Intervention Name(s)
MM
Intervention Description
The hemorrhoidectomy was performed by radiofrequency (LigaSure TM Small Jaw® Covidien®, Colorado, USA) or ultrasound (Focus® Ultracision® harmonic scalpel; Ethicon Endo-Surgery®, Inc., Cincinnati, Ohio). The anodermal wedge was incised, eventually removing external fibrosis and/or skin tags when present. Upward dissection started at this level with en-bloc excision of mucosal and submucosal layers from the underlying internal anal sphincter up to the anorectal ring. A compressive haemostatic sponge was left in place for 12-24 hours.
Primary Outcome Measure Information:
Title
Pain evaluation
Description
postoperative pain assessment with Visual Analogue Scale Score
Time Frame
30 postoperative days.
Title
Analgesic use
Description
use of analgesic drugs in the postopertive days
Time Frame
30 postoperative days.
Secondary Outcome Measure Information:
Title
Presence of recurrence
Description
Patients were considered to have recurrent hemorrhoidal symptoms when any of the following were recorded: bleeding, itching, pain or discomfort affecting patient's perception of quality of life, which could either be associated or not to prolapse recurrence. The Rovrik' score was adopted to assess this issue.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Campania Luigi Vanvitelli
City
Napoli
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
I am not sure in the current study phase

Learn more about this trial

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

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