Single-port Versus Conventional Laparoscopic Colorectal Surgery

NCT01626963 | Unknown Phase 1 DMC

• 1 other identifier: SUR-089
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Inflammatory Bowel Disease; Benign Colorectal Neoplasm; Diverticular Disease

Keywords

single-port access; laparoscopic surgery; surgical trauma

Outcome Measures

Primary Outcomes (1)

• Operative Time

  Operative Time

  assessment of electronic records at 30 days from surgery

Secondary Outcomes (10)

• Pain scores

  change from baseline at 1,2,3,4 and 5 days from surgery

• Complication / Conversion-to-open-surgery rates

  assessment at 30 days post-op

• Quality of Life indicators

  change from baseline at 2, 4 weeks, & 3 months after surgery

• Cosmetic appearance

  change from baseline at 2, 4 weeks and three months after surgery

• Cost comparison

  assessment at the end of the study, up to 2 years post-op

Study Arms (2)

SPA

EXPERIMENTAL

Single-port access surgery

Procedure: Single-port access surgery

CL

ACTIVE COMPARATOR

Conventional Laparoscopic access

Procedure: Conventional Laparoscopic Access

Interventions

Single-port access surgery PROCEDURE

Surgery carried out through a single incision laparoscopic approach

SPA

Conventional Laparoscopic Access PROCEDURE

Surgery through standard multiport laparoscopic approach

CL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• North Tees and Hartlepool NHS Foundation Trust: lead

Study Sites (1)

University Hospital North Tees

Stockton-on-Tees, TS19 8PE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Inflammatory Bowel Diseases; Diverticular Diseases

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Gastroenteritis

Central Study Contacts

David W Borowski, MD FRCSEd

CONTACT

0044 1642 624078; david.borowski@nth.nhs.uk

Talvinder S Gill, MS FRCS

CONTACT

0044 1642 617617; talvinder.gill@nth.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant General and Colorectal Surgeon

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: June 25, 2012
• Study Start: January 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 24, 2016

Record last verified: 2016-03

Locations

GB (1)