NCT00485316

Brief Summary

The aim of the investigators' randomized trial is to compare the short-term clinical outcome and survival between laparoscopic-assisted and open resection of colorectal carcinoma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 1993

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 1993

Completed
13.8 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

March 31, 2009

Status Verified

March 1, 2009

Enrollment Period

15.1 years

First QC Date

June 11, 2007

Last Update Submit

March 30, 2009

Conditions

Colorectal Carcinoma

Keywords

Colorectal carcinomaRectal carcinomaLaparoscopyLaparoscopic surgeryOpen surgeryRandomized trial

Outcome Measures

Primary Outcomes (1)

  • Overall survival and disease-free survival

Secondary Outcomes (8)

  • Operative time

  • Blood loss

  • Postoperative analgesic requirements

  • Recovery of gastrointestinal function (time to resume normal diet, time first passing flatus, time of first bowel motion)

  • Time to walk independently

  • +3 more secondary outcomes

Interventions

Laparoscopic assisted resection of colorectal carcinomaPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed to have colorectal carcinoma at all locations except transverse colon
  • Informed consent available

You may not qualify if:

  • Patients with tumor \>6 cm in size, or with tumor infiltration to adjacent organs on imagings
  • Patients with previous abdominal surgery near the region of the colorectal surgery
  • Patients with intestinal obstruction or perforation
  • Patients with recurrent disease
  • Patients with synchronous colorectal carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong SAR, China

Location

Related Publications (2)

  • Ng SS, Lee JF, Yiu RY, Li JC, Hon SS, Mak TW, Ngo DK, Leung WW, Leung KL. Laparoscopic-assisted versus open total mesorectal excision with anal sphincter preservation for mid and low rectal cancer: a prospective, randomized trial. Surg Endosc. 2014 Jan;28(1):297-306. doi: 10.1007/s00464-013-3187-x. Epub 2013 Sep 7.

    PMID: 24013470DERIVED

  • Li JC, Leung KL, Ng SS, Liu SY, Lee JF, Hon SS. Laparoscopic-assisted versus open resection of right-sided colonic cancer--a prospective randomized controlled trial. Int J Colorectal Dis. 2012 Jan;27(1):95-102. doi: 10.1007/s00384-011-1294-5. Epub 2011 Aug 23.

    PMID: 21861071DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Ka Lau Leung, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

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

June 11, 2007

First Posted

June 12, 2007

Study Start

September 1, 1993

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

March 31, 2009

Record last verified: 2009-03

Locations

CN(1)