Plain English Summary
Not provided at time of registration
Trial website
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 measure
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; surgeons 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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23111090
Publication citations
-
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.