Clinical Assessment of Laparoscopic and Robotic Surgery for Rectal Cancer - Randomized Phase II Trial

National Cancer Center, Korea1 site in 1 country146 target enrollmentMarch 2012

ConditionsRectal Neoplasm

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Rectal Neoplasm
Sponsor: National Cancer Center, Korea
Enrollment: 146
Locations: 1
Primary Endpoint: Quality of mesorectal excision
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

December 2017

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Cancer Center, Korea

Responsible Party

Principal Investigator

Ji Won Park

Principal Investigator

National Cancer Center, Korea

Eligibility Criteria

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

Outcomes

Primary Outcomes

Quality of mesorectal excision

Time Frame: 7days after surgery (Pathologic report)

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)

Secondary Outcomes

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)