Dataset Information

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.gov NCT04230772 . Registered on January 15, 2020.

SUBMITTER: Luo R

PROVIDER: S-EPMC7866755 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

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.

Luo Rui R Zheng Fangfang F Zhang Haobo H Zhu Weiquan W He Penghui P Liu Dongning D

Trials 20210206 1

<h4>Background</h4>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.<h4>Method/design</h4>Accordingly, a prospective, open-label, ...[more]

PMID: 33549133

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Project description:BackgroundNatural orifice specimen extraction (NOSE) is a technique that involves collecting a specimen for extraction through a natural opening avoiding a mini-laparotomy incision. The aim of this study was to compare NOSE and transabdominal specimen extraction in laparoscopic (LAP) colorectal cancer surgery for postoperative outcomes and oncological safety.MethodA systematic search was conducted in five electronic databases from inception till October 2020. Articles were selected based on the inclusion criteria (studies comparing LAP and NOSE colorectal surgeries reporting at least one of the outcomes) and analysed. Primary outcomes included postoperative complications, pathological results (resection margins and lymph node collection), and oncological outcomes. Secondary outcomes included operating time, blood losses, use of analgesics, functional recovery, duration of hospital stay, and cosmetic results. Fixed and random-effect models were used to measure the pooled estimates.ResultsNineteen studies involving a total of 3432 participants were analysed (3 randomized clinical trials (RCTs) and 16 retrospective non-randomized studies). Pooled results showed significantly reduced postoperative complications (OR 0.54; 95 per cent c.i. 0.44 to 0.67; P < 0.00001). Pathological outcomes of NOSE were comparable to LAP with no significant difference noted in terms of resection margins (P > 0.05) and lymph node collection (weighted mean difference (WMD) -0.47; 95 per cent c.i. -0.94 to 0; P = 0.05). Pooled analysis demonstrated comparable long-term outcomes in terms of cancer recurrence (OR 0.94; 95 per cent c.i. 0.63 to 1.39; P = 0.75), 5-year disease-free survival (HR 0.97; 95 per cent c.i. 0.73 to 1.29; P = 0.83), and overall survival (HR 0.93, 95 per cent c.i. 0.58 to -1.51; P = 0.78). Finally, the NOSE group had decreased use of additional analgesia after surgery and earlier resumption of oral intake when compared with LAP (respectively OR 0.28; 95 per cent c.i. 0.20 to 0.37; P < 0.00001 and WMD -0.35; 95 per cent c.i. -0.54 to -0.15; P = 0.0005).ConclusionThis meta-analysis showed that in comparison with LAP, NOSE decreases severe postoperative morbidity while improving postoperative recovery without compromising oncological safety, but it is limited by the small number of RCTs performed in this field.

Dataset Information

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.

Background

Method/design

Discussion

Trial registration

Publications

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.

Similar Datasets

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