NCT00884130

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. 1.To estimate the cost implications and clinical benefits of incorporating laparoscopic colorectal surgery into routine clinical practice.
  2. 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. 3.To investigate whether there are differences in quality of life following laparoscopic colorectal surgery as compared to open surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2009

Completed
Last Updated

April 20, 2009

Status Verified

April 1, 2009

Enrollment Period

1.6 years

First QC Date

April 16, 2009

Last Update Submit

April 16, 2009

Conditions

Colorectal Surgery

Keywords

LaparoscopyColorectal surgeryQuality of lifeeconomic analysisPatients undergoing laparoscopic colorectal surgery

Outcome Measures

Primary Outcomes (1)

  • The cost effectiveness of laparoscopic colorectal surgery

    6 weeks

Secondary Outcomes (2)

  • Costs of laparoscopic and open colorectal surgery

    6 weeks

  • Quality of life of patients having laparoscopic and open colorectal surgery

    6 weeks

Study Arms (2)

Laparoscopic

Patients having a laparoscopic colorectal resection

Procedure: laparoscopic colorectal resection

Open

Patients having an open colorectal resection

Procedure: open colorectal resection

Interventions

laparoscopic colorectal resectionPROCEDURE
Laparoscopic
open colorectal resectionPROCEDURE
Open

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All patients having a colorectal resection, including benign and malignant tumours, inflammatory bowel disease, diverticular disease, and endometriosis

You may not qualify if:

  • Children
  • Emergency procedures
  • Patients unable to consent, unable to complete a quality of life diary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Surrey County Hospital

Guildford, Surrey, GU2 7XX, United Kingdom

Location

Study Officials

  • Henry m Dowson, MBBS FRCS

    Minimal Access Therapy Training Unit

    PRINCIPAL INVESTIGATOR

  • Timothy Rockall, MBBS FRCS

    Minimal Access Therapy Training Unit

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 16, 2009

First Posted

April 20, 2009

Study Start

January 1, 2006

Primary Completion

August 1, 2007

Study Completion

October 1, 2007

Last Updated

April 20, 2009

Record last verified: 2009-04

Locations

GB(1)