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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01196000
Other study ID # 07158
Secondary ID NCI-2010-01427
Status Withdrawn
Phase N/A
First received September 3, 2010
Last updated April 16, 2012
Start date December 2011

Study information

Verified date April 2012
Source City of Hope Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

RATIONALE: Robotic-assisted laparoscopic surgery may be a less invasive type of surgery for rectal cancer and may have fewer side effects and improve recovery. It is not yet known whether robotic-assisted laparoscopic surgery is more effective than laparoscopic surgery in treating patients with rectal cancer.

PURPOSE: This randomized clinical trial studies robotic-assisted laparoscopic surgery to see how well it works compared to laparoscopic surgery in treating patients with rectal cancer that can be removed by surgery.


Description:

OBJECTIVES:

I. To evaluate robotic-assisted rectal cancer surgery versus standard laparoscopic rectal cancer resection by means of a randomized, controlled trial.

II. To assess technical ease of the operation, as determined by the clinical indicator of low conversion rate to open operation.

III. To assess surgical accuracy and improved oncological outcome as determined by clear pathological resection margins.

IV. To assess quality of life and analyze cost-effectiveness to aid evidence-based knowledge to inform NHS and other service providers and decision-makers.

V. To analyze disease-free and overall survival and local recurrence rates at 3-year follow-up.

OUTLINE:

Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo standard laparoscopic resection.

ARM II: Patients undergo robotic-assisted laparoscopic resection.

After completion of study treatment, patients are followed up at 1 month, 6 months, and then annually thereafter for 3 years.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion

- Able to provide written informed consent

- Diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection (i.e. staged T1-3, N0-2, M0 by CT and MRI or transrectal ultrasound)

- Rectal cancer suitable for resection by either standard or robotic-assisted laparoscopic procedure

- Fit for robotic-assisted or standard laparoscopic rectal resection

- ASA =< 3

- Capable of completing required questionnaires at time of consent

Exclusion

- Benign lesions of the rectum

- Cancers of the anal canal

- Locally advanced cancers not amenable to curative surgery

- Locally advanced cancers requiring en bloc multi-visceral resection

- Synchronous colorectal tumours requiring multi-segment surgical resection

- Co-existent inflammatory bowel disease

- Clinical or radiological evidence of metastatic spread

- Concurrent or previous diagnosis of invasive cancer within 5 years that could confuse diagnosis (non-melanomatous skin cancer or superficial bladder cancer treated with curative intent are acceptable; for other cases please discuss with Chief Investigator via CTRU)

- History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements

- Pregnancy

- Participation in another rectal cancer clinical trial relating to surgical technique

Study Design

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


Intervention

Procedure:
conventional laparoscopic surgery
operation using conventional laparoscopic techniques
robotic-assisted laparoscopic surgery
operation that involves use of laparoscopic assistance with robotic assistance
quality-of-life assessment
Ancillary studies
Other:
questionnaire administration
Ancillary studies

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
City of Hope Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of conversion to open surgery as an indicator of surgical technical difficulty At completion of surgery No
Secondary Circumferential resection margin positivity rate At completion of pathology review No
Secondary Local recurrence rate At 3 years No
Secondary Intra-operative and post-operative complications At day 30 and 6 months No
Secondary Operative mortality At day 30 No
Secondary Self reported bladder and sexual function At day 30 and 6 months No
Secondary Health related quality of life At day 30 and 6 months No
Secondary Disease free and overall survival At 3 years No
Secondary Intra-operative laparoscopic skills (randomly selected cases only) as assessed by the global assessment tool for evaluation of intra-operative laparoscopic skills (GOALS) Upon completion of GOALS assessment by an independent expert No
Secondary Quality of the plane of surgery as assessed by central review of photographs At completion of the central review of photographs No
Secondary Health economics At day 30 and 6 months No
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