NCT01130233

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 25, 2010

Status Verified

May 1, 2010

Enrollment Period

5 years

First QC Date

May 24, 2010

Last Update Submit

May 24, 2010

Conditions

Rectal CancerAdenocarcinoma

Keywords

rectal cancer

Outcome Measures

Primary Outcomes (1)

  • Bladder function

    Urodynamic Questionnaire

    one year

Secondary Outcomes (2)

  • tumor status

    One year

  • Quality of life

    one year

Study Arms (2)

robotic

EXPERIMENTAL

robotic assisted rectal resection

Procedure: robotic assisted rectal resection

laparoscopic

ACTIVE COMPARATOR

laparoscopic rectal resection

Procedure: laparoscopic rectal resection

Interventions

robotic assisted rectal resectionPROCEDURE

robotic assisted rectal resection

robotic
laparoscopic rectal resectionPROCEDURE

laparoscopic rectal resection

laparoscopic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven new case of rectal cancer with the lower border within 15 cm from anal verge
  • Age \>18 years
  • Informed consent obtained
  • American Society of Anesthesiologist class 1-3
  • No contraindication to laparoscopic surgery
  • Acceptable operating risk

You may not qualify if:

  • Locally advanced fixed tumor with the need for exenterative surgery
  • Severe cardiac or pulmonary comorbidity rendering pneumoperitoneum hazardous
  • Multiple previous operations with the anticipation of dense peritoneal adhesions
  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Rectal NeoplasmsAdenocarcinoma

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Wai Lun Law, MBBS, MS

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wai Lun Law, MBBS, MS

CONTACT

+852 22554763lawwl@hkucc.hku.hk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 24, 2010

First Posted

May 25, 2010

Study Start

June 1, 2009

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

May 25, 2010

Record last verified: 2010-05

Locations

HK(1)