Effect of Salpingectomy During Conservative Hysterectomy (SALPINGOVA)

This study is currently recruiting participants.
Verified July 2012 by University Hospital, Tours
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01628432
First received: June 22, 2012
Last updated: October 29, 2013
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628432

Contacts
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

Locations
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         
Sponsors and Collaborators
University Hospital, Tours
Investigators
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: October 29, 2013
Health Authority: France: 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 April 15, 2014