EndometriosisNCT04062916
Improvement in Quality of Life and Pain Scores After Laparoscopic Management of Deep Infiltrating Endometriosis
An observational study of Endometriosis, run by Acibadem Fulya Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
This is a retrospective cohort study that evaluates the postoperative pain findings of a consecutive series of laparoscopic surgeries for deep infiltrating endometriosis (DIE). Read more about this study
- Who is it for?
- Ages 22 to 50 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- BSGE pelvic pain questionnaire and VAS scores
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2013to Jun 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 22 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with endometriosis 65 women whose main symptom was pain and who did not respond to medical treatment and underwent endometriosis surgery
Who may be able to join
- Patients with deep infiltration endometriosis and endometrioma diagnosed through bimanual gynecologic examination, gynecologic ultrasound or through laparoscopically confirmed endometrioma and DIE together;
- DIE with bowel involvement that required shaving or segmental resection for colorectal lesions and nodules;
- Who completed the VAS score and BSGE questionnaire;
- Follow-up period of at least 3 months;
- Patients resistant to medical therapy (NSAIDs, OCPs, levonorgestrel-releasing intrauterine device (IUD), and progesterone) or refuse to use medical therapy.
Who cannot join
- Any other endometriosis patient that do no meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
This is a retrospective cohort study that evaluates the postoperative pain findings of a consecutive series of laparoscopic surgeries for deep infiltrating endometriosis (DIE).
Read the detailed description
The study was carried out in university hospitals (Istanbul, Turkey). Patients diagnosed through bimanual gynecologic examination, gynecologic ultrasound or magnetic resonance imaging-confirmed endometrioma and DIE together; who underwent a laparoscopic surgery by a team of gynecologists, colorectal surgeons, and a urologist were retrospectively evaluated. The data were collected in a specific database and analyzed for postoperative pain outcomes through a comparison with preoperative symptoms scored using a visual analogue score (VAS), and the British Society of Gynecologic Endoscopy (BSGE) pelvic pain questionnaire.
- Conditions
- Endometriosis
- Being tested
- BSGE pelvic pain questionnaire and VAS scores
- Keywords
- endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BSGE pelvic pain questionnaire and VAS scoresOther
Patients were evaluated using the BSGE pelvic pain questionnaire in terms of pre-operative and post-operative pain assessment in order to determine the effects of endometriosis surgery on the quality of life. The patients were asked to indicate their levels of dyspareunia, dysmenorrhea, and chronic pelvic pain on a VAS on the pelvic pain questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| women with endometriosis | 65 women whose main symptom was pain and who did not respond to medical treatment and underwent endometriosis surgery Receives: Other: BSGE pelvic pain questionnaire and VAS scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life after endometriosis surgery
Effects of endometriosis surgery on the quality of life by using BSGE pelvic pain questionnaire
Measured: 7 years
Pain levels after endometriosis surgery
Effects of endometriosis surgery on pelvic pain by using VAS scores
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study startJan 2013
- Primary completionMay 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem Fulya Hastanesi
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Ercan Bastu, MSc, MD, Principal investigator, Acibadem Fulya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062916
- Sponsor's protocol ID
- AcibademFulyaHendo
- Status last verified
- Aug 2019
- First submitted
- 16 Aug 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Quality of Life and Pain Scores After Laparoscopic Management of Deep Infiltrating Endometriosis
- ClinicalTrials.gov ID
- NCT04062916
- Acronym / sponsor ID
- AcibademFulyaHendo
- Conditions
- Endometriosis
- Keywords
- endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Acibadem Fulya HastanesiResearch network
- Study start
- Jan 2013 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 20 Aug 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.
This is a retrospective cohort study that evaluates the postoperative pain findings of a consecutive series of laparoscopic surgeries for deep infiltrating endometriosis (DIE).
Detailed description
The study was carried out in university hospitals (Istanbul, Turkey). Patients diagnosed through bimanual gynecologic examination, gynecologic ultrasound or magnetic resonance imaging-confirmed endometrioma and DIE together; who underwent a laparoscopic surgery by a team of gynecologists, colorectal surgeons, and a urologist were retrospectively evaluated. The data were collected in a specific database and analyzed for postoperative pain outcomes through a comparison with preoperative symptoms scored using a visual analogue score (VAS), and the British Society of Gynecologic Endoscopy (BSGE) pelvic pain questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women with endometriosis | – | Other: BSGE pelvic pain questionnaire and VAS scores65 women whose main symptom was pain and who did not respond to medical treatment and underwent endometriosis surgery |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with endometriosis 65 women whose main symptom was pain and who did not respond to medical treatment and underwent endometriosis surgery
Key inclusion criteria (5 listed)
- Patients with deep infiltration endometriosis and endometrioma diagnosed through bimanual gynecologic examination, gynecologic ultrasound or through laparoscopically confirmed endometrioma and DIE together;
- DIE with bowel involvement that required shaving or segmental resection for colorectal lesions and nodules;
- Who completed the VAS score and BSGE questionnaire;
- Follow-up period of at least 3 months;
- Patients resistant to medical therapy (NSAIDs, OCPs, levonorgestrel-releasing intrauterine device (IUD), and progesterone) or refuse to use medical therapy.
Key exclusion criteria (1 listed)
- Any other endometriosis patient that do no meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BSGE pelvic pain questionnaire and VAS scoresPatients were evaluated using the BSGE pelvic pain questionnaire in terms of pre-operative and post-operative pain assessment in order to determine the effects of endometriosis surgery on the quality of life. The patients were asked to indicate their levels of dyspareunia, dysmenorrhea, and chronic pelvic pain on a VAS on the pelvic pain questionnaire. | Other | women with endometriosis |
Primary outcome
Quality of Life after endometriosis surgery
Time frame: 7 years
Effects of endometriosis surgery on the quality of life by using BSGE pelvic pain questionnaire
Pain levels after endometriosis surgery
Time frame: 3 years
Effects of endometriosis surgery on pelvic pain by using VAS scores
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 20 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
Ercan Bastu, MSc, MD principal investigator
Acibadem Fulya Hospital
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 Endometriosis, run by Acibadem Fulya Hastanesi 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 5 inclusion and 1 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 20 Aug 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?
Quality of Life after endometriosis surgery (time frame: 7 years). 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 20 Aug 2019.