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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01720082
Other study ID # ACOI - SICE
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received October 31, 2012
Last updated November 2, 2012
Start date March 2013
Est. completion date February 2014

Study information

Verified date November 2012
Source Associazione Chirurghi Ospedalieri Italiani
Contact Nereo Vettoretto, MD
Phone 00393492237383
Email nereovet@gmail.com
Is FDA regulated No
Health authority Italy: National Institute of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date February 2014
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Female
Age group 14 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Single incision laparoscopic appendectomy
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.
Multiport 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.

Locations

Country Name City State
Italy M.Mellini Hospital Chiari BS

Sponsors (2)

Lead Sponsor Collaborator
Associazione Chirurghi Ospedalieri Italiani Società Italiana di Chirurgia Endoscopica e nuove tecnologie (SICE)

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Morbidity and mortality 30 days Yes
Secondary Post-operative pain score Visual Analogic Scale (VAS scale) 3 days No
Secondary Operative time 1 day No
Secondary Cosmetic result VAS scale 6 months No
Secondary Post-operative hospital stay 7 days No
Secondary Incision related morbidity during hospital stay (7days): infectious morbidity during follow-up (6 months): incisional hernias 6 months Yes
Secondary Quality of life Gastro Intestinal Quality of Life Index (GIQLI) score at discharge and at 6 months follow-up 6 months No
See also
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Completed NCT05104346 - Presentation and Outcomes of Acute Appendicitis During COVID Pandemic N/A
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Completed NCT01348464 - A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy N/A