Clinical Outcomes and Prognostic Factors of Robotic Assisted Rectal Cancer Resection Alone vs. Robotic Rectal Cancer Resection With Natural Orifice Specimen Extraction
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Rectal Neoplasms
- Sponsor
- Taiyuan Li
- Enrollment
- 98
- Primary Endpoint
- Overall survival
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Robotic rectal cancer resection with natural orifice extraction is a recently developed minimally invasive surgery for patients with rectal cancer. However, it's safety and feasibility remain undiscussed and controversial. This study reported the clinical outcomes and prognostic factors of robotic assisted rectal cancer resection alone vs. robotic rectal cancer resection with natural orifice extraction to discuss aforementioned question.
Detailed Description
Robotic rectal cancer resection with natural orifice extraction is a recently developed minimally invasive surgery for patients with rectal cancer. However, it's safety and feasibility remain undiscussed and controversial. This study reported the clinical outcomes and prognostic factors of robotic assisted rectal cancer resection alone vs. robotic rectal cancer resection with natural orifice extraction to discuss aforementioned question. From January 2015 to November 2016, a consecutive wave of 49 patients underwent robotic rectal cancer resection with natural orifice extraction and 49 matched patients underwent conventional robotic assisted rectal cancer resection were systematically analyzed in this study.
Investigators
Taiyuan Li
Prof., Chief physician, Head of The Fifth Department of General Surgery
The First Affiliated Hospital of Nanchang University
Eligibility Criteria
Inclusion Criteria
- •T stage 1-3;
- •aged between 18 to 75;
- •the tumor margin is at least 4 cm from the anus;
- •body mass index ≤30kg/m2;
- •no distant metastases； (6）tumor size≤5cm.
Exclusion Criteria
- •emergency surgery for intestinal obstruction or massive bleeding;
- •history of abdominal or pelvic surgery.
Outcomes
Primary Outcomes
Overall survival
Time Frame: Up to 36 months
To determine the survival differences between NOSE group and RARC group. Overall survival is defined as the time from surgery to death from any causes
Disease-free survival
Time Frame: Up to 36 months
To determine the survival differences between NOSE group and RARC group. Disease-free survival is defined as the time from surgery to local or distant recurrence
Secondary Outcomes
- Operation time(1 day)
- Estimated intraoperative blood loss(1 day)
- Postoperative hospital stay(30 days)
- Postoperative visual analogue scale scale on day 1(1 day)
- Time to pass flatus(30 days)
- Hospitalization costs(30 day)
- Specimen length(30 day)
- Proximal margin(30 day)
- Distal margin(30 days)
- Postoperative white blood cell count(30 days)
- Postoperative procalcitonin(30 days)
- Histological differentiation(30 days)
- Number of lymph nodes harvested(30 days)
- Postoperative C-reactive protein(30 days)