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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN66443895
Enrollment
80
Registered
2011-03-10
Start date
2011-01-01
Completion date
Unknown
Last updated
2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Oral and Gastrointestinal

Interventions

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)

Sponsors

University of Aberdeen (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 25, 2026