Single-port Versus Conventional Laparoscopic Colorectal Surgery

N

North Tees and Hartlepool NHS Foundation Trust

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Benign Colorectal Neoplasm
Diverticular Disease
Inflammatory Bowel Disease
Colorectal Cancer

Treatments

Procedure: Conventional Laparoscopic Access
Procedure: Single-port access surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT01626963
SUR-089

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

50 participants in 2 patient groups

SPA
Experimental group
Description:
Single-port access surgery
Treatment:
Procedure: Single-port access surgery
CL
Active Comparator group
Description:
Conventional Laparoscopic access
Treatment:
Procedure: Conventional Laparoscopic Access

Trial contacts and locations

0

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Central trial contact

David W Borowski, MD FRCSEd; Talvinder S Gill, MS FRCS

Data sourced from clinicaltrials.gov

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