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

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ClinicalTrials.gov Identifier: NCT01720082
Recruitment Status : Unknown
Verified November 2012 by Nereo Vettoretto, Associazione Chirurghi Ospedalieri Italiani.
Recruitment status was:  Not yet recruiting
First Posted : November 2, 2012
Last Update Posted : November 5, 2012
Sponsor:
Collaborator:
Società Italiana di Chirurgia Endoscopica e nuove tecnologie (SICE)
Information provided by (Responsible Party):
Nereo Vettoretto, Associazione Chirurghi Ospedalieri Italiani

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.

Condition or disease Intervention/treatment Phase
Acute Appendicitis Procedure: Single incision laparoscopic appendectomy Procedure: Multiport laparoscopic appendectomy Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2013
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Morbidity and mortality [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Post-operative pain score [ Time Frame: 3 days ]
    Visual Analogic Scale (VAS scale)

  2. Operative time [ Time Frame: 1 day ]
  3. Cosmetic result [ Time Frame: 6 months ]
    VAS scale

  4. Post-operative hospital stay [ Time Frame: 7 days ]
  5. Incision related morbidity [ Time Frame: 6 months ]
    during hospital stay (7days): infectious morbidity during follow-up (6 months): incisional hernias

  6. Quality of life [ Time Frame: 6 months ]
    Gastro Intestinal Quality of Life Index (GIQLI) score at discharge and at 6 months follow-up



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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Nereo Vettoretto, MD, Associazione Chirurghi Ospedalieri Italiani
ClinicalTrials.gov Identifier: NCT01720082     History of Changes
Other Study ID Numbers: ACOI - SICE
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: November 5, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases