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Randomized Trial :Hemorrhoidal Pedicle Ligation vs Laser vs Open Hemorrhoidectomy

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ClinicalTrials.gov Identifier: NCT03757728
Recruitment Status : Enrolling by invitation
First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
Biolitec Pharma Ltd.
Information provided by (Responsible Party):
Tomas Poskus, Vilnius University

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.


Condition or disease Intervention/treatment Phase
Hemorrhoids Second Degree Hemorrhoids Third Degree Procedure: Haemorrhoidectomy operations Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hemorrhoidal Pedicle Ligation vs Laser Hemorrhoidectomy vs Open Hemorrhoidectomy: Randomized, Double Blind, Multicenter Trial
Actual Study Start Date : April 2016
Actual Primary Completion Date : April 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arm Intervention/treatment
open haemorrhoidectomy
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
for treatment of symptomatic 2 to 3 degree haemorrhoids

Haemorrhodal pedicle ligation
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
for treatment of symptomatic 2 to 3 degree haemorrhoids

Intrahaemoroidal laser coagulation
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
for treatment of symptomatic 2 to 3 degree haemorrhoids




Primary Outcome Measures :
  1. Recurrence rate of rectal prolapse [ Time Frame: one years ]
    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).

  2. Recurrence rate of rectal bleeding [ Time Frame: one years ]
    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).


Secondary Outcome Measures :
  1. Continence [ Time Frame: after one year ]
    Using Wexner fecal incontinence score (Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum 1993; 36:77-97)

  2. Recurrence of any perianal symptoms [ Time Frame: One years ]
    Evalluation by abdominal surgeon: pain, bleeding, external haemorrhoids, etc

  3. Time to return to work [ Time Frame: One years ]
    Time to return to work or regular activity, in days, reported by the patient

  4. Intensity and duration of postoperative perianal pain [ Time Frame: 7 postoperative days ]
    Intensity and duration of perianal pain after the operation (in days) based on visual analogue scale during after first 7 days of the operation

  5. Quality of life [ Time Frame: One years ]
    Quality of life based on Short-form (SF)-36 questionnaire (https://www.rand.org/health/surveys_tools/mos/36-item-short-form.html )

  6. Fecal incontinence quality of life (FIQOL) score [ Time Frame: One years ]
    Fecal incontinence quality of life (FIQOL) score at 1 year (Rockwood TH, Church JM, Fleshman JW. Fecal incontinence quality of life scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum 2000; 43:9-17)

  7. Evaluation of the operation by the patient [ Time Frame: One years ]
    Evaluation of the operation by the patient on visual analogue scale from 1 to 10 at 1-year visit.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757728


Locations
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Lithuania
Center of Abdominal Surgery, Vilnius University Hospital Santariskiu Clinics, Lithuania, 2 Santariskiu Street,
Vilnius, Lithuania, LT-08661
Sponsors and Collaborators
Vilnius University
Biolitec Pharma Ltd.

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Responsible Party: Tomas Poskus, Professor, Vilnius University
ClinicalTrials.gov Identifier: NCT03757728     History of Changes
Other Study ID Numbers: 158200-15-792-322
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 2017
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases