Laparoscopic Appendectomy by Multi-port vs Single Port. (AMUSING)
Primary Purpose
Acute Appendicitis
Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Single incision laparoscopic appendectomy
Multiport laparoscopic appendectomy
Sponsored by
About this trial
This is an interventional treatment trial for Acute Appendicitis
Eligibility 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
Sites / Locations
- M.Mellini Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Single incision laparoscopic appendectomy
Multiport Laparoscopic appendectomy
Arm Description
Acute appendicitis with surgical indication
Acute appendicitis with surgical indication
Outcomes
Primary Outcome Measures
Morbidity and mortality
Secondary Outcome Measures
Post-operative pain score
Visual Analogic Scale (VAS scale)
Operative time
Cosmetic result
VAS scale
Post-operative hospital stay
Incision related morbidity
during hospital stay (7days): infectious morbidity during follow-up (6 months): incisional hernias
Quality of life
Gastro Intestinal Quality of Life Index (GIQLI) score at discharge and at 6 months follow-up
Full Information
NCT ID
NCT01720082
First Posted
October 31, 2012
Last Updated
November 2, 2012
Sponsor
Associazione Chirurghi Ospedalieri Italiani
Collaborators
Società Italiana di Chirurgia Endoscopica e nuove tecnologie (SICE)
1. Study Identification
Unique Protocol Identification Number
NCT01720082
Brief Title
Laparoscopic Appendectomy by Multi-port vs Single Port.
Acronym
AMUSING
Official Title
Randomized Controlled Trial Comparing Single Incision Laparoscopic Appendectomy Versus Standard Three Port Appendectomy in a Selected Cohort of Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Associazione Chirurghi Ospedalieri Italiani
Collaborators
Società Italiana di Chirurgia Endoscopica e nuove tecnologie (SICE)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Appendicitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single incision laparoscopic appendectomy
Arm Type
Active Comparator
Arm Description
Acute appendicitis with surgical indication
Arm Title
Multiport Laparoscopic appendectomy
Arm Type
Active Comparator
Arm Description
Acute appendicitis with surgical indication
Intervention Type
Procedure
Intervention Name(s)
Single incision laparoscopic appendectomy
Other Intervention Name(s)
SILA
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Multiport laparoscopic appendectomy
Other Intervention Name(s)
LA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Morbidity and mortality
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Post-operative pain score
Description
Visual Analogic Scale (VAS scale)
Time Frame
3 days
Title
Operative time
Time Frame
1 day
Title
Cosmetic result
Description
VAS scale
Time Frame
6 months
Title
Post-operative hospital stay
Time Frame
7 days
Title
Incision related morbidity
Description
during hospital stay (7days): infectious morbidity during follow-up (6 months): incisional hernias
Time Frame
6 months
Title
Quality of life
Description
Gastro Intestinal Quality of Life Index (GIQLI) score at discharge and at 6 months follow-up
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nereo Vettoretto, MD
Phone
00393492237383
Email
nereovet@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nereo Vettoretto, MD
Organizational Affiliation
ACOI - SICE
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ferdinando Agresta, MD
Organizational Affiliation
ACOI - SICE
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luigi Boni, MD, FACS
Organizational Affiliation
SICE
Official's Role
Study Chair
Facility Information:
Facility Name
M.Mellini Hospital
City
Chiari
State/Province
BS
ZIP/Postal Code
25032
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nereo Vettoretto, MD
12. IPD Sharing Statement
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Laparoscopic Appendectomy by Multi-port vs Single Port.
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