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Completed

NCT Number: NCT02086435

Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes

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.

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Key information

Conditions

Uterine Myoma Connective Tissue Diseases Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chair of Obstetrics and Gynecology - University division - UMG

Catanzaro, CZ, 88100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Extracorporeal morcellation

Procedure

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

Other names: protected morcellation, morcellation in endobag

Intracorporeal morcellation

Procedure

patients treated with standard intracorporeal morcellation, using reusable electronic device

Other names: Power morcellation, Standard intracorporeal morcellation

Primary outcomes

  1. Operative time

    Time frame: The day of surgery

    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

Secondary outcomes

  1. Total operative time

    Time frame: The day of surgery

    from skin incision to skin closure

  2. Handling of morcellation

    Time frame: The day of surgery

    expressed on the VAS scale where 1 means very bad handling and 10 excellent handling

  3. Blood loss

    Time frame: 2 hours after the end of surgery

    Blood loss will be calculated by the difference of Hb level 2 hours after surgery and the morning of the surgery

  4. Postoperative hospital stay

    Time frame: The day of patient discharge, average 4 day after surgery

  5. Postoperative pain

    Time frame: The day of patient discharge, average 4 day after surgery

    measured on the VAS scale where 1 stands for a little pain and 10 for intense pain

  6. Rate of complications

    Time frame: The day of patient discharge, average 4 day after surgery

    need of transfusion or laparotomic conversion

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study title

A Randomized Controlled Trial on Intracorporeal Versus Extracorporeal Morcellation With Endobag Extraction in Patients Undergoing Laparoscopic Myomectomy: Clinical Efficacy and Safety Outcomes

Acronym: IEME

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Mar 13, 2014
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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