Trial Outcomes & Findings for The Long-term Value of Preoperative Duplex Before Surgery for Varicose Veins (NCT NCT01195623)

NCT ID: NCT01195623

Last Updated: 2013-02-15

Results Overview

number of reoperations (legs) in the two treatment arms

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 293 participants
• Primary outcome timeframe: 7 years mean
• Results posted on: 2013-02-15

Participant Flow

Participant milestones

Measure	Varicose Vein Surgery With Preoperative Duplex The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail	Varicose Vein Surgery Without Preoperative Duplex The surgeon has planned surgery for varicose veins from a clinical examination only
Overall Study STARTED	148	145
Overall Study COMPLETED	113	108
Overall Study NOT COMPLETED	35	37

Reasons for withdrawal

Measure	Varicose Vein Surgery With Preoperative Duplex The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail	Varicose Vein Surgery Without Preoperative Duplex The surgeon has planned surgery for varicose veins from a clinical examination only
Overall Study Lost to Follow-up	35	37

Baseline Characteristics

The Long-term Value of Preoperative Duplex Before Surgery for Varicose Veins

Baseline characteristics by cohort

Measure	Varicose Vein Surgery With Preoperative Duplex n=148 Participants The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail	Varicose Vein Surgery Without Preoperative Duplex n=145 Participants The surgeon has planned surgery for varicose veins from a clinical examination only	Total n=293 Participants Total of all reporting groups
Age Continuous	56.3 years STANDARD_DEVIATION 10.6 • n=5 Participants	52.6 years STANDARD_DEVIATION 12.9 • n=7 Participants	54 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants	109 Participants n=7 Participants	217 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	36 Participants n=7 Participants	76 Participants n=5 Participants
Region of Enrollment Sweden	148 participants n=5 Participants	145 participants n=7 Participants	293 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 years mean

Population: The number of legs has been analyzed, randomized 166 legs in the duplex group and 177 in the no-duplex group

number of reoperations (legs) in the two treatment arms

Outcome measures

Measure	Varicose Vein Surgery With Preoperative Duplex n=124 Participants The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail	Varicose Vein Surgery Without Preoperative Duplex n=134 Participants The surgeon has planned surgery for varicose veins from a clinical examination only
Rate of Re-do Surgery	15 legs	38 legs

SECONDARY outcome

Timeframe: 7 years

Population: The number of legs with recurrence of varicose veins in the saphenofemoral junction (SFJ)or saphenopopliteal junction (SPJ)

number of recurrences in treatment arms but also nature of recurrences

Outcome measures

Measure	Varicose Vein Surgery With Preoperative Duplex n=95 legs The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail	Varicose Vein Surgery Without Preoperative Duplex n=99 legs The surgeon has planned surgery for varicose veins from a clinical examination only
Recurrence Rate	13 legs	46 legs

Adverse Events

Varicose Vein Surgery With Preoperative Duplex

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Varicose Vein Surgery Without Preoperative Duplex

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lena Blomgren MD PhD

Uppsala UH

Phone: +46851774173

Email: lena.blomgren@karolinska.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place