NCT03891537

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

March 25, 2019

Last Update Submit

March 26, 2019

Conditions

Keywords

Bilateral Tubal LigationPostoperative Discomforts

Outcome Measures

Primary Outcomes (2)

  • postoperative dysmenorrhea

    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.

    1st year postoperative

  • postoperative dyspareunia

    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.

    1st year postoperative

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • postoperative asymptomatic
  • Additional treatments for pain and complaints

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fallopian Tube DiseasesDysmenorrhea

Condition Hierarchy (Ancestors)

Adnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesMenstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator, M.D, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

March 25, 2019

First Posted

March 27, 2019

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2019

Last Updated

March 28, 2019

Record last verified: 2019-03

Locations