Clinical Outcomes and Prognostic Factors of Robotic Assisted Rectal Cancer Resection Alone vs. Robotic Rectal Cancer Resection With Natural Orifice Specimen Extraction

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.

Study Overview

• Status: Completed
• Conditions: Rectal Neoplasms; Robotic Surgery; Natural Orifice Specimen Extraction Surgery
• Intervention / Treatment: Procedure: Robotic Assisted Rectal Cancer Resection Alone; Procedure: Robotic Assisted Rectal Cancer Resection With Natural Orifice Specimen Extraction

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.

• Study Type: Observational
• Enrollment (Actual): 98

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RARC group; Participants in this group underwent robotic assisted rectal cancer resection	Procedure: Robotic Assisted Rectal Cancer Resection Alone; participants in this group underwent robotic assisted rectal cancer resection alone, the specimens were extracted through the incision on the abdominal wall.
NOSE group; Participants in this group underwent robotic rectal cancer resection assisted rectal with natural orifice extraction	Procedure: Robotic Assisted Rectal Cancer Resection With Natural Orifice Specimen Extraction; participants in this group underwent robotic rectal cancer resection，the specimens were extractd through anus and vagina.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	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	Up to 36 months
Disease-free survival	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	Up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time	To determine the differences between NOSE group and RARC group	1 day
Estimated intraoperative blood loss	To determine the differences between NOSE group and RARC group	1 day
Postoperative hospital stay	To determine the surgical and patients burdern differences between NOSE group and RARC group	30 days
Postoperative visual analogue scale scale on day 1	To determine the surgical differences between NOSE group and RARC group. Maxium sacle is 10, miniun scale is 0. 0 represents no pain. 10 represents maximun pain.	1 day
Time to pass flatus	To determine the surgical differences between NOSE group and RARC group	30 days
Hospitalization costs	to determine the patients burden differences between NOSE group and RARC group	30 day
Specimen length	To determine the surgical differences between NOSE group and RARC group	30 day
Proximal margin	To determine the pathological differences between NOSE group and RARC group	30 day
Distal margin	To determine the pathological differences between NOSE group and RARC group	30 days
Histological differentiation	To determine the pathological differences between NOSE group and RARC group	30 days
Number of lymph nodes harvested	To determine the pathological differences between NOSE group and RARC group	30 days
Postoperative white blood cell count	To determine the surgical stress response differences NOSE group and RARC group	30 days
Postoperative procalcitonin	To determine the surgical stress response differences NOSE group and RARC group	30 days
Postoperative C-reactive protein	To determine the surgical stress response differences NOSE group and RARC group	30 days

Collaborators and Investigators

• Sponsor: Taiyuan Li

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 8, 2020
• First Submitted That Met QC Criteria: February 8, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 14, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: RARN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No