Condition category
Circulatory System
Date applied
21/01/2011
Date assigned
10/03/2011
Last edited
02/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://w3.abdn.ac.uk/hsru/scarless/

Contact information

Type

Scientific

Primary contact

Dr Christiane Pflanz-Sinclair

ORCID ID

Contact details

Centre for Healthcare Randomised Trials (CHaRT)
Health Services Research Unit
3rd Floor
Health Sciences Building
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
c.pflanzsinclair@abdn.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9282

Study information

Scientific title

Single port/incision laparoscopic surgery compared with standard 3 port laparoscopic surgery for appendicectomy: a randomised controlled trial

Acronym

SCARLESS

Study hypothesis

1. To compare the effectiveness of single port/incision laparoscopic appendicectomy with standard laparoscopic appendicectomy
2. To assess the feasibility of a randomised trial comparing single port laparoscopic to standard laparoscopic surgery for other surgical techniques

Objectives:
The primary objective is to compare effectiveness in terms of patient reported outcomes, clinical outcomes, resource use.

The secondary objective is to assess feasibility by quantifying patient eligibility and acceptability, feasibility of blinding participants to the intervention received, surgeon perception of interventions.

Ethics approval

Multicentre Research Ethics Committee (MREC) approved on the 8th December 2010 (ref: 10/SO802/77)

Study design

Randomised interventional treatment based single centre pilot/feasibility trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Can be found at https://w3.abdn.ac.uk/hsru/scarless/Secure/Download/DownloadPage.aspx

Condition

Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Gastrointestinal

Intervention

Interventions:
Participants will be randomised to either single port/incision laparoscopic surgery (SPILS) or standard 3 port laparoscopic surgery.

Single port/incision laparoscopic surgery (SPILS): single intra-umbilical incision for appendicectomy. A multi channel port or three conventional trocars will be inserted. Conventional laparoscopic instruments will be used but roticulating/curved instruments will be also available for the procedure (if required).

Standard 3 port laparoscopic surgery: Three surgical incisions for appendicectomy (intra/supraumbilical incision to create a pneumoperitoneum and further two incisions located in the left iliac fossa and hypogastrium). Standard laparoscopic instruments will be used for the procedure as per existing hospital protocol.

Patients will be followed-up post-operatively using a 1 to 7 days diary (to be completed while in hospital and home (if patient has been discharged). Postal questionnaires will be completed by participants at 6 weeks after surgery.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Pain Numerical Rating Scale at days 1 to 7 post surgery
2. Body Image Questionnaire at 6 weeks

Secondary outcome measures

1. Patient reported measures:
Hospital Experience Questionnaire (HEQ) measured at 6 weeks; analgesic usage peri-operatively, Days 1-7 (diary) and at 6 weeks and time to return to normal activities at 6 weeks after surgery.
2. Clinical outcomes:
Analgesic use; duration of operation (minutes) and complication rates; conversion
rates peri-operatively ; infection rates (intra-abdominal and wound) peri-operatively and at 6 weeks; hospital re-admission rates at 6 weeks after surgery; reoperation rates and port-site hernia at 6 weeks after surgery.
3. Feasibility measures:
Eligible patients per month; proportion formally considered for trial entry; proportion randomised (and reasons why not); proportion who are unaware of their received intervention at 24 hours; proportion of those recruited with complete data set at 6 weeks; surgeon’s perception of SPILS approach and the suitability of available equipment peri-operatively.

Overall trial start date

01/01/2011

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 16 years and over, either sex
2. Presenting at Aberdeen Royal Infirmary (ARI)
3. Diagnosed with acute appendicitis and for whom laparoscopic surgical management is judged appropriate

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 80; UK sample size: 80

Participant exclusion criteria

1. Patients who have had previous open abdominal surgery through midline incision
2. Patients who have had previous umbilical hernia repair with mesh
3. Patients unable to consent

Recruitment start date

01/01/2011

Recruitment end date

31/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Healthcare Randomised Trials (CHaRT)
Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

Research and Innovation
University Office
King's College
Aberdeen
AB24 3FX
United Kingdom

Sponsor type

University/education

Website

http://www.abdn.ac.uk/

Funders

Funder type

Government

Funder name

Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZG/2/498)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23111090

Publication citations

  1. Protocol

    Malik M, McCormack K, Krukowski ZH, McDonald A, McPherson G, Cook JA, Ahmed I, , Single port/incision laparoscopic surgery compared with standard three-port laparoscopic surgery for appendicectomy - a randomised controlled trial., Trials, 2012, 13, 201, doi: 10.1186/1745-6215-13-201.

Additional files

Editorial Notes