Laparoscopic Appendectomy by Multi-port vs Single Port.

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial Comparing Single Incision Laparoscopic Appendectomy Versus Standard Three Port Appendectomy in a Selected Cohort of Patients

Conditions
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Acute Appendicitis

Intervention / Treatment
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* Procedure: Single incision laparoscopic appendectomy
* Procedure: Multiport laparoscopic appendectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single incision laparoscopic appendectomy<br>Acute appendicitis with surgical indication | Procedure: Single incision laparoscopic appendectomy<br>* 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.<br>* Other names: SILA;|
| Active Comparator: Multiport Laparoscopic appendectomy<br>Acute appendicitis with surgical indication | Procedure: Multiport laparoscopic appendectomy<br>* 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.<br>* Other names: LA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity and mortality |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain score | Visual Analogic Scale (VAS scale) | 3 days | 
| Operative time |  | 1 day | 
| Cosmetic result | VAS scale | 6 months | 
| Post-operative hospital stay |  | 7 days | 
| Incision related morbidity | during hospital stay (7days): infectious morbidity during follow-up (6 months): incisional hernias | 6 months | 
| Quality of life | Gastro Intestinal Quality of Life Index (GIQLI) score at discharge and at 6 months follow-up | 6 months |