Pelvic PainNCT04652011
Long-term Management of Patients Surgically Treated for Chronic Pelvic Pain by Minimally Invasive Surgery
An observational study of Pelvic Pain, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
Trial summary
It is a retrospective observational study based on the analysis of the medical records of patients treated for chronic pelvic pain and benign gynecological pathologies at the Gynecology Unit of the University Hospital of Modena from 2010 to 2019. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- Minimally Invasive Gynecologic Surgery, osteopathic manipulative treatment and Pain killer
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2019to 1 Jul 2021
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic pelvic pain and a benign gynecologic disease associated, referring to Gynecologic Unit of University Hospital of Modena, who underwent minimally invasive surgery from 2010 to 2019
Who may be able to join
- Underwent Minimally invasive gynecologic surgery from 2010 to 2019
- Chronic pelvic pain
- Benign gynecologic disease (Endometriosis, myoma, adenomyosis, pelvic organ prolapse
Who cannot join
- malignant gynecologic disease
- chronic pelvic pain not linked to gynecologic disease
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Carlo Alboni
Modena, 41125
Carlo Alboni, MD, PhD, 0594224387, alboni.carlo@aou.mo.it
About this study
Official title: Long-term Management of Patients With Benign Gynecological Pathology and Chronic Pelvic Pain and Follow-up After Minimally Invasive Surgery
It is a retrospective observational study based on the analysis of the medical records of patients treated for chronic pelvic pain and benign gynecological pathologies at the Gynecology Unit of the University Hospital of Modena from 2010 to 2019. The aim of the study is to analyze the effects of medical and surgical treatments on chronic pelvic pain and associated pathologies.
- Conditions
- Pelvic Pain
- Being tested
- Minimally Invasive Gynecologic Surgery, osteopathic manipulative treatment, Pain killer
- Keywords
- Pelvic Pain, Endometriosis, Minimally invasive Surgery
- Medical subject headings
- Pelvic Pain, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Gynecologic SurgeryProcedure or surgery
Minimally Invasive Surgery for gynecologic disease (laparoscopy, robotic surgery, vaginal surgery)
osteopathic manipulative treatmentProcedure or surgery
Osteopathic manipulative treatment
Pain killerDrug
Common pain killer (paracetamol, Ibuprofen, ketoprofen)
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic pelvic pain | Patients with chronic pelvic pain and a benign gynecologic disease associated, referring to our Unit, medically or surgically treated from 2010 to 2019 Receives: Procedure: Minimally Invasive Gynecologic Surgery; Procedure: osteopathic manipulative treatment; Drug: Pain killer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after surgery
Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after surgery
Measured: Baseline and 6 months after surgery
Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after Osteopathic manipulative treatment
Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after Osteopathic manipulative treatment
Measured: Baseline and 6 months after Osteopathic manipulative treatment
Secondary outcomes (3)
Change From Baseline in constipation on the constipation score system (CSS) by Agachan-Wexner at 6 months after surgery
Change From Baseline in constipation on the constipation score system (CSS) by Agachan-Wexner at 6 months after surgery
Measured: Baseline and 6 months after surgery
Analysis of postoperative complications using Clavien-Dindo classification
Analysis of postoperative (1 month after surgery) complications using Clavien-Dindo classification
Measured: 1 month after surgery
Incidence of endometriosis among patients with chronic pelvic pain
Incidence of endometriosis among patients with chronic pelvic pain
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Oct 2019
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Alboni, MD, PhD, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652011
- Sponsor's protocol ID
- 0024582/19
- Status last verified
- Dec 2020
- First submitted
- 16 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I prefer to not share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Management of Patients With Benign Gynecological Pathology and Chronic Pelvic Pain and Follow-up After Minimally Invasive Surgery
- ClinicalTrials.gov ID
- NCT04652011
- Acronym / sponsor ID
- 0024582/19
- Conditions
- Pelvic Pain
- Keywords
- Pelvic Pain, Endometriosis, Minimally invasive Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 3 Dec 2020 (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.
It is a retrospective observational study based on the analysis of the medical records of patients treated for chronic pelvic pain and benign gynecological pathologies at the Gynecology Unit of the University Hospital of Modena from 2010 to 2019. The aim of the study is to analyze the effects of medical and surgical treatments on chronic pelvic pain and associated pathologies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic pelvic pain | – | Procedure: Minimally Invasive Gynecologic Surgery, Procedure: osteopathic manipulative treatment, Drug: Pain killerPatients with chronic pelvic pain and a benign gynecologic disease associated, referring to our Unit, medically or surgically treated from 2010 to 2019 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic pelvic pain and a benign gynecologic disease associated, referring to Gynecologic Unit of University Hospital of Modena, who underwent minimally invasive surgery from 2010 to 2019
Key inclusion criteria (3 listed)
- Underwent Minimally invasive gynecologic surgery from 2010 to 2019
- Chronic pelvic pain
- Benign gynecologic disease (Endometriosis, myoma, adenomyosis, pelvic organ prolapse
Key exclusion criteria (2 listed)
- malignant gynecologic disease
- chronic pelvic pain not linked to gynecologic disease
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 |
|---|---|---|
| Minimally Invasive Gynecologic SurgeryMinimally Invasive Surgery for gynecologic disease (laparoscopy, robotic surgery, vaginal surgery) | Procedure or surgery | Patients with chronic pelvic pain |
| osteopathic manipulative treatmentOsteopathic manipulative treatment | Procedure or surgery | Patients with chronic pelvic pain |
| Pain killerCommon pain killer (paracetamol, Ibuprofen, ketoprofen) | Drug | Patients with chronic pelvic pain |
Primary outcome
Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after surgery
Time frame: Baseline and 6 months after surgery
Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after surgery
Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after Osteopathic manipulative treatment
Time frame: Baseline and 6 months after Osteopathic manipulative treatment
Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after Osteopathic manipulative treatment
3 secondary outcomes
Change From Baseline in constipation on the constipation score system (CSS) by Agachan-Wexner at 6 months after surgery
Time frame: Baseline and 6 months after surgery
Analysis of postoperative complications using Clavien-Dindo classification
Time frame: 1 month after surgery
Incidence of endometriosis among patients with chronic pelvic pain
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Individual participant dataSharing planned: No. I prefer to not share individual participant data
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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.
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 Pelvic Pain, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
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 3 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: status not confirmed, as of the sponsor's last update on 3 Dec 2020. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlo Alboni, MD, PhD (0594224387, alboni.carlo@aou.mo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after surgery (time frame: Baseline and 6 months after surgery). 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 3 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.