Clinical Assessment of Laparoscopic and Robotic Surgery for Rectal Cancer - Randomized Phase II Trial
18 Years
80 Years
Both
Rectal Neoplasm
Trial Information
Clinical Assessment of Laparoscopic and Robotic Surgery for Rectal Cancer - Randomized Phase II Trial
This study was designed as randomized phase II trial (laparoscopic versus robotic). The
primary end point is quality of mesorectal excision.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Quality of mesorectal excision
Outcome Description:
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)
Outcome Time Frame:
7days after surgery (Pathologic report)
Safety Issue:
Yes
Principal Investigator
Ji Won Park, Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Center
Authority:
Korea: Institutional Review Board
Study ID:
NCC-CTS603
NCT ID:
NCT01591798
Start Date:
March 2012
Completion Date:
December 2017
Related Keywords:
- Rectal Neoplasm
- Rectal cancer
- Robotic surgery
- Laparoscopic surgery
- Neoplasms
- Rectal Neoplasms
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