NCT01720082

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

November 5, 2012

Status Verified

November 1, 2012

Enrollment Period

5 months

First QC Date

October 31, 2012

Last Update Submit

November 2, 2012

Conditions

Acute Appendicitis

Outcome Measures

Primary Outcomes (1)

  • Morbidity and mortality

    30 days

Secondary Outcomes (6)

  • Post-operative pain score

    3 days

  • Operative time

    1 day

  • Cosmetic result

    6 months

  • Post-operative hospital stay

    7 days

  • Incision related morbidity

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Single incision laparoscopic appendectomy

ACTIVE COMPARATOR

Acute appendicitis with surgical indication

Procedure: Single incision laparoscopic appendectomy

Multiport Laparoscopic appendectomy

ACTIVE COMPARATOR

Acute appendicitis with surgical indication

Procedure: Multiport laparoscopic appendectomy

Interventions

Single incision laparoscopic appendectomyPROCEDURE

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.

Also known as: SILA
Single incision laparoscopic appendectomy
Multiport laparoscopic appendectomyPROCEDURE

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.

Also known as: LA
Multiport Laparoscopic appendectomy

Eligibility Criteria

Age14 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Complicated appendicitis after exploration or previously diagnosed (CT)
  • Psychical inability
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M.Mellini Hospital

Chiari, BS, 25032, Italy

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Nereo Vettoretto, MD

    ACOI - SICE

    STUDY CHAIR

  • Ferdinando Agresta, MD

    ACOI - SICE

    STUDY CHAIR

  • Luigi Boni, MD, FACS

    SICE

    STUDY CHAIR

Central Study Contacts

Nereo Vettoretto, MD

CONTACT

00393492237383nereovet@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 31, 2012

First Posted

November 2, 2012

Study Start

March 1, 2013

Primary Completion

August 1, 2013

Study Completion

February 1, 2014

Last Updated

November 5, 2012

Record last verified: 2012-11

Locations

IT(1)