Cost Effectiveness of Laparoscopic Colorectal Surgery

This study has been completed.
Sponsor:
Collaborators:
Minimal Access Therapy Training Unit
Ethicon Endo-Surgery (Europe) GmbH
Information provided by:
University of Surrey
ClinicalTrials.gov Identifier:
NCT00884130
First received: April 16, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Colorectal Surgery
Procedure: laparoscopic colorectal resection
Procedure: open colorectal resection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cost Effectiveness of Laparoscopic Colorectal Surgery

Further study details as provided by University of Surrey:

Primary Outcome Measures:
  • The cost effectiveness of laparoscopic colorectal surgery [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Costs of laparoscopic and open colorectal surgery [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Quality of life of patients having laparoscopic and open colorectal surgery [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: January 2006
Study Completion Date: October 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Laparoscopic
Patients having a laparoscopic colorectal resection
Procedure: laparoscopic colorectal resection
Open
Patients having an open colorectal resection
Procedure: open colorectal resection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884130

Locations
United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom, GU2 7XX
Sponsors and Collaborators
University of Surrey
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
  More Information

No publications provided

Responsible Party: Alison Sawyer, Postgraduate Medical School, University of Surrey
ClinicalTrials.gov Identifier: NCT00884130     History of Changes
Other Study ID Numbers: 05/Q1909/74
Study First Received: April 16, 2009
Last Updated: April 16, 2009
Health Authority: United Kingdom: Royal Surrey County Hospital, Research & Development Team

Keywords provided by University of Surrey:
Laparoscopy
Colorectal surgery
Quality of life
economic analysis
Patients undergoing laparoscopic colorectal surgery

ClinicalTrials.gov processed this record on October 23, 2014