NCT04265417

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

1.9 years

First QC Date

February 8, 2020

Last Update Submit

February 14, 2020

Conditions

Rectal NeoplasmsRobotic SurgeryNatural Orifice Specimen Extraction Surgery

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (14)

  • 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

  • +9 more secondary outcomes

Study Arms (2)

RARC group

Participants in this group underwent robotic assisted rectal cancer resection

Procedure: Robotic Assisted Rectal Cancer Resection Alone

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

Interventions

Robotic Assisted Rectal Cancer Resection AlonePROCEDURE

participants in this group underwent robotic assisted rectal cancer resection alone, the specimens were extracted through the incision on the abdominal wall.

RARC group
Robotic Assisted Rectal Cancer Resection With Natural Orifice Specimen ExtractionPROCEDURE

participants in this group underwent robotic rectal cancer resection，the specimens were extractd through anus and vagina.

NOSE group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

The resected specimens were kept and sent to the laboratory for pathological examination

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof., Chief physician, Head of The Fifth Department of General Surgery

Study Record Dates

First Submitted

February 8, 2020

First Posted

February 11, 2020

Study Start

January 6, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share