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
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Adenocarcinoma
Procedure: robotic assisted rectal resection
Procedure: laparoscopic rectal resection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing the Bladder and Sexual Functions of Patients Who Undergo Laparoscopic and Robotic Assisted Resection for Rectal Cancer

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Bladder function [ Time Frame: one year ] [ Designated as safety issue: No ]
    Urodynamic Questionnaire


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 98
Study Start Date: June 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: robotic
robotic assisted rectal resection
Procedure: robotic assisted rectal resection
robotic assisted rectal resection
Active Comparator: laparoscopic
laparoscopic rectal resection
Procedure: laparoscopic rectal resection
laparoscopic rectal resection

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130233

Contacts
Contact: Wai Lun Law, MBBS, MS +852 22554763 lawwl@hkucc.hku.hk

Locations
Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Wai Lun LAW, MBBS, MS    +852 22554763    lawwl@hkucc.hku.hk   
Principal Investigator: Wai Lun Law, MBBS, MS         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Wai Lun Law, MBBS, MS The University of Hong Kong
  More Information

No publications provided

Responsible Party: Professor Wai Lun LAW, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01130233     History of Changes
Other Study ID Numbers: UW 09-132
Study First Received: May 24, 2010
Last Updated: May 24, 2010
Health Authority: Hong Kong: Institutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster

Keywords provided by The University of Hong Kong:
rectal cancer

Additional relevant MeSH terms:
Adenocarcinoma
Rectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 17, 2014