Clinical trial NCT00884130: Cost Effectiveness of Laparoscopic Colorectal Surgery
Official title: Cost Effectiveness of Laparoscopic Colorectal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Surgery
Keywords: Laparoscopy
Colorectal surgery
Quality of life
economic analysis
Patients undergoing laparoscopic colorectal surgery
Lead sponsor: University of Surrey
Sponsor class: OTHER
Collaborators: name: Minimal Access Therapy Training Unit
name: Ethicon Endo-Surgery (Europe) GmbH
First posted: 2009-04-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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:

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.


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

Primary outcomes:
measure: The cost effectiveness of laparoscopic colorectal surgery
timeFrame: 6 weeks
Secondary outcomes:
measure: Costs of laparoscopic and open colorectal surgery
timeFrame: 6 weeks
measure: Quality of life of patients having laparoscopic and open colorectal surgery
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
state: Surrey
Study officials:
affiliation: Minimal Access Therapy Training Unit
name: Henry m Dowson, MBBS FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Minimal Access Therapy Training Unit
name: Timothy Rockall, MBBS FRCS
role: STUDY_CHAIR
References: