Clinical trial NCT04265417: Clinical Outcomes and Prognostic Factors of Robotic Assisted Rectal Cancer Resection Alone vs. Robotic Rectal Cancer Resection With Natural Orifice Specimen Extraction
Official title: Clinical Outcomes and Prognostic Factors of Robotic Assisted Rectal Cancer Resection Alone vs. Robotic Rectal Cancer Resection With Natural Orifice Specimen Extraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Neoplasms
Robotic Surgery
Natural Orifice Specimen Extraction Surgery
Lead sponsor: The First Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From January 2015 to November 2016, a consecutive wave of patients with rectal cancer underwent conventional robotic assisted rectal cancer resection and robotic rectal cancer resection with natural orifice extraction were invited to participate in this study.

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.

Eligibility criteria: Inclusion Criteria:

1. T stage 1-3;
2. aged between 18 to 75;
3. the tumor margin is at least 4 cm from the anus;
4. body mass index ≤30kg/m2;
5. no distant metastases； (6）tumor size≤5cm.

Exclusion Criteria:

1. emergency surgery for intestinal obstruction or massive bleeding;
2. history of abdominal or pelvic surgery.

Primary outcomes:
measure: Overall survival
timeFrame: Up to 36 months
measure: Disease-free survival
timeFrame: Up to 36 months
Secondary outcomes:
measure: Operation time
timeFrame: 1 day
measure: Estimated intraoperative blood loss
timeFrame: 1 day
measure: Postoperative hospital stay
timeFrame: 30 days
measure: Postoperative visual analogue scale scale on day 1
timeFrame: 1 day
measure: Time to pass flatus
timeFrame: 30 days
measure: Hospitalization costs
timeFrame: 30 day
measure: Specimen length
timeFrame: 30 day
measure: Proximal margin
timeFrame: 30 day
measure: Distal margin
timeFrame: 30 days
measure: Histological differentiation
timeFrame: 30 days
measure: Number of lymph nodes harvested
timeFrame: 30 days
measure: Postoperative white blood cell count
timeFrame: 30 days
measure: Postoperative procalcitonin
timeFrame: 30 days
measure: Postoperative C-reactive protein
timeFrame: 30 days
Other outcomes:
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Study officials:
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