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

Primary Purpose

Hemorrhoids

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laser hemorrhoidoplasty
open surgical hemorrhoidectomy
Sponsored by
Assiut University
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 SexesAccepts Healthy Volunteers

Inclusion Criteria: II-III hemorrhoidal disease failure of conservative treatment Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    LHP GROUP

    MM GROUP

    Arm Description

    patients received Laser Hemorrhoidoplasty procedure

    patients received conventional open surgical hemorrhoidectomy

    Outcomes

    Primary Outcome Measures

    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').
    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.

    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.

    Full Information

    First Posted
    January 22, 2023
    Last Updated
    March 14, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05770141
    Brief Title
    Laser Hemorrhoidoplasty Versus Open Surgical Hemorrhoidectomy in Second and Third Degree Piles
    Official Title
    Laser Hemorrhoidoplasty Procedure Versus Open Surgical Hemorrhoidectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    February 1, 2025 (Anticipated)
    Study Completion Date
    March 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

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

    5. Study Description

    Brief Summary
    The study aims to compare the pain , duration of intervention and long term outcomes of laser hemorrhoidoplasty versus open surgical hemorrhoidectomy
    Detailed Description
    Hemorrhoidal disease is ranked first among diseases of the rectum and large intestine, and the estimated worldwide prevalence ranges from 2.9% to 27.9%, of which more than 4% are symptomatic . Age distribution demonstrates a Gaussian distribution with a peak incidence between 45 and 65 years with subsequent decline after 65 years .Men are more frequently affected than women . The anorectal vascular cushions along with the internal anal sphincter are essential in the maintenance of continence by providing soft tissue support and keeping the anal canal closed tightly. Hemorrhoids are considered to be due to the downward displacement of suspensory (Treitz) muscle . There are many treatments of hemorrhoids varying from medications and band ligation to stapled hemorrhoidopexy, laser photocoagulation, sclerotherapy, Doppler-guided artery ligation, and finally surgery . The indications for the surgical treatment include the presence of a significant external component, hypertrophied papillae, associated fissure, extensive thrombosis or recurrence of symptoms after repeated RBL. The technique employed may be open (Milligan-Morgan) or closed (Ferguson) . Post hemorrhoidectomy pain is the commonest problem associated with the surgical techniques. The other early complications are urinary retention (20.1%), bleeding (secondary or reactionary) (2.4%-6%) and subcutaneous abscess (0.5%). The long-term complications include anal fissure (1% -2.6%), anal stenosis (1%), incontinence (0.4%), fistula (0.5%) and recurrence of hemorrhoids . The study aims to compare the pain , duration time of intervention and long term outcomes of laser hemorrhoidoplasty versus open surgical hemorrhoidectomy

    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
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    LHP GROUP
    Arm Type
    Other
    Arm Description
    patients received Laser Hemorrhoidoplasty procedure
    Arm Title
    MM GROUP
    Arm Type
    Other
    Arm Description
    patients received conventional open surgical hemorrhoidectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    laser hemorrhoidoplasty
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    open surgical hemorrhoidectomy
    Intervention Description
    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, 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').
    Time Frame
    30 postoperative days
    Title
    bleeding
    Description
    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.
    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.
    Time Frame
    6 months
    Other Pre-specified Outcome Measures:
    Title
    anal stenosis
    Description
    Patients who experience anal stenosis describe constipation, bleeding, pain, and incomplete evacuation.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: II-III hemorrhoidal disease failure of conservative treatment Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ebram Hakim, doctor
    Phone
    +201090079495
    Email
    anabebonaser@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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