CTRI Number |
CTRI/2020/07/026409 [Registered on: 07/07/2020] Trial Registered Prospectively |
Last Modified On: |
04/07/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Does the removal of the tubes at the time of surgery for removal of the uterus, cause a decrease in the ovarys function |
Scientific Title of Study
|
Is opportunistic salpingectomy in premenopausal women detrimental to ovarian steroidogenesis? A randomised control trial. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Nitin Alexander Abraham |
Designation |
Pg Registrar |
Affiliation |
Christian Medical College |
Address |
Department of Obstetrics and Gynecology Unit 1,
Christian Medical College Hospital, Vellore
Vellore TAMIL NADU 632004 India |
Phone |
9940961456 |
Fax |
|
Email |
abraham.nitin28@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Elsy Thomas |
Designation |
Professor |
Affiliation |
Christian Medical College |
Address |
Department of Obstetrics and Gynecology Unit 1,
Christian Medical College Hospital, Vellore
Vellore TAMIL NADU 632002 India |
Phone |
9442413900 |
Fax |
|
Email |
et@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
Name |
Nitin Alexander Abraham |
Designation |
Pg Registrar |
Affiliation |
Christian Medical College |
Address |
Department of Obstetrics and Gynecology Unit 1,
Christian Medical College Hospital, Vellore
Vellore TAMIL NADU 632004 India |
Phone |
9940961456 |
Fax |
|
Email |
abraham.nitin28@gmail.com |
|
Source of Monetary or Material Support
|
Internal/Fluid major research grant, Christian Medical College Hospital, Vellore, Tamil Nadu, Pin 632004 |
|
Primary Sponsor
|
Name |
Internal fluid major research grant |
Address |
Christian Medical College Hospital, Vellore, Tamil Nadu, Pin 632004 |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Nitin Alexander Abraham |
Christian Medical College Hospital |
Department of Obstetrics and Gynecology, Division of Unit 1 and Unit 2, Outpatient department and inpatient ward, Vellore, Tamil Nadu, 632004. Vellore TAMIL NADU |
9940961456
abraham.nitin28@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Review Board of Christian Medical College, Vellore |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Hysterectomy with salpingectomy (Intervention arm) |
Patient meeting inclusion criteria and randomized to intervention arm will undergo hysterectomy via any route along with bilateral partial or total salpingectomy. |
Comparator Agent |
Hysterectomy without salpingectomy (Control arm) |
Patients meeting inclusion criteria and randomized to control arm will undergo hysterectomy via any route without salpingectomy. |
|
Inclusion Criteria
|
Age From |
35.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Female |
Details |
1. 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 |
|
ExclusionCriteria |
Details |
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 |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
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
|
Outcome |
TimePoints |
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 |
At completion of surgery |
Failure of intended surgery due to salpingectomy
-Conversion from laparoscopy or vaginal hysterectomy to laparotomy |
At completion of surgery |
|
Target Sample Size
|
Total Sample Size="240" Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
|
13/07/2020 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Ovarian
cancer is one of the commonest gynecological cancers among women, presenting at an advanced stage and
therefore having a poor prognosis, with a low 5 year survival rate. This is due to the fact that there
are no adequate screening techniques available for the detection of ovarian
cancer.
Of late,
the fallopian tube is thought to be either the site of the primary cancer or
the conduit for the carcinogens or neoplastic cells
There is
evidence 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 of
fallopian tubes in high risk women who underwent a prophylactic risk reducing
bilateral salpingo-oophorectomy showed precancerous lesions in the fallopian
tube and not in the ovary. This forms the basis for
opportunistic salpingectomy where both the fallopian tubes are removed (totally
or partially) in patients who are undergoing pelvic surgery for benign
conditions thereby decreasing their risk of ovarian cancer in later life.
The
current dilemma among gynecologists is whether an opportunistic salpingectomy
causes damage to ovarian blood supply and there-by decreasing its
function. We intend to study the same,
by randomizing patients planned for hysterectomy for benign conditions into two
groups, one with a salpingectomy and the other without, and assessing their
ovarian function by comparing the difference in FSH levels at six months to one
year post-operatively. FSH levels increase due to loss of negative feedback
from ovarian hormones. The correlation of an increased FSH and menopausal
transition have been well studied previously. We will be using FSH as a
surrogate marker for ovarian hormone production.
We hope
to show that there will not be a significant difference between the two groups and
thus we can offer this procedure to more patients without concern of
compromising ovarian function.
Methodology:
Patients planned for hysterectomy will be informed about the nature of the
study and consenting patients will be recruited. A blood sample will be sent
for analysis of FSH value. Once the patient reaches the operating theater, she
will randomly be allotted to either arm of the study via block randomization
and using opaque sealed envelopes which will be kept locked inside the
operation theater. Intra-operatively, the following details will be collected
by the surgical team: total duration of surgery, duration of only
salpingectomy, estimated total blood loss, estimated blood loss during
salpingectomy alone, cold knife or cautery used for salpingectomy,
intra-operative complications due to salpingectomy or failure of intended
surgery due to salpingectomy. If patient is in the intervention arm and total
salpingectomy is not possible, a partial salpingectomy (removal of a part of
the tube) will be done. If this as well is not possible, the procedure will be
abandoned and the patient will no longer be a part of the study. If patient is
in the control arm and intra-operatively is found to have an abnormality of the
fallopian tubes or ovaries, they may be removed and the patient will no longer
be a part of the study.
Prior to
discharge, patient will be asked to follow up after six months to one year with
a repeat FSH value and at the time they will be interviewed for symptoms of hot
flushes or genitourinary symptoms. |