Laparoscopic Versus Open Left Colonic Resection | NCT00894725

Studies
Laparoscopic Versus Open Left Colonic Resection

NCT00894725

Sponsor

Università Vita-Salute San Raffaele

Status

Completed

Last Update Posted

May 7, 2009Estimated

Enrollment

268Actual

Phase

Phase 3

Conditions

Colon Cancer
Benign Disease

Interventions

laparoscopic left colonic resection
open left colonic resection

Countries

Italy

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

May 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

Feb 2000

Primary Completion Date

Dec 2004Actual

Completion Date

Dec 2008Actual

First Submitted Date

May 6, 2009

First Submission Date that Met QC Criteria

May 6, 2009

First Posted Date

May 7, 2009Estimated

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

May 6, 2009

Last Update Posted Date

May 7, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 main goal of this study is to clarify if laparoscopy (LPS) could become the standard approach in patients undergoing left colonic resection.

268 patient candidates to left colonic resection were randomly assigned to LPS (n=134) or open (n=134) approach. Postoperative care protocol was the same in both groups. Trained members of the surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital costs. Long-term morbidity, quality of life, and 5-year survival have also been evaluated.

Detailed Description

The study design was explained to the potential participants who were asked to sign a written informed consent before randomization.

Eligible patients were randomly allocated to LPS or open surgery. Randomization list was computer generated. Assignments were made by means of sealed sequenced masked envelopes which were opened, before the induction of anesthesia, by a nurse unaware of the trial design.

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

268Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LPS	Experimental	laparoscopic left colonic resection	Procedure: laparoscopic left colonic resection
Open	Active Comparator	open left colonic resection	Procedure: open left colonic resection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laparoscopic left colonic resection	Procedure	laparoscopic colonic resection	LPS

Measure	Description	Time Frame
short-term morbidity rate		30 days

Measure	Description	Time Frame
long-term outcome		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > 18 years
suitability to elective surgery

Exclusion Criteria:

cancer infiltrating adjacent organs assessed by computed tomography
cardiovascular dysfunction (New York Heart Association class > 3)
respiratory dysfunction (arterial pO2 < 70 mmHg)
hepatic dysfunction (Child-Pugh class C)
ongoing infection
plasma neutrophil level < 2.0x109/L

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marco Braga, MD	San Raffaele Vita-Salute University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Raffaele Hospital, Surgical Department		Milan		20132	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20602506	Derived	Braga M, Frasson M, Zuliani W, Vignali A, Pecorelli N, Di Carlo V. Randomized clinical trial of laparoscopic versus open left colonic resection. Br J Surg. 2010 Aug;97(8):1180-6. doi: 10.1002/bjs.7094.

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