Cost Effectiveness of Laparoscopic Colorectal Surgery

NCT ID: NCT00884130

Last Updated: 2009-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Laparoscopic

Patients having a laparoscopic colorectal resection

laparoscopic colorectal resection

Intervention Type PROCEDURE

Open

Patients having an open colorectal resection

open colorectal resection

Intervention Type PROCEDURE

Interventions

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laparoscopic colorectal resection

Intervention Type PROCEDURE

open colorectal resection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minimal Access Therapy Training Unit

OTHER

Sponsor Role collaborator

Ethicon Endo-Surgery (Europe) GmbH

INDUSTRY

Sponsor Role collaborator

University of Surrey

OTHER

Sponsor Role lead

Responsible Party

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Postgraduate Medical School, University of Surrey

Principal Investigators

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Henry m Dowson, MBBS FRCS

Role: PRINCIPAL_INVESTIGATOR

Minimal Access Therapy Training Unit

Timothy Rockall, MBBS FRCS

Role: STUDY_CHAIR

Minimal Access Therapy Training Unit

Locations

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Royal Surrey County Hospital

Guildford, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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05/Q1909/74

Identifier Type: -

Identifier Source: org_study_id

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