Efficacy Study of Robotic Surgery for Rectal Cancer

Rectal Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01591798
• Other study ID #: NCC-CTS603
• Status: Recruiting
• Phase: Phase 2
• First received: March 16, 2012
• Last updated: May 3, 2012
• Start date: March 2012
• Est. completion date: December 2017

Study information

• Verified date: May 2012
• Source: National Cancer Center, Korea
• Contact: Jae Hwan Oh, Dr.
• Phone: 82-31-920-1637
• Email: jayoh[@]ncc.re.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: December 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Neoplasm
• Rectal Neoplasms

Intervention

Procedure:
• Robotic surgery
Robotic assisted rectal resection
• Laparoscopic surgery
Laparoscopic assisted rectal resection

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	7days after surgery (Pathologic report)	Yes
Secondary	Short-term postoperative outcome		Within postoperative 30 days	Yes
Secondary	Sexual and urinary function, Quality of life, Anorectal function	IIEF, FSFI, IPSS, EORTC C30, CR38, FISI, MSKCC bowel fuction tool, Manometry	Baseline, postop 3 weeks, 3months, 12 months, 24 months, 36 months	No
Secondary	Long-term outcome	3 year disese-free survival	Postoperative 36 months	Yes