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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03757728
Other study ID # 158200-15-792-322
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date November 2018

Study information

Verified date November 2018
Source Vilnius University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Procedure:
Haemorrhoidectomy operations
for treatment of symptomatic 2 to 3 degree haemorrhoids

Locations

Country Name City State
Lithuania Center of Abdominal Surgery, Vilnius University Hospital Santariskiu Clinics, Lithuania, 2 Santariskiu Street, Vilnius

Sponsors (2)

Lead Sponsor Collaborator
Vilnius University Biolitec Pharma Ltd.

Country where clinical trial is conducted

Lithuania, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Continence Using Wexner fecal incontinence score (Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum 1993; 36:77-97) after one year
Secondary Recurrence of any perianal symptoms Evalluation by abdominal surgeon: pain, bleeding, external haemorrhoids, etc One years
Secondary Time to return to work Time to return to work or regular activity, in days, reported by the patient One years
Secondary Intensity and duration of postoperative perianal pain Intensity and duration of perianal pain after the operation (in days) based on visual analogue scale during after first 7 days of the operation 7 postoperative days
Secondary Quality of life Quality of life based on Short-form (SF)-36 questionnaire (https://www.rand.org/health/surveys_tools/mos/36-item-short-form.html ) One years
Secondary Fecal incontinence quality of life (FIQOL) score 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) One years
Secondary Evaluation of the operation by the patient Evaluation of the operation by the patient on visual analogue scale from 1 to 10 at 1-year visit. One years
See also
  Status Clinical Trial Phase
Completed NCT06420986 - Open Hemorrohoidectomy Vs Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptoms N/A
Completed NCT03848468 - Comparison Study: Ligasure Versus Conventional Hemorrhoidectomy in III and IV Degree Hemorrhoids. N/A