EndometriosisNCT03353935
Functional Outcomes After Nerve Sparing Surgery for Deep Endometriosis
An observational study of Endometriosis, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
Patients who underwent surgery for deep endometriosis were submitted to procedures aiming at sparing the pelvic autonomic nervous system. They were observed prospectively followed and interviewed in order to evaluate functional outcomes after surgery. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Validated questionnaires
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Mar 2017
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Study population: All patients undergoimg nerve-sparing surgery for deep endometriosis were enrolled if they were operated by a single surgeon with extensive background in minimally-invasive pelvic surgery.
Who may be able to join
- Deep endometriosis
- Surgical treatment
- Single surgeon
Who cannot join
- Lost to follow-up
- unwillingness to answer the interview
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Obstetrics and Gynecology Universita' Dell'Insubria
Varese, 21100
About this study
Official title: Functional Outcomes of Nerve-sparing Laparoscopic Eradication of Deep Infiltrating Endometriosis: a Prospective Analysis Using Validated Questionnaires
Patients who underwent surgery for deep endometriosis were submitted to procedures aiming at sparing the pelvic autonomic nervous system. They were observed prospectively followed and interviewed in order to evaluate functional outcomes after surgery.
Read the detailed description
Surgical tretament for deep endometriosis can produce lesions at the level of the pelvic autonomic system.
Before surgery and 3-12 months after the nerve-sparing surgical procedures, patients were assessed for urinary, sexual and fecal function, in order to evaluate whether sparing of the nerves during the intervention had a beneficial impact on post-operative pelvic function.
- Conditions
- Endometriosis
- Being tested
- Validated questionnaires
- Keywords
- surgery, pelvic function
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validated questionnairesOther
Patients were administered pre- and post-operatively the three validated questionnaires ((FSFI, ICIQ-UI short form Italian, NBD score) investigating sexual, urinary, and fecal function, respectively.
| Study group | Role | What they receive |
|---|---|---|
| NERVE SPARING | Patients who underwent surgery for deep endometriosis were submitted to surgical procedures aiming at sparing the pelvic ortho- and parasympathetic nerves. The subjects were then followed with interviews using validated questionnaires, to assess the possible changes in post-operative urinary sexual and fecal function. Receives: Other: Validated questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic function
Any change in urinary, sexual or fecal function after surgery, compared to pre-operatively
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study startJan 2016
- Primary completionMar 2017
- Study completionMar 2017
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Uccella, Università degli Studi dell'Insubria
- Investigators
- Stefano Uccella, Principal investigator, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353935
- Sponsor's protocol ID
- 630
- Status last verified
- Nov 2017
- First submitted
- 21 Nov 2017
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes of Nerve-sparing Laparoscopic Eradication of Deep Infiltrating Endometriosis: a Prospective Analysis Using Validated Questionnaires
- ClinicalTrials.gov ID
- NCT03353935
- Acronym / sponsor ID
- 630
- Conditions
- Endometriosis
- Keywords
- surgery, pelvic function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 27 Nov 2017 (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.
Patients who underwent surgery for deep endometriosis were submitted to procedures aiming at sparing the pelvic autonomic nervous system. They were observed prospectively followed and interviewed in order to evaluate functional outcomes after surgery.
Detailed description
Surgical tretament for deep endometriosis can produce lesions at the level of the pelvic autonomic system.
Before surgery and 3-12 months after the nerve-sparing surgical procedures, patients were assessed for urinary, sexual and fecal function, in order to evaluate whether sparing of the nerves during the intervention had a beneficial impact on post-operative pelvic function.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NERVE SPARING | – | Other: Validated questionnairesPatients who underwent surgery for deep endometriosis were submitted to surgical procedures aiming at sparing the pelvic ortho- and parasympathetic nerves. The subjects were then followed with interviews using validated questionnaires, to assess the possible changes in post-operative urinary sexual and fecal function. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients undergoimg nerve-sparing surgery for deep endometriosis were enrolled if they were operated by a single surgeon with extensive background in minimally-invasive pelvic surgery.
Key inclusion criteria (3 listed)
- Deep endometriosis
- Surgical treatment
- Single surgeon
Key exclusion criteria (2 listed)
- Lost to follow-up
- unwillingness to answer the interview
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 |
|---|---|---|
| Validated questionnairesPatients were administered pre- and post-operatively the three validated questionnaires ((FSFI, ICIQ-UI short form Italian, NBD score) investigating sexual, urinary, and fecal function, respectively. | Other | NERVE SPARING |
Primary outcome
Pelvic function
Time frame: 6-12 months
Any change in urinary, sexual or fecal function after surgery, compared to pre-operatively
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 27 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Stefano Uccella principal investigator
Università degli Studi dell'Insubria
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 Università degli Studi dell'Insubria 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: finished, as of the sponsor's last update on 27 Nov 2017. 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?
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?
Pelvic function (time frame: 6-12 months). 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 27 Nov 2017.