Single-port Versus Conventional Laparoscopic Colorectal Surgery
NCT ID: NCT01626963
Last Updated: 2016-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2014-01-31
2016-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SPA
Single-port access surgery
Single-port access surgery
Surgery carried out through a single incision laparoscopic approach
CL
Conventional Laparoscopic access
Conventional Laparoscopic Access
Surgery through standard multiport laparoscopic approach
Interventions
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Single-port access surgery
Surgery carried out through a single incision laparoscopic approach
Conventional Laparoscopic Access
Surgery through standard multiport laparoscopic approach
Eligibility Criteria
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Inclusion Criteria
* body habitus suitable for single-port access surgery
Exclusion Criteria
* planned open procedure for surgical reason
* multiple previous abdominal operations
* body-mass index \> 40
18 Years
ALL
No
Sponsors
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North Tees and Hartlepool NHS Foundation Trust
OTHER
Responsible Party
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David W Borowski
Consultant General and Colorectal Surgeon
Locations
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University Hospital North Tees
Stockton-on-Tees, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SUR-089
Identifier Type: -
Identifier Source: org_study_id
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