Laparoscopic Assisted Versus Open Resection for Colorecta... | NCT00485316

Studies
Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma

NCT00485316

Sponsor

Chinese University of Hong Kong

Status

Completed

Last Update Posted

Mar 31, 2009Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Colorectal Carcinoma

Interventions

Laparoscopic assisted resection of colorectal carcinoma

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1993

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Jun 11, 2007

First Submission Date that Met QC Criteria

Jun 11, 2007

First Posted Date

Jun 12, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2009

Last Update Posted Date

Mar 31, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Since the introduction of laparoscopic cholecystectomy in 1987, laparoscopic surgery has been attempted and applied to many surgical operations. Surgeons in Hong Kong began to perform laparoscopic surgery for colorectal carcinoma in early 1992. Early reports of laparoscopic surgery for colorectal carcinoma from Hong Kong and worldwide suggested better short-term clinical outcomes when compared with open surgery, but there were concerns over port site metastases and adequacy of long-term oncological clearance. Besides, only a few randomized trials thus far have compared laparoscopic-assisted and open surgery for rectal carcinoma.

The aim of our randomized trial is to compare the short-term clinical outcome and survival between laparoscopic-assisted and open resection of colonic and rectal carcinoma.

Patients will undergo different types of surgery according to the location of the tumors: right or extended right hemicolectomy for cecal, ascending colon, or hepatic flexure tumors; left hemicolectomy for descending colon tumors; sigmoid colectomy for sigmoid colon tumors; anterior resection for rectosigmoid or upper rectal tumors; low anterior resection with total mesorectal excision for mid- and low rectal tumors; abdominoperineal resection for very low rectal tumors. Patients will be randomly allocated to laparoscopic assisted or conventional open surgery.

Short-term clinical outcome and long-term survival data will be prospectively recorded and compared between the two treatment arms.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic assisted resection of colorectal carcinoma	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival and disease-free survival

Secondary Outcomes

Measure	Description	Time Frame
Operative time
Blood loss
Postoperative analgesic requirements

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ka Lau Leung, MD	Chinese University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Wales Hospital		Hong Kong SAR			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24013470	Derived	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.
21861071	Derived

ID	Term
D015179	Colorectal Neoplasms
D012004	Rectal Neoplasms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site