Randomized Trial on Robotic Assisted Resection for Rectal Cancer

May 24, 2010 updated by: The University of Hong Kong

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

98

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
        • Principal Investigator:
          • Wai Lun Law, MBBS, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bladder function
Time Frame: one year
Urodynamic Questionnaire
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor status
Time Frame: One year
recurrence and survival
One year
Quality of life
Time Frame: one year
Questionnaire
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Wai Lun Law, MBBS, MS, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

May 24, 2010

First Posted (Estimate)

May 25, 2010

Study Record Updates

Last Update Posted (Estimate)

May 25, 2010

Last Update Submitted That Met QC Criteria

May 24, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 09-132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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