Effect of Salpingectomy During Conservative Hysterectomy (SALPINGOVA)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Genital Diseases, Female Hysterotomy; Affecting Fetus Leiomyomata Uteri Adenomyosis, Endometriosis Dysfunctional Uterine Bleeding Cervical Dysplasia Uterine Prolapse |
Procedure: conservative hysterectomy I Procedure: Conservative hysterectomy II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Effect of Total Salpingectomy During Conservative Hysterectomy for Benign Disease on Ovarian Function: Non Inferiority Randomized Controlled Trial |
- percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months) [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- AMH measurement at 3 days, 6 weeks, and 6, 12 months after hysterectomy endovaginal ultrasound evaluation of the ovarian volume and vascularisation quality of life (WHQ questionnaire) reintervention procedures complications [ Time Frame: day3, week 6, month 6 and month 12 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 350 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | November 2016 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: conservative hysterectomy I
bilateral salpingectomy during hysterectomy with conservation of the ovaries
|
Procedure: conservative hysterectomy I
conservative hysterectomy for benign disease
|
|
Active Comparator: conservative hysterectomy II
standard conservative hysterectomy with conservation of both ovaries and tubes
|
Procedure: Conservative hysterectomy II
bilateral salpingectomy during hysterectomy without conservation of the ovaries
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 52 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Lobna OULDAMER, MD | (33)2.47.47.48.44 | l.ouldamer@chu-tours.fr |
| Contact: Catherine FREMONT | (33) 2.18.37.05.35 | fremont@mrd.univ-tours.fr |
| France | |
| CHU | Recruiting |
| Angers, France, 49933 | |
| Contact: Philippe DESCAMPS, MD (33) 2 41 35 48 99 phdescamps@chu-angers.fr | |
| Principal Investigator: Philippe DESCAMPS, MD | |
| Hôpital Sud | Active, not recruiting |
| Lyon, France, 69495 | |
| CHR | Not yet recruiting |
| Orleans, France, 45032 | |
| Contact: Sandrine AVIGDOR, MD (33) 2 38 61 30 59 sandrine.avigdor@chr-orleans.fr | |
| Principal Investigator: Sandrine AVIGDOR, MD | |
| Hôpital St Joseph | Active, not recruiting |
| Paris, France, 75674 | |
| CHU | Recruiting |
| Poitiers, France, 86000 | |
| Contact: Xavier FRITEL, PhD (33) 5 49 44 33.60 xavier.fritel@univ-poitiers.fr | |
| Principal Investigator: Xavier FRITEL, PhD | |
| CHU | Recruiting |
| Rennes, France, 35203 | |
| Contact: Jean LEVEQUE, MD (33) 2 99 26 71 71 jean.leveque@chu-rennes.fr | |
| Principal Investigator: Jean LEVEQUE, MD | |
| CHU | Recruiting |
| Tours, France, 37044 | |
| Contact: Lobna OULDAMER, MD (33) 2.47.47.48.44 l.ouldamer@chu-tours.fr | |
| Contact: Catherine FREMONT (33) 2.18.37.05.35 fremont@med.univ-tours.fr | |
| Sub-Investigator: Henri MARRET, PhD | |
| Sub-Investigator: Thomas HEBERT, MD | |
| Sub-Investigator: Gilles BODY, PhD | |
| Sub-Investigator: Annie JACQUET, MD | |
| Principal Investigator: | Lobna OULDAMER, MD | CHRU de TOURS |
More Information
No publications provided
| Responsible Party: | University Hospital, Tours |
| ClinicalTrials.gov Identifier: | NCT01628432 History of Changes |
| Other Study ID Numbers: | PHRN11/LO/SALPINGOVA |
| Study First Received: | June 22, 2012 |
| Last Updated: | March 29, 2013 |
| Health Authority: | France: L’Agence nationale de sécurité du médicament et des produits de santé |
Additional relevant MeSH terms:
|
Uterine Cervical Dysplasia Cervical Intraepithelial Neoplasia Endometriosis Genital Diseases, Female Hemorrhage Leiomyoma Myofibroma Metrorrhagia Prolapse Uterine Hemorrhage Uterine Prolapse Precancerous Conditions Neoplasms |
Uterine Cervical Diseases Uterine Diseases Carcinoma in Situ Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Pathologic Processes Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Connective Tissue Connective Tissue Diseases Pathological Conditions, Anatomical Pelvic Organ Prolapse |
ClinicalTrials.gov processed this record on May 23, 2013