## Protocol Section
### Identification Module
**NCT ID:** NCT02885779

**Acronym:** ANTATROC

**Brief Title:** Comparison of 2 Techniques of Invasive Mini Surgery: Coelioscopy Mini-trocar and Monotrocar in the Adnexa no Carcinologic Surgery : Forward-looking Observational Study.

**Official Title:** Comparison of 2 Techniques of Invasive Mini Surgery: Coelioscopy Mini-trocar and Monotrocar in the Adnexa no Carcinologic Surgery : Forward-looking Observational Study.

#### Organization Study ID Info
**ID:** ANTATROC-IPC 2015-011
#### Organization
**Class:** OTHER
**Full Name:** Institut Paoli-Calmettes
### Status Module
#### Completion Date
**Date:** 2015-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-09-01

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-08-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-09

**Type:** ACTUAL

#### Start Date
**Date:** 2015-05

**Status Verified Date:** 2016-08

#### Study First Post Date
**Date:** 2016-09-01
**Type:** ESTIMATED
**Study First Submit Date:** 2016-08-18
**Study First Submit QC Date:** 2016-08-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Institut Paoli-Calmettes

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The advantages of the celioscopy mini--trocar and monotrocar technical are recognized.

There is however no forward-looking or retrospective study comparing the microcomputed-celioscopy (use of microphone) - trocar of 3mm of diameter in access celioscopic pluri--trocar) in the celioscopy monotrocar ( a single intra-umbilical section) in gynecological surgery.

The objective of this preliminary study is to compare both surgical care in terms of morbidity died operating, in adnexa surgeries.

### Conditions Module

**Conditions:**

- Gynecologic Surgical Procedures for Adnexa Surgery in Ovarian Disease

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 16

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patient having an operating indication of adnexa surgery : unilateral or bilateral adnexectomy

**Label:** Patient having an operating indication of adnexa surgery

### Outcomes Module

#### Primary Outcomes

**Description:** consumption of analgesic for pains in immediate operating comment

**Measure:** Immediate post operative pains

**Time Frame:** Up to 1 month

**Description:** consumption of analgesic for pains

**Measure:** Court term post operative pains

**Time Frame:** Up to 2 month

**Description:** consumption of analgesic for pains

**Measure:** Medium term post operative pains

**Time Frame:** Up to 3 month

#### Secondary Outcomes

**Description:** Blood loss

**Measure:** Complications per operating

**Time Frame:** During surgery

**Description:** Addition of trocar

**Measure:** Complications per operating

**Time Frame:** During surgery

**Description:** Duration of hospitalization

**Measure:** Complications post operating

**Time Frame:** Up to 1 month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria :

* Age \> 18 ans
* OMS = 2
* Patient having an operating indication of adnexa surgery : unilateral or bilateral adnexectomy

Exclusion Criteria:

* Contraindication to coelioscopy intervention

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Operating indication of adnexa surgery : unilateral or bilateral adnexectomy

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Marseille

**Country:** France

**Facility:** Institut Paoli-Calmettes

**State:** Bouches-du-Rhône

**Zip:** 13273

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000000291

- Term: Adnexal Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000006058

- Term: Gonadal Disorders

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12972

- Name: Ovarian Diseases

- Relevance: HIGH

- As Found: Ovarian Diseases

- ID: M3643

- Name: Adnexal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M9163

- Name: Gonadal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010049

- Term: Ovarian Diseases

### Misc Info Module

- Version Holder: 2024-05-24
