Cost Effectiveness of Laparoscopic Colorectal Surgery

April 16, 2009 updated by: University of Surrey

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:

  1. To estimate the cost implications and clinical benefits of incorporating laparoscopic colorectal surgery into routine clinical practice.
  2. 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.
  3. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Laparoscopic
Patients having a laparoscopic colorectal resection
Procedure: laparoscopic colorectal resection
Open
Patients having an open colorectal resection
Procedure: open colorectal resection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Surrey

Collaborators

Minimal Access Therapy Training Unit
Ethicon Endo-Surgery (Europe) GmbH

Investigators

  • Principal Investigator: Henry m Dowson, MBBS FRCS, Minimal Access Therapy Training Unit
  • Study Chair: Timothy Rockall, MBBS FRCS, Minimal Access Therapy Training Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

April 16, 2009

First Submitted That Met QC Criteria

April 16, 2009

First Posted (Estimate)

April 20, 2009

Study Record Updates

Last Update Posted (Estimate)

April 20, 2009

Last Update Submitted That Met QC Criteria

April 16, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 05/Q1909/74

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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