Efficacy Study of Robotic Surgery for Rectal Cancer

National Cancer Center, Korea146 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

146

Conditions

Rectal Neoplasm

Interventions

Robotic surgeryPROCEDURE

Robotic assisted rectal resection

Laparoscopic surgeryPROCEDURE

Laparoscopic assisted rectal resection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 7days after surgery (Pathologic report)