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

Completed

• Conditions: Rectal Neoplasms; Natural Orifice Specimen Extraction Surgery; Robotic Surgery
• Interventions: Procedure: Robotic Assisted Rectal Cancer Resection Alone; Procedure: Robotic Assisted Rectal Cancer Resection With Natural Orifice Specimen Extraction

• Registration Number: NCT04265417
• Lead Sponsor: Taiyuan Li

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.

Study Timeline

• Study Start: 2015-01-06
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-01
• Status Verified: 2020-02
• Study First Submitted: 2020-02-08
• Study First Submitted QC: 2020-02-08
• Study First Posted: 2020-02-11
• Last Update Submitted: 2020-02-14
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RARC group	Robotic Assisted Rectal Cancer Resection Alone	Participants in this group underwent robotic assisted rectal cancer resection
NOSE group	Robotic Assisted Rectal Cancer Resection With Natural Orifice Specimen Extraction	Participants in this group underwent robotic rectal cancer resection assisted rectal with natural orifice extraction

Primary Outcome Measures

Name	Time	Method
Overall survival	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	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 Outcome Measures

Name	Time	Method
Postoperative white blood cell count	30 days	To determine the surgical stress response differences NOSE group and RARC group
Operation time	1 day	To determine the differences between NOSE group and RARC group
Estimated intraoperative blood loss	1 day	To determine the differences between NOSE group and RARC group
Postoperative hospital stay	30 days	To determine the surgical and patients burdern differences between NOSE group and RARC group
Postoperative visual analogue scale scale on day 1	1 day	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.
Time to pass flatus	30 days	To determine the surgical differences between NOSE group and RARC group
Hospitalization costs	30 day	to determine the patients burden differences between NOSE group and RARC group
Specimen length	30 day	To determine the surgical differences between NOSE group and RARC group
Proximal margin	30 day	To determine the pathological differences between NOSE group and RARC group
Distal margin	30 days	To determine the pathological differences between NOSE group and RARC group
Postoperative procalcitonin	30 days	To determine the surgical stress response differences NOSE group and RARC group
Histological differentiation	30 days	To determine the pathological differences between NOSE group and RARC group
Number of lymph nodes harvested	30 days	To determine the pathological differences between NOSE group and RARC group
Postoperative C-reactive protein	30 days	To determine the surgical stress response differences NOSE group and RARC group