Efficacy Study of Robotic Surgery for Rectal Cancer

Phase 2

• Conditions: Rectal Neoplasm
• Interventions: Procedure: Robotic surgery; Procedure: Laparoscopic surgery

• Registration Number: NCT01591798
• Lead Sponsor: National Cancer Center, Korea

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-16
• Status Verified: 2012-05
• Study First Submitted QC: 2012-05-02
• Last Update Submitted: 2012-05-03
• Study First Posted: 2012-05-04
• Last Update Posted: 2012-05-07
• Primary Completion: 2014-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic surgery	Robotic surgery	Proctectomy using robot
Laparoscopic surgery	Laparoscopic surgery	Conventional laparoscopic rectal resection

Primary Outcome Measures

Name	Time	Method
Quality of mesorectal excision	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 Outcome Measures

Name	Time	Method
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	IIEF, FSFI, IPSS, EORTC C30, CR38, FISI, MSKCC bowel fuction tool, Manometry
Long-term outcome	Postoperative 36 months	3 year disese-free survival

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of