Cost Effectiveness of Laparoscopic Colorectal Surgery

Colorectal Surgery Clinical Trial

Official title:

Cost Effectiveness of Laparoscopic Colorectal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884130
• Other study ID #: 05/Q1909/74
• Status: Completed
• Phase: N/A
• First received: April 16, 2009
• Last updated: April 16, 2009
• Start date: January 2006
• Est. completion date: October 2007

Study information

• Verified date: April 2009
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Royal Surrey County Hospital, Research & Development Team
• Study type: Observational

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Surgery

Intervention

Procedure:
• laparoscopic colorectal resection

• open colorectal resection

Locations

Country	Name	City	State
United Kingdom	Royal Surrey County Hospital	Guildford	Surrey

Sponsors (3)

Lead Sponsor	Collaborator
University of Surrey	Ethicon Endo-Surgery (Europe) GmbH, Minimal Access Therapy Training Unit

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cost effectiveness of laparoscopic colorectal surgery		6 weeks	No
Secondary	Costs of laparoscopic and open colorectal surgery		6 weeks	No
Secondary	Quality of life of patients having laparoscopic and open colorectal surgery		6 weeks	No