Randomized Trial on Robotic Assisted Resection for Rectal Cancer
Conditions
Rectal Cancer - Adenocarcinoma
Conditions: official terms
Adenocarcinoma - Rectal Neoplasms
Conditions: Keywords
rectal cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: robotic assisted rectal resection Type: Procedure
Name: laparoscopic rectal resection Type: Procedure
Overall Status
Recruiting
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.
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Queen Mary Hospital
Hong Kong, Hong Kong
Status: Recruiting
Contact: Wai Lun LAW, MBBS, MS - +852 22554763 - lawwl@hkucc.hku.hk
Start Date
June 2009
Completion Date
December 2014
Sponsors
The University of Hong Kong
Source
The University of Hong Kong
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page