Tubal ObstructionNCT03891537
Neural Therapy Effect and Bilateral Tubal Ligation
An observational study of Tubal Obstruction and Dysmenorrhea, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Tubal Obstruction, Dysmenorrhea
- How many people
- 113 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2016to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients who had bilateral tubal ligation with modified Pomeroy technique and had complaints such as dysmenorrhea dyspareunia in the first postoperative year
Who may be able to join
- patients who underwent bilateral tubal ligation with modified Pomeroy technique,
- Patients with dysmenore, dyspareunia and menstrual bleeding,
Who cannot join
- postoperative asymptomatic
- Additional treatments for pain and complaints
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 33404
About this study
Official title: Evaluation Of The Neural Therapy Effect On Long Term Postoperative Discomforts İn Patients Who Undergo Bilateral Tubal Ligation
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.
- Conditions
- Tubal Obstruction, Dysmenorrhea
- Keywords
- Bilateral Tubal Ligation, Postoperative Discomforts
- Medical subject headings
- Fallopian Tube Diseases, Dysmenorrhea
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1st year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Jan 2016
- Primary completion1 Jan 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tubal ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891537
- Sponsor's protocol ID
- 2018.10.36
- Status last verified
- Mar 2019
- First submitted
- 25 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Neural Therapy Effect On Long Term Postoperative Discomforts İn Patients Who Undergo Bilateral Tubal Ligation
- ClinicalTrials.gov ID
- NCT03891537
- Acronym / sponsor ID
- 2018.10.36
- Conditions
- Tubal Obstruction, Dysmenorrhea
- Keywords
- Bilateral Tubal Ligation, Postoperative Discomforts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who had bilateral tubal ligation with modified Pomeroy technique and had complaints such as dysmenorrhea dyspareunia in the first postoperative year
Key inclusion criteria (2 listed)
- patients who underwent bilateral tubal ligation with modified Pomeroy technique,
- Patients with dysmenore, dyspareunia and menstrual bleeding,
Key exclusion criteria (2 listed)
- postoperative asymptomatic
- Additional treatments for pain and complaints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tubal Obstruction and Dysmenorrhea, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative dysmenorrhea (time frame: 1st year postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.