Conventional stripping versus cryostripping: a prospective randomised trial to compare improvement in quality of life and complications.

OBJECTIVES: To assess the improvement in quality of life and complication rates in patients undergoing great saphenous vein (GSV) stripping using two different techniques. DESIGN: A single centre prospective randomised trial. PATIENTS AND METHODS: 160 patients with primary varicose veins and GSV incompetence were randomised to either conventional stripping or cryostripping combined with phlebectomy of varices. Quality of life was assessed as the primary outcome measure prior to surgery and 6 months later, using the SF-36 questionnaire. Operative data, pain score and procedure related complications were evaluated as secondary outcome measures. We assessed the area of bruising and symptoms attributable to saphenous nerve injury. RESULTS: The number of completely analysed patients was 77 in the conventional stripping group and 69 in the cryostripping group. When comparing the preoperative SF-36 scores to the results after 6 months, there was an improvement in all eight domains, which reached statistical significance in six domains in both groups. The mean area of bruising measured in the thigh was significantly greater in the conventional stripping group (161 S.D. 63cm(2) versus 123 S.D. 52cm(2), p=0.010, Student's t test). The number of patients with paraesthesia due to saphenous nerve injury was numerically lower in the cryostripping group at one week [15 (22%), versus 28 (34%), N.S.] but no difference was observed at 6 months. Postoperative pain score evaluation in the evening and 24 hours after the operation revealed no significant difference. CONCLUSIONS: The study confirmed significant improvement in quality of life measured by SF-36 questionnaire after both conventional and cryostripping with no difference between the two stripping techniques. Cryostripping results in less bruising than conventional stripping.     

A prospective randomised trial of PIN versus conventional stripping in varicose vein surgery.

A prospective, randomised trial was carried out to examine the efficacy of perforate invagination (PIN, Credenhill Ltd, Derbyshire, UK) stripping of the long saphenous vein (LSV) in comparison to conventional stripping (Astratech AB, Sweden) in the surgical management of primary varicose veins. Eighty patients with primary varicosities secondary to sapheno-femoral junction (SFJ) incompetence and LSV reflux were recruited. Patients were randomised to PIN or conventional stripping with all other operative techniques remaining constant. Follow-up was performed at 1 and 6 weeks postoperatively. There were no statistically significant differences between the two techniques in terms of time taken to strip the vein, percentage of vein stripped or the area of bruising at 1 week. The size of the exit site was significantly smaller with the PIN device (P < or = 0.01). Optimal use of the conventional stripper provides results comparable to the PIN device. Choice of stripping device remains the surgeon's, bearing in mind that the PIN stripper achieves slightly better cosmesis.     

Local anaesthetic flush reduces postoperative pain and haematoma formation after great saphenous vein stripping--a randomised controlled trial.

OBJECTIVES: To observe the effect of local anaesthetic flush through the great saphenous vein (GSV) tunnel on postoperative pain and haematoma formation following saphenous vein stripping operations. DESIGN: Prospective, double-blind, randomised, control trial. METHODS: One hundred patients were randomized to receive 20 ml of local anaesthetic (bupivacaine 0.25% + adrenaline) or saline control flush through the GSV tunnel after stripping in a double-blind study. Visual analogue pain scores were used to measure postoperative pain daily for the 1st week, then at 3 weeks and 6 weeks. Patients were examined during the 1st, 3rd and 6th week for haematoma formation. RESULTS: In the control group the median postoperative pain score was 4 (range 0-7) in the immediate postoperative period compared to a median of 1 (range 0-4) in the LA group (p<0.001). The median pain score on day-4 was 4 (range 1-6) (control) vs. 1 (range 0-3) (LA group) (p<0.001, Mann-Whitney Utest) and on day-6 it was 1 (range 0-5) (control) vs. 0 (range 0-5) (LA group) (p<0.001, Mann-Whitney). Twelve patients (24%) developed a haematoma in the GSV tunnel in the control group compared to three patients (6%) in the LA group (p = 0.007). CONCLUSION: Flushing of the GSV tunnel with bupivacaine plus adrenaline significantly reduces postoperative pain and haematoma formation in patients undergoing GSV stripping for varicose veins.     

日间手术模式下腔内射频消融术与静脉剥脱导管主干剥脱术治疗大隐静脉曲张疗效比较

目的 比较日间手术模式下大隐静脉腔内射频消融术与静脉剥脱导管主干剥脱治疗大隐静脉曲张的安全性及有效性.方法 收集2020年2月至2021年1月大连市金州区第一人民医院收治的84例行日间手术的大隐静脉曲张患者的临床资料,根据手术方式的不同将患者分为射频组(n=44,采用大隐静脉主干射频消融术+小腿浅表静脉泡沫硬化+部分小...     

Randomized clinical trial comparing surgery with conservative treatment for uncomplicated varicose veins

BACKGROUND: Surgical treatment of medically uncomplicated varicose veins is common, but its clinical effectiveness remains uncertain. METHODS: A randomized clinical trial was carried out at two large acute National Health Service hospitals in different parts of the UK (Sheffield and Exeter). Some 246 patients were recruited from 536 consecutive referrals to vascular outpatient clinics with uncomplicated varicose veins suitable for surgical treatment. Conservative management, consisting of lifestyle advice, was compared with surgical treatment (flush ligation of sites of reflux, stripping of the long saphenous vein and multiple phlebectomies, as appropriate). Changes in health status were measured using the Short Form (SF) 6D and EuroQol (EQ) 5D, quality of life instruments based on SF-36 and EuroQol, complications of treatment, symptomatic measures, anatomical extent of varicose veins and patient satisfaction. RESULTS: In the first 2 years after treatment there was a significant quality of life benefit for surgery of 0.083 (95 per cent confidence interval (c.i.) 0.005 to 0.16) quality-adjusted life years (QALYs) based on the SF-6D score and 0.13 (95 per cent c.i. 0.016 to 0.25) based on the EQ-5D score. Significant benefits were also seen in symptomatic and anatomical measures. CONCLUSION: Surgical treatment provides symptomatic relief and significant improvements in quality of life in patients referred to secondary care with uncomplicated varicose veins.     

Efficacy of testosterone replacement therapy on pain in hypogonadal men with chronic pain syndrome: A subanalysis of a prospective randomised controlled study in Japan (EARTH study)

The present study investigated the efficacy of 6 months of testosterone replacement therapy (TRT) on chronic pain syndrome in late-onset hypogonadal (LOH) men. Sixty hypogonadal patients with chronic pain syndrome (31 patients in TRT group and 29 controls) were extracted from a previous randomised controlled study in Japan. Chronic pain was evaluated based on bodily pain (BP) subscale of Short-form (36) Health Survey (SF-36), and patients with a score of 50.0 or less were defined as suffering from chronic pain. SF-36 scores, Aging Male Symptoms (AMS) scale, international prostatic symptoms score (IPSS) and prostate-specific antigen (PSA) levels at baseline and a 6-month visit for the two groups were collected and compared. There were no statistically significant differences in baseline backgrounds between the two groups. Six-month TRT could contribute to significant improvements in BP, mental health of SF-36 and sleep disturbance (AMS question 4). Though the PSA level in the TRT group also significantly elevated at 6 months, the increase was not clinically significant. No significant improvements were evident in any characteristics in the controls. In conclusion, 6-month TRT can improve pain and some aspects of quality of life in LOH men with chronic pain.     

The effect of long saphenous vein stripping on quality of life

PURPOSE: Long saphenous vein (LSV) stripping in the treatment of varicose veins may reduce the recurrence of varices but may also increase morbidity rates. The effect of stripping on health-related quality of life (HRQoL) is unknown. The aim of this study was to examine the effect of LSV surgery, with and without successful stripping, on HRQoL. METHODS: This prospective study comprises 102 consecutive patients who underwent varicose vein surgery that included attempted stripping of the LSV to the knee. HRQoL was assessed before surgery and at 4 weeks, 6 months, and 2 years after surgery with the Aberdeen varicose vein severity score (AVSS; disease-specific) and the Short-Form 36 (SF-36; generic). Patients defined as stripped were those in whom complete thigh stripping to the knee was confirmed with postoperative duplex scanning at 2 years. Patients defined as incompletely stripped were those in whom any LSV remnant was found in the thigh after surgery. Deep venous reflux (DVR) was defined as reflux of 0.5 seconds or more in at least the popliteal vein. RESULTS: Sixty-six of 102 patients (65%) provided complete HRQoL data at all four time points. At baseline, there was no significant difference between patients who were stripped (n = 25) and incompletely stripped (n = 41) in terms of AVSS, SF-36, age, gender, DVR, or CEAP grade. Significantly more patients in the incompletely stripped group underwent surgery for recurrent disease (29/41, 71%, versus 8/25, 32%; P =.002, with chi(2) test). Both groups gained significant improvements in AVSS scores for as much as 2 years. After adjustment for recurrent disease, stripping conferred additional benefit in terms of AVSS at 6 months (median [interquartile range]) (9 [4 to 16] versus 15 [9 to 24]; P =.031) and 2 years (7 [2 to 10] versus 9 [5 to 15]; P =.014), which was statistically significant in patients without preoperative DVR but not significant in patients with preoperative DVR. SF-36 scores were not affected by stripping. CONCLUSION: LSV surgery leads to a significant improvement in disease-specific HRQoL for as much as 2 years. In patients without DVR, stripping to the knee confers additional benefit.     

腔镜下大隐静脉隔绝术治疗大隐静脉曲张

目的:探讨腔镜下大隐静脉隔绝术治疗大隐静脉曲张的可行性及其疗效。方法:随机将2000年1月至2004年1月115例、132条下肢大隐静脉曲张患肢分为A、B两组,A组行腔镜下大隐静脉隔绝术,B组行传统的大隐静脉高位结扎剥脱术,对两种方法进行对比研究。结果:平均切口长度A组为(2. 0±0 .6)cm,B组为(8±1 .1)cm,平均切口长度A组明显短于B组(P<0 .05);平均手术时间A组为(35±10)min,B组为(90±17)min,手术时间A组明显短于B组(P<0 .05);术后两组症状消失,均未发生并发症;患者均获随访,随访1~36个月,A组无复发,B组局部复发4例,复发率6. 06%。结论:腔镜下大隐静脉隔绝术高位结扎、电灼大腿段大隐静脉,阻断其小腿段所有属支及交通支,使大隐静脉与体循环隔绝,不需抽剥大隐静脉,患者创伤小,疗效好,复发率低,是治疗大隐静脉曲张的理想术式。     

人工虎骨粉治疗老年脆性骨折的有效性临床研究

目的探讨人工虎骨粉对老年脆性骨折患者肿胀、疼痛的缓解作用,及对生活质量的影响。方法选择62例脆性骨折患者,采用随机信封方法分为两组,每组各31例,患者均给予骨折的综合治疗,干预组给予工虎骨粉口服,对照组给予碳酸钙和维生素D口服。于干预前及干预第15、30天记录肿胀评分、疼痛评分。分别于干预前及干预后3、6个月记录简化Fugl-Meyer运动功能、生活质量(SF-36)。结果干预第15、30天,两组的肿胀、疼痛评分下降,干预组低于对照组,差异有统计学意义(P<0.05);治疗后3、6个月,两组的运动功能、生活质量评分升高,干预治疗组高于对照组,差异有统计学意义(P<0.05)。结论人工虎骨粉可有效缓解脆性骨折老年患者的早期肿痛,改善患者运动功能,提高生活质量。     

Outcome assessment in osteoarthritic patients undergoing total knee arthroplasty

The purpose of this study was to better understand the relationship between knee pain, locomotor functional status, and health-related quality of life (HRQoL) outcomes in osteoarthritic (OA) patients undergoing primary total knee arthroplasty (TKA). Nine OA patients were recruited. Pain, locomotor function, and HRQoL were evaluated one day before and 6 months after TKA by means of a visual analogue scale (VAS) for knee pain, the function score of the Knee Society (KS), the metabolic cost of gait (C), the total mechanical work during gait (Wtot), and the Medical Outcomes Study Short Form-36 Health Survey (MOS SF-36). Our results showed a decrease in knee pain and metabolic cost of gait and an improvement in quality of life. Moreover we showed a relationship between: (1) the VAS score for knee pain, the function score of the KS, and MOS SF-36 Physical Functioning, Role-Physical, and Bodily Pain subscales; and (2) the C, the Wtot, and the MOS SF-36 Vitality subscale.     

Randomised trial of pre-operative colour duplex marking in primary varicose vein surgery: outcome is not improved.

OBJECTIVE: the ability of colour duplex to accurately locate incompetent venous sites has been widely published; its value in pre-operative marking in simple primary varicose vein surgery is evaluated in this study. DESIGN OF STUDY: prospective randomised controlled trial. SETTING: regional vascular service, hospital patients. SUBJECTS: consecutive patients (149) undergoing primary varicose vein surgery where the only difference was one group of patients received duplex marking prior to surgery. Six weeks and 12 months post-operatively all patients had a colour duplex scan to determine the accuracy of surgery and the presence of residual/recurrent varicose veins and completed the Aberdeen, SF-36, and EuroQol quality of life questionnaires. INTERVENTIONS: varicose vein surgery. MAIN OUTCOME MEASURES: Duplex evidence of venous incompetence, quality of life measures using the SF-36 and Aberdeen Varicose Veins Questionnaire. RESULTS: pre-operative marking of primary varicose veins by skilled duplex ultrasonography does not improve the accuracy or recurrence rate following surgery. Quality of life improved significantly following surgery in both groups, however there was no difference in this improvement between the groups. CONCLUSION: the trial has not demonstrated any additional benefit of pre-operative colour duplex marking over that of clinical and hand held Doppler marking in terms of satisfactory varicose vein surgery performance at 6 weeks or 12 months in patients with primary varicose veins of the long saphenous system. It role in the short saphenous system is less clear.     

Randomized clinical trial comparing bipolar coagulating and standard great saphenous stripping for symptomatic varicose veins

BACKGROUND: Typical side-effects of saphenous stripping for symptomatic varicose veins include painful thigh haematomas, which a new bipolar coagulating electric vein stripper (EVS) may reduce. METHODS: In a randomized, single-blind trial at three vascular centres, 99 patients were assigned to EVS and 101 to conventional stripping. The primary outcome was postoperative pain at rest and following physical exercise (climbing stairs). Haematomas were quantified by ultrasonography. Further endpoints were duration of postoperative compression, sick leave and quality of life (measured by the Chronic Lower Limb Venous Insufficiency Questionnaire (CIVIQ) and Short Form 36 (SF-36). RESULTS: Mean resting visual analogue scale for pain 24 h after surgery was 1.6 in the EVS group and 3.3 in the conventional stripping group (mean difference 1.7, 95 per cent confidence interval (c.i.) 1.4 to 1.9, P < 0.001). Mean ratings following exercise were 3.3 and 5.5 (mean difference 2.3, 95 per cent c.i. 2.0 to 2.6, P < 0.001) respectively. No patient in the EVS group had a measurable thigh haematoma, compared with 74 patients after conventional stripping (P < 0.001). The EVS significantly decreased the length of compression therapy and sick leave, and produced superior CIVIQ and SF-36 ratings. CONCLUSION: The EVS was safe and effective in avoiding painful haematomas following varicose vein surgery.     

高位结扎联合点式与传统剥脱术应用于大隐静脉曲张患者的临床对比

目的 探讨高位结扎联合点式与传统剥脱术应用于大隐静脉曲张患者的临床效果.方法 80例研究对象均选自北京市通州区西集卫生院2018年9月至2021年7月收治的大隐静脉曲张患者,随机数字表法将其分为对照组和观察组,每组各40例.对照组患者予以大隐静脉高位结扎联合传统剥脱术治疗,观察组患者予以大隐静脉高位结扎联合点式剥脱术治...     

功率自行车对老年髋关节置换患者术后早期功能恢复的疗效分析

目的探讨早期下肢功率自行车应用对老年髋关节置换患者功能恢复的影响。 方法前瞻性收集南京中医药大学附属常州市中医院骨科150例行髋关节置换术后两周的患者，根据纳入标准，纳入87例患者，随机分为常规组及常规+自行车训练组。常规训练组患者在康复治疗师指导下进行常规康复训练，常规+自行车训练组患者在常规康复训练基础上进行下肢功率自行车训练。两组患者都于术后8 w、4个月分别采用Harris评分及WOMAC量表对髋关节及全身健康状况进行评定。 结果两组患者在治疗过程中均未出现严重并发症。WOMAC评分：术后8 w常规+自行车训练组患者髋关节僵硬程度[（26±20）分]较对照组[（26±23）分]改善明显，差异有统计学意义（t=9.765，P<0.05），功能及疼痛评分差异均无统计学意义。术后4个月WOMAC各项评分提示，常规+自行车训练组患者功能[（22±18）分]优于常规训练组[（25±19）分]，差异具有统计学意义（t=5.434，P<0.05）。Harris评分：术后8 w及4个月常规+自行车训练组[（82±6）分、（88±12）分]高于同期常规康复训练组[（86±6）分、（82±6）分]，差异具有统计学意义（P<0.05）。 结论老年髋关节置换患者术后早期进行常规康复训练及功率自行车训练，能显著改善患者疼痛及促进患者术后髋关节功能恢复。     

Ultrasound-guided foam sclerotherapy combined with sapheno-femoral ligation compared to surgical treatment of varicose veins: early results of a randomised controlled trial.

AIM: This study is a prospective randomised controlled trial comparing sapheno-femoral ligation, great saphenous stripping and multiple avulsions with sapheno-femoral ligation and ultrasound guided foam sclerotherapy to the saphenous vein. Primary end points were patient recovery period and quality of life and secondary end points frequency of complications on the two arms of the trial and the cost of the treatment. MATERIAL AND METHOD: Sixty patients with primary varicose veins due to GSV incompetence and suitable for day case surgery were randomly allocated to undergo ultrasound-guided sclerotherapy with sapheno-femoral ligation under local anaesthesia (n=30) or sapheno-femoral ligation, stripping and multiple avulsions under general anaesthesia (n=30). The study protocol included history, physical examination, assignment of CEAP class and assessment venous clinical severity score (VCSS), completion of the aberdeen vein questionnaire (AVQ) and colour duplex ultrasound. RESULTS: All treatments were completed as intended. Median time to return to normal activities was significantly reduced in the foam sclerotherapy group (2 days) compared to the surgical group (8 days) (p<0.001, Mann-Whitney). AVQ score was also significantly reduced at 3 months by 46% in the sclerotherapy group, and by 40% in the conventional surgery group (p<0.001, Wilcoxon). The time taken to complete treatment was shorter in the foam sclerotherapy plus SFJ ligation group: 45 vs. 85 min (p<0.001, Mann-Whitney). The overall cost of the procedure in the sclerotherapy group ( 672.97 pounds) was significantly less compared to conventional surgery ( 1120.64 pounds). At 3 weeks, there was no statistical difference in the complication rate between the two groups. At 3 months, median CEAP class dropped from four pre-operatively to one following treatment in both groups and the median VCSS score dropped from five to one in group one and from seven to three in group two (p<0.001, Wilcoxon test). In group one four patients (13%) had a recanalised vein which needed further sessions of foam sclerotherapy, resulting in a short-term closure rate of 87%. CONCLUSION: Ultrasound guided sclerotherapy combined with sapheno-femoral ligation was less expensive, involved a shorter treatment time and resulted in more rapid recovery compared to sapheno-femoral ligation, saphenous stripping and phlebectomies.     

Prospective analysis of quality of life and survival following mesorectal excision for rectal cancer.

BACKGROUND: Little is known of how the quality of life of patients with rectal cancer changes after surgery, and whether or not quality of life is associated with and predictive of survival. The aims of this study were to address these issues. METHODS: The Medical Outcomes Study Short Form 36 (SF-36), and the European Organization for the Research and Treatment of Cancer QLQ-C30 and QLQ-CR38 quality of life questionnaires were administered to patients before surgery for rectal cancer, on discharge home and at 3-month intervals after operation for up to 1 year. Survival was measured in days from the time of surgery to death. RESULTS: Sixty-five patients with a median age of 67 years participated. Most quality of life scores dropped significantly below baseline in the early postoperative period. From the third month onwards some scores, such as the global quality of life score and emotional function score on the QLQ-C30, improved. Other scores, including role function, fatigue and pain on the QLQ-C30, were similar to baseline values after 3-6 months and remained unchanged. However, scores such as sexual enjoyment and male sexual problems on the QLQ-CR38 were worse than baseline in the early postoperative period and remained poor thereafter. Stepwise regression analyses showed that preoperative quality of life dimension scores for physical function, nausea/vomiting and sexual enjoyment, together with age, predicted postoperative 1-year survival with an accuracy of 76.8 per cent. CONCLUSION: The findings of this study confirm that quality of life after rectal cancer surgery changes with time. It is generally worst in the early postoperative period. Preoperative quality of life is a good predictor of survival at 1 year.     

Quality of life in patients undergoing inguinal hernia repair.

Inguinal hernia repair is one of the most common surgical procedures undertaken in the NHS. Despite this, no previous work has examined quality of life in this patient group. This study examines quality of life preoperatively and at 3 and 6 months postoperatively in 140 patients undergoing inguinal hernia repair in the context of a randomised controlled trial of laparoscopic versus open hernia repair. Surgery was undertaken on a day case basis, and quality of life was assessed using the Short Form 36 (SF36). In the initial phase of the study, 57% of those screened for suitability met the study inclusion criteria and were randomised. No significant differences were found between laparoscopic and open hernia repair in terms of quality of life at 3 and 6 months postoperatively. No difference was found between 3 and 6 month scores, suggesting that patients had already made a good recovery by 3 months. A significant improvement was found between preoperative and postoperative scores, with the greatest change arising on dimensions assessing pain, physical function, and role limitation owing to physical restriction. After standardising for age, sex, and social class, a comparison of the hernia patients to population norms for the SF36 was consistent with improvement from preoperative to postoperative assessment. This study has demonstrated the improvement in quality of life in patients undergoing elective inguinal hernia repair by experienced surgeons on a day case basis. It has also demonstrated the feasibility of assessing quality of life using generic measures in this patient group. Further work in this area is required. Ultimately, the priority given to elective inguinal hernia repair will depend on how the demonstrated benefits compare with those derived from other elective surgical procedures.     

Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study)

PURPOSE: This study was designed as a prospective multicenter randomized comparison of procedure-related complications, patient recuperation, and quality-of-life outcomes between patients undergoing vein stripping with high ligation and patients undergoing great saphenous vein (GSV) obliteration with temperature-controlled radiofrequency ablation without adjunctive high ligation (Closure procedure). METHODS: Eighty-five patients (86 limbs) from five sites (France, 2; Austria, 1; United States, 2) were randomly allocated to undergo radiofrequency obliteration (RFO) or stripping and high ligation (S&L). Final analysis included data for 44 limbs in the RFO group and 36 limbs in the S&L group. Follow-up examinations were performed at 72 hours, 1 week, 3 weeks, and 4 months. All patients completed the CIVIQ2 quality-of-life (QOL) questionnaire and underwent clinical and ultrasound examinations at each follow-up visit. RESULTS: Immediate success on the day of treatment was reported for 95% (42 of 44) of limbs in the RFO group and 100% (36 of 36) of limbs in the S&L group. In seven RFO limbs (16.3%) a scan obtained 72 hours after the procedure showed flow in the proximal GSV. Five of these segments had reflux in the open segment. At 1 week two of these closed, and an additional segment closed at 3 weeks. In no cases did flow reappear after complete occlusion of the GSV. Time to return to normal activities was significantly less in the RFO group (mean, 1.15 days; 95% confidence interval [CI], 0.05-2.34) compared with the S&L group (mean, 3.89 days; CI, 2.67-5.12; P =.02). In the RFO group, 80.5% of patients returned to routine activities of daily living within 1 day, compared with 46.9% of patients in the S&L group (P <.01). Patients in the RFO group were able to return to work in 4.7 days (CI, 1.16-8.17), compared with 12.4 days (CI, 8.66-16.23) for the S&L group (P <.05). Analysis of the QOL surveys showed statistically significant differences in favor of the RFO group for global score and pain score during follow-up. The magnitude of the difference, however, progressively decreased between 1 week and 4 months. CONCLUSIONS: In the absence of significant complications, such as deep vein thrombosis and pulmonary embolism, severe neuritic sequelae, and skin burns, there are significant early advantages to endovascular obliteration of the GSV compared with conventional vein stripping.     

Randomized clinical trial of the effect of adding subfascial endoscopic perforator surgery to standard great saphenous vein stripping

BACKGROUND: This randomized trial was undertaken to investigate the fate of incompetent perforating veins (IPVs) following saphenofemoral ligation and stripping of the great saphenous vein (GSV), with or without subfascial endoscopic perforator surgery (SEPS). METHODS: Patients with venous reflux (greater than 0.5 s) of the GSV and additional IPVs were allocated randomly to standard surgery (saphenofemoral ligation, stripping and phlebectomies alone) or with the addition of SEPS. Patients with ulceration, recurrent veins, deep venous reflux/thrombosis or saphenopopliteal reflux were excluded. Duplex ultrasonography was carried out before operation, and at 1 week, 6 weeks, 6 months and 1 year after surgery. Quality of life questionnaires were completed and visual analogue scale scores collected at the same time points. RESULTS: Thirty-eight patients were allocated to SEPS and 34 to the no SEPS group. Two patients in the no SEPS group were excluded (one withdrew and the other had the wrong treatment). There were no differences between the two groups with respect to pain, mobility or quality of life scores during follow-up. A significantly higher proportion of patients in the no SEPS group had IPVs on duplex imaging at 1 year (25 of 32 versus 12 of 38; P < 0.001). CONCLUSION: IPVs do not remain closed following standard varicose vein surgery. The addition of SEPS was not associated with significant morbidity but did reduce the number of IPVs. Up to 1 year this had no effect on recurrence rates or quality of life, but late results remain to be seen. Registration number: ISRCTN18288048 (http://www.controlled-trials.com).     

The Vein Graft Surveillance Trial: Rationale, Design and Methods

OBJECTIVES: to compare the amputation rates, quality of life and health care costs in patients receiving duplex ultrasound scanning against clinical surveillance following femoropopliteal and femorocrural vein bypass. DESIGN: multi-centre, prospective, randomised controlled trial. METHODS: 1200 patients with a patent vein graft at 30 days postoperatively will be randomised to either clinical or duplex follow-up. All patients are seen in an out-patient clinic at 6 weeks, then 3, 6, 9, 12 and 18 months postoperatively. At each appointment patients are examined clinically; palpable pulses in the graft and crural vessels, presenting symptoms and their ankle-branchial pressure indices (ABPIs) measured. In the duplex group only, the results of the scan are monitored. The incidence of radiological and/or surgical interventions throughout the follow-up period are also noted. Quality of life is measured using the SF-36 and EuroQol questionnaires at the 6 and 18 month appointments. Hospital stays and resource use are documented for health economic analysis. RESULTS: the primary endpoint of this study is amputation or death from vascular causes; however, graft patency rates will also be compared between the groups. Quality of life and health economic data will be used to determine if there is any benefit in either arm in these outcomes between follow-up strategies. CONCLUSIONS: this large, randomised-controlled trial will hopefully provide direct evidence on the benefit of duplex surveillance for vein grafts in terms of limb salvage, quality of life of the patients and cost-benefit to the purchaser.