## Protocol Section
### Identification Module
**NCT ID:** NCT03570879

**Acronym:** MYMOTE-1

**Brief Title:** Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens.

**Official Title:** Analysis of Surgical Outcomes in Women Undergoing Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens

#### Organization Study ID Info
**ID:** MYMOTE-1
#### Organization
**Class:** OTHER
**Full Name:** Università degli Studi dell'Insubria
### Status Module
#### Completion Date
**Date:** 2024-05-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2021-09-30

**Type:** ACTUAL

**Last Update Submit Date:** 2021-09-28

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2023-05-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-05-01

**Type:** ESTIMATED

**Status Verified Date:** 2021-09

#### Study First Post Date
**Date:** 2018-06-27
**Type:** ACTUAL
**Study First Submit Date:** 2018-05-30
**Study First Submit QC Date:** 2018-06-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Università degli Studi dell'Insubria

#### Responsible Party

**Investigator Affiliation:** Università degli Studi dell'Insubria

**Investigator Full Name:** Antonio Simone Laganà

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Laparoscopic myomectomy represents the fertility-sparing gold standard approach for the management of subserosal and intramural uterine myomas: this technique allows faster recovery, less complications and improved surgical outcomes than laparotomy.

Despite these validated cornerstones of minimally invasive gynecology, the best approach for specimen retrieval is still debated. Among these approaches, surgical specimen retrieval after laparoscopic myomectomy could be performed by mini-laparotomy, by power morcellation using morcellator inserted through one of the ancillary trocars, or by transvaginal extraction through an endobag inserted at level of the posterior vaginal fornix (between the utero-sacral ligaments).

Unfortunately, mini-laparotomy has poor esthetic outcome and does not conform the current standards of minimally invasive surgery.

In addition, on 24 November 24 2014 the Food and Drug Administration updated a Safety Communication about Power Morcellation, warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids, due to the risk of spreading an unsuspected uterine sarcoma within the abdomen and pelvis.

Considering this scenario, transvaginal extraction may represents a feasible approach for specimen retrieval. In this view, the current study aims to retrospectively compare surgical outcomes in women that underwent laparoscopic myomectomy with subsequent power morcellation (before the issuing of the abovementioned Safety Communication by the Food and Drug Administration) or transvaginal extraction (after the issuing of the abovementioned Safety Communication by the Food and Drug Administration) of the surgical specimens.

### Conditions Module

**Conditions:**

- Myoma;Uterus

**Keywords:**

- Laparoscopy

- Power morcellation

- Transvaginal extraction

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 250

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Women that underwent laparoscopic myomectomy with subsequent power morcellation of the surgical specimens.

**Intervention Names:**

- Device: Power morcellation

**Label:** Power morcellation

#### Arm Group 2

**Description:** Women that underwent laparoscopic myomectomy with subsequent transvaginal extraction of the surgical specimens.

**Intervention Names:**

- Procedure: Transvaginal extraction

**Label:** Transvaginal extraction

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Power morcellation

**Description:** Power morcellation of surgical specimens after laparoscopic myomectomy.

**Name:** Power morcellation

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Transvaginal extraction

**Description:** Transvaginal extraction of surgical specimens after laparoscopic myomectomy.

**Name:** Transvaginal extraction

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Number of surgical complications (Clavien-Dindo Classification)

**Measure:** Complication rate

**Time Frame:** Within 12 months after surgery.

#### Secondary Outcomes

**Description:** Duration of the surgery, expressed in minutes.

**Measure:** Operative time

**Time Frame:** Through study completion, an average of 10 years (retrospective analysis)

**Description:** Blood loss during the surgery, expressed in milliliters (ml).

**Measure:** Blood loss

**Time Frame:** Through study completion, an average of 10 years (retrospective analysis)

**Description:** Duration of the hospitalization, expressed in days

**Measure:** Hospital stay

**Time Frame:** Through study completion, an average of 10 years (retrospective analysis)

**Description:** Sexual function evaluated by Female Sexual Function Index questionnaire, investigating quantity and quality of sex \[scale total score minimum: 2 (worse outcome), maximum: 36 (best outcome)\]

**Measure:** Sexual function

**Time Frame:** 6 and 12 months after surgery.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Women affected by single or multiple uterine myomas.
* Signed informed consent.

Exclusion Criteria:

* Human papilloma virus-related pathologies at pap-smear within the 12 months preceding surgery.
* Women with obliteration of the cul-de-sac.
* Women with the suspected cancer of gynecological origin.
* Women who had never experienced complete sexual intercourse before the operation.

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**Study Population:** Women that underwent laparoscopic myomectomy with subsequent power morcellation (before the issuing of the abovementioned Safety Communication by the Food and Drug Administration) or transvaginal extraction (after the issuing of the abovementioned Safety Communication by the Food and Drug Administration) of the surgical specimens.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** antoniosimone.lagana@asst-settelaghi.it

**Name:** Antonio Simone Laganà, M.D.

**Phone:** +393296279579

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Università degli Studi dell'Insubria

**Name:** Antonio Simone Laganà, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Università degli Studi dell'Insubria

**Name:** Jvan Casarin, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Università degli Studi dell'Insubria

**Name:** Antonella Cromi, M.D., Ph.D.

**Role:** STUDY_CHAIR

**Official 4:**

**Affiliation:** Università degli Studi dell'Insubria

**Name:** Fabio Ghezzi, M.D.

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009379

- Term: Neoplasms, Muscle Tissue

- ID: D000018204

- Term: Neoplasms, Connective and Soft Tissue

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000009372

- Term: Neoplasms, Connective Tissue

- ID: D000003240

- Term: Connective Tissue Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12166

- Name: Myoma

- Relevance: LOW

- As Found: Unknown

- ID: M10901

- Name: Leiomyoma

- Relevance: HIGH

- As Found: Myoma;Uterus

- ID: M25846

- Name: Myofibroma

- Relevance: HIGH

- As Found: Myoma;Uterus

- ID: M20350

- Name: Neoplasms, Connective and Soft Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M12317

- Name: Neoplasms, Connective Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007889

- Term: Leiomyoma

- ID: D000047708

- Term: Myofibroma

### Misc Info Module

- Version Holder: 2024-05-24
