A randomised controlled trial of perivenous tumescent anaesthesia in addition to general anaesthesia for surgical ligation and stripping of the great saphenous vein

2019 ◽  
Vol 35 (5) ◽  
pp. 305-315 ◽  
Author(s):  
Sandip Nandhra ◽  
Tom Wallace ◽  
Joseph El-Sheikha ◽  
Daniel Carradice ◽  
Ian Chetter
Keyword(s):  
Quality Of Life ◽  
General Anaesthesia ◽  
Saphenous Vein ◽  
Primary Outcome ◽  
Great Saphenous Vein ◽  
Bodily Pain ◽  
Secondary Outcome ◽  
Surgical Ligation ◽  
Significant Difference

Introduction Open surgical ligation and stripping of the great saphenous vein is a highly cost-effective treatment when compared with conservative management and foam sclerotherapy but has limitations including post-operative morbidity and pain. This study aims to identify if the addition of tumescent anaesthesia could improve patient outcomes following treatment. Methods Patients with primary superficial venous incompetence undergoing open surgical ligation and stripping of the great saphenous vein were randomised to either General Anaesthesia (GA) alone (GA) procedure or the addition of tumescent (G + T). The primary outcome was bodily pain (within SF-36) at one week. Additional outcomes included post-procedural pain score (100 mm visual analogue scale), complications and quality of life. Results A total of 90 patients were randomised for inclusion. There was no significant difference in primary outcome; bodily pain at one week. Secondary outcome of 4-h post-procedural scores were significantly lower in the G + T group (32 (20–54) mm vs. (GA alone) 56 (24–70) mm (P = 0.016)). Complications were minor and equivalent. Both groups saw a significant increase (worsening) in Aberdeen Varicose Vein Questionnaire scores at week 1 with the G + T group faring worse at six weeks (10.0 (Interquartile Range [IQR] 5.6–17.9) vs. 4.3 (IQR 2.7–7.9) P = 0.004). Conclusion The G + T group did not demonstrate a significant difference in the one-week bodily pain domain. The addition of tumescent anaesthesia does improve immediate post-operative pain but appears to negatively impact on six-week quality of life. EudraCT Number: 2011-005574-39

Rationale, baseline characteristics and methodology of the non-interventional VIVA study in postmenopausal osteoporosis

2014 ◽  
Vol 23 (01) ◽  
pp. 49-55
Author(s):  
L. C. Hofbauer ◽  
D. Felsenberg ◽  
M. Amling ◽  
A. Kurth ◽  
P. Hadji
Keyword(s):  
Quality Of Life ◽  
Postmenopausal Osteoporosis ◽  
Primary Outcome ◽  
Osteoporosis Treatment ◽  
Secondary Outcome ◽  
Matched Pairs ◽  
Fracture History ◽  
Baseline Characteristics ◽  
Study Inclusion

SummaryIt is important to understand compliance and persistence with medication use in the clinical practice of osteoporosis treatment. The purpose of this work is to describe the “intravenous ibandronate versus oral alendronate” (VIVA) study, a non-interventional trial to assess the compliance and persistence of osteopenic postmenopausal women with treatment via weekly oral alendronate or intravenous ibandronate (Bonviva®) every three months.4477 patients receiving ibandronate 3 mg i. v. quarterly and 1491 patients receiving alendronate 70 mg orally weekly were included in the study. Matched pairs of 901 subjects in each group were also generated. Matching was performed on the basis of age, body mass index, fracture history at study inclusion, prior treatment with bisphosphonates and the number of concomitant disorders. Secondary outcome measures of osteoporosis related fractures, mobility restriction and pain, analgesia, quality of life questionnaires as well as attitudes to medications were assessed. The primary outcome parameters of compliance and persistence will be tracked in these subjects.At baseline, the entire collectives differed significantly on body weight (less in ibandronate group), duration since osteo - porosis diagnosis (longer in ibandronate), and incidence of prior osteoporotic fracture (higher in ibandronate group). The matched-pairs differed only on mobility restriction and quality of life (both worse in ibandronate group).The results from the VIVA study trial will provide scientific rationale for clinical recommendations in the pharmacological treatment of postmenopausal osteoporosis.

scholarly journals Cryosclerosis. Az elfelejtett endovénás cryoablatio a vena saphena magna elégtelenségének kezelésében. Egy prospektív összehasonlító vizsgálat középtávú eredményei

2016 ◽  
Vol 157 (50) ◽  
pp. 1994-2001
Author(s):  
István Bence Bálint ◽  
Ákos Farics ◽  
László Vizsy ◽  
Eszter Vargovics ◽  
Renáta Bálint ◽  
...  
Keyword(s):  
Saphenous Vein ◽  
Great Saphenous Vein ◽  
Clinical Severity ◽  
Secondary Outcome ◽  
Rank Test ◽  
Clinical Failure ◽  
Severity Scores ◽  
Significant Difference ◽  
Vena Saphena Magna ◽  
Occlusion Rate

Introduction: Cryosclerosis was introduced by Milleret and Le Pivert in the 1980s. Method: A prospective non-randomized comparative study has been performed on initial 96 patients. 48 patients were treated by cryosclerosis and the others received conventional stripping. 52 cases were analyzed for 2-years. The primary end-point of the study was to determine the occlusion rate of cryosclerosis. The clinical failure, the improvement in the Clinical Etiologic Anatomic Pathophysiologic classification and Venous Clinical Severity Scores were analyzed as secondary outcome. Results: Total recanalization of the great saphenous vein causing clinical failure was observed in one case (4%). The reopening of the great saphenous vein was observed in 4 limbs (15%) that did not cause the incompetence of the trunk. The occlusion rate was 81%. Recurrent varicosity was observed by 35% and 42% of the patients in the cryosclerosis and stripping groups respectively. There was no significant difference between the groups (log rank test, p = 0.391). There was significant improvement in both the Clinical Etiologic Anatomic Pathophysiologic classification and Venous Clinical Severity Scores in each group without remarkable differences observed between the groups either at baseline or on the mid-term. Conclusions: Cryosclerosis seems to be effective in the remodeling of the great saphenous vein. The method has no remarkable mid-term clinical advantages over classical stripping so far. Orv. Hetil., 2016, 157(50), 1994–2001.

Impact of Great Saphenous Vein Foam Sclerotherapy on Quality of Life and Photoplethysmography Findings in Chronic Venous Insufficiency

2020 ◽  
Vol 46 (3) ◽  
pp. 369-375
Author(s):  
Felipe Coelho Neto ◽  
Rodrigo Gomes de Oliveira ◽  
Fernando Thomazinho ◽  
Anna Paula Weinhardt Batista ◽  
Iruena Moraes Kessler
Keyword(s):  
Quality Of Life ◽  
Saphenous Vein ◽  
Chronic Venous Insufficiency ◽  
Venous Insufficiency ◽  
Great Saphenous Vein ◽  
Foam Sclerotherapy

scholarly journals The effect of neck dissection on quality of life after chemoradiation

2008 ◽  
Vol 139 (4) ◽  
pp. 511-518 ◽  
Author(s):  
Amy Anne Donatelli-Lassig ◽  
Sonia A. Duffy ◽  
Karen E. Fowler ◽  
David L. Ronis ◽  
Douglas B. Chepeha ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Neck Dissection ◽  
Bodily Pain ◽  
Stage Iv ◽  
Veterans Administration ◽  
Significant Decrement ◽  
Sf 36 ◽  
Significant Difference ◽  
Patients Experience

Objective To determine differences in quality of life (QOL) between patients with head and neck cancer who receive chemoradiation versus chemoradiation and neck dissection. Methods A prospective cohort study was conducted at two tertiary otolaryngology clinics and a Veterans Administration hospital. Sample: 103 oropharyngeal patients with Stage IV squamous cell carcinoma treated via chemoradiation ± neck dissection. Intervention: self-administered health survey to collect health, demographic, and QOL information pretreatment and 1 year later. Main outcome measures: QOL via SF-36 and HNQoL. Descriptive statistics were calculated for health/clinical characteristics, demographics, and QOL scores. t tests evaluated changes in QOL over time. Results Sixty-five patients underwent chemoradiation and 38 patients underwent chemoradiation and neck dissection. Only the pain index of the SF-36 showed a significant difference between groups ( P < 0.05) with the neck dissection group reporting greater pain. Conclusions After post-treatment neck dissection, patients experience statistically significant decrement in bodily pain domain scores, but other QOL scores are similar to those of patients who underwent chemoradiation alone.

Comparative efficacy and life quality effects of surgical stripping, radiofrequency ablation, and cyanoacrylate embolization in patients undergoing treatment for great saphenous vein insufficiency

2020 ◽  
pp. 026835552094729
Author(s):  
Yasin Ay ◽  
Esra Gunes ◽  
Sevket Tuna Turkkolu ◽  
Emre Selcuk ◽  
Muhittin Calim ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Radiofrequency Ablation ◽  
Saphenous Vein ◽  
Great Saphenous Vein ◽  
The Other ◽  
Clinical Severity ◽  
Life Questionnaire ◽  
Sf 36 ◽  
Vein Insufficiency

Objectives To compare traditional surgery with two minimally invasive endo-venous procedures in terms of their long-term effect on the quality of life in great saphenous vein insufficiency (GSV). Method This prospective observational study included 217 patients that underwent surgical stripping (n = 62), radiofrequency ablation (n = 70), or cyanoacrylate embolization (n = 85) for the treatment of GSV insufficiency. Venous Clinical Severity Score (VCSS) assessments were made, 36-item Short-Form Health Survey (SF-36) questionnaire and Chronic Venous Insufficiency quality of life Questionnaire (CIVIQ-14) were administered, before and 1 year after the treatments. Results Surgical stripping group had significantly higher closure rates than the other groups (p < 0.05). At 12 months, decrease in VCSS scores was less pronounced in the cyanoacrylate embolization group when compared to the other two groups (p < 0.05). Improvement in CIVIQ-14 scores was better in the radiofrequency ablation group when compared to the cyanoacrylate embolization group (p < 0.05). Surgical stripping or radiofrequency ablation groups performed better on several domains of SF-36, when compared to the cyanoacrylate embolization group. Conclusions Surgical stripping and radiofrequency ablation seem to provide a better quality of life results at one year in patients undergoing treatment for GSV insufficiency.

Assessment of Quality of Life in MA.17: A Randomized, Placebo-Controlled Trial of Letrozole After 5 Years of Tamoxifen in Postmenopausal Women

2005 ◽  
Vol 23 (28) ◽  
pp. 6931-6940 ◽  
Author(s):  
Timothy J. Whelan ◽  
Paul E. Goss ◽  
James N. Ingle ◽  
Joseph L. Pater ◽  
Dongsheng Tu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Bodily Pain ◽  
Response Analysis ◽  
Life Questionnaire ◽  
Change Scores ◽  
Estrogen Synthesis ◽  
Sf 36 ◽  
Significant Difference ◽  
The Impact

Purpose To evaluate the impact of letrozole compared with placebo after adjuvant tamoxifen on quality of life (QOL) in the MA.17 trial. Methods Patients completed the Short Form 36-item Health Survey (SF-36) and the Menopause Specific Quality of Life Questionnaire (MENQOL) at baseline, 6 months, and annually. Mean change scores from baseline were compared between groups for summary measures and domains. A response analysis compared the proportion of patients who demonstrated an important change in QOL. Results Of 5,187 randomly assigned women in the trial, 3,612 (69.9%) participated in the QOL substudy: 1,799 were allocated to placebo and 1,813 were allocated to letrozole. No differences were seen between groups in mean change scores from baseline for the SF-36 physical and mental component summary scores at 6, 12, 24, and 36 months. Small (< 0.2 standard deviations) but statistically significant differences in mean change scores from baseline were seen for the SF-36 domains of physical functioning (12 months), bodily pain (6 months) and vitality (6 and 12 months), and the MENQOL vasomotor (6, 12, and 24 months) and sexual domains (12 and 24 months). On the response analysis, a significant difference was seen between groups for the bodily pain domain (percentage of patients reporting a worsening of QOL, 47% placebo v 51% letrozole; P = .009) and the vasomotor domain (22% placebo v 29% letrozole; P = .001). Conclusion Letrozole did not have an adverse impact on overall QOL. Small effects were seen in some domains consistent with a minority of patients experiencing changes in QOL compatible with a reduction in estrogen synthesis.

scholarly journals Comparison of cyanoacrylate closure and radiofrequency ablation for the treatment of incompetent great saphenous veins: 36-Month outcomes of the VeClose randomized controlled trial

2018 ◽  
Vol 34 (6) ◽  
pp. 380-390 ◽  
Author(s):  
Nick Morrison ◽  
Raghu Kolluri ◽  
Michael Vasquez ◽  
Monte Madsen ◽  
Andrew Jones ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Radiofrequency Ablation ◽  
Saphenous Vein ◽  
Great Saphenous Vein ◽  
Controlled Trial ◽  
Closure Rate ◽  
Randomized Controlled ◽  
Saphenous Veins

Objective To evaluate the 36-month efficacy and safety of cyanoacrylate closure for the treatment of incompetent great saphenous veins in comparison with radiofrequency ablation. Methods In this multicenter, prospective, randomized controlled trial, 222 symptomatic subjects with incompetent great saphenous veins were assigned to either cyanoacrylate closure or radiofrequency ablation. The primary endpoint, complete closure of the target great saphenous vein, was determined using duplex ultrasound examination starting from three-month visit. Results At month 36, the great saphenous vein closure rates were 94.4% for the cyanoacrylate closure group and 91.9% for the radiofrequency ablation group. Stable improvement in symptoms and quality of life was observed in both groups. Adverse event rates between the 24- and 36-month visits were similar between the groups as were serious adverse events which were infrequent and judged unrelated to either the device or the procedure in both groups. Conclusions This trial continues to demonstrate the safety and efficacy of cyanoacrylate closure for the treatment of great saphenous vein incompetence with great saphenous vein closure rate at 36 months similar to that of radiofrequency ablation, indicating non-inferiority of cyanoacrylate closure to radiofrequency ablation. The improvement in quality of life outcomes were also sustained and similar between the two treatment groups.

Improvements of deep vein reflux following radiofrequency ablation for saphenous vein incompetence

2016 ◽  
Vol 32 (1) ◽  
pp. 55-60 ◽  
Author(s):  
Suh Min Kim ◽  
In Mok Jung ◽  
Jung Kee Chung
Keyword(s):  
Quality Of Life ◽  
Radiofrequency Ablation ◽  
Treatment Outcomes ◽  
Saphenous Vein ◽  
Great Saphenous Vein ◽  
Deep Vein ◽  
Vein Reflux

Objectives The aim of this study was to describe the changes of deep vein reflux after radiofrequency ablation for great saphenous vein incompetence. Method The data on 139 limbs which were treated with radiofrequency ablation for great saphenous vein incompetence were prospectively collected and reviewed. Results Deep vein reflux was present in 43 of 139 limbs (30.9%). There were no significant differences in the rate of successful closure, the incidence of procedure-related complications, and the improvements of symptoms and quality of life between the limbs with or without deep vein reflux. With a mean follow-up of 5.9 months, the peak reflux velocity and duration of reflux were improved in all limbs with deep vein reflux and it was completely corrected in 13 limbs (30.2%) after radiofrequency ablation. Conclusions The presence of deep vein reflux does not affect the treatment outcomes of radiofrequency ablation for great saphenous vein incompetence and is improved in all patients. Deep vein reflux is not a barrier to performing radiofrequency ablation.

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