Clinical trial · Interventional
Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes
A Randomized Controlled Trial on Intracorporeal Versus Extracorporeal Morcellation With Endobag Extraction in Patients Undergoing Laparoscopic Myomectomy: Clinical Efficacy and Safety Outcomes
NCT02086435CI-TRIAL-00017599IEMEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Myoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extracorporeal morcellation | Procedure | — | UNRESOLVED |
| Intracorporeal morcellation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Extracorporeal morcellation
- 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
- interventionNames
- Procedure: Extracorporeal morcellation
- type
- ACTIVE_COMPARATOR
- label
- Intracorporeal morcellation
- description
- Intracorporeal morcellation patients treated with standard intracorporeal morcellation, using reusable electronic device
- interventionNames
- Procedure: Intracorporeal morcellation
Primary outcomes (1)
- measure
- Operative time
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDVenturella 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 26801067