Single-port Versus Conventional Laparoscopic Colorectal Surgery

NCT ID: NCT01626963

Last Updated: 2016-03-24

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Inflammatory Bowel Disease Benign Colorectal Neoplasm Diverticular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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SPA

Single-port access surgery

Group Type EXPERIMENTAL

Single-port access surgery

Intervention Type PROCEDURE

Surgery carried out through a single incision laparoscopic approach

CL

Conventional Laparoscopic access

Group Type ACTIVE_COMPARATOR

Conventional Laparoscopic Access

Intervention Type PROCEDURE

Surgery through standard multiport laparoscopic approach

Interventions

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Single-port access surgery

Surgery carried out through a single incision laparoscopic approach

Intervention Type PROCEDURE

Conventional Laparoscopic Access

Surgery through standard multiport laparoscopic approach

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Tees and Hartlepool NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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David W Borowski

Consultant General and Colorectal Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital North Tees

Stockton-on-Tees, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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David W Borowski, MD FRCSEd

Role: CONTACT

0044 1642 624078

Talvinder S Gill, MS FRCS

Role: CONTACT

0044 1642 617617 ext. 3136

Facility Contacts

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David W Borowski, MD FRCSEd

Role: primary

0044 6142 624078

Talvinder S Gill, MS FRCS

Role: backup

0044 1642 617617 ext. 3136

Other Identifiers

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SUR-089

Identifier Type: -

Identifier Source: org_study_id

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