Cost Effectiveness of Laparoscopic Colorectal Surgery | NCT00884130

Studies
Cost Effectiveness of Laparoscopic Colorectal Surgery

NCT00884130

Sponsor

University of Surrey

Status

Completed

Last Update Posted

Apr 20, 2009Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Colorectal Surgery

Interventions

laparoscopic colorectal resection
open colorectal resection

Countries

United Kingdom

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

Apr 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

Jan 2006

Primary Completion Date

Aug 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Apr 16, 2009

First Submission Date that Met QC Criteria

Apr 16, 2009

First Posted Date

Apr 20, 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

Apr 16, 2009

Last Update Posted Date

Apr 20, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of SurreyOTHER

Collaborators

Name	Class
Minimal Access Therapy Training Unit	OTHER
Ethicon Endo-Surgery (Europe) GmbH	INDUSTRY

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

Hypothesis: The total costs of laparoscopic colorectal surgery are less than those of open surgery.

Secondary hypothesis: Patients quality of life is higher following laparoscopic surgery, as compared to open colorectal surgery.

Research objectives:

To estimate the cost implications and clinical benefits of incorporating laparoscopic colorectal surgery into routine clinical practice.
To examine whether the increased operative costs of laparoscopic surgery are compensated for by a faster recovery, shorter duration of hospital stay, and a reduction in late complications, as compared to open surgery.
To investigate whether there are differences in quality of life following laparoscopic colorectal surgery as compared to open surgery.

Lay summary:

Patients needing an operation for a bowel problem have traditionally had an open operation with an incision on the abdomen, and this is the type of operation that is currently performed in the majority of cases in the United Kingdom today (over 90%). Laparoscopic (or keyhole) surgery has been introduced into bowel surgery, but is currently not widely performed. This is because thus far there have been no clear-cut benefits demonstrated with this technique and the perceived costs are higher than an open operation. The investigators aim to evaluate both of these issues.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laparoscopic		Patients having a laparoscopic colorectal resection	Procedure: laparoscopic colorectal resection
Open		Patients having an open colorectal resection	Procedure: open colorectal resection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laparoscopic colorectal resection	Procedure		Laparoscopic
open colorectal resection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The cost effectiveness of laparoscopic colorectal surgery		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Costs of laparoscopic and open colorectal surgery		6 weeks
Quality of life of patients having laparoscopic and open colorectal surgery		6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients having a colorectal resection, including benign and malignant tumours, inflammatory bowel disease, diverticular disease, and endometriosis

Exclusion Criteria:

Children
Emergency procedures
Patients unable to consent, unable to complete a quality of life diary

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

All patients requiring a colorectal resection between January 2006 and August 2007 at The Royal Surrey County Hospital, UK.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henry m Dowson, MBBS FRCS	Minimal Access Therapy Training Unit	Principal Investigator
Timothy Rockall, MBBS FRCS	Minimal Access Therapy Training Unit	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Surrey County Hospital		Guildford	Surrey	GU2 7XX	United Kingdom