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

• ClinicalTrials.gov Identifier: NCT05770141
• Recruitment Status: Not yet recruiting
• First Posted: March 15, 2023
• Last Update Posted: March 15, 2023
• Sponsor: Assiut University
• Information provided by (Responsible Party): Ebram Nasser Hakim Boules, Assiut University

Tracking Information

• First Submitted Date: January 22, 2023
• First Posted Date: March 15, 2023
• Last Update Posted Date: March 15, 2023
• Estimated Study Start Date: April 1, 2023
• Estimated Primary Completion Date: February 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 14, 2023)

• Pain evaluation [ Time Frame: 30 postoperative days ]
  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 [ Time Frame: 30 postoperative days ]
  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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 14, 2023)

Presence of recurrence [ Time Frame: 6 months ]

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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 14, 2023)

anal stenosis [ Time Frame: 6 months ]

Patients who experience anal stenosis describe constipation, bleeding, pain, and incomplete evacuation.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Laser Hemorrhoidoplasty Versus Open Surgical Hemorrhoidectomy in Second and Third Degree Piles
• Official Title: Laser Hemorrhoidoplasty Procedure Versus Open Surgical Hemorrhoidectomy
• 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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hemorrhoids

Intervention

• Procedure: laser hemorrhoidoplasty
  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.
• Procedure: open surgical hemorrhoidectomy
  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.

Study Arms

• LHP GROUP
  patients received Laser Hemorrhoidoplasty procedure
  Intervention: Procedure: laser hemorrhoidoplasty
• MM GROUP
  patients received conventional open surgical hemorrhoidectomy
  Intervention: Procedure: open surgical hemorrhoidectomy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: March 14, 2023): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 1, 2025
• Estimated Primary Completion Date: February 1, 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Ebram Hakim, doctor; +201090079495; anabebonaser@gmail.com

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05770141
• Other Study ID Numbers: laser hemorrhoidoplasty
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Ebram Nasser Hakim Boules, Assiut University
• Original Responsible Party: Same as current
• Current Study Sponsor: Assiut University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assiut University
• Verification Date: March 2023