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. 2015 Feb 23;2015(2):CD001097. doi: 10.1002/14651858.CD001097.pub3

Makarova 2001.

Methods Study design: randomised, parallel trial
Method of randomisation: not stated. Patients treated by elasticated compression for 5 years before study and divided into stable (unchanging CEAP clinical class) and progressive (deteriorating CEAP class) on entry into study
Blinding not stated
Exclusions post randomisation: not stated
Exclusions for failure to consent: 40
Dropouts (lost to follow‐up): 3
Duration of study (postoperatively): 7 years
Comparable treatment and control groups
Participants Country: Russia
No: 168 participants entered. 149 completed 5‐year observation period. 19 refused surgery. 128 entered surgical period. 125 completed 7 years of follow‐up (63 treatment, 62 control)
Age: not stated
Sex: not stated
Inclusion criteria: CEAP C2 to C4
 Ultrasound reflux in both GSV and SFV
Exclusion criteria: history of DVT, episodes of acute oedema of lower extremity, trauma, major surgery, hospital stay with bed rest longer than 3 days. Ultrasound findings (confirmed on phlebography) of occlusion/stenosis of femoral vein or massive collateral venous pathways
Interventions Treatment: unilateral GSV stripping and stab avulsions of varicose tributaries. Phlebographically confirmed incompetent perforating veins subfascially ligated in 20 participants by open long medial vertical approach. All 63 participants underwent SFV valve correction by internal valvuloplasty
Control: unilateral GSV stripping and stab avulsions of varicose tributaries. Phlebographically confirmed incompetent perforating veins subfascially ligated in 21 participants by open long medial vertical approach
No reference made to the use of low‐dose heparin and graduated compression stockings
Outcomes No change in CEAP clinical class (defined as stable improvement) nor increase in clinical class (defined as aggravation), recurrent varicose veins
RT and RVI were measured yearly by duplex scanning for 7 or 8 years postoperatively
Notes Complications not mentioned
 Healing of 27 venous ulcers developing during 5 years prestudy; observation not mentioned separately
 12 valvuloplasty failures (of 64) mainly during third year postoperatively of follow‐up
 Large quantity of data not suitable for analysis
 Study suggests possible benefit of valve repair at 7 years
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk No details given
Allocation concealment (selection bias) High risk No details given
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No details given
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No details given
Incomplete outcome data (attrition bias) 
 All outcomes Low risk At the end of the fifth year, 19 participants withdrew from the study and were not included in the final data analysis
Selective reporting (reporting bias) Low risk All outcomes reported as planned
Other bias Low risk None