Colorectal SurgeryNCT00884130
Cost Effectiveness of Laparoscopic Colorectal Surgery
An observational study of Colorectal Surgery, run by University of Surrey at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- laparoscopic colorectal resection and open colorectal resection
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2006to Oct 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients requiring a colorectal resection between January 2006 and August 2007 at The Royal Surrey County Hospital, UK.
Who may be able to join
- All patients having a colorectal resection, including benign and malignant tumours, inflammatory bowel disease, diverticular disease, and endometriosis
Who cannot join
- Children
- Emergency procedures
- Patients unable to consent, unable to complete a quality of life diary
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX
About this study
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.
Read more
Research objectives:
- To estimate the cost implications and clinical benefits of incorporating laparoscopic colorectal surgery into routine clinical practice.
- 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.
- 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.
- Conditions
- Colorectal Surgery
- Being tested
- laparoscopic colorectal resection, open colorectal resection
- Keywords
- Laparoscopy, Colorectal surgery, Quality of life, economic analysis, Patients undergoing laparoscopic colorectal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic colorectal resectionProcedure or surgery
open colorectal resectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic | Patients having a laparoscopic colorectal resection Receives: Procedure: laparoscopic colorectal resection | |
| Open | Patients having an open colorectal resection Receives: Procedure: open colorectal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cost effectiveness of laparoscopic colorectal surgery
Measured: 6 weeks
Secondary outcomes (2)
Costs of laparoscopic and open colorectal surgery
Measured: 6 weeks
Quality of life of patients having laparoscopic and open colorectal surgery
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startJan 2006
- Primary completionAug 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- Minimal Access Therapy Training Unit, Ethicon Endo-Surgery (Europe) GmbH
- Investigators
- Henry m Dowson, MBBS FRCS, Principal investigator, Minimal Access Therapy Training UnitTimothy Rockall, MBBS FRCS, Study chair, Minimal Access Therapy Training Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884130
- Sponsor's protocol ID
- 05/Q1909/74
- Status last verified
- Apr 2009
- First submitted
- 16 Apr 2009
- Last updated
- 20 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Effectiveness of Laparoscopic Colorectal Surgery
- ClinicalTrials.gov ID
- NCT00884130
- Acronym / sponsor ID
- 05/Q1909/74
- Conditions
- Colorectal Surgery
- Keywords
- Laparoscopy, Colorectal surgery, Quality of life, economic analysis, Patients undergoing laparoscopic colorectal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- Minimal Access Therapy Training Unit, Ethicon Endo-Surgery (Europe) GmbH
- Study start
- Jan 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 20 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To estimate the cost implications and clinical benefits of incorporating laparoscopic colorectal surgery into routine clinical practice.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic | – | Procedure: laparoscopic colorectal resectionPatients having a laparoscopic colorectal resection |
| Open | – | Procedure: open colorectal resectionPatients having an open colorectal resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients requiring a colorectal resection between January 2006 and August 2007 at The Royal Surrey County Hospital, UK.
Key inclusion criteria (1 listed)
- All patients having a colorectal resection, including benign and malignant tumours, inflammatory bowel disease, diverticular disease, and endometriosis
Key exclusion criteria (3 listed)
- Children
- Emergency procedures
- Patients unable to consent, unable to complete a quality of life diary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic colorectal resection | Procedure or surgery | Laparoscopic |
| open colorectal resection | Procedure or surgery | Open |
Primary outcome
The cost effectiveness of laparoscopic colorectal surgery
Time frame: 6 weeks
2 secondary outcomes
Costs of laparoscopic and open colorectal surgery
Time frame: 6 weeks
Quality of life of patients having laparoscopic and open colorectal surgery
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry m Dowson, MBBS FRCS principal investigator
Minimal Access Therapy Training Unit
Timothy Rockall, MBBS FRCS study chair
Minimal Access Therapy Training Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Surgery, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cost effectiveness of laparoscopic colorectal surgery (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2009.