scholarly journals HYDROXYCHLOROQUINE FOR THE TREATMENT OF SEVERE RESPIRATORY INFECTION BY COVID-19: A RANDOMIZED CONTROLLED TRIAL

2021 ◽  
Author(s):  
Carmen Hernandez-Cardenas ◽  
Ireri Thirion-Romero ◽  
Norma E. Rivera-Martinez ◽  
Patricia Meza-Meneses ◽  
Arantxa Remigio-Luna ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Severe Disease ◽  
Public Health Problem ◽  
Major Public Health Problem ◽  
Serious Adverse Events ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Secondary Outcomes

ABSTRACTThe novel coronavirus pandemic (COVID–19) represents a major public health problem due to its rapid spread and its ability to generate severe pneumonia. Thus, it is essential to find a treatment that reduces mortality. Our objective was to estimate whether treatment with 400 mg/day of Hydroxychloroquine for 10 days reduces in-hospital mortality in subjects with severe respiratory disease due to COVID-19 compared with placebo.Material and methodsA double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of Hydroxychloroquine for the treatment of severe disease by COVID-19 through an intention-to-treat analysis. Eligible for the study were adults aged more than 18 years with COVID-19 confirmed by RT-PCR and lung injury requiring hospitalization with or without mechanical ventilation. Primary outcome was 30-day mortality. Secondary outcomes: days of mechanical ventilation, days of hospitalization and cumulative incidence of serious adverse events.ResultsA total of 214 patients with COVID-19 were recruited, randomized and analyzed. They were hypoxemic with a mean SpO2 of 65% ± 20, tachycardic (pulse rate 108±17 min-1) and tachypneic (32 ±10 min-1); 162 were under mechanical ventilation at randomization. Thirty-day mortality was similar in both groups (38% in Hydroxychloroquine vs. 41% in placebo, hazard ratio [HR] 0.88, 95% Confidence Interval [95%CI] 0.51-1.53). In the surviving participants, no significant difference was found in secondary outcomes.ConclusionNo beneficial effect or significant harm could be demonstrated in our randomized controlled trial including 214 patients, using relatively low doses of Hydroxychloroquine compared with placebo in hospitalized patients with severe COVID-19.CONSORT GUIDELINES

scholarly journals Hydroxychloroquine for the treatment of severe respiratory infection by COVID-19: A randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0257238
Author(s):  
Carmen Hernandez-Cardenas ◽  
Ireri Thirion-Romero ◽  
Sebastián Rodríguez-Llamazares ◽  
Norma E. Rivera-Martinez ◽  
Patricia Meza-Meneses ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Severe Disease ◽  
Public Health Problem ◽  
Major Public Health Problem ◽  
Serious Adverse Events ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Secondary Outcomes

Introduction The novel coronavirus pandemic (COVID–19) represents a major public health problem and it is key to find a treatment that reduces mortality. Our objective was to estimate whether treatment with 400 mg/day of Hydroxychloroquine for 10 days reduces in-hospital mortality in subjects with severe respiratory disease due to COVID-19 compared with placebo. Material and methods A double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of Hydroxychloroquine for the treatment of severe disease by COVID-19 through an intention-to-treat analysis. Eligible for the study were adults aged more than 18 years with COVID-19 confirmed by RT-PCR and lung injury requiring hospitalization with or without mechanical ventilation. Primary outcome was 30-day mortality. Secondary outcomes: days of mechanical ventilation, days of hospitalization and cumulative incidence of serious adverse events. Results A total of 214 patients with COVID-19 were recruited, randomized and analyzed. They were hypoxemic with a mean SpO2 of 65% ± 20, tachycardic (pulse rate 108±17 min-1) and tachypneic (32 ±10 min-1); 162 were under mechanical ventilation at randomization. Thirty-day mortality was similar in both groups (38% in Hydroxychloroquine vs. 41% in placebo, hazard ratio [HR] 0.88, 95% Confidence Interval [95%CI] 0.51–1.53). In the surviving participants, no significant difference was found in secondary outcomes. Conclusion No beneficial effect or significant harm could be demonstrated in our randomized controlled trial including 214 patients, using relatively low doses of Hydroxychloroquine compared with placebo in hospitalized patients with severe COVID-19.

Efficacy of a step-down regimen of oral prednisolone in axial spondyloarthritis: result of a double-blind randomized controlled trial (COBRA-AS Study)

Rheumatology ◽  
2020 ◽  
Author(s):  
Debashish Mishra ◽  
Varun Dhir ◽  
G S R S N K Naidu ◽  
Aastha Khullar ◽  
Vishal Kumar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Oral Prednisolone ◽  
Functional Improvement ◽  
Inadequate Response ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Step Down

Abstract Objectives To evaluate the efficacy and safety of a step-down regimen of oral prednisolone over 24 weeks in patients of axial SpA (axSpA). Methods This proof-of-concept double-blind randomized controlled trial enrolled patients with active axSpA (BASDAI ≥4) having predominantly axial disease (≤1 active joint currently) and inadequate response to NSAIDs. They were randomized to receive either oral prednisolone (n = 32) or placebo (n = 33) at a dose of 60, 40, 30, 20, 15 and 10 mg daily for 1 week each, following which they received 5 mg prednisolone (or placebo) daily for 18 weeks. The primary endpoint was a 50% improvement in the BASDAI (BASDAI50) at week 24. Analysis was intention to treat. Results A BASDAI50 was achieved by 12 of 32 patients (37.5%) in the prednisolone arm and 3 of 33 patients (9.1%) in the placebo arm at 24 weeks [difference 28.4% (95% CI 7.9, 46.7)]. However, there was no difference in achieving a 20 or 40% improvement in the Assessment of SpondyloArthritis international Society response between the groups. Although there was a significant intergroup difference in adjusted ΔBASDAI and ΔAnkylosing Spondylitis Disease Activity Score with CRP at 24 weeks, there was no difference at 12 weeks. There was also no significant difference in ΔBASFI, ΔBAS-G or ΔBASMI at 12 or 24 weeks. No serious adverse events were noted. There was significant weight gain in the first 12 weeks in the prednisolone group vs placebo [0.9 (s.d. 0.4) kg], but not at 24 weeks. Conclusions In this small study, oral prednisolone was efficacious in axSpA in achieving the primary outcome, but many crucial secondary outcomes such as functional improvement were not met. Its impact on bone loss was not studied. Trial registration: CTRI/2018/01/011342.

scholarly journals Efficacy of montelukast in the management of COVID-19: double blind randomized placebo controlled trial

2021 ◽  
Vol 10 (12) ◽  
pp. 1374
Author(s):  
Vijay Kumar ◽  
Avinash A. Ganapule ◽  
Sushmita Supriya ◽  
Divendu Bhushan ◽  
Pallavi Lohani ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Final Analysis ◽  
Standard Operating Procedure ◽  
Double Blind ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Double Blinded

Background: Objective of the study was to determine the efficacy of montelukast in reducing the severity of COVID-19 symptoms using a double blinded randomized controlled trial.Methods: Parallel, double-blinded randomized controlled trial (RCT) with placebo as comparison to montelukast. All patients above the age of 14 years both males and females, admitted with a diagnosis of mild or moderate COVID-19 (on the basis of a positive reverse transcriptase polymerase chain reaction (RT-PCR) report) at our facility during the study period from 01 September 2020-31 January 2021) and excluding those having adverse reaction to montelukast or those not willing to participate, and pregnant and lactating females. Patients in the intervention arm were given tablet montelukast 10 mg OD HS from the day of admission for 10 days. The patients in the placebo group were given an identical appearing placebo at bedtime for 10 days from the day of admission. The rest of the treatment was given as per the standard operating procedure (SOP) of the institute with minor adjustments as per the treating team’s judgement. Primary outcome was progression of the disease to severe grade and secondary outcomes were discharge on or before day 10 from admission, admission to ICU, need for mechanical ventilation and in-hospital mortality.Results: A total of 94 patients were enrolled for the study. 90 patients, 45 in each arm were included in the final analysis. The baseline characteristics of the two arms including age, sex, comorbidities, severity at admission and treatment given apart from montelukast or placebo, were comparable with respect to these variables. This study did not find any improvement in primary outcome of progression to severe disease and secondary outcomes of intensive care unit (ICU) admission, mortality or need of mechanical ventilation, discharge on or by day 10 with the use of montelukast as compared to placebo in mild to moderate cases of COVID-19.Conclusions: There was no difference in primary or secondary outcomes with the use of Montelukast compared to placebo.

Ketamine for rapid reduction of suicidal ideation: a randomized controlled trial

2015 ◽  
Vol 45 (16) ◽  
pp. 3571-3580 ◽  
Author(s):  
J. W. Murrough ◽  
L. Soleimani ◽  
K. E. DeWilde ◽  
K. A. Collins ◽  
K. A. Lapidus ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Suicidal Ideation ◽  
Rating Scale ◽  
Controlled Trial ◽  
Public Health Problem ◽  
Nmda Receptor Antagonist ◽  
Rapid Reduction ◽  
Randomized Controlled ◽  
Assessment Period ◽  
Significant Difference

Background.Suicide is a devastating public health problem and very few biological treatments have been found to be effective for quickly reducing the intensity of suicidal ideation (SI). We have previously shown that a single dose of ketamine, a glutamate N-methyl-d-aspartate (NMDA) receptor antagonist, is associated with a rapid reduction in depressive symptom severity and SI in patients with treatment-resistant depression.Method.We conducted a randomized, controlled trial of ketamine in patients with mood and anxiety spectrum disorders who presented with clinically significant SI (n = 24). Patients received a single infusion of ketamine or midazolam (as an active placebo) in addition to standard of care. SI measured using the Beck Scale for Suicidal Ideation (BSI) 24 h post-treatment represented the primary outcome. Secondary outcomes included the Montgomery–Asberg Depression Rating Scale – Suicidal Ideation (MADRS-SI) score at 24 h and additional measures beyond the 24-h time-point.Results.The intervention was well tolerated and no dropouts occurred during the primary 7-day assessment period. BSI score was not different between the treatment groups at 24 h (p = 0.32); however, a significant difference emerged at 48 h (p = 0.047). MADRS-SI score was lower in the ketamine group compared to midazolam group at 24 h (p = 0.05). The treatment effect was no longer significant at the end of the 7-day assessment period.Conclusions.The current findings provide initial support for the safety and tolerability of ketamine as an intervention for SI in patients who are at elevated risk for suicidal behavior. Larger, well-powered studies are warranted.

scholarly journals AB0545 COMPARISON BETWEEN METHOTREXATE AND APREMILAST IN PSORIATIC ARTHRITIS-A SINGLE BLINDED RANDOMIZED CONTROLLED TRIAL (APREMEPsA STUDY)

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1305-1306
Author(s):  
J. Samanta ◽  
G. Naidu ◽  
A. Chattopadhyay ◽  
A. Basnet ◽  
T. Narang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Controlled Trial ◽  
Joint Disease ◽  
Phase Iii ◽  
Secondary Outcome ◽  
Serious Adverse Events ◽  
Randomized Controlled ◽  
Significant Difference

Background:Both methotrexate and apremilast were found to be effective in controlling joint disease in psoriatic arthritis (PsA) patients [1-4]. However, there are no head-to-head trials comparing the efficacy of these two drugs in PsA.Objectives:Primary outcome measure was rate of major cDAPSA response (>85% change in cDAPSA score from baseline) at week 24 and secondary outcome measures were ACR 20 response, change in Psoriasis Area and Severity Index (PASI), Maastricht enthesitis score, Leeds dactylitis index, and health assessment questionnaire-disability index (HAQ-DI) and number of adverse events at week 24 between methotrexate and apremilast groups.Methods:Single blinded (physician), parallel group, randomized controlled trial was conducted at a single centre in India between October 2019 and December 2020. Adult PsA patients (age>18 years), fulfilling CASPAR criteria, not receiving methotrexate/apremilast in last 3 months and never receiving bDMARDs or, JAK inhibitors, having active articular disease (one or more swollen joint or, having one or more tender entheseal point) were recruited in this study.Results:A total of 31 patients were recruited (15 in apremilast arm and 16 in methotrexate arm) amongst whom 26 patients completed 24 weeks follow up (13 patients in apremilast arm and 13 patients in methotrexate arm). At baseline, median (IQR) swollen joints were 2 (1) in apremilast group and 2.5 (4) in methotrexate group. Median cDAPSA score at baseline was 23 (9) in apremilast group and 20 (21) in methotrexate group. Major cDAPSA response at week 24 was achieved in three (20%) subjects in apremilast arm and six (37.5%) subjects in methotrexate arm (p=0.433). Seven (46.67%) subjects in apremilast group and nine (56.25%) subjects in methotrexate group achieved ACR 20 response at 24-weeks (p=0.724). The change of PASI score from baseline was significant in apremilast group (2.0, p=0.003) and methotrexate group (0.35, p=0.003), but when compared between the two groups, there was no significant difference(p=0.378). Change in enthesitis score was not significant in both the groups (0.0 in apremilast group, p=0.285; 0.0 in methotrexate group, p=1.0). The median change in dactylitis score [0.0 (9.1), p=0.028] and HAQ-DI score (0.33, p=0.01) were significant in methotrexate group only. However, when compared to the change in apremilast group, the difference was not significant for both the parameters. A total of 9 minor adverse events, 3 with apremilast and 6 with methotrexate, were observed with transaminitis (number of events) being the commonest event noted with methotrexate. There were no serious adverse events noted in either of the groups.Conclusion:There was no significant difference between methotrexate and apremilast in terms of efficacy as measured by cDAPSA and ACR20 responses. Both the drugs were well tolerated by the study population. A larger study with head-to-head comparison between methotrexate and apremilast is needed to conform these findings.References:[1]Baranauskaite A, Raffayová H, Kungurov NV, et al; RESPOND investigators. Infliximab plus methotrexate is superior to methotrexate alone in the treatment of psoriatic arthritis in methotrexate-naive patients: the RESPOND study Ann Rheum Dis. 2012;71:541-8.[2]Mease PJ, Gladman DD, Collier DH, et al. Etanercept and Methotrexate as Monotherapy or in Combination for Psoriatic Arthritis: Primary Results From a Randomized, Controlled Phase III Trial. Arthritis Rheumatol 2019;71:1112-24.[3]Gladman DD, Kavanaugh A, Gómez-Reino JJ, et al. Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1-3 studies. RMD Open. 2018;4(1):e000669.[4]Wells AF, Edwards CJ, Kivitz AJ, et al. Apremilast monotherapy in DMARD-naive psoriatic arthritis patients: results of the randomized, placebo-controlled PALACE 4 trial. Rheumatology (Oxford) 2018;57:1253-63.Disclosure of Interests:None declared.

Effects of electroacupuncture therapy for depression: study protocol for a multi-centered, randomized controlled trial

2019 ◽  
Author(s):  
Wa Cai ◽  
Wen Ma ◽  
Ai-Wen Chen ◽  
Wei-Dong Shen
Keyword(s):  
Randomized Controlled Trial ◽  
Western Medicine ◽  
Negative Impact ◽  
Controlled Trial ◽  
Depression Scale ◽  
Public Health Problem ◽  
Major Public Health Problem ◽  
Hamilton Depression Scale ◽  
Efficacy And Safety ◽  
Randomized Controlled

Abstract Background As a major public health problem, depression has a negative impact on individuals and society. The aim of this well-designed trial is to evaluate the efficacy and safety of electroacupuncture (EA) treatment for depression. Methods/Design A three-arm parallel, non-blinded, randomized controlled trial was performed in four hospitals (centers). 144 participants will be divided into three groups: electroacupuncture (EA) group, hand acupuncture (HA) group and western medicine group. Participants in EA group and HA group received 12 sessions of acupuncture treatment for 4 weeks. Participants allocated to western medicine group will only take 20mg fluoxetine orally per day for 4 weeks. The primary outcome is Hamilton Depression Scale (HAMD). Secondary outcomes are Self-Rating Depression Scale (SDS), Depression Scale of traditional Chinese medicine (Depression Scale of TCM), brain fMRI and blood biomarkers including neurotransmitters 5-HT, DA, NE, inflammatory cytokines IL-1β, TNF-α, IL-6 and neurotrophin BDNF. All the outcomes will be assessed at baseline, 4 weeks after EA treatment onset and 6-month follow-up. Discussion The results of this trial will verify the efficacy and safety of EA treatment for depressive patients and provide acupuncturists and clinicians with robust clinical evidence.

scholarly journals The The Effectiveness of Early Mobilization Time on Balance and Functional Ability after Ischemic Stroke

2019 ◽  
Vol 7 (7) ◽  
pp. 1088-1092
Author(s):  
Umi Budi Rahayu ◽  
Samekto Wibowo ◽  
Ismail Setyopranoto
Keyword(s):  
Randomized Controlled Trial ◽  
Ischemic Stroke ◽  
Functional Ability ◽  
Controlled Trial ◽  
Early Mobilization ◽  
Berg Balance Scale ◽  
Early Mobilisation ◽  
Inclusion Criteria ◽  
Randomized Controlled ◽  
Significant Difference

BACKGROUND: Early mobilisation (EM) after-ischemic stroke is a motor learning intervention aimed to restore nerve cells and to improve balance and functional ability. Unfortunately, the study of when this intervention began has not been widely studied. AIM: On this study was compared the effect of EM started at 24 hours and 48 hours after an ischemic stroke on balance and functional ability. MATERIAL AND METHODS: Randomized controlled trial involving 40 patients on 2 groups meeting predefined inclusion criteria. The levels of balance were measured using the Berg Balance Scale, and the functional ability was measured using the Barthel Index, at 5th and 7th day. RESULTS: A significant difference was observed in both balance (p = 0.038) and functional ability (p = 0.021) obtained on the 7th day of assessment between both groups. A significant difference on the 5th day was observed only in the functional ability (p = 0.002) and not in the balance (p = 0.147), between the groups. CONCLUSION: EM started at 24 hours after the ischemic stroke has been found to have a better impact on balance and functional ability compared to that at 48 hours.

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

scholarly journals Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aaron Gazendam ◽  
◽  
Seper Ekhtiari ◽  
Nolan S. Horner ◽  
Nicole Simunovic ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pain Control ◽  
Shoulder Arthroscopy ◽  
Controlled Trial ◽  
Arthroscopic Surgery ◽  
Standard Of Care ◽  
Opioid Prescription ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Arthroscopic Knee

Abstract Background Opioids continue to be the analgesic of choice for postoperative pain control following arthroscopic knee and shoulder surgery. Despite their widespread use, there are limited evidence-based clinical practice guidelines for postoperative opioid prescribing. The Non-Opioid Prescriptions after Arthroscopic Surgery in Canada (NO PAin) Trial is a randomized controlled trial (RCT) designed to determine whether a non-opioid analgesia approach to postoperative pain, compared to usual care, reduces oral morphine equivalents (OME) consumed in patients undergoing outpatient knee and shoulder arthroscopy. Methods This is a multi-centre, RCT with a target sample size of 200 patients. Adult (18+ years of age) patients undergoing outpatient knee and shoulder arthroscopy will be randomized to a non-opioid postoperative protocol (intervention) or the current standard of care (control). The intervention will consist of a standardized non-opioid analgesic prescription, a limited rescue opioid prescription, and a patient education infographic. The control is defined as the treating surgeons’ pre-trial postoperative analgesic regimen. Exclusion criteria include chronic opioid use, concomitant open surgery, contraindications to the prescribed analgesics or ongoing workers compensation/litigation. The primary outcome is OMEs consumed at 6 weeks postoperatively. Secondary outcomes will include patient-reported pain and satisfaction, quantity of OMEs prescribed, number of opioid refills, and any adverse events up to 6 weeks postoperatively. Utilizing the intention to treat principle for all analyses, independent samples t-test and presented with a p-value as well as a mean difference (MD) with 95% confidence intervals (CIs) will be performed for primary and secondary outcomes. Discussion The ongoing opioid epidemic and overprescribing of opioids in orthopaedics serve as the rationale for this trial. There is a lack of evidence upon which to develop post-operative pain management guidelines for patients undergoing arthroscopic surgery. A prospective evaluation of this relatively inexpensive intervention will demonstrate whether an explicit effort to reduce the number of opioids prescribed results in a reduction in the amount of opioids consumed and help to inform future studies and guidelines. Trial registration The NO PAin trial has been prospectively registered with clinicaltrials.gov (NCT04566250).

scholarly journals Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rui Luo ◽  
Fangfang Zheng ◽  
Haobo Zhang ◽  
Weiquan Zhu ◽  
Penghui He ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Natural Orifice ◽  
Specimen Extraction ◽  
Natural Orifice Specimen Extraction ◽  
Robotic Assisted ◽  
Randomized Controlled ◽  
Robotic Assisted Surgery ◽  
Secondary Outcomes

Abstract Background Natural orifice specimen extraction surgery for colorectal cancer has been introduced in order to reduce the abdominal incision, demonstrating major development potential in minimally invasive surgery. We are conducting this randomized controlled trial to assess whether robotic NOSES is non-inferior to traditional robotic-assisted surgery for patients with colorectal cancer in terms of primary and secondary outcomes. Method/design Accordingly, a prospective, open-label, randomized controlled, parallel-group, multicenter, and non-inferiority trial will be conducted to discuss the safety and efficacy of robotic natural orifice extraction surgery compared to traditional robotic-assisted surgery. Here, 550 estimated participants will be enrolled to have 80% power to detect differences with a one-sided significance level of 0.025 in consideration of the non-inferiority margin of 10%. The primary outcome is the incidence of surgical complications, which will be classified using the Clavien-Dindo system. Discussion This trial is expected to reveal whether robotic NOSES is non-inferior to traditional robotic-assisted surgery, which is of great significance in regard to the development of robotic NOSES for patients with colorectal cancer in the minimally invasive era. Furthermore, robotic NOSES is expected to exhibit superiority to traditional robotic-assisted surgery in terms of both primary and secondary outcomes. Trial registration ClinicalTrials.govNCT04230772. Registered on January 15, 2020.

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