Randomized Controlled Trial Comparing Single Incision Laparoscopic Appendectomy Versus Standard Three Port Appendectomy in a Selected Cohort of Patients
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Morbidity and mortality
Study Overview
Brief Summary
Laparoscopic appendectomy (LA) is nowadays considered the gold standard in fertile women affected by uncomplicated appendicitis. The level of evidence for benefits from LA in this subgroup is high. Since the dissemination of single access surgery (no-scars surgery) ameliorated outcome has been supposed in these patients regarding post-operative pain, hospital stay and cosmetics results, and keeping the same safety as LA. This randomized controlled study is supposed to give answers to these questions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 14 Years to 60 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age: 14-60
- •American Society of Anesthesiologists (ASA) score: I-III
- •absence of non-correctable coagulopathy (international normalized ratio >1,5, or platelet count <90 × 109/l).
- •diagnosis: acute appendicitis with surgical indication
Exclusion Criteria
- •Complicated appendicitis after exploration or previously diagnosed (CT)
- •Psychical inability
- •Pregnancy
Arms & Interventions
Single incision laparoscopic appendectomy
Acute appendicitis with surgical indication
Intervention: Single incision laparoscopic appendectomy (Procedure)
Multiport Laparoscopic appendectomy
Acute appendicitis with surgical indication
Intervention: Multiport laparoscopic appendectomy (Procedure)
Outcomes
Primary Outcomes
Morbidity and mortality
Time Frame: 30 days
Secondary Outcomes
- Incision related morbidity(6 months)
- Quality of life(6 months)
- Post-operative pain score(3 days)
- Operative time(1 day)
- Cosmetic result(6 months)
- Post-operative hospital stay(7 days)
Investigators
Nereo Vettoretto
MD
Associazione Chirurghi Ospedalieri Italiani