Does the removal of the tubes at the time of surgery for removal of the uterus, cause a decrease in the ovarys function

Phase 3

Not yet recruiting

Conditions: Other intraoperative and postprocedural complications and disorders of genitourinary system,

Registration Number: CTRI/2020/07/026409

Lead Sponsor: Internal fluid major research grant

Brief Summary: Ovariancancer is one of the commonest gynecological cancers among women, presenting at an advanced stage andtherefore having a poor prognosis, with a low 5 year survival rate. This is due to the fact that thereare no adequate screening techniques available for the detection of ovariancancer.

Of late,the fallopian tube is thought to be either the site of the primary cancer orthe conduit for the carcinogens or neoplastic cells

There isevidence to show that in women who had previously undergone a tubal ligation,there is a decreased risk of ovarian cancer in later life. In addition, pathological examination offallopian tubes in high risk women who underwent a prophylactic risk reducingbilateral salpingo-oophorectomy showed precancerous lesions in the fallopiantube and not in the ovary. This forms the basis foropportunistic salpingectomy where both the fallopian tubes are removed (totallyor partially) in patients who are undergoing pelvic surgery for benignconditions thereby decreasing their risk of ovarian cancer in later life.

Thecurrent dilemma among gynecologists is whether an opportunistic salpingectomycauses damage to ovarian blood supply and there-by decreasing itsfunction. We intend to study the same,by randomizing patients planned for hysterectomy for benign conditions into twogroups, one with a salpingectomy and the other without, and assessing theirovarian function by comparing the difference in FSH levels at six months to oneyear post-operatively. FSH levels increase due to loss of negative feedbackfrom ovarian hormones. The correlation of an increased FSH and menopausaltransition have been well studied previously. We will be using FSH as asurrogate marker for ovarian hormone production.

We hopeto show that there will not be a significant difference between the two groups andthus we can offer this procedure to more patients without concern ofcompromising ovarian function.

Methodology:Patients planned for hysterectomy will be informed about the nature of thestudy and consenting patients will be recruited. A blood sample will be sentfor analysis of FSH value. Once the patient reaches the operating theater, shewill randomly be allotted to either arm of the study via block randomizationand using opaque sealed envelopes which will be kept locked inside theoperation theater. Intra-operatively, the following details will be collectedby the surgical team: total duration of surgery, duration of onlysalpingectomy, estimated total blood loss, estimated blood loss duringsalpingectomy alone, cold knife or cautery used for salpingectomy,intra-operative complications due to salpingectomy or failure of intendedsurgery due to salpingectomy. If patient is in the intervention arm and totalsalpingectomy is not possible, a partial salpingectomy (removal of a part ofthe tube) will be done. If this as well is not possible, the procedure will beabandoned and the patient will no longer be a part of the study. If patient isin the control arm and intra-operatively is found to have an abnormality of thefallopian tubes or ovaries, they may be removed and the patient will no longerbe a part of the study.

Prior todischarge, patient will be asked to follow up after six months to one year witha repeat FSH value and at the time they will be interviewed for symptoms of hotflushes or genitourinary symptoms.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 240

Inclusion Criteria

Women above 35 years of age 2.
Benign uterine pathology 3.
No adnexal pathology diagnosed pre or intra operatively 4.
Planned for hysterectomy via laparoscopic, vaginal or abdominal approach.

Exclusion Criteria

1.High risk for ovarian cancer 2.Endometriosis 3.On hormonal replacement within two weeks of surgery 4.Post-menopausal 5.Not willing to consent for the study 6.Intraoperatively unable to perform total or partial salpingectomy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure the difference in ovarian steroidogenesis in terms of FSH, between patients who have an opportunistic salpingectomy versus those who do not, at six months to one year post-operatively.	Six months to one year postoperatively

Secondary Outcome Measures

Name	Time	Method
Duration of entire surgery and salpingectomy time	At completion of surgery
Intra-operative blood loss - total and due to salpingectomy	At completion of surgery
Difference in FSH based on method of salpingectomy (cold knife vs cautery)	Six months to one year postoperatively
Intraoperative complication due to salpingectomy	-Major vessel, urinary tract, bowel or other severe injury during surgery
Failure of intended surgery due to salpingectomy	-Conversion from laparoscopy or vaginal hysterectomy to laparotomy

Trial Locations

Locations (1): Christian Medical College Hospital
🇮🇳
Vellore, TAMIL NADU, India
Christian Medical College Hospital
🇮🇳Vellore, TAMIL NADU, India
Nitin Alexander Abraham
Principal investigator
9940961456
abraham.nitin28@gmail.com