Randomized Trial on Robotic Assisted Resection for Rectal Cancer

This study is currently recruiting participants.
Verified May 2010 by The University of Hong Kong
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01130233
First received: May 24, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted

May 24, 2010
May 24, 2010
June 2009
June 2014   (final data collection date for primary outcome measure)
Bladder function [ Time Frame: one year ] [ Designated as safety issue: No ]
Urodynamic Questionnaire
Same as current
No Changes Posted
  • tumor status [ Time Frame: One year ] [ Designated as safety issue: No ]
    recurrence and survival
  • Quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
    Questionnaire
Same as current
Not Provided
Not Provided
 
Randomized Trial on Robotic Assisted Resection for Rectal Cancer
Randomized Controlled Trial Comparing the Bladder and Sexual Functions of Patients Who Undergo Laparoscopic and Robotic Assisted Resection for Rectal Cancer

Hypothesis: the bladder and sexual functions can be better preserved in patients with robotic assisted rectal surgery

This is a randomized trial comparing the bladder and sexual function of patients who undergo laparoscopic and robotic assisted rectal resection for rectal cancer.

This is a randomized trial comparing the bladder and sexual function of patients who undergo laparoscopic and robotic assisted rectal resection for rectal cancer

The primary objective of this study is to compare the bladder and sexual functions of patients who undergo laparoscopic and robotic assisted resection for rectal cancer through a randomized controlled trial.

The secondary outcome measures include

  1. The operative outcome in terms of the complication rate, hospital stay and reoperation of the two groups;
  2. The quality of life of the patients and the cost of the two groups
  3. The quality of the resected specimens
  4. The local recurrence rates at two years after the surgery
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Rectal Cancer
  • Adenocarcinoma
  • Procedure: robotic assisted rectal resection
    robotic assisted rectal resection
  • Procedure: laparoscopic rectal resection
    laparoscopic rectal resection
  • Experimental: robotic
    robotic assisted rectal resection
    Intervention: Procedure: robotic assisted rectal resection
  • Active Comparator: laparoscopic
    laparoscopic rectal resection
    Intervention: Procedure: laparoscopic rectal resection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
98
December 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Histologically proven new case of rectal cancer with the lower border within 15 cm from anal verge
  2. Age >18 years
  3. Informed consent obtained
  4. American Society of Anesthesiologist class 1-3
  5. No contraindication to laparoscopic surgery
  6. Acceptable operating risk

Exclusion Criteria:

  1. Locally advanced fixed tumor with the need for exenterative surgery
  2. Severe cardiac or pulmonary comorbidity rendering pneumoperitoneum hazardous
  3. Multiple previous operations with the anticipation of dense peritoneal adhesions
  4. No informed consent
Both
18 Years and older
No
Contact: Wai Lun Law, MBBS, MS +852 22554763 lawwl@hkucc.hku.hk
Hong Kong
 
NCT01130233
UW 09-132
No
Professor Wai Lun LAW, The University of Hong Kong
The University of Hong Kong
Not Provided
Principal Investigator: Wai Lun Law, MBBS, MS The University of Hong Kong
The University of Hong Kong
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP