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Techniques in Coloproctology Jan 2024This systematic review and meta-analysis aimed to evaluate the safety and efficacy of sclerotherapy methods for hemorrhoidal disease (HD) over the past 40 years. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This systematic review and meta-analysis aimed to evaluate the safety and efficacy of sclerotherapy methods for hemorrhoidal disease (HD) over the past 40 years.
METHODS
The review followed the 2020 Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. A comprehensive literature search was conducted, including studies reporting the use of sclerotherapy in patients with HD. Study eligibility criteria were defined, and data were extracted independently by the authors. Random-effects meta-analyses were performed to assess outcomes of interest.
RESULTS
Out of 1965 records identified, 44 studies met the inclusion criteria, involving 9729 patients. The majority of studies were conducted in Japan, followed by the UK, Italy, and Portugal. The median age of participants was 52 years, and the majority were male. The Goligher grade distribution indicated varying degrees of HD severity. Sclerotherapy was predominantly administered through anoscopy, with polidocanol being the most commonly used agent. The procedure was generally performed without pre-injection analgesia. The meta-analysis of 14 randomized controlled trials (RCTs) revealed that sclerotherapy was not inferior to control interventions in terms of success rate (risk ratio [RR] 1.00, 95% CI 0.71-1.41) and recurrence rate (RR 1.11, 95% CI 0.69-1.77), while resulting in fewer complications (RR 0.46, 95% CI 0.23-0.92).
CONCLUSIONS
This systematic review highlights the safety and efficacy of sclerotherapy for HD, which yields similar success rates and fewer complications compared to other conservative or surgical approaches. Further research is warranted to optimize sclerotherapy techniques and evaluate long-term outcomes.
REGISTRATION
PROSPERO 2023 CRD42023396910.
Topics: Male; Humans; Female; Middle Aged; Sclerotherapy; Hemorrhoids; Italy; Odds Ratio; Polidocanol
PubMed: 38261136
DOI: 10.1007/s10151-023-02908-w -
Expert Opinion on Investigational Drugs Dec 2009Polidocanol is a liquid surfactant having endothelial cell lytic properties. In the form of a controlled, dispensed microfoam it is administered endovenously as a... (Review)
Review
BACKGROUND
Polidocanol is a liquid surfactant having endothelial cell lytic properties. In the form of a controlled, dispensed microfoam it is administered endovenously as a sclerosing agent in the treatment of varicose veins.
OBJECTIVE
This review summarizes efficacy of polidocanol endovenous microfoam sclerotherapy using a proprietary dispensing system to control foam characteristics and gas content for treating varicose veins.
METHODS
We reviewed in vitro, Phase I, Phase II and limited Phase III data for polidocanol microfoam with a focus on controlled foam formulation in therapy.
RESULTS/CONCLUSIONS
Clinical trials of controlled dispensing of polidocanol microfoam provide evidence of effective treatment of chronic venous insufficiency with low toxicity, minimal risk and few complications.
Topics: Chemistry, Pharmaceutical; Clinical Trials as Topic; Dosage Forms; Embolism, Air; Humans; Injections, Intravenous; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Varicose Veins; Venous Insufficiency
PubMed: 19912070
DOI: 10.1517/13543780903376163 -
World Journal of Gastroenterology Jun 2020With the development of cross-sectional imaging modalities and the increasing attention being paid to physical examinations, the prevalence of pancreatic cystic... (Review)
Review
With the development of cross-sectional imaging modalities and the increasing attention being paid to physical examinations, the prevalence of pancreatic cystic neoplasms (PCNs) has increased. PCNs comprise a broad differential spectrum with some PCNs having low or no malignant potential and others having high malignant potential. The morbidity and mortality rates related to major pancreatic surgical resection are high. Long-term surveillance may not only increase the financial burden and psychological stress for patients but also result in a missed malignancy. Minimally invasive endoscopic ultrasound (EUS)-guided ethanol ablation was first reported in 2005. Several other agents, such as paclitaxel, lauromacrogol, and gemcitabine, were reported to be effective and safe for the treatment of PCNs. These ablative agents are injected through a needle inserted into the cyst transgastric or transduodenal puncture. This treatment method has been substantially developed in the last 15 years and is regarded as a promising treatment to replace surgical resection for PCNs. While several reviews of EUS-guided ablation have been published, no systematic review has evaluated this method from patient preparation to follow-up in detail. In the present review, we systematically describe EUS-guided injective ablation with regard to the indications, contraindications, preoperative treatment, endoscopic procedure, postoperative care and follow-up, evaluation method, treatment efficiency, safety profile, tips and tricks, and current controversies and perspectives.
Topics: Endosonography; Humans; Pancreatic Cyst; Pancreatic Neoplasms; Polidocanol; Ultrasonography, Interventional
PubMed: 32684736
DOI: 10.3748/wjg.v26.i23.3213 -
Dentistry Journal Oct 2021Various treatments for oral vascular malformation (VM) have been reported. Polidocanol and absolute ethanol have also been reported for sclerotherapy. However, there are...
Various treatments for oral vascular malformation (VM) have been reported. Polidocanol and absolute ethanol have also been reported for sclerotherapy. However, there are still few reports on the therapeutic effect and dosage of polidocanol sclerotherapy. Therefore, we examined its therapeutic effects on oral VM. There were 17 sites of VMs, with nine patients diagnosed with oral VM at the Department of Dental and Oral Surgery, Tsukuba University Hospital. The medical records were retrospectively investigated to determine the site, hemangioma volume, polidocanol injection volume, and therapeutic effect. The volume of hemangiomas was calculated using magnetic resonance images. Based on the site, oral VMs were observed in the tongue, buccal mucosa, lips, and oral floor in eight, three, five, and one patients, respectively. The average size of the site was 3071 mm. The average injection dose of polidocanol at one site was 2.86 mL, the average number of administrations was 1.6, and the response rate was 88.2%. No adverse events were observed. The median numerical rating scale scores were 2/10 (0-6/10) and 0/10 (0-1/10) the day after surgery and 1 week after surgery, respectively. Univariate regression analysis of the total dose in successful cases provided the following formula: 1.3 + 0.00025 × volume (mm) (mg). Polidocanol sclerotherapy is an effective treatment method for oral VM.
PubMed: 34677181
DOI: 10.3390/dj9100119 -
Orthopaedics & Traumatology, Surgery &... Jun 2022The optimal treatment of aneurysmal bone cysts (ABC) remains controversial. Surgery has long been considered as the treatment that yields the best outcomes. Some authors... (Review)
Review
INTRODUCTION
The optimal treatment of aneurysmal bone cysts (ABC) remains controversial. Surgery has long been considered as the treatment that yields the best outcomes. Some authors now prefer using less invasive options as the primary treatment. The primary objective of this systematic literature review was to determine if treatments that are less invasive than surgery are also effective in curing the ABC. The secondary objective was to determine the respective role of each treatment in the therapeutic arsenal.
HYPOTHESIS
Less invasive treatments can replace surgery as the base treatment for ABC.
PATIENTS AND METHODS
A PubMed® search was carried out for this review. The inclusion criteria were ABC treatment without cyst removal, case series, clinical case reports, reviews, publication in French or English. Excluded were articles that described the results of surgical treatment only, cranial or maxillofacial cysts, secondary ABC, duplicates, no abstract available. Based on the first six items of the "MINOR criteria", we selected 42 studies. For each selected study, we analyzed the number of cases, clinical response to treatment, radiological healing, recurrence or failure rate, complications and side effects of the treatment.
RESULTS
This review found that less invasive treatments generate results that are at least as good as surgery, often with fewer complications. Thus, in certain cases, these treatments can be recommended as first-line therapy. This category includes selective arterial embolization, sclerotherapy (alcohol, polidocanol) and injection of demineralized bone matrix.
DISCUSSION
Selective arterial embolization yields good results. While this is a difficult, operator-dependent technique that is not suitable for all ABCs (no identifiable feeding vessel), we recommend it as the primary treatment for spinal ABCs. For ABCs in other locations, sclerotherapy can be used as the primary treatment. However, this treatment becomes inconvenient if the number of injections is too high. Radiation therapy is not a first-line treatment because of its side effects. Bisphosphonates and denosumab can be used when the other treatments are contraindicated.
Topics: Bone Cysts, Aneurysmal; Embolization, Therapeutic; Humans; Radiography; Sclerotherapy; Treatment Outcome
PubMed: 35331923
DOI: 10.1016/j.otsr.2022.103272 -
Annals of Coloproctology Dec 2022The surgical management of patients with full-thickness rectal prolapse (FTRP) continues to remain a challenge in the laparoscopic era. This study retrospectively...
PURPOSE
The surgical management of patients with full-thickness rectal prolapse (FTRP) continues to remain a challenge in the laparoscopic era. This study retrospectively assesses a cohort of patients undergoing a transanal suture sacro rectopexy supported by sclerosant injection into the presacral space under ultrasound guidance.
METHODS
Patients with FTRP underwent a sutured transrectal presacral fixation of 2/3 of the circumference of the rectum from the third sacral vertebra to the sacrococcygeal junction through a side-viewing operating proctoscope. The procedure was supplemented by ultrasound-guided injection into the retrorectal space of a 2 mL solution of sodium tetradecyl sulfate/polidocanol mixed with air. Patients were functionally assessed before and 6 months after surgery with the Agachan constipation score and the Pescatori incontinence score.
RESULTS
There were 36 adult patients (26 males; the range of age, 23-92 years). The mean operative time was 27 minutes (range, 23-50 minutes) with no recorded perioperative morbidity. The median follow-up was 66 months (range, 48-84 months) with 1 (2.8%) recurrence presenting 18 months after surgery. There were 19 patients (52.8%) who presented with incontinence before surgery with 17 out of 19 (89.5%) reporting improvement in their Pescatori score (P<0.001). No patient had worsening incontinence and there were no de novo incontinence cases. Constipation scores improved in 23 out of 36 patients (63.9%) with a mean score reduction difference of 7.91 (P=0.001).
CONCLUSION
Transanal sutured sacral rectopexy with supplemental presacral sclerosant injection is safe and effective in the management of FTRP with sustained improvement in bowel function.
PubMed: 34674514
DOI: 10.3393/ac.2021.00262.0037 -
Diagnostic and Interventional Imaging Jun 2020The purpose of this study was to retrospectively evaluate the efficacy and safety of a sequential treatment including percutaneous polidocanol sclerotherapy and...
PURPOSE
The purpose of this study was to retrospectively evaluate the efficacy and safety of a sequential treatment including percutaneous polidocanol sclerotherapy and radiofrequency ablation (RFA) in terms of volume reduction and complication rate in large, benign, partially cystic thyroid nodules with solid components.
MATERIALS AND METHOD
From April 2017 to April 2019, 46 patients with 47 large benign partially cystic thyroid nodules underwent sequential treatment. There were 14 men and 32 women with a mean age of 49.9±11.5 (SD) years (range: 18-75 years). The volume of initial nodules was 12.7±12.3 (SD) mL (range: 2.16-75.62mL). Volume reduction after percutaneous polidocanol sclerotherapy and further RFA was evaluated respectively. Patients had clinical and ultrasound evaluations at a follow-up time of 12.1±5.3 (SD) months (range: 1.5-23.9 months). Technical success and complications were accessed retrospectively.
RESULTS
After unsatisfying results with polidocanol sclerotherapy alone the 46 patients with 47 large benign partially cystic thyroid nodules had further RFA. Mean volume reduction of 47 nodules was 90.5±11.3 (SD) % (range: 43.9-99.3%) one month after RFA, 94.9±6.2 (SD) % (range: 66.9-99.5%) three months after RFA, and 95.8±5.5 (SD) % (range: 71.0-99.8%) six months after RFA. No recurrence or nodule enlargement after RFA was observed at the last follow-up. The complication rate of RFA was 12.5% (8/46 patients), with minor complications only.
CONCLUSIONS
The sequential treatment regimen, including percutaneous polidocanol sclerotherapy and RFA, is an appropriate and safe treatment strategy for large benign partially cystic thyroid nodules with solid components.
Topics: Adolescent; Adult; Aged; Catheter Ablation; Female; Humans; Male; Middle Aged; Neoplasm Recurrence, Local; Polidocanol; Radiofrequency Ablation; Retrospective Studies; Thyroid Nodule; Treatment Outcome; Young Adult
PubMed: 31889636
DOI: 10.1016/j.diii.2019.11.005 -
European Review For Medical and... Apr 2016Polidocanol is the most frequently used sclerosant for sclerotherapy all around the world. Our experimental research aims to find out the angiogenic effects of...
OBJECTIVE
Polidocanol is the most frequently used sclerosant for sclerotherapy all around the world. Our experimental research aims to find out the angiogenic effects of Polidocanol.
MATERIALS AND METHODS
Angiogenic activity of polidocanol was examined in vivo in the chick chorioallantoic membrane (CAM) model, cell viability assay (human umbilical vein endothelial cells - HUVECs) and in vitro tube formation assay of HUVECs.
RESULTS
In CAM assay, a significant decrease on CAM vessel growth was observed after the application of polidocanol solutions. Vessel growth inhibition was strongly dose-dependent. There was a cytotoxic effect on HUVECs in the presence of polidocanol observed with MTT assay (p < 0.05). In the tube formation assay, statistically significant decrease in tube formation was observed in polidocanol group. It was found that polidocanol had an anti-angiogenic effect (p < 0.05). The results provide evidence that polidocanol decreases angiogenesis and has a cytotoxic effect on ECs.
CONCLUSIONS
These results provide evidence that Polidocanol (lauromacrogol 400) have strong anti-angiogenic effects in vitro and in vivo. Further researches needed to reveal early and long-term effects of polidocanol in the human vascular system and new treatment approach as an anti-angiogenic therapy.
Topics: Angiogenesis Inhibitors; Animals; Cell Survival; Chickens; Chorioallantoic Membrane; Human Umbilical Vein Endothelial Cells; Humans; Neovascularization, Physiologic; Polidocanol; Polyethylene Glycols
PubMed: 27097963
DOI: No ID Found -
The Cochrane Database of Systematic... Dec 2011Sclerotherapy has been used in clinical practice for centuries, but there is still no consensus about which, if any, sclerosing agent provides the best results. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Sclerotherapy has been used in clinical practice for centuries, but there is still no consensus about which, if any, sclerosing agent provides the best results.
OBJECTIVES
To assess the effectiveness and safety of sclerosing agents in the treatment of telangiectasias of the lower limbs.
SEARCH METHODS
The Cochrane Peripheral Vascular Diseases (PVD) Group searched their Specialised Register (last searched 26 May 2011) and CENTRAL (2011, Issue 2). We searched references within identified studies and from the Cited References in the Web of Science. We contacted study authors and pharmaceutical companies. There were no language restrictions.
SELECTION CRITERIA
We included randomised or quasi-randomised controlled trials on the treatment of telangiectasias comparing sclerotherapy with a normal saline placebo, no treatment or an alternative sclerotherapy regimen.
DATA COLLECTION AND ANALYSIS
Both authors determined which studies to include, extracted the data and rated risk of bias. One author (LS) contacted study authors and pharmaceutical companies and analysed the results.
MAIN RESULTS
Ten studies involving 484 patients were included. There was no evidence suggesting superior efficacy of any one sclerosant over another, but there was evidence of superiority of sclerotherapy to placebo.The evidence did not suggest an increase in patient satisfaction with any one agent versus another, but there was evidence that patients were less satisfied with placebo.There was some evidence suggesting that polidocanol (POL) was more likely to cause adverse reactions at a concentration of 1% compared with lower concentrations or hypertonic saline, and that sodium tetradecyl sulfate (STS) was more likely to cause adverse reactions at a concentration of 1% compared with POL at 0.5%.There was some evidence suggesting that STS was more painful than POL, heparsal (20% saline mixed with heparin 100 units/mL) or placebo, and that POL was no more painful than placebo. Evidence from one study suggested that hypertonic saline (HS) was more painful than POL.The data were not suitable for meta-analysis.
AUTHORS' CONCLUSIONS
The evidence did not suggest superior efficacy or patient satisfaction for any one sclerosing agent used in the treatment of telangiectasias of the lower limbs, but the agents studied showed superiority to a normal saline placebo. However, the amount of available evidence in this field is small and the overall methodological quality of the research was poor, as was the quality of reporting. More research is needed to determine the optimal agent(s) and the ideal dosing to achieve the best results and maximize patient satisfaction. Future research efforts should incorporate more demographic data and symptom measures to allow for comparison with findings from observational studies, thereby aiding assessment of how various risk groups respond to treatment.
Topics: Heparin; Humans; Leg; Patient Satisfaction; Polidocanol; Polyethylene Glycols; Randomized Controlled Trials as Topic; Sclerosing Solutions; Sclerotherapy; Sodium Chloride; Sodium Tetradecyl Sulfate; Telangiectasis
PubMed: 22161437
DOI: 10.1002/14651858.CD008826.pub2 -
The Cochrane Database of Systematic... May 2015Achilles tendinopathy is a common condition, often with significant functional consequences. As a wide range of injection treatments are available, a review of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Achilles tendinopathy is a common condition, often with significant functional consequences. As a wide range of injection treatments are available, a review of randomised trials evaluating injection therapies to help inform treatment decisions is warranted.
OBJECTIVES
To assess the effects (benefits and harms) of injection therapies for people with Achilles tendinopathy.
SEARCH METHODS
We searched the following databases up to 20 April 2015: the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, AMED, CINAHL and SPORTDiscus. We also searched trial registers (29 May 2014) and reference lists of articles to identify additional studies.
SELECTION CRITERIA
We included randomised and quasi-randomised controlled trials evaluating injection therapies in adults with an investigator-reported diagnosis of Achilles tendinopathy. We accepted comparison arms of placebo (sham) or no injection control, or other active treatment (such as physiotherapy, pharmaceuticals or surgery). Our primary outcomes were function, using measures such as the VISA-A (Victorian Institute of Sport Assessment-Achilles questionnaire), and adverse events.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data from the included studies. We assessed treatment effects using mean differences (MDs) and 95% confidence intervals (CIs) for continuous variables and risk ratios (RRs) and 95% CIs for dichotomous variables. For follow-up data, we defined short-term as up to six weeks, medium-term as up to three months and longer-term as data beyond three months. We performed meta-analysis where appropriate.
MAIN RESULTS
We included 18 studies (732 participants). Seven trials exclusively studied athletic populations. The mean ages of the participants in the individual trials ranged from 20 years to 50 years. Fifteen trials compared an injection therapy with a placebo injection or no injection control, four trials compared an injection therapy with active treatment, and one compared two different concentrations of the same injection. Thus no trials compared different injection therapies. Two studies had three trial arms and we included them twice in two different categories. Within these categories, we further subdivided injection therapies by mode of action (injury-causing versus direct repair agents).The risk of bias was unclear (due to poor reporting) or high in six trials published between 1987 and 1994. Improved methodology and reporting for the subsequent trials published between 2004 and 2013 meant that these were at less risk of bias.Given the very low quality evidence available from each of four small trials comparing different combinations of injection therapy versus active treatment and the single trial comparing two doses of one injection therapy, only the results of the first comparison (injection therapy versus control) are presented.There is low quality evidence of a lack of significant or clinically important differences in VISA-A scores (0 to 100: best function) between injection therapy and control groups at six weeks (MD 0.79, 95% CI -4.56 to 6.14; 200 participants, five trials), three months (MD -0.94, 95% CI -6.34 to 4.46; 189 participants, five trials) or between six and 12 months (MD 0.14, 95% CI -6.54 to 6.82; 132 participants, three trials). Very low quality evidence from 13 trials showed little difference between the two groups in adverse events (14/243 versus 12/206; RR 0.97, 95% CI 0.50 to 1.89), most of which were minor and short-lasting. The only major adverse event in the injection therapy group was an Achilles tendon rupture, which happened in a trial testing corticosteroid injections. There was very low quality evidence in favour of the injection therapy group in short-term (under three months) pain (219 participants, seven trials) and in the return to sports (335 participants, seven trials). There was very low quality evidence indicating little difference between groups in patient satisfaction with treatment (152 participants, four trials). There was insufficient evidence to conclude on subgroup differences based on mode of action given that only two trials tested injury-causing agents and the clear heterogeneity of the other 13 trials, which tested seven different therapies that act directly on the repair pathway.
AUTHORS' CONCLUSIONS
There is insufficient evidence from randomised controlled trials to draw conclusions on the use, or to support the routine use, of injection therapies for treating Achilles tendinopathy. This review has highlighted a need for definitive research in the area of injection therapies for Achilles tendinopathy, including in older non-athletic populations. This review has shown that there is a consensus in the literature that placebo-controlled trials are considered the most appropriate trial design.
Topics: Achilles Tendon; Adrenal Cortex Hormones; Adult; Aprotinin; Athletes; Fibroblasts; Glycosaminoglycans; Hemodialysis Solutions; Humans; Injections, Intralesional; Middle Aged; Platelet Transfusion; Polidocanol; Polyethylene Glycols; Randomized Controlled Trials as Topic; Sodium Chloride; Tendinopathy; Young Adult
PubMed: 26009861
DOI: 10.1002/14651858.CD010960.pub2