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Single-port Versus Conventional Laparoscopic Colorectal Surgery

Primary Purpose

Colorectal Cancer, Inflammatory Bowel Disease, Benign Colorectal Neoplasm

Status
Unknown status
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Single-port access surgery
Conventional Laparoscopic Access
Sponsored by
North Tees and Hartlepool NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring single-port access, laparoscopic surgery, surgical trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • large bowel disorder requiring surgical resection
  • body habitus suitable for single-port access surgery

Exclusion Criteria:

  • 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

Sites / Locations

  • University Hospital North TeesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SPA

CL

Arm Description

Single-port access surgery

Conventional Laparoscopic access

Outcomes

Primary Outcome Measures

Operative Time
Operative Time

Secondary Outcome Measures

Pain scores
Pain scores on visual Analog Scale
Complication / Conversion-to-open-surgery rates
Complication / Conversion-to-open-surgery rates
Quality of Life indicators
Quality of Life indicators
Cosmetic appearance
Body-Image scale
Cost comparison
Assessment of overall cost, including theatre time, disposable equipment and length of hospital stay
LoS
Length of hospital stay
IL-6
Immune response to tissue trauma (Interleukin-6)
IL-8
Interleukin-8
WBCC
White Blood Cell Count
CRP
C-reactive Protein

Full Information

First Posted
June 18, 2012
Last Updated
March 22, 2016
Sponsor
North Tees and Hartlepool NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01626963
Brief Title
Single-port Versus Conventional Laparoscopic Colorectal Surgery
Official Title
Randomised-controlled Trial on the Immune Response to Single-port Access Versus Conventional Laparoscopic Colorectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Tees and Hartlepool NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Inflammatory Bowel Disease, Benign Colorectal Neoplasm, Diverticular Disease
Keywords
single-port access, laparoscopic surgery, surgical trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SPA
Arm Type
Experimental
Arm Description
Single-port access surgery
Arm Title
CL
Arm Type
Active Comparator
Arm Description
Conventional Laparoscopic access
Intervention Type
Procedure
Intervention Name(s)
Single-port access surgery
Intervention Description
Surgery carried out through a single incision laparoscopic approach
Intervention Type
Procedure
Intervention Name(s)
Conventional Laparoscopic Access
Intervention Description
Surgery through standard multiport laparoscopic approach
Primary Outcome Measure Information:
Title
Operative Time
Description
Operative Time
Time Frame
assessment of electronic records at 30 days from surgery
Secondary Outcome Measure Information:
Title
Pain scores
Description
Pain scores on visual Analog Scale
Time Frame
change from baseline at 1,2,3,4 and 5 days from surgery
Title
Complication / Conversion-to-open-surgery rates
Description
Complication / Conversion-to-open-surgery rates
Time Frame
assessment at 30 days post-op
Title
Quality of Life indicators
Description
Quality of Life indicators
Time Frame
change from baseline at 2, 4 weeks, & 3 months after surgery
Title
Cosmetic appearance
Description
Body-Image scale
Time Frame
change from baseline at 2, 4 weeks and three months after surgery
Title
Cost comparison
Description
Assessment of overall cost, including theatre time, disposable equipment and length of hospital stay
Time Frame
assessment at the end of the study, up to 2 years post-op
Title
LoS
Description
Length of hospital stay
Time Frame
assessment at 30 days from surgery
Title
IL-6
Description
Immune response to tissue trauma (Interleukin-6)
Time Frame
change from baseline at 2,6,24 and 72 hours from surgery
Title
IL-8
Description
Interleukin-8
Time Frame
change from baseline at 2,6,24 and 72 hours from surgery
Title
WBCC
Description
White Blood Cell Count
Time Frame
change from baseline at 2,6,24 and 72 hours from surgery
Title
CRP
Description
C-reactive Protein
Time Frame
change from baseline at 2,6,24 and 72 hours from surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: large bowel disorder requiring surgical resection body habitus suitable for single-port access surgery Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David W Borowski, MD FRCSEd
Phone
0044 1642 624078
Email
david.borowski@nth.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Talvinder S Gill, MS FRCS
Phone
0044 1642 617617
Ext
3136
Email
talvinder.gill@nth.nhs.uk
Facility Information:
Facility Name
University Hospital North Tees
City
Stockton on Tees
ZIP/Postal Code
TS19 8PE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David W Borowski, MD FRCSEd
Phone
0044 6142 624078
Email
david.borowski@nth.nhs.uk
First Name & Middle Initial & Last Name & Degree
Talvinder S Gill, MS FRCS
Phone
0044 1642 617617
Ext
3136
Email
talvinder.gill@nth.nhs.uk

12. IPD Sharing Statement

Learn more about this trial

Single-port Versus Conventional Laparoscopic Colorectal Surgery

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