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Neural Therapy Effect and Bilateral Tubal Ligation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891537
Recruitment Status : Completed
First Posted : March 27, 2019
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital

Tracking Information
First Submitted Date March 25, 2019
First Posted Date March 27, 2019
Last Update Posted Date March 28, 2019
Actual Study Start Date January 1, 2016
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 26, 2019)
  • postoperative dysmenorrhea [ Time Frame: 1st year postoperative ]
    Postoperative dysmenorrhea in the first postoperative year was evaluated by viscous pain scale (VAS) in patients who underwent bilateral tubal ligation with the modified Pomeroy technique. There is no pain at zero points according to visuel pain scale;Ten points are very severe - unbearable pain. patients will score between one to ten pains.
  • postoperative dyspareunia [ Time Frame: 1st year postoperative ]
    Postoperative dyspareunia in the first postoperative year was evaluated by viscous pain scale (VAS) in patients who underwent bilateral tubal ligation with the modified Pomeroy technique. There is no pain at zero points according to visuel pain scale;Ten points are very severe - unbearable pain. patients will score between one to ten pains.
Original Primary Outcome Measures
 (submitted: March 25, 2019)
  • postoperative dysmenorrhea [ Time Frame: 1st year postoperative ]
    Postoperative dysmenorrhea in the first postoperative year was evaluated by viscous pain scale (VAS) in patients who underwent bilateral tubal ligation with the modified Pomeroy technique. VAS SCORE 0 NO NEVER POINTS, VAS SCORE RECEIVED AS 10 RESISTANT PAINS. PATIENTS RECEIVED POINTS TO BE PAID AND SAVED.
  • postoperative dyspareunia [ Time Frame: 1st year postoperative ]
    Postoperative dyspareunia in the first postoperative year was evaluated by viscous pain scale (VAS) in patients who underwent bilateral tubal ligation with the modified Pomeroy technique. VAS SCORE 0 NO NEVER POINTS, VAS SCORE RECEIVED AS 10 RESISTANT PAINS. PATIENTS RECEIVED POINTS TO BE PAID AND SAVED.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neural Therapy Effect and Bilateral Tubal Ligation
Official Title Evaluation Of The Neural Therapy Effect On Long Term Postoperative Discomforts İn Patients Who Undergo Bilateral Tubal Ligation
Brief Summary

The aim of this study is to evaluate the effect of nebulisation in patients with bilateral tubal ligation in the first postoperative year, the amount of dysmenorrhea, dyspareunia and menstrual bleeding, recurrent vaginitis and cystitis.

A retrospective analysis of bilateral tubal ligation with optional modified Pomeroy technique in the family planning unit and evaluation of the results of patients who underwent Neural Therapy during and postoperatively will be evaluated.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who had bilateral tubal ligation with modified Pomeroy technique and had complaints such as dysmenorrhea dyspareunia in the first postoperative year
Condition
  • Tubal Obstruction
  • Dysmenorrhea
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 25, 2019)
113
Original Actual Enrollment Same as current
Actual Study Completion Date January 1, 2019
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients who underwent bilateral tubal ligation with modified Pomeroy technique,
  • Patients with dysmenore, dyspareunia and menstrual bleeding,

Exclusion Criteria:

  • postoperative asymptomatic
  • Additional treatments for pain and complaints
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03891537
Other Study ID Numbers 2018.10.36
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
Study Sponsor Kanuni Sultan Suleyman Training and Research Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Kanuni Sultan Suleyman Training and Research Hospital
Verification Date March 2019