|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
13 January 2015 |
|
Main ID: |
ISRCTN22302839 |
|
Date of registration:
|
20/08/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effects of compressive bandages following stripping of greater saphenous vein (GSV) (EFFecten van COMpressief DRukverband na Varices OPeratie)
|
|
Scientific title:
|
Effects of compressive bandages following stripping of GSV |
|
Date of first enrolment:
|
24/02/2010 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN22302839 |
|
Study type:
|
Interventional |
|
Study design:
|
Prospective randomised controlled trial (Treatment)
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
TA
Sigterman |
|
Address:
|
Hoograamstraat 113
6211BJ
maastricht
Netherlands |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Primary insufficiency of GSV (CEAP classification; C2 en C3)
2. Unilateral crossectomy and strip of GSV
3. Bilateral crossectomy and strip of GSV
Exclusion criteria: 1. CEAP classification C5-C6
2. Non-compliance with postoperative compressive therapy
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Venous insufficiency
Circulatory System
Venous insufficiency (chronic)(peripheral)
|
|
Intervention(s)
|
Randomization of subjects with the aid of a computer performed randomisation list generated. Randomization works with a block size of 8 subjects to promote equal distribution of numbers of patients on the two treatment groups. All patients gave written consent to participate in the study.
Study population:
The study population will consist of two groups:
1. The group of 50 patients who receive postoperative compressive bandages for 4 hours (intervention group).
2. A group of 50 patients who receive postoperative compressive bandages for 72 hours (control group).
Follow-up:
Patients were seen day 3 and day 14 postoperative for primary and secondary outcomes.
|
|
Primary Outcome(s)
|
|
The primary endpoint is edema of the leg, objectified by volume measurements at day 14 post-operative, performed by the investigator. A Perometer® (Bösl Medizintechnik, Aachen- Deutschland) will be used. This leg volume measurement will be performed on three standardized points on the leg: 10 cm above the upper edge of the patella, at the tuberosity of the tibia and 5 cm below the tuberosity of the tibia
|
|
Secondary Outcome(s)
|
1. Post-operative pain will be scored by the patient on a standardized Visual Analogue Scale (VAS) from 1 to 10.
2. Postoperative complications such as subcutaneous hematoma formation, thrombophlebitis and postoperative swelling will be documented.
3. Time to full recovery and quality of life are secondary endpoints. The HRQOL will be estimated by the SF-36 questionnaire, which will be asked to fill in at randomization and after 2 weeks. At this point the patient will also be asked to determine the time in days to full recovery after the surgery.
|
|
Source(s) of Monetary Support
|
|
Investigator initiated and funded
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|