Efficacy Study of Robotic Surgery for Rectal Cancer

National Cancer Center (NCC)

Status and phase: Unknown; Phase 2

Conditions: Rectal Neoplasm

Treatments: Procedure: Robotic surgery; Procedure: Laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01591798

NCC-CTS603

Details and patient eligibility

About

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.

Full description

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

Enrollment: 146 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Robotic surgery

Experimental group

Description:

Proctectomy using robot

Treatment:

Procedure: Robotic surgery

Laparoscopic surgery

Active Comparator group

Description:

Conventional laparoscopic rectal resection

Treatment:

Procedure: Laparoscopic surgery