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
About this trial
This is an interventional treatment trial for Hemorrhoids
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
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
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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