Laparoscopic Appendectomy by Multi-port vs Single Port. (AMUSING)

This study is not yet open for participant recruitment.
Verified November 2012 by Associazione Chirurghi Ospedalieri Italiani
Sponsor:
Collaborator:
Società Italiana di Chirurgia Endoscopica e nuove tecnologie (SICE)
Information provided by (Responsible Party):
Nereo Vettoretto, Associazione Chirurghi Ospedalieri Italiani
ClinicalTrials.gov Identifier:
NCT01720082
First received: October 31, 2012
Last updated: November 2, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Acute Appendicitis
Procedure: Single incision laparoscopic appendectomy
Procedure: Multiport laparoscopic appendectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Single Incision Laparoscopic Appendectomy Versus Standard Three Port Appendectomy in a Selected Cohort of Patients

Resource links provided by NLM:


Further study details as provided by Associazione Chirurghi Ospedalieri Italiani:

Primary Outcome Measures:
  • Morbidity and mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Post-operative pain score [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Visual Analogic Scale (VAS scale)

  • Operative time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Cosmetic result [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    VAS scale

  • Post-operative hospital stay [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Incision related morbidity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    during hospital stay (7days): infectious morbidity during follow-up (6 months): incisional hernias

  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Gastro Intestinal Quality of Life Index (GIQLI) score at discharge and at 6 months follow-up


Estimated Enrollment: 300
Study Start Date: March 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single incision laparoscopic appendectomy
Acute appendicitis with surgical indication
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.
Other Name: SILA
Active Comparator: Multiport Laparoscopic appendectomy
Acute appendicitis with surgical indication
Procedure: 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.
Other Name: LA

  Eligibility

Ages Eligible for Study:   14 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720082

Contacts
Contact: Nereo Vettoretto, MD 00393492237383 nereovet@gmail.com

Locations
Italy
M.Mellini Hospital Not yet recruiting
Chiari, BS, Italy, 25032
Principal Investigator: Nereo Vettoretto, MD         
Sponsors and Collaborators
Associazione Chirurghi Ospedalieri Italiani
Società Italiana di Chirurgia Endoscopica e nuove tecnologie (SICE)
Investigators
Study Chair: Nereo Vettoretto, MD ACOI - SICE
Study Chair: Ferdinando Agresta, MD ACOI - SICE
Study Chair: Luigi Boni, MD, FACS SICE
  More Information

No publications provided

Responsible Party: Nereo Vettoretto, MD, Associazione Chirurghi Ospedalieri Italiani
ClinicalTrials.gov Identifier: NCT01720082     History of Changes
Other Study ID Numbers: ACOI - SICE
Study First Received: October 31, 2012
Last Updated: November 2, 2012
Health Authority: Italy: National Institute of Health

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014