Randomized Trial on Robotic Assisted Resection for Rectal Cancer

Phase 3

• Conditions: Rectal Cancer; Adenocarcinoma
• Interventions: Procedure: robotic assisted rectal resection; Procedure: laparoscopic rectal resection

• Registration Number: NCT01130233
• Lead Sponsor: The University of Hong Kong

Brief 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

Study Timeline

• Study Start: 2009-06
• Status Verified: 2010-05
• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-05-24
• Last Update Submitted: 2010-05-24
• Study First Posted: 2010-05-25
• Last Update Posted: 2010-05-25
• Primary Completion: 2014-06
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
robotic	robotic assisted rectal resection	robotic assisted rectal resection
laparoscopic	laparoscopic rectal resection	laparoscopic rectal resection

Primary Outcome Measures

Name	Time	Method
Bladder function	one year	Urodynamic Questionnaire

Secondary Outcome Measures

Name	Time	Method
tumor status	One year	recurrence and survival
Quality of life	one year	Questionnaire

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong