Laser Hemorrhoidoplasty Versus Open Surgical Hemorrhoidectomy in Second and Third Degree Piles

NCT05770141 | Unknown

• 1 other identifier: laser hemorrhoidoplasty
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to compare the pain , duration of intervention and long term outcomes of laser hemorrhoidoplasty versus open surgical hemorrhoidectomy

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (2)

• Pain evaluation

  postoperative pain assessment with Visual Analogue Scale Score, The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

  30 postoperative days

• bleeding

  The timing of bleeding after hemorrhoidectomy varies, and can be generally divided into immediate and delayed.5 Immediate bleeding occurs within 24 to 48 hours of a procedure and is likely related to loss of control of the vascular pedicle. Delayed bleeding is defined as bleeding reported up to 2 weeks postprocedure, and is more often related to infection or local trauma , patients often report frequent passing of small to moderate amounts of clot and bright red blood starting after bowel movement.

  30 postoperative days

Secondary Outcomes (1)

• Presence of recurrence

  6 months

Other Outcomes (1)

• anal stenosis

  6 months

Study Arms (2)

LHP GROUP

OTHER

patients received Laser Hemorrhoidoplasty procedure

Procedure: laser hemorrhoidoplasty

MM GROUP

OTHER

patients received conventional open surgical hemorrhoidectomy

Procedure: open surgical hemorrhoidectomy

Interventions

laser hemorrhoidoplasty PROCEDURE

A skin incision 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 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) 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.

LHP GROUP

open surgical hemorrhoidectomy PROCEDURE

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.

MM GROUP

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• II-III hemorrhoidal disease
• failure of conservative treatment

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ebram Hakim, doctor

CONTACT

+201090079495; anabebonaser@gmail.com

Study Design

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

Study Record Dates

• First Submitted: January 22, 2023
• First Posted: March 15, 2023
• Study Start: April 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 15, 2023

Record last verified: 2023-03