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| Name | Class |
|---|---|
| Società Italiana di Chirurgia Endoscopica e nuove tecnologie (SICE) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single incision laparoscopic appendectomy | Active Comparator | Acute appendicitis with surgical indication |
|
| Multiport Laparoscopic appendectomy | Active Comparator | Acute appendicitis with surgical indication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single incision laparoscopic appendectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity and mortality | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain score | Visual Analogic Scale (VAS scale) | 3 days |
| Operative time | 1 day | |
| Cosmetic result |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nereo Vettoretto, MD | Contact | 00393492237383 | nereovet@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nereo Vettoretto, MD | ACOI - SICE | Study Chair |
| Ferdinando Agresta, MD | ACOI - SICE | Study Chair |
| Luigi Boni, MD, FACS |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M.Mellini Hospital | Chiari | BS | 25032 | Italy |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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|
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| Multiport laparoscopic appendectomy | Procedure | 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. |
|
|
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 |
| SICE |
| Study Chair |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |