Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes (IEME)

University Magna Graecia

Status: Completed

Conditions: Uterine Myoma

Treatments: Procedure: Extracorporeal morcellation; Procedure: Intracorporeal morcellation

Study type: Interventional

Funder types: Other

Identifiers

NCT02086435

SafeMorcellation

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

93 participants in 2 patient groups

Extracorporeal morcellation

Experimental group

Description:

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

Treatment:

Procedure: Extracorporeal morcellation

Intracorporeal morcellation

Active Comparator group

Description:

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

Treatment:

Procedure: Intracorporeal morcellation