Efficacy Study of Robotic Surgery for Rectal Cancer

NCT ID: NCT01591798

Last Updated: 2012-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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This study was designed as randomized phase II trial (laparoscopic versus robotic). The primary end point is quality of mesorectal excision.

Conditions

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Rectal Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robotic surgery

Proctectomy using robot

Group Type EXPERIMENTAL

Robotic surgery

Intervention Type PROCEDURE

Robotic assisted rectal resection

Laparoscopic surgery

Conventional laparoscopic rectal resection

Group Type ACTIVE_COMPARATOR

Laparoscopic surgery

Intervention Type PROCEDURE

Laparoscopic assisted rectal resection

Interventions

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Robotic surgery

Robotic assisted rectal resection

Intervention Type PROCEDURE

Laparoscopic surgery

Laparoscopic assisted rectal resection

Intervention Type PROCEDURE

Other Intervention Names

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da Vinci Surgical System

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ji Won Park

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ji Won Park, Dr.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center

Locations

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National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jae Hwan Oh, Dr.

Role: CONTACT

82-31-920-1637

Ji Won Park, Dr.

Role: CONTACT

82-31-920-1894

Facility Contacts

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Jae Hwan Oh, Dr.

Role: primary

82-31-920-1637

Other Identifiers

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NCC-CTS603

Identifier Type: -

Identifier Source: org_study_id

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