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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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