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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer, Adenocarcinoma

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Bladder function

Outcome Description:

Urodynamic Questionnaire

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Wai Lun Law, MBBS, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Hong Kong

Authority:

Hong Kong: Institutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster

Study ID:

UW 09-132

NCT ID:

NCT01130233

Start Date:

June 2009

Completion Date:

December 2014

Related Keywords:

  • Rectal Cancer
  • Adenocarcinoma
  • rectal cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Rectal Neoplasms

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