Gynecologic Surgical Procedures for Adnexa Surgery in Ovarian DiseaseANTATROCNCT02885779
Comparison of 2 Techniques of Invasive Mini Surgery: Coelioscopy Mini-trocar and Monotrocar in the Adnexa no Carcinologic Surgery : Forward-looking Observational Study.
An observational study of Gynecologic Surgical Procedures for Adnexa Surgery in Ovarian Disease, run by Institut Paoli-Calmettes at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Surgical Procedures for Adnexa Surgery in Ovarian Disease
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Operating indication of adnexa surgery : unilateral or bilateral adnexectomy
Who may be able to join
- Age > 18 ans
- OMS = 2
- Patient having an operating indication of adnexa surgery : unilateral or bilateral adnexectomy
Who cannot join
- Contraindication to coelioscopy intervention
Trial locations and contacts
1 site in 1 country.
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient having an operating indication of adnexa surgery | Patient having an operating indication of adnexa surgery : unilateral or bilateral adnexectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate post operative pains
consumption of analgesic for pains in immediate operating comment
Measured: Up to 1 month
Court term post operative pains
consumption of analgesic for pains
Measured: Up to 2 month
Medium term post operative pains
consumption of analgesic for pains
Measured: Up to 3 month
Secondary outcomes (3)
Complications per operating
Blood loss
Measured: During surgery
Complications per operating
Addition of trocar
Measured: During surgery
Complications post operating
Duration of hospitalization
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startMay 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic Surgical Procedures for Adnexa Surgery in Ovarian DiseaseStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885779
- Sponsor's protocol ID
- ANTATROC-IPC 2015-011
- Acronym
- ANTATROC
- Status last verified
- Aug 2016
- First submitted
- 18 Aug 2016
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02885779
- Acronym / sponsor ID
- ANTATROC / ANTATROC-IPC 2015-011
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient having an operating indication of adnexa surgery | – | –Patient having an operating indication of adnexa surgery : unilateral or bilateral adnexectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Operating indication of adnexa surgery : unilateral or bilateral adnexectomy
Key inclusion criteria (3 listed)
- Age > 18 ans
- OMS = 2
- Patient having an operating indication of adnexa surgery : unilateral or bilateral adnexectomy
Key exclusion criteria (1 listed)
- Contraindication to coelioscopy intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immediate post operative pains
Time frame: Up to 1 month
consumption of analgesic for pains in immediate operating comment
Court term post operative pains
Time frame: Up to 2 month
consumption of analgesic for pains
Medium term post operative pains
Time frame: Up to 3 month
consumption of analgesic for pains
3 secondary outcomes
Complications per operating
Time frame: During surgery
Complications per operating
Time frame: During surgery
Complications post operating
Time frame: Up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Surgical Procedures for Adnexa Surgery in Ovarian Disease, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate post operative pains (time frame: Up to 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2016.