Acute Appendicitis
Conditions
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.
Interventions
A multiport device will be introducted through a 2-2.5 transumbilical incision. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.
PROCEDUREMultiport laparoscopic appendectomy
Three ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic). One additional trocar can be inserted following surgeons preference. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects (10/12 trocars)will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.
Sponsors
Società Italiana di Chirurgia Endoscopica e nuove tecnologie (SICE)
Associazione Chirurghi Ospedalieri Italiani
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morbidity and mortality | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | 1 day | — |
| Cosmetic result | 6 months | VAS scale |
| Post-operative pain score | 3 days | Visual Analogic Scale (VAS scale) |
| Incision related morbidity | 6 months | during hospital stay (7days): infectious morbidity during follow-up (6 months): incisional hernias |
| Quality of life | 6 months | Gastro Intestinal Quality of Life Index (GIQLI) score at discharge and at 6 months follow-up |
| Post-operative hospital stay | 7 days | — |
Countries
Italy
Contacts
Primary ContactNereo Vettoretto, MD
Outcome results
None listed