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

Gynecologic Surgical Procedures for Adnexa Surgery in Ovarian Disease Clinical Trial

— ANTATROC  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02885779
• Other study ID #: ANTATROC-IPC 2015-011
• Status: Completed
• Phase: N/A
• First received: August 18, 2016
• Last updated: August 26, 2016
• Start date: May 2015
• Est. completion date: September 2015

Study information

• Verified date: August 2016
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gynecologic Surgical Procedures for Adnexa Surgery in Ovarian Disease
• Ovarian Diseases

Locations

Country	Name	City	State
France	Institut Paoli-Calmettes	Marseille	Bouches-du-Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate post operative pains	consumption of analgesic for pains in immediate operating comment	Up to 1 month	No
Primary	Court term post operative pains	consumption of analgesic for pains	Up to 2 month	No
Primary	Medium term post operative pains	consumption of analgesic for pains	Up to 3 month	No
Secondary	Complications per operating	Blood loss	During surgery	No
Secondary	Complications per operating	Addition of trocar	During surgery	No
Secondary	Complications post operating	Duration of hospitalization	Up to 1 month	No