NCT01591798

Brief Summary

After introducing minimally invasive surgery, robotic surgery has been increasingly used in colorectal cancer. However, there is a few prospective study for robotic surgery. The aim of this trial is to evaluate the effectiveness and safety of robotic surgery in mid or low rectal cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 4, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 7, 2012

Status Verified

May 1, 2012

Enrollment Period

2.8 years

First QC Date

March 16, 2012

Last Update Submit

May 3, 2012

Conditions

Rectal Neoplasm

Keywords

Rectal cancerRobotic surgeryLaparoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Quality of mesorectal excision

    Evaluating the quality of mesorectal excision in rectal specimen according to the criteria suggested by Nagtegaal ID, et al. (J Clin Oncol. 2002;20:1729-34)

    7days after surgery (Pathologic report)

Secondary Outcomes (3)

  • Short-term postoperative outcome

    Within postoperative 30 days

  • Sexual and urinary function, Quality of life, Anorectal function

    Baseline, postop 3 weeks, 3months, 12 months, 24 months, 36 months

  • Long-term outcome

    Postoperative 36 months

Study Arms (2)

Robotic surgery

EXPERIMENTAL

Proctectomy using robot

Procedure: Robotic surgery

Laparoscopic surgery

ACTIVE COMPARATOR

Conventional laparoscopic rectal resection

Procedure: Laparoscopic surgery

Interventions

Robotic surgeryPROCEDURE

Robotic assisted rectal resection

Also known as: da Vinci Surgical System
Robotic surgery
Laparoscopic surgeryPROCEDURE

Laparoscopic assisted rectal resection

Laparoscopic surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mid or low rectal cancer (within 9cm from anal verge)
  • pathologically proven as adenocarcinoma
  • written informed consent
  • no severe functional disability in lung and heart

You may not qualify if:

  • invading adjacent organ
  • distant metastasis (lung, liver, brain, bone, distant lymph nodes etc.)
  • lateral pelvic lymph node metastasis
  • Have severe concomitant disease that might limit compliance or completion of the protocol.
  • Have any other malignancy that might impact 5-year survival or might be potentially confused with rectal cancer.
  • If female, be pregnant or breast feeding.
  • Hereditary colorectal cancer (HNPCC, FAP etc)
  • emergency operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Robotic Surgical ProceduresLaparoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and AgricultureEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical Procedures

Study Officials

  • Ji Won Park, Dr.

    National Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae Hwan Oh, Dr.

CONTACT

82-31-920-1637jayoh@ncc.re.kr

Ji Won Park, Dr.

CONTACT

82-31-920-1894sowisdom@ncc.re.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 16, 2012

First Posted

May 4, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2017

Last Updated

May 7, 2012

Record last verified: 2012-05

Locations

KR(1)