Randomized Trial :Hemorrhoidal Pedicle Ligation vs Laser vs Open Hemorrhoidectomy

NCT03757728 | Unknown

• 1 other identifier: 158200-15-792-322
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare three different modalities for treatment of symptomatic 2 ° to 3 ° haemorrhoids: open haemorrhoidectomy, intrahaemorrhoidal laser procedure and haemorrhoidal pedicle ligation. To assess early outcomes (after one week and one month) of the procedures: pain, bleeding, wound healing, return to work and quality of life; To assess late outcomes (after one year) of the procedures: late functional results (continence) and recurrence of symptoms and haemorrhoids. Study design This is a multi-center, double-blind, prospective RCT comparing three different modalities for treatment of symptomatic 2 ° to 3 ° haemorrhoids: open haemorrhoidectomy, intrahaemorrhoidal laser coagulation and haemorrhoidal artery ligation.

Conditions

Hemorrhoids Second Degree; Hemorrhoids Third Degree

Outcome Measures

Primary Outcomes (2)

• Recurrence rate of rectal prolapse

  Visual rectal prolapse during postoperative anoscopy requiring any kind of medical attention or treatment (visit to the doctor or pharmacy, medical, invasive or surgical treatment).

  one years

• Recurrence rate of rectal bleeding

  Intensity and frequency of postoperative bleeding requiring any kind of medical attention or treatment (visit to the doctor or pharmacy, medical, invasive or surgical treatment).

  one years

Secondary Outcomes (7)

• Continence

  after one year

• Recurrence of any perianal symptoms

  One years

• Time to return to work

  One years

• Intensity and duration of postoperative perianal pain

  7 postoperative days

• Quality of life

  One years

Study Arms (3)

open haemorrhoidectomy

OTHER

Open haemorrhoidectomy is performed using an anal retractor, exposed haemorrhoids at 3 - 7- 11 hours are excised using cautery. The arteries are ligated or cauterized. Open or closed technique is used (the choice of the surgeon). The Spongostan plug is then introduced

Procedure: Haemorrhoidectomy operations

Haemorrhodal pedicle ligation

OTHER

Haemorrhodal pedicle ligation is performed using operating proctoscope. The pedicle of symptomatic haemorrhoid is suture ligated with absorbable Vycril 2/0. Mucopexy is performed simultaneously if the prolapse is noticed. No tissue removal is performed

Procedure: Haemorrhoidectomy operations

Intrahaemoroidal laser coagulation

OTHER

Intrahaemoroidal laser coagulation is performed using disposable THD kit \[Biolitec Co\]. The haemorrhoidal pedicle is sutured. 1mm opening is created at the external haemorrhoid (skin level). Laser is then introduced up to pedicle and coagulation performed. This is repeated to all the piles. The procedure is finished with placing Spongostan plug into anal canal

Procedure: Haemorrhoidectomy operations

Interventions

Haemorrhoidectomy operations PROCEDURE

for treatment of symptomatic 2 to 3 degree haemorrhoids

Haemorrhodal pedicle ligation; Intrahaemoroidal laser coagulation; open haemorrhoidectomy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All consented \>18 year old male and female patients with 2 to 3 degree

You may not qualify if:

• Patients with 1st and 4th degree haemorrhoids.
• Patients with associated anorectal pathology (anorectal fistula, abscess, fissure, tumor or inflammatory bowel disease).
• Patients who had undergone previous anorectal surgery.
• ASA \> 3.
• Pregnancy

Sponsors & Collaborators

• Vilnius University: lead
• Biolitec Pharma Ltd.: collaborator

Study Sites (1)

Center of Abdominal Surgery, Vilnius University Hospital Santariskiu Clinics, Lithuania, 2 Santariskiu Street,

Vilnius, LT-08661, Lithuania

Location

Study Design

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

Study Record Dates

• First Submitted: November 18, 2018
• First Posted: November 29, 2018
• Study Start: April 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

LI (1)