NCT02086435

Brief Summary

The aim of this study protocol will be to compare the technique of intracorporeal morcellation using reusable electronic device (standard technique) with a technique of removal "protected" by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

9 months

First QC Date

March 9, 2014

Last Update Submit

April 19, 2015

Conditions

Uterine Myoma

Keywords

MyomectomyLaparoscopic myomectomyMorcellationRisk of disseminationUterine SarcomaParasitic myoma

Outcome Measures

Primary Outcomes (1)

  • Operative time

    calculated from the time, after secured hemostasis of the uterine breach, in which the myoma is clamped and subjected to intracorporeal or added in endobag for extracorporeal morcellation to the moment when the 'last fragment of myoma will be considered removed from the surgical field

    The day of surgery

Secondary Outcomes (6)

  • Total operative time

    The day of surgery

  • Handling of morcellation

    The day of surgery

  • Blood loss

    2 hours after the end of surgery

  • Postoperative hospital stay

    The day of patient discharge, average 4 day after surgery

  • Postoperative pain

    The day of patient discharge, average 4 day after surgery

  • +1 more secondary outcomes

Study Arms (2)

Extracorporeal morcellation

EXPERIMENTAL

Extracorporeal morcellation in which patients are treated with "protected" removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself

Procedure: Extracorporeal morcellation

Intracorporeal morcellation

ACTIVE COMPARATOR

Intracorporeal morcellation patients treated with standard intracorporeal morcellation, using reusable electronic device

Procedure: Intracorporeal morcellation

Interventions

Extracorporeal morcellationPROCEDURE

patients treated with "protected" removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself

Also known as: protected morcellation, morcellation in endobag
Extracorporeal morcellation
Intracorporeal morcellationPROCEDURE

patients treated with standard intracorporeal morcellation, using reusable electronic device

Also known as: Power morcellation, Standard intracorporeal morcellation
Intracorporeal morcellation

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing laparoscopy for uterine myomas with international guidelines surgical indications
  • Presence of at least one uterine myoma larger than 4 cm
  • Aged between 18 and 40 years

You may not qualify if:

  • Presence of uterine neoformations suspicious for malignancy
  • Medical major disorders associated
  • Acute or chronic psychiatric disorders
  • Ascertained Premenstrual syndrome
  • Use of drugs that can affect cognitive ability or state of consciousness and alertness during the last six months prior to enrollment
  • Presence of calcified fibroids ultrasound examination
  • Presence of adnexal lesions
  • Detection of a pattern of endometrial hyperplasia with atypia determined in the course endometrial biopsy performed for abnormal uterine bleeding
  • Abnormal PAP test
  • Positive Pregnancy Test
  • Previous use of laparoscopic surgery increased

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chair of Obstetrics and Gynecology - University division - UMG

Catanzaro, CZ, 88100, Italy

Location

Related Publications (1)

  • Venturella R, Rocca ML, Lico D, La Ferrera N, Cirillo R, Gizzo S, Morelli M, Zupi E, Zullo F. In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial. Fertil Steril. 2016 May;105(5):1369-1376. doi: 10.1016/j.fertnstert.2015.12.133. Epub 2016 Jan 19.

    PMID: 26801067DERIVED

MeSH Terms

Conditions

Myofibroma

Interventions

Morcellation

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Minimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Fulvio Zullo

    Magna Graecia University of Catanzaro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor Obstetric Gynecology

Study Record Dates

First Submitted

March 9, 2014

First Posted

March 13, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2014

Study Completion

April 1, 2015

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

IT(1)