Single port/incision laparoscopic surgery compared with standard 3 port laparoscopic surgery for appendicectomy
| ISRCTN | ISRCTN66443895 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66443895 |
| Secondary identifying numbers | 9282 |
- 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
Scientific
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 |
Study information
| Study design | Randomised interventional treatment based single centre pilot/feasibility trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Can be found at https://w3.abdn.ac.uk/hsru/scarless/Secure/Download/DownloadPage.aspx |
| 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 | 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 study start date | 01/01/2011 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 80; UK sample size: 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
- Scotland
- United Kingdom
Study participating centre
Centre for Healthcare Randomised Trials (CHaRT)
Aberdeen
AB25 2ZD
United Kingdom
AB25 2ZD
United Kingdom
Sponsor information
University of Aberdeen (UK)
University/education
University/education
Research and Innovation
University Office
King's College
Aberdeen
AB24 3FX
Scotland
United Kingdom
| Website | http://www.abdn.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/016476m91 |
Funders
Funder type
Government
Scottish Government Health and Social Care Directorate
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- SGHSC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 30/10/2012 | Yes | No | |
| Results article | results | 01/01/2015 | Yes | No |
Editorial Notes
26/10/2018: Publication reference added.
