Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression
AbstractAlthough placebo-controlled trials are considered the gold standard for evaluating the efficacy of healthcare interventions, they can be perceived to be controversial and challenging to conduct for surgical treatments. The SUcceSS trial is the first placebo-controlled trial of lumbar decompression surgery for symptomatic lumbar canal stenosis. The SUcceSS trial has experienced common issues affecting the implementation of randomised placebo-controlled surgery trials, accentuated by the COVID-19 pandemic. Using the SUcceSS trial as an example, we discuss key challenges and mitigation strategies specific to the condu...
Source: Trials - December 6, 2023 Category: Research Source Type: clinical trials
Reconstruction of the Pelvic Floor and Perineal Wound After Rectal ELAPE
Conditions: Rectum Cancer Interventions: Procedure: Plastic surgery of the pelvic floor and perineal wound with counter-displaced skin-subcutaneous fascial flaps after extralevatory abdominal-perineal extirpation of the rectum; Procedure: Plastic surgery of the pelvic floor and perineal wound with local tissues; Procedure: Plastic surgery of the pelvic floor and perineal wound with mesh endoprosthesis Sponsors: Kuban State Medical University; State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital; City Clinical Oncology Hospital No 1 Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 4, 2023 Category: Research Source Type: clinical trials
Auricular Vagus Stimulation and STEMI
Conditions: Vagus Nerve Stimulation; Acute Coronary Syndrome; Ischemia Reperfusion Injury Intervention: Device: TENS Sponsors: Bakulev Scientific Center of Cardiovascular Surgery; State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - August 15, 2023 Category: Research Source Type: clinical trials
Cite Share Efficacy, Safety, and Tolerability of Higher Doses Estrogen Therapy in Women With Premature Ovarian Insufficiency (POI)
Condition: Primary Ovarian Insufficiency Interventions: Drug: Transdermal estradiol gel 0.1% 1.5mg/ day; Drug: Transdermal estradiol gel 0.1% 2.0mg/ day Sponsor: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare Active, not recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 21, 2023 Category: Research Source Type: clinical trials
Efficacy, Safety, and Tolerability of Higher Doses Estrogen Therapy in Women With Premature Ovarian Insufficiency
Condition: Primary Ovarian Insufficiency Interventions: Drug: Transdermal estradiol gel 0.1% 1.5mg/ day; Drug: Transdermal estradiol gel 0.1% 2.0mg/ day Sponsor: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare Active, not recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 21, 2023 Category: Research Source Type: clinical trials
Cite Share Efficacy, Safety, and Tolerability of Higher Doses Estrogen Therapy in Women With Premature Ovarian Insufficiency (POI)
Condition: Primary Ovarian Insufficiency Interventions: Drug: Transdermal estradiol gel 0.1% 1.5mg/ day; Drug: Transdermal estradiol gel 0.1% 2.0mg/ day Sponsor: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare Active, not recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 21, 2023 Category: Research Source Type: clinical trials
