Effect of Salpingectomy During Conservative Hysterectomy
Conditions
Genital Diseases, Female - Hysterotomy; Affecting Fetus - Leiomyomata Uteri - Adenomyosis, Endometriosis - Dysfunctional Uterine Bleeding - Cervical Dysplasia - Uterine Prolapse
Conditions: official terms
Adenomyosis - Cervical Intraepithelial Neoplasia - Endometriosis - Genital Diseases, Female - Metrorrhagia - Uterine Cervical Dysplasia - Uterine Hemorrhage - Uterine Prolapse
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Intervention
Name: conservative hysterectomy I Type: Procedure
Name: Conservative hysterectomy II Type: Procedure
Overall Status
Recruiting
Summary
The study compares the effect of bilateral salpingectomy associated with conservative hysterectomy on ovarian function to the standard hysterectomy with conservation of both ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation, complications, quality of life.
Detailed Description
Hysterectomy is one of the most common gynecologic procedures performed in clinical practice. In this study we focused on non menopausal patients under 52 years having hysterectomies for benign disease : uterine leiomyomas, adenomyosis, endometriosis, dysfunctional uterine bleeding, genital prolapse, cervical dysplasia... with failure of conservative treatment.

the standard procedure during hysterectomy with conservation of the ovaries has been the preservation of fallopian tubes with the clamps placed as close to the uterine corpus as possible. this is suggested to decrease interference with the vascular structures in the mesosalpinx and mesovarium. however it is unclear whether tubal conservation at the time of hysterectomy has any influence on ovarian blood flow or ovarian reserve. another point to be considered is the occurrence of post-hysterectomy carcinoma in the preserved fallopian tube, theoretically, these cases could be prevented if tubal excision is performed during hysterectomy The study compares the effect of bilateral salpingectomy associated with conservative hysterectomy on ovarian function to the standard hysterectomy with conservation of both ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation, complications, quality of life.

impact of treatments on ovarian reserve are tested by measuring AMH at baseline and 3 days, 6 weeks and 6, 12 months after surgeries.

quality of life is also assessed at these time points, with a questionnaire (Women Health Questionnaire WHQ).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 52 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- age ≥ 18 years and less than 52 years

- indication of a conservative hysterectomy for benign disease

- signed informed consent

- non menopausal women (AMH >0,21 ng/ml)

Exclusion Criteria:

- pregnancy

- desire of future pregnancy

- menopausal status

- patient unable to give informed consent

- any physical or psychiatric condition that could impair with patient's ability to cooperate with post operative data collection

- previous salpingo and /or oophorectomy (unilateral or bilateral)

- genital cancer disease or atypical endometrial hyperplasia

- hyperandrogenia

- any ovarian mass that needs surgical exploration

- any immunotherapy that could interfere with immunological tests
Locations
CHU
Angers, France
Status: Recruiting
Contact: Philippe DESCAMPS, MD - (33) 2 41 35 48 99 - phdescamps@chu-angers.fr
CHU
Kremlin Bicetre, France
Status: Active, not recruiting
CHU
Lille, France
Status: Recruiting
Contact: Geraldine GIRAUDET, MD - (33) 3.20.44.66.38 - Geraldine.GIRAUDET@CHRU-LILLE.FR
Hôpital Sud
Lyon, France
Status: Recruiting
Contact: François GOLFIER, PhD - (33) 4.78.86.41.79 - francois.golfier@chu-lyon.fr
Hôpital St Joseph
Paris, France
Status: Withdrawn
CHU
Poitiers, France
Status: Recruiting
Contact: Xavier FRITEL, PhD - (33) 5 49 44 33.60 - xavier.fritel@univ-poitiers.fr
CHU
Rennes, France
Status: Recruiting
Contact: Jean LEVEQUE, MD - (33) 2 99 26 71 71 - jean.leveque@chu-rennes.fr
CHU
Tours, France
Status: Recruiting
Contact: Lobna OULDAMER, MD - (33) 2.47.47.48.44 - l.ouldamer@chu-tours.fr
Start Date
July 2012
Completion Date
October 2017
Sponsors
University Hospital, Tours
Source
University Hospital, Tours
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page