Does salpingectomy during a hysterectomy cause POF? Secundary: what is the incidence of premalignant changes within Fallopian tubes of women without a hereditary high risk to develop serous carcinoma?
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
concentration AMH, FSH and oestradiol pre- and six months postoperatively.
Does a salpingectomy during hysterectomy for benign indications change hormonal
status significantly, indicating a shift towards menopausal status?
Secondary outcome
What is the incidence of premalignancies in Fallopian tubes from women not at
hereditary high risk to develop serous carcinomas? Is there a difference in
quality of life (QoL) between the two groups?
Background summary
recent studies in women at hereditary high risk to develop ovarian cancer
indicate that high grade serous carcinomas arise from (ectopic and dysplastic)
tubal epithelium. Historically, in pre-menopausal women undergoing a
hysterectomy for benign indications (such as bleeding disorders, fibroids and
adenomyosis) adnexa, including the Fallopian tubes, are usually left in situ.
However removing the tubes during a hysterectomy potentially prevents the
development of serous ovarian carcinomas. Such a simple preventive procedure
should avoid serious adverse effects of adnexectomy, like premature ovarian
failure (POF).
Study objective
Does salpingectomy during a hysterectomy cause POF? Secundary: what is the
incidence of premalignant changes within Fallopian tubes of women without a
hereditary high risk to develop serous carcinoma?
Study design
This is a randomised controlled trial in which will be randomised between
salpingectomy or no salpingectomy during a hysterectomy for benign indication.
Intervention
One group will undergo a regular hysterectomy only (either vaginal, abdominal
or laparoscopically) (=control group). The other group will receive a regular
hysterectomy including a bilateral salpingectomy (case group).
Study burden and risks
preoperative: two extra blood fials (2 x 5 ml). Six months post operative:
extra visit for two fials blood (2 x 5ml). It might be that in the groups of
women that receive a salpingectomy the risk of serous carcinomas is diminished.
Dr. Deelenlaan 5
Tilburg 5042 AD
NL
Dr. Deelenlaan 5
Tilburg 5042 AD
NL
Listed location countries
Age
Inclusion criteria
Otherwise healthy women undergoing hysterectomy for benign indications (eg. bleeding disorder, fibroids, adenomyosis) without a family history of ovarian / tubal / breast cancer, will be asked to participate.
Exclusion criteria
Family history of cancer, history of any form of cancer
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39317.028.12 |