Single-port Versus Conventional Laparoscopic Colorectal Surgery

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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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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