Randomized Trial on Robotic Assisted Resection for Rectal Cancer

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01130233

Enrollment

Registered

2010-05-25

Start date

2009-06-30

Completion date

2014-12-31

Last updated

2010-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma, Rectal Cancer

Keywords

rectal cancer

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

Interventions

PROCEDURErobotic assisted rectal resection

robotic assisted rectal resection

PROCEDURElaparoscopic rectal resection

laparoscopic rectal resection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Bladder function	one year	Urodynamic Questionnaire

Secondary

Measure	Time frame	Description
tumor status	One year	recurrence and survival
Quality of life	one year	Questionnaire

Countries

Hong Kong

Contacts

Primary ContactWai Lun Law, MBBS, MS

lawwl@hkucc.hku.hk+852 22554763

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026