In the adult population, the age-adjusted prevalence of trunk varices (varicose veins of the deep veins of the legs) has been estimated as 40% in men and 32% in women (Evans 1999). Varicose veins account for 50,000 in-patient hospital episodes per year in England alone (London 2000). Primary varicose veins are due to valvular failure. Treatment for primary varicose veins is considered appropriate if the veins are symptomatic (NICE 2001). Common symptoms attributable to varicose veins include aching, itching and poor cosmesis (cosmetic appearance). Less common, but more serious, symptoms include haemorrhage and thrombophlebitis (inflammation of a vein with accompanying formation of a blood clot).
There are a variety of treatments available for varicose veins including compression stockings, injection sclerotherapy (injection of an irritant substance), as well as surgical methods of treatment. Many surgical treatments are practiced. These may involve ligation (tying) of the affected vein (long or short saphenous veins), stripping of the affected trunk veins and avulsions (removal) of the varicosities (dilated segments). Some surgeons use a combination of surgery and injection sclerotherapy. Newer surgical treatments include subfascial ligation and pin stripping. Subfascial ligation is a procedure that involves cutting through the skin and deep fascia (a sheet of connective tissue) and tying off the incompetent perforating veins that link the veins in the skin to the deep veins in the muscle. PIN-stripping (Perforate INvaginate stripping) is a technique that involves stripping the vein into itself in a manner similar to turning a stocking inside out. This results in a smaller exit wound. However, there is no consensus as to which is the best surgical technique to treat varicose veins.
The most common surgical operation is ligation of the sapheno-femoral vein, stripping of the long saphenous vein (LSV) and avulsions. The operation can be associated with significant blood loss, especially if it is a bilateral procedure. Tourniquets have been used as a means to exsanguinate (remove all blood from) limbs where there can be a risk of significant blood loss such as in orthopaedic surgery (Wakankar 1999), and arterial bypass surgery (Eyers 2000). There are potential problems with the use of tourniquets on lower limbs including thrombosis (Kumar 1998), and nerve damage (On 2000). The nature of varicose vein surgery is such that the potential for blood loss could be significant and this has led to some authors advocating the use of tourniquets (Farrands 1987; Robinson 2000; Sykes 2000).
There are a number of potential tourniquets in widespread use; these include the Rhys-Davies Cuff and Lofquist cuff. The Rhys-Davies cuff was developed as a means for exsanguination of limbs during orthopaedic operations (Rhys-Davies 1985). The Lofquist cuff, also known by its manufacturers name the Boazal cuff, is a pneumatic tourniquet originally invented by Dr. Johan Löfqvist.
To determine whether the use or non-use of tourniquet has any effect on the outcomes of varicose vein surgery, including blood loss and operative time.
Criteria for considering studies for this review
Types of studies
All randomised controlled trials that evaluate the use of a tourniquet in varicose vein surgery.
Types of participants
All patients having surgery for primary varicose veins. Those treated for cosmesis and also for symptomatic varicose veins (ache, itch, etc.) were included. It was intended to include sub-group analysis according to the severity and symptomology of the veins. It is hoped that future updates of this review will include such information from any identified studies.
Trials including patients undergoing treatment for the complications of varicose veins, venous ulceration and chronic venous insufficiency were excluded.
Types of interventions
All types of tourniquets used in varicose vein surgery compared to not using a tourniquet.
Types of outcome measures
- Blood loss: total blood loss during varicose vein surgery.
- Operative time: the total operative time was examined to assess the impact of using tourniquets.
- Complications and morbidity: the complications and morbidity associated with the use or non-use of tourniquets was examined. Common complications were identified and compared between use of and non-use of tourniquets and between different types of tourniquet. It was envisaged that potential complications could include nerve damage, ischaemia, bruising and pain.
- Patient satisfaction and quality of life (QoL) data: Quality of life assessment using either generic or disease specific measures was analysed, where included.
- Economic analysis: It was intended to include cost-effective analysis and resource usage.
Search methods for identification of studies
The search aimed to identify all papers relating to the use of tourniquets in surgical interventions for varicose veins.
For the original (2002) review where possible (e.g. in the smaller databases), searches were not restricted by publication type or study design. However, methodological filters aimed at identifying guidelines, systematic reviews and clinical trials were applied in the larger databases such as MEDLINE. Date and language restrictions were not used.
For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Specialised Register (last searched April 2013) and the Cochrane Central Register of Controlled Trials (CENTRAL) 2013, Issue 3, part of The Cochrane Library, (www.thecochranelibrary.com). See (Appendix 1) for details of the search strategy used to search CENTRAL. The Specialised Register is maintained by the TSC and is constructed from weekly electronic searches of MEDLINE, EMBASE, CINAHL, AMED, and through handsearching relevant journals. The full list of the databases, journals and conference proceedings which have been searched, as well as the search strategies used are described in the (Specialised Register) section of the Cochrane Peripheral Vascular Diseases Group module in The Cochrane Library (www.thecochranelibrary.com).
For the original review the authors searched 13 electronic bibliographic databases covering biomedical science, social science, health economic and grey literature (including current research). Various health services research related resources were consulted via the Internet. These included health economics and HTA organisations, guideline producing agencies, generic research and trials registers, and specialist sites. The searches were originally conducted during April 2000, although the major database searches were re-run in October 2000 and March 2001. Further details are given in Table 1; Table 2; Appendix 2; Appendix 3; Appendix 4 and Appendix 5.
Searching other resources
The reference lists of relevant articles were checked.
Data collection and analysis
Selection of trials
Two authors (KR, SP) independently assessed and selected trials for inclusion to the review. Suitability for inclusion was determined on the basis of the inclusion and exclusion criteria. Any disagreements were adjudicated by a third author (CB). Where data were missing, authors were contacted to provide additional details.
The quality of the studies was assessed by examining the following areas which have been shown to be indicators of trial quality:
1) comparability of groups in control and intervention arms at baseline,
2) the analysis of results on an intention-to-treat basis,
3) completeness of follow-up,
4) the blinding and objectivity of outcome assessment,
5) the appropriateness and completeness of statistical analysis of results.
Data from the trials were extracted by KR and SP independently and then cross-checked for agreement. Any disagreements were arbitrated by JAM. The following data were extracted where possible:
- method of randomisation,
- criteria for participant inclusion and exclusion,
- details of types of tourniquet and surgery,
- duration of surgery,
- patient characteristics,
- number of participants assigned to each treatment group,
- number of participants with co-morbid conditions,
- baseline comparability of treatment groups,
- outcome measures including blood loss, operative time, complications and morbidity, patient satisfaction and QoL data,
- economic analysis,
- number of participants withdrawn and reasons for withdrawal.
It was our intention to perform meta-analysis where sufficient homogeneity was found and to test for heterogeneity using subjective clinical judgement and the Chi-square test. However, as the data were not homogeneous, meta-analysis was not performed.
Description of studies
Results of the search
See (Appendix 1).
No additional studies were found for Inclusion or Exclusion as a result of the 2013 searches.
Full copies of 20 papers were screened from the search results.
Summary details of included studies are given in the Characteristics of included studies table. Only three trials were suitable for inclusion in the review (Corbett 1989; Sykes 2000; Thompson 1990). One study identified from the National Research Register (Hickey 1998), was subsequently published and included in the review (Sykes 2000) together with a further duplicate publication of this study (Sykes 1999).
Corbett 1989 was a trial undertaken in a district general hospital in the UK. The study involved 26 participants and, using the toss of a coin, randomised 40 limbs between use or non-use of a tourniquet. In bilateral cases the coin was spun twice, once to decide the surgeon (consultant or registrar), and once to decide to which leg the tourniquet would be applied. Both groups were similar at baseline. The severity of varicose veins was assessed on a subjective basis as either mild, moderate or severe.
Varicose vein surgery was performed using a sapheno-femoral flush ligation, stripping of the long saphenous vein (LSV) to below the knee and avulsions of varices through multiple stab incisions.
The type of tourniquet used was an Esmarch bandage which was applied in the sterile field in a circular motion (centripetal) to exsanguinate the limb, and secured at mid-thigh. Post-operatively the limb was bandaged up to the tourniquet before it was removed. Groin wounds were closed using an absorbable suture (PDS, Ethilon) and the stab incisions were closed with Micropore tape (See Table 3).
Sykes 2000 was a trial undertaken in a district general hospital in the UK. The trial randomised 50 participants between use or non-use of a tourniquet. The two groups were comparable at baseline. Treatment groups were allocated randomly using sealed envelopes on the day of the operation. The severity of varicose veins was assessed using a 1 to 5 scale based on symptoms:
1 = no symptoms
2 = symptoms
3 = skin changes
4 = healed ulcer
5 = active ulcer
People with varicose veins were recruited from the waiting list and assessed using a hand held Doppler. People with deep venous insufficiency, extensive anterior thigh veins, deep vein thrombosis (DVT), or sapheno-popliteal reflux were excluded.
The type of tourniquet used was a sterile Lofquist Cuff (Boazal, Sweden). This was inflated to 120 mmHg and secured to the upper thigh. All participants had a Trendelenberg 30° tilt, synchronous groin dissection and phlebectomies by a consultant and registrar, LSV stripping using a disposable Vasistrip (Astra), and phlebectomy using a stab incision and Oesch hooks. All legs had thrombo-embolic deterrent (TED) stockings, cotton wool and bandages applied post-operatively. The bandages were removed 48 hours post-operatively by the district nurse and the TED stockings were worn for two weeks. (See Table 3.)
Thompson 1990 was a trial conducted at a district general hospital in the UK. The trial randomised 100 consecutive participants to use or non-use of a tourniquet during varicose vein surgery. Twenty-one participants had bilateral (both legs) varicose veins and therefore a total of 121 limbs were included into the study. However, at the three month follow-up there were only 101 limbs available for analysis. No details were provided on the number of participants this equated to, or the reasons for withdrawals or losses to follow-up. No details were given regarding the method of randomisation or whether the unit of randomisation was the participant or the limb. Those with bilateral varicose veins had the tourniquet applied to the right leg only; the left leg acted as the non-tourniquet limb. Participants with vascular insufficiency, cardiovascular disease or previous DVT were excluded.
The type of tourniquet used was a Rhys-Davies cuff. This was applied to the leg and inflated to 500 mmHg. The non-tourniquet group was operated at a 30° Trendelenberg tilt. All participants in both groups had ligation of the sapheno-femoral junction flush with the femoral vein. Incisions were made using a number 11 scalpel blade and avulsions using Dunhill or mosquito forceps. Groin wounds were closed using either nylon or PDS (Ethicon) and stab wounds closed using steristrips. Legs were dressed with gauze, crepe and tubigrip. Participants were kept in overnight and the dressings were removed after three weeks (See Table 3).
Ten studies were non-randomised cohort studies (Fischer 1994; Klenerman 1977; Lahl 2000; Lofqvist 1988; Meyer 1997; Mildner 2000; Robinson 2000; Royle 1984; Streichenberger 1991; Tsavellas 2000), two were review articles (Fischer 1991; Wigger 1998), one was a description of surgical technique (Sachs 1994), one a postal questionnaire (Tsavellas 2000b), and one was a letter commenting on the use of tourniquets (Farrands 1987).
Risk of bias in included studies
The methodological quality of the included studies was relatively poor. All three studies had a small sample size and there were no a priori sample size calculations performed by any of the studies. The methods of randomisation were also poorly reported and the blinding to allocation was unclear. One trial (Corbett 1989), reported that randomisation was on the basis of toss of a coin by the anaesthetist. Another reported that sealed envelopes were used (Sykes 2000). However, there were details missing on how the randomisation sequence was generated and whether the envelopes were opaque. The final trial (Thompson 1990), merely reported that it was a randomised study in the abstract and provided no other details. There were also concerns that in bilateral operations treatment allocation was not random, for example, the right leg having the tourniquet applied and the left having no tourniquet.
Effects of interventions
The extensive search strategy found a total of three trials that were included in the review. These trials randomised 176 participants and 211 limbs to either use or non-use of a tourniquet during varicose vein surgery.
The main outcome measures were intra-operative blood loss, operative time and weight of varices. The mean blood loss was estimated by weighing swabs but the authors state that blood loss onto drapes or surgeons' gowns was not taken into account. In addition, the measured blood loss was restricted to that lost during avulsing and did not include losses during groin dissection or stripping. The mean blood loss was 16 ml (range 0 to 136 ml) in the tourniquet group and 107 ml (range 16 to 581 ml) in the non-tourniquet group (P < 0.001 using Wilcoxon's rank sum test). There was no statistically significant difference between the groups in terms of mean operating time or weight of varices. No details were provided regarding the blinding of outcome assessment. There were no reports of complications from use of the tourniquet.
The main outcome measures were median peri-operative blood loss, operative time, bruising, patient pain and activity, and cosmesis. The median blood loss in the tourniquet group was 0 ml (range 0 to 20 ml) compared to 125 ml (range 20 to 300 ml) in the non-tourniquet group (P < 0.01). No details were provided on how blood loss was estimated. The mean operative time was shorter when the tourniquet was used (30 min, range 11 to 47 min), compared to not using the tourniquet (37 min, range 18 to 50 min; P < 0.01). Median bruising area of the thigh was reduced in the tourniquet group (72 cm², range 30 to 429 cm²) compared to the non-tourniquet group (179 cm², range 24 to 669 cm²; P < 0.01). There were no significant differences in terms of patient pain, activity and cosmesis, as assessed using a zero to seven visual analogue score (VAS). No details were given on blinding of outcome assessment. Three patients had temporary saphenous neuralgia (two in the non-tourniquet group), and two patients had wound complications post-operatively (both in the non-tourniquet group).
The main outcome measures were mean blood loss, bruising, length of operation and cosmetic result. Results were reported on 101 legs (47 in the tourniquet group and 54 in the non-tourniquet group). No details of the reasons for losses to follow-up were provided. The mean blood loss was less in the tourniquet group (13.5 ml, range 1 to 56 ml) compared to the non-tourniquet group (133 ml, range 5 to 430 ml; P < 0.01). No details were provided on how the blood loss was estimated. The cosmetic results at six weeks, as assessed by a blinded observer using a linear analogue score, were better in the tourniquet group (P < 0.01). The mean score for cosmesis as assessed by the participant was also better in the tourniquet group (P < 0.01). There were no statistically significant differences found in terms of length of the operation and bruising at three weeks.
All of the trials examined the effect of using a tourniquet in terms of total blood loss. However, there were variations in defining total blood loss and how it was measured, with only Corbett (Corbett 1989), reporting how blood loss was estimated. This lack of detail in the other two trials could mean that there were significant variations in how total blood loss was estimated. Furthermore, Corbett (Corbett 1989), and Thompson (Thompson 1990), reported mean blood loss whereas Sykes (Sykes 2000), reported median blood loss. A summary of the findings on blood loss is presented in Table 3.
All of the trials included operative time as an outcome measure but there were variations in how this was measured. Corbett (Corbett 1989), defined the operative time from the start of avulsing to dressing the wounds. However, Thompson (Thompson 1990), defined it as the time from entering theatre to completion of the dressings. No details were provided in the third trial (Sykes 2000).
None of the trials determined the relative cost-effectiveness of the use of a tourniquet.
The available evidence on the evaluation of the use of tourniquets in varicose vein operations is limited to three randomised controlled trials (Corbett 1989; Sykes 2000; Thompson 1990). These trials were all of poor quality and had deficiencies in trial design, sample size and measurement of outcomes. None of the trials had sufficient power and sample size to determine the differences between use or non-use of a tourniquet during varicose vein surgery. There were also variations in how outcomes were measured, with two trials reporting means (Corbett 1989; Thompson 1990), and the third reporting medians (Sykes 2000). The small sample size also meant that there were insufficient numbers included to detect any rare potential complications from the use of tourniquet.
However, despite these limitations, all three trials agreed that the amount of blood loss can be significantly reduced when a tourniquet is used with no increase in operative time, reported adverse events or subjective outcome. The mean and median blood loss in the comparisons were relatively small and not necessarily clinically significant. However, those patients who did not have a tourniquet had a wider range of total blood loss, and those in the upper limits certainly lost a significant amount of blood. A further consideration is that any potential for reduction of exposure to blood for health care staff should be considered in light of the possibilities of blood-borne diseases such as HIV and hepatitis C.
A reduction in blood loss could result in a reduction of post-operative bruising, but only one trial (Sykes 2000), included this as an outcome measure. Although it did find a significant reduction in bruising area with the use of a tourniquet, the trial had a relatively small sample size of 25 patients in each group.
The trials were also not of sufficient size to determine the incidence of potential relatively rare complications such as nerve damage or arterial injury (especially in older patients). This is a consideration when recommending the use of tourniquets as large numbers of varicose vein operations are undertaken, and so there could be the potential for significant number of additional complications caused by using a tourniquet.
None of the trials explored the cost-effectiveness of the use or non-use of a tourniquet. The trials did not find any increase in the length of operation, which has a significant impact in terms of overall costs. However, there was no discussion of the costs of the tourniquets, other equipment or any additional potential costs such as staffing or training.
Implications for practice
The limited evidence would seem to suggest that the use of a tourniquet in routine varicose vein surgery may reduce the blood loss during the operation.
Implications for research
There is a need for a large randomised controlled trial, which includes an economic evaluation using a bottom up approach to costings, to determine whether the limited evidence for the use of tourniquets can be validated.
We would like to thank the NHS HTA programme for providing part-funding of the research; the views of this report are those of the researchers and not necessarily those of the HTA programme. We would also like to thank the Peripheral Vascular Diseases Review Group for their assistance with the literature searches and the Cochrane Consumer Network for providing the updated Plain Language Summary.
Data and analyses
This review has no analyses.
Appendix 1. CENTRAL search strategy 2013
Appendix 2. Search strategies used in the major databases
Appendix 3. Search strategy for EMBASE 1980 - 2001 (SilverPlatter WebSPIRS)
Appendix 4. Search strategy for MEDLINE 1966 - 2001 (Ovid Biomed)
Appendix 5. Methodological search filters used in Ovid Medline
Last assessed as up-to-date: 9 April 2013.
Protocol first published: Issue 1, 1999
Review first published: Issue 4, 2002
Contributions of authors
Kathryn Rigby - reviewed articles, extracted data, wrote text of review.
Simon Palfreyman - reviewed articles, extracted data, wrote text of review.
Catherine Beverley - searched electronic databases, handsearched journals, extracted data.
Jonathan Michaels - reviewed articles, contributed to writing the text of review.
Declarations of interest
KR and JM report that this review was done as part of HTA commissioned research to look at cost-effectiveness of treatments for varicose veins. This included funds for a RCT of varicose veins treatments. JM reports having received funds for private research consultancy from various companies not relating to varicose veins, some relating to vascular disease and technology appraisal in general. JM has also been awarded an NIHR programme grant for research relating to vascular services.
Sources of support
- Sheffield Vascular Institute, Northern General Hospital, Sheffield, UK.
- NHS R&D HTA Programme, UK.
- Chief Scientist Office, Scottish Government Health Directorates, The Scottish Government, UK.The PVD Group editorial base is supported by the Chief Scientist Office.
Medical Subject Headings (MeSH)
MeSH check words
* Indicates the major publication for the study