NCT02612818|Unknown
Prevention of Adhesions During Celioscopy for Endometriosis. Impact of the Use of Anti-adhesion Treatment on Clinical Signs and Fertility at One Year
ENDHY
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ENDHY
Sponsor study identifier
observational
364
1 country
1
Study Start
November 24, 2015
Actual (reported)Primary Completion
July 2018
Actual (reported)Study Completion
May 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Thus is a longitudinal, prospective, multicentric observational study performed in mainland France, among a sample of gynaecology surgeons practising at endometriosis "expert" centres. The aim of this study is to describe, under real treatment conditions in patients suffering from endometriosis, the impact of the use of anti-adhesion treatment during celioscopy surgery on the development of clinical signs in the patients and their fertility at one year.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 20, 2015
Actual (reported)November 24, 2015
Actual (reported)November 24, 2015
Actual (reported)July 2018
Actual (reported)May 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change on the clinical signs
The clinical change will be established after one year via the pain symptomatology reported by the patient, the rate of relapse (re-hospitalisation) and the rate of any eventual complications from the celioscopy (adhesions, etc.).
At 2 months and one year after the baseline visit (i.e. celioscopy)
Fertility
rate of pregnancy women
One year after the baseline visit (i.e. celioscopy)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Subsequent patients of procreation age having undergone a cœlioscopy for endometriosis, for whom a spontaneous pregnancy is possible, whether or not they wish to become pregnant immediately, and meeting all of the selection criteria will be included in the study.
Nordic Pharma
Paris, 75007, France
Hélène HERMAN-DEMARS, MD
Nordic Pharma
364 participants (actual enrollment reported by the registry).
First Submitted
November 20, 2015
First Posted
November 24, 2015
Study Start
November 24, 2015
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 2018
Actual (reported)Study Completion
May 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 1, 2018
Record last verified: 2017-07
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Source: ClinicalTrials.gov.
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