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Foam sclerotherapy versus ambulatory phlebectomy for the treatment of varicose vein tributaries: study protocol for a randomised controlled trial.

ABSTRACT: BACKGROUND:Ambulatory phlebectomies and foam sclerotherapy are two of the most common treatments for varicose vein tributaries. Many studies have been published on these treatments, but few comparative studies have attempted to determine their relative effectiveness. METHODS/DESIGN:This is a prospective single-centre randomised clinical trial. Patients with primary truncal vein incompetence and varicose vein tributaries requiring treatment will be assigned randomly to either ambulatory phlebectomies or foam sclerotherapy. The primary outcome measure is the re-intervention rate for the varicose vein tributaries during the study period. The secondary outcomes include the degree of pain during the first two post-operative weeks and the time to return to usual activities or work. Improvements in clinical scores, quality of life scores, occlusion rates and cost-effectiveness for each intervention are other secondary outcomes. The re-intervention rate will be considered from the third month. DISCUSSION:This study compares ambulatory phlebectomies and foam sclerotherapy in the treatment of varicose vein tributaries. The re-intervention rates, safety, patient experience and the cost-effectiveness of each intervention will be assessed. This study aims to recruit 160 patients and is expected to be completed by the end of 2019. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03416413 . Registered on 31 January 2018.

SUBMITTER: Belramman A

PROVIDER: S-EPMC6610823 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Foam sclerotherapy versus ambulatory phlebectomy for the treatment of varicose vein tributaries: study protocol for a randomised controlled trial.

Belramman Amjad A Bootun Roshan R Lane Tristan R A TRA Davies Alun H AH

Trials 20190703 1

<h4>Background</h4>Ambulatory phlebectomies and foam sclerotherapy are two of the most common treatments for varicose vein tributaries. Many studies have been published on these treatments, but few comparative studies have attempted to determine their relative effectiveness.<h4>Methods/design</h4>This is a prospective single-centre randomised clinical trial. Patients with primary truncal vein incompetence and varicose vein tributaries requiring treatment will be assigned randomly to either ambul ...[more]

PMID: 31269978

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Project description:IntroductionHaemorrhoidal disease (HD) is a common condition with significant epidemiologic and economic implications. While it is possible to treat symptomatic grade 1-2 haemorrhoids with rubber band ligation (RBL) or sclerotherapy (SCL), the effectiveness of these treatments compatible with current standards has not yet been investigated with a randomised controlled trial. The hypothesis is that SCL is not inferior to RBL in terms of symptom reduction (patient-related outcome measures (PROMs)), patient experience, complications or recurrence rate.Methods and analysisThis protocol describes the methodology of a non-inferiority, multicentre, randomised controlled trial comparing rubber band ligation and sclerotherapy for symptomatic grade 1-2 haemorrhoids in adults (> 18 years). Patients are preferably randomised between the two treatment arms. However, patients with a strong preference for one of the treatments and refuse randomisation are eligible for the registration arm. Patients either receive 4 cc Aethoxysklerol 3% SCL or 3 × RBL. The primary outcome measures are symptom reduction by means of PROMs, recurrence and complication rates. Secondary outcome measures are patient experience, number of treatments and days of sick leave from work. Data are collected at 4 different time points.DiscussionThe THROS trial is the first large multicentre randomised trial to study the difference in effectivity between RBL and SCL for the treatment of grade 1-2 HD. It will provide information as to which treatment method (RBL or SCL) is the most effective, gives fewer complications and is experienced by the patient as the best option.Ethics and disseminationThe study protocol has been approved by the Medical Ethics Review Committee of the Amsterdam University Medical Centers, location AMC (nr. 2020_053). The gathered data and results will be submitted for publication in peer-reviewed journals and spread to coloproctological associations and guidelines.Trial registrationDutch Trial Register NL8377 . Registered on 12-02-2020.

Project description:BACKGROUND:Fibrotic interstitial lung diseases (ILDs) are chronic and often progressive conditions resulting in substantial morbidity and mortality. Shortness of breath, a symptom often linked to oxygen desaturation on exertion, is tightly linked to worsening quality of life in these patients. Although ambulatory oxygen is used empirically in their treatment, there are no ILD-specific guidelines on its use. To our knowledge, no studies are available on the effects of ambulatory oxygen on day-to-day life in patients with ILD. METHODS/DESIGN:Ambulatory oxygen in fibrotic lung disease (AmbOx) is a multicentre, randomised controlled crossover trial (RCT) funded by the Research for Patient Benefit Programme of the National Institute for Health Research. The trial will compare ambulatory oxygen used during daily activities with no ambulatory oxygen in patients with fibrotic lung disease whose oxygen saturation (SaO2) is ?94% at rest, but drops to ?88% on a 6-min Walk Test. The randomised controlled trial (RCT) will evaluate the effects on health status (measured by the King's Brief ILD Questionnaire: K-BILD) of ambulatory oxygen used at home, at an optimal flow rate determined by titration at screening visit, and administered for a 2-week period, compared to 2 weeks off oxygen. Key secondary outcomes will include breathlessness on activity scores, as measured by the University of California San Diego Shortness of Breath Questionnaire, global patient assessment of change scores, as well as quality of life scores (St George's Respiratory Questionnaire), anxiety and depression scores (Hospital Anxiety and Depression Scale), activity markers measured by SenseWear Armbands, pulse oximetry measurements, patient-reported daily activities, patient- and oxygen company-reported oxygen cylinder use. The study also includes a qualitative component and will explore in interviews patients' experiences of the use of a portable oxygen supply and trial participation in a subgroup of 20 patients and carers. DISCUSSION:This is the first RCT of the effects of ambulatory oxygen during daily life on health status and breathlessness in fibrotic lung disease. The results generated should provide the basis for setting up ILD-specific guidelines for the use of ambulatory oxygen. TRIAL REGISTRATION:National Clinical Trials Registry, identifier: NCT02286063 . Registered on 8 October 2014 (retrospectively registered).

Project description:The prevalence of chronic venous disease is high and occurs more frequently in females. According to the clinical, etiological, anatomical, and pathological classification (CEAP) definition, the reticular veins are included in the C1 class and are mainly associated with aesthetic complaints. Several invasive techniques are used for treatment, including mini phlebectomy, laser ablation, and radiofrequency ablation. However, a wide range of sclerosing agents may serve as minimally invasive alternatives, promoting chemical sclerosis of the vein wall. Although this technique is routinely performed around the world, there is no consensus on the most efficacious and safe chemical agent to be used.Inclusion criteria are women between 18 and 69 years old with at least 10 cm long reticular veins in the lower limbs, on the outer side of the leg/thigh. Patients with CEAP 2 to 6, or with allergies, pregnancy, performing breastfeeding, or with any dermatologic or clinical problems will be excluded. Patients with venous ultrasound mapping showing involvement of saphenous trunks and/or a deep venous system will also be excluded. Patients will be randomized into two groups, one receiving 75% pure glucose and the other group receiving 0.2% polidocanol diluted in 70% glucose. Just one limb and one session per patient will be performed. The sclerosing agent volume will not exceed 5 mL. Clinical follow-up will include visits on days 7 and 60, always with photographic documentation.This project aims to enroll 96 patients and subject them to a double-blind treatment after the randomization process. The design is intended to evaluate efficacy through a primary end point and safety through a secondary end point. Forty-eight patients have currently been enrolled. Preliminary results for these patients showed that 25 received treatment, 2 were excluded, and 22 returned after 7 days and showed no greater adverse events. To date, establishing efficacy criteria has not been possible, and no patients have reached the 60-day return point. These data may help doctors choose the best chemical agent for the treatment of reticular veins.ClinicalTrials.gov Identifier: NCT02054325, 3/02/2014.

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Dataset Information

Foam sclerotherapy versus ambulatory phlebectomy for the treatment of varicose vein tributaries: study protocol for a randomised controlled trial.

Publications

Foam sclerotherapy versus ambulatory phlebectomy for the treatment of varicose vein tributaries: study protocol for a randomised controlled trial.

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