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

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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Faculty Opinions recommendation of Effects of a telephone-delivered multiple health behavior change intervention (CanChange) on health and behavioral outcomes in survivors of colorectal cancer: a randomized controlled trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.718016195.793485783 ◽

2013 ◽

Author(s):

Kellie Mathis

Keyword(s):

Colorectal Cancer ◽

Randomized Controlled Trial ◽

Health Behavior ◽

Controlled Trial ◽

Behavioral Outcomes ◽

Health Behavior Change ◽

Behavior Change Intervention ◽

Randomized Controlled ◽

Multiple Health Behavior Change ◽

Multiple Health

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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

BMC Musculoskeletal Disorders ◽

10.1186/s12891-021-04354-x ◽

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).

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Pulmonary metastasectomy in colorectal cancer: a randomized controlled trial

ANZ Journal of Surgery ◽

10.1111/ans.16658 ◽

2021 ◽

Vol 91 (3) ◽

pp. 473-473

Author(s):

Fergus Macbeth ◽

Norman R. Williams ◽

Tom Treasure

Keyword(s):

Colorectal Cancer ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Pulmonary Metastasectomy ◽

Randomized Controlled

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Natural orifice specimen extraction in laparoscopic colorectal cancer surgery: A case series study

International Journal of Surgery Case Reports ◽

10.1016/j.ijscr.2020.12.059 ◽

2021 ◽

Vol 78 ◽

pp. 204-209

Author(s):

Shinsuke Masubuchi ◽

Junji Okuda ◽

Masashi Yamamoto ◽

Yoshihiro Inoue ◽

Keitaro Tanaka ◽

...

Keyword(s):

Colorectal Cancer ◽

Case Series ◽

Cancer Surgery ◽

Natural Orifice ◽

Specimen Extraction ◽

Colorectal Cancer Surgery ◽

Natural Orifice Specimen Extraction ◽

Case Series Study ◽

Series Study

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Feasibility, engagement, and acceptability of a behavioral pain management intervention for colorectal cancer survivors with pain and psychological distress: data from a pilot randomized controlled trial

Supportive Care in Cancer ◽

10.1007/s00520-021-06126-8 ◽

2021 ◽

Author(s):

Sarah A. Kelleher ◽

Hannah M. Fisher ◽

Joseph G. Winger ◽

Tamara J. Somers ◽

Hope E. Uronis ◽

...

Keyword(s):

Colorectal Cancer ◽

Randomized Controlled Trial ◽

Psychological Distress ◽

Pain Management ◽

Cancer Survivors ◽

Controlled Trial ◽

Management Intervention ◽

Randomized Controlled ◽

Colorectal Cancer Survivors ◽

Pilot Randomized Controlled Trial

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Efficacy of metformin and fermentable fiber combination therapy in adolescents with severe obesity and insulin resistance: study protocol for a double-blind randomized controlled trial

Trials ◽

10.1186/s13063-021-05060-8 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Edward C. Deehan ◽

Eloisa Colin-Ramirez ◽

Lucila Triador ◽

Karen L. Madsen ◽

Carla M. Prado ◽

...

Keyword(s):

Insulin Resistance ◽

Randomized Controlled Trial ◽

Combination Therapy ◽

Gut Microbiome ◽

Controlled Trial ◽

Fecal Microbiota ◽

Metabolic Effects ◽

Microbiota Composition ◽

Randomized Controlled ◽

Secondary Outcomes

Abstract Background Accumulating evidence suggests that the metabolic effects of metformin and fermentable fibers are mediated, in part, through diverging or overlapping effects on the composition and metabolic functions of the gut microbiome. Pre-clinical animal models have established that the addition of fiber to metformin monotherapy improves glucose tolerance. However, possible synergistic effects of combination therapy (metformin plus fiber) have not been investigated in humans. Moreover, the underlying mechanisms of synergy have yet to be elucidated. The aim of this study is to compare in adolescents with obesity the metabolic effects of metformin and fermentable fibers in combination with those of metformin or fiber alone. We will also determine if therapeutic responses correlate with compositional and functional features of the gut microbiome. Methods This is a parallel three-armed, double-blinded, randomized controlled trial. Adolescents (aged 12–18 years) with obesity, insulin resistance (IR), and a family history of type 2 diabetes mellitus (T2DM) will receive either metformin (850 mg p.o. twice/day), fermentable fibers (35 g/day), or a combination of metformin plus fiber for 12 months. Participants will be seen at baseline, 3, 6, and 12 months, with a phone follow-up at 1 and 9 months. Primary and secondary outcomes will be assessed at baseline, 6, and 12 months. The primary outcome is change in IR estimated by homeostatic model assessment of IR; key secondary outcomes include changes in the Matsuda index, oral disposition index, body mass index z-score, and fat mass to fat-free mass ratio. To gain mechanistic insight, endpoints that reflect host-microbiota interactions will also be assessed: obesity-related immune, metabolic, and satiety markers; humoral metabolites; and fecal microbiota composition, short-chain fatty acids, and bile acids. Discussion This study will compare the potential metabolic benefits of fiber with those of metformin in adolescents with obesity, determine if metformin and fiber act synergistically to improve IR, and elucidate whether the metabolic benefits of metformin and fiber associate with changes in fecal microbiota composition and the output of health-related metabolites. This study will provide insight into the potential role of the gut microbiome as a target for enhancing the therapeutic efficacy of emerging treatments for T2DM prevention. Trial registration ClinicalTrials.gov NCT04578652. Registered on 8 October 2020.

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