Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05840991
Status:
RECRUITING
Last Update Posted:
2023-06-05
First Post:
2023-04-17
Brief Title:
Effect of Short-term Compression Therapy After Thermal Ablation for Varicose Veins
Sponsor:
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Organization:
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study Overview
Official Title:
Effect of Short-term Compression Therapy After Thermal Ablation for Varicose Veins a Prospective Multicenter Non-inferiority Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective multicenter non-inferiority randomized controlled trial is designed to evaluate the effect after short-term compression therapy following thermal ablation of varicose veins Patients will be randomly assigned in a 11 ratio to one of the following treatments A elastic bandage for 48h or B elastic bandage for the first 24h and then a compression full-length stocking 23-32mm Hg for 1 week The two groups will be compared on several variables including target vein occlusion rate at 3 months primary outcome indicator as well as pain quality of life clinical severity of varicose veins postoperative complications time to return to normal work and compliance
Detailed Description:
A prospective multicenter non-inferiority randomized controlled trial is designed to evaluate the effect after short-term compression therapy following thermal ablation of varicose veins Patients will be randomly assigned in a 11 ratio to one of the following treatments A elastic bandage for 48h or B elastic bandage for the first 24h and then a compression full-length stocking 23-32mm Hg for 1 week The two groups will be compared on several variables including target vein occlusion rate at 3 months primary outcome indicator as well as pain quality of life clinical severity of varicose veins postoperative complications time to return to normal work and compliance
The current study will take place in nine hospitals in six provinces in China Target Population Patients referred to those with primary lower extremity saphenous varicose veins diagnosed in 9 target hospitals from April 2023 to August 2023 and all participants included in the trial signed an informed consent form
Intervention
Group A elastic bandage for 48h Group B elastic bandage for the first 24h and then a compression full-length stocking 23-32mm Hg for 1 week Follow-up
At baseline patients will be asked to fill a validated visual analogue scale VAS quality of life questionnaires AVVQ and clinical severity of varicose veins VCSS They will also be asked to attend a follow-up in 1 week and at 3 months
At 1 week target vein closure rate will be examined by double ultrasound scan DUS and patients will be asked to fill VAS AVVQ VCSS postoperative complications time to return to normal work and compliance
At 3 months target vein closure rate will be examined by double ultrasound scan DUS and patients will be asked to fill VAS AVVQ VCSS postoperative complications time to return to normal work and compliance
Sample Size
The target vein closure rate in the control group was set to 98 and α0025 unilateral and 1-β09 were taken combined with clinical expert recommendations a non-inferiority threshold δ of -6 was taken We would need to recruit 230 patients 115 per group to show a difference However to increase the robustness of the results considering a potential lost-to-review rate of 20 of study subjects combined with the low probability of adverse events in this trial the total sample size was expanded to 360
Study duration
With 3 months follow-up therefore the study will be running for 12 months with a target recruitment of 360 patients
The current study will take place in nine hospitals in six provinces in China Target Population Patients referred to those with primary lower extremity saphenous varicose veins diagnosed in 9 target hospitals from April 2023 to August 2023 and all participants included in the trial signed an informed consent form
Intervention
Group A elastic bandage for 48h Group B elastic bandage for the first 24h and then a compression full-length stocking 23-32mm Hg for 1 week Follow-up
At baseline patients will be asked to fill a validated visual analogue scale VAS quality of life questionnaires AVVQ and clinical severity of varicose veins VCSS They will also be asked to attend a follow-up in 1 week and at 3 months
At 1 week target vein closure rate will be examined by double ultrasound scan DUS and patients will be asked to fill VAS AVVQ VCSS postoperative complications time to return to normal work and compliance
At 3 months target vein closure rate will be examined by double ultrasound scan DUS and patients will be asked to fill VAS AVVQ VCSS postoperative complications time to return to normal work and compliance
Sample Size
The target vein closure rate in the control group was set to 98 and α0025 unilateral and 1-β09 were taken combined with clinical expert recommendations a non-inferiority threshold δ of -6 was taken We would need to recruit 230 patients 115 per group to show a difference However to increase the robustness of the results considering a potential lost-to-review rate of 20 of study subjects combined with the low probability of adverse events in this trial the total sample size was expanded to 360
Study duration
With 3 months follow-up therefore the study will be running for 12 months with a target recruitment of 360 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None