Single port/incision laparoscopic surgery compared with standard 3 port laparoscopic surgery for appendicectomy

ISRCTN	ISRCTN66443895
DOI	https://doi.org/10.1186/ISRCTN66443895
Protocol serial number	9282
Sponsor	University of Aberdeen (UK)
Funder	Scottish Government Health and Social Care Directorate

Submission date: 21/01/2011
Registration date: 10/03/2011
Last edited: 26/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Christiane Pflanz-Sinclair
Scientific

Centre for Healthcare Randomised Trials (CHaRT)
Health Services Research Unit
3rd Floor, Health Sciences Building
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Email	c.pflanzsinclair@abdn.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised interventional treatment based single centre pilot/feasibility trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Single port/incision laparoscopic surgery compared with standard 3 port laparoscopic surgery for appendicectomy: a randomised controlled trial
Study acronym	SCARLESS
Study objectives	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(s)	Multicentre Research Ethics Committee (MREC) approved on the 8th December 2010 (ref: 10/SO802/77)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Pain Numerical Rating Scale at days 1 to 7 post surgery 2. Body Image Questionnaire at 6 weeks
Key secondary outcome measure(s)	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.
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Sex	All
Target sample size at registration	80
Key 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
Key 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
Date of first enrolment	01/01/2011
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Centre for Healthcare Randomised Trials (CHaRT)

Aberdeen
AB25 2ZD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2015		Yes	No
Protocol article	protocol	30/10/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

26/10/2018: Publication reference added.