Colorectal CancerPhase 1/2NCT01626963
Single-port Versus Conventional Laparoscopic Colorectal Surgery
A Phase 1/2 study testing Single-port access surgery and Conventional Laparoscopic Access in people with Colorectal Cancer and Inflammatory Bowel Disease, run by North Tees and Hartlepool NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Conventional multi-port laparoscopic surgery (CL) is now a standard approach to colorectal resections, due to it's short-term benefits over conventional open surgery. In recent years, several studies have demonstrated that - in suitable patients - single-port access surgery (SPA) has similar clinical outcome compared… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Inflammatory Bowel Disease, Benign Colorectal Neoplasm
- What is being tested?
- Single-port access surgery and Conventional Laparoscopic Access
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Dec 2016
- Phase
- Phase 1/2
- 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
Who may be able to join
- large bowel disorder requiring surgical resection
- body habitus suitable for single-port access surgery
Who cannot join
- patients not capable of informed consent and/or quality of life assessment
- planned open procedure for surgical reason
- multiple previous abdominal operations
- body-mass index > 40
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital North Tees
Stockton-on-Tees, TS19 8PE
David W Borowski, MD FRCSEd, 0044 6142 624078, david.borowski@nth.nhs.uk
Talvinder S Gill, MS FRCS, 0044 1642 617617 ext. 3136, talvinder.gill@nth.nhs.uk
About this study
Official title: Randomised-controlled Trial on the Immune Response to Single-port Access Versus Conventional Laparoscopic Colorectal Surgery
Conventional multi-port laparoscopic surgery (CL) is now a standard approach to colorectal resections, due to it's short-term benefits over conventional open surgery. In recent years, several studies have demonstrated that - in suitable patients - single-port access surgery (SPA) has similar clinical outcome compared to CL, with additional cosmetic benefits. It remains, however, unclear whether the trauma of surgery is also less for SPA compared to CL.
In this study, the investigators aim to randomise patients who are deemed suitable for SPA surgery to either SPA approach, or CL; in addition to clinical outcomes including length of operating time, post-operative pain scores, complications, quality of life indicators and cosmetic appearance, the investigators aim to compare the physiological response to trauma through biochemical markers (including C-reactive protein, White Blood Cell count) and cytokine expression (i.e. Interleukins IL-6 and IL-8). Patients will be analysed according to intention-to-treat analysis, with 25 patients in the SPA and 25 patients in the CL group. The patients will be operated by surgeons proficient in both CL and SPA surgery, and followed-up for the duration of their hospitalisation as well as at their routine out-patient visits, using questionnaires.
- Conditions
- Colorectal Cancer, Inflammatory Bowel Disease, Benign Colorectal Neoplasm, Diverticular Disease
- Being tested
- Single-port access surgery, Conventional Laparoscopic Access
- Keywords
- single-port access, laparoscopic surgery, surgical trauma
- Medical subject headings
- Colorectal Neoplasms, Inflammatory Bowel Diseases, Diverticular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-port access surgeryProcedure or surgery
Surgery carried out through a single incision laparoscopic approach
Conventional Laparoscopic AccessProcedure or surgery
Surgery through standard multiport laparoscopic approach
| Study group | Role | What they receive |
|---|---|---|
| SPA | Experimental | Single-port access surgery Receives: Procedure: Single-port access surgery |
| CL | Active comparator | Conventional Laparoscopic access Receives: Procedure: Conventional Laparoscopic Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
Operative Time
Measured: assessment of electronic records at 30 days from surgery
Secondary outcomes (10)
Pain scores
Pain scores on visual Analog Scale
Measured: change from baseline at 1,2,3,4 and 5 days from surgery
Complication / Conversion-to-open-surgery rates
Complication / Conversion-to-open-surgery rates
Measured: assessment at 30 days post-op
Quality of Life indicators
Quality of Life indicators
Measured: change from baseline at 2, 4 weeks, & 3 months after surgery
Cosmetic appearance
Body-Image scale
Measured: change from baseline at 2, 4 weeks and three months after surgery
Cost comparison
Assessment of overall cost, including theatre time, disposable equipment and length of hospital stay
Measured: assessment at the end of the study, up to 2 years post-op
LoS
Length of hospital stay
Measured: assessment at 30 days from surgery
IL-6
Immune response to tissue trauma (Interleukin-6)
Measured: change from baseline at 2,6,24 and 72 hours from surgery
IL-8
Interleukin-8
Measured: change from baseline at 2,6,24 and 72 hours from surgery
WBCC
White Blood Cell Count
Measured: change from baseline at 2,6,24 and 72 hours from surgery
CRP
C-reactive Protein
Measured: change from baseline at 2,6,24 and 72 hours from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startJan 2014
- Primary completionJul 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Tees and Hartlepool NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David W Borowski, North Tees and Hartlepool NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626963
- Sponsor's protocol ID
- SUR-089
- Status last verified
- Mar 2016
- First submitted
- 18 Jun 2012
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised-controlled Trial on the Immune Response to Single-port Access Versus Conventional Laparoscopic Colorectal Surgery
- ClinicalTrials.gov ID
- NCT01626963
- Acronym / sponsor ID
- SUR-089
- Conditions
- Colorectal Cancer, Inflammatory Bowel Disease, Benign Colorectal Neoplasm, Diverticular Disease
- Keywords
- single-port access, laparoscopic surgery, surgical trauma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- North Tees and Hartlepool NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 Jun 2012 (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.
Conventional multi-port laparoscopic surgery (CL) is now a standard approach to colorectal resections, due to it's short-term benefits over conventional open surgery. In recent years, several studies have demonstrated that - in suitable patients - single-port access surgery (SPA) has similar clinical outcome compared to CL, with additional cosmetic benefits. It remains, however, unclear whether the trauma of surgery is also less for SPA compared to CL.
In this study, the investigators aim to randomise patients who are deemed suitable for SPA surgery to either SPA approach, or CL; in addition to clinical outcomes including length of operating time, post-operative pain scores, complications, quality of life indicators and cosmetic appearance, the investigators aim to compare the physiological response to trauma through biochemical markers (including C-reactive protein, White Blood Cell count) and cytokine expression (i.e. Interleukins IL-6 and IL-8). Patients will be analysed according to intention-to-treat analysis, with 25 patients in the SPA and 25 patients in the CL group. The patients will be operated by surgeons proficient in both CL and SPA surgery, and followed-up for the duration of their hospitalisation as well as at their routine out-patient visits, using questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPA | Experimental | Procedure: Single-port access surgerySingle-port access surgery |
| CL | Active comparator | Procedure: Conventional Laparoscopic AccessConventional Laparoscopic access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- large bowel disorder requiring surgical resection
- body habitus suitable for single-port access surgery
Key exclusion criteria (4 listed)
- patients not capable of informed consent and/or quality of life assessment
- planned open procedure for surgical reason
- multiple previous abdominal operations
- body-mass index > 40
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 |
|---|---|---|
| Single-port access surgerySurgery carried out through a single incision laparoscopic approach | Procedure or surgery | SPA |
| Conventional Laparoscopic AccessSurgery through standard multiport laparoscopic approach | Procedure or surgery | CL |
Primary outcome
Operative Time
Time frame: assessment of electronic records at 30 days from surgery
Operative Time
10 secondary outcomes
Pain scores
Time frame: change from baseline at 1,2,3,4 and 5 days from surgery
Complication / Conversion-to-open-surgery rates
Time frame: assessment at 30 days post-op
Quality of Life indicators
Time frame: change from baseline at 2, 4 weeks, & 3 months after surgery
Cosmetic appearance
Time frame: change from baseline at 2, 4 weeks and three months after surgery
Cost comparison
Time frame: assessment at the end of the study, up to 2 years post-op
LoS
Time frame: assessment at 30 days from surgery
IL-6
Time frame: change from baseline at 2,6,24 and 72 hours from surgery
IL-8
Time frame: change from baseline at 2,6,24 and 72 hours from surgery
WBCC
Time frame: change from baseline at 2,6,24 and 72 hours from surgery
CRP
Time frame: change from baseline at 2,6,24 and 72 hours from surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Single-port access surgery and Conventional Laparoscopic Access in people with Colorectal Cancer and Inflammatory Bowel Disease, run by North Tees and Hartlepool NHS Foundation Trust 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Mar 2016. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David W Borowski, MD FRCSEd (0044 1642 624078, david.borowski@nth.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative Time (time frame: assessment of electronic records at 30 days from surgery). 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 24 Mar 2016.