Randomized Trial on Robotic Assisted Resection for Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

Randomized Controlled Trial Comparing the Bladder and Sexual Functions of Patients Who Undergo Laparoscopic and Robotic Assisted Resection for Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01130233
• Other study ID #: UW 09-132
• Status: Recruiting
• Phase: Phase 3
• First received: May 24, 2010
• Last updated: May 24, 2010
• Start date: June 2009
• Est. completion date: December 2014

Study information

• Verified date: May 2010
• Source: The University of Hong Kong
• Contact: Wai Lun Law, MBBS, MS
• Phone: +852 22554763
• Email: lawwl[@]hkucc.hku.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Institutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• robotic assisted rectal resection
robotic assisted rectal resection
• laparoscopic rectal resection
laparoscopic rectal resection

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder function	Urodynamic Questionnaire	one year	No
Secondary	tumor status	recurrence and survival	One year	No
Secondary	Quality of life	Questionnaire	one year	No