Prospective Randomised Study Comparing Laparoscopic Versu... | NCT00782457

Studies
Prospective Randomised Study Comparing Laparoscopic Versus Open Surgery in Patients With Rectal Cancer

NCT00782457

Sponsor

Hospital Universitario Virgen de la Arrixaca

Status

Completed

Last Update Posted

Mar 18, 2015Estimated

Enrollment

200Estimated

Phase

Phase 3

Conditions

RECTAL CANCER

Interventions

RECTAL CANCER RESECTION

Countries

Not provided

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

Oct 2008

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

Jan 2002

Primary Completion Date

Feb 2007Actual

Completion Date

Dec 2010

First Submitted Date

Oct 29, 2008

First Submission Date that Met QC Criteria

Oct 29, 2008

First Posted Date

Oct 31, 2008Estimated

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 17, 2015

Last Update Posted Date

Mar 18, 2015Estimated

Description Module

Brief Summary

The aim of this study is to compare laparoscopic versus open approach on the surgical treatment of mid and low-lying rectal cancer, both performed by the same surgical team with experience in open colorectal surgery and advanced laparoscopic surgery, assessing preoperative and anatomopathological results and long-term outcome.

Detailed Description

Not provided

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OPEN SURGERY	Active Comparator		Procedure: RECTAL CANCER RESECTION
LAPAROSCOPIC SURGERY	Experimental		Procedure: RECTAL CANCER RESECTION

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RECTAL CANCER RESECTION	Procedure		LAPAROSCOPIC SURGERY OPEN SURGERY

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay		1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mid- and low-lying rectal cancer (between 0 and 11 cm from the anal margin)
Histology of adenocarcinoma

Exclusion Criteria:

Locally advanced disease (T4)
Emergency surgery
Rectal cancer over familial colic polyposis

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19644973	Derived	Lujan J, Valero G, Hernandez Q, Sanchez A, Frutos MD, Parrilla P. Randomized clinical trial comparing laparoscopic and open surgery in patients with rectal cancer. Br J Surg. 2009 Sep;96(9):982-9. doi: 10.1002/bjs.6662.

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms