EndometriosisNCT03899935
Laparoscopy for Endometriosis in Obese Patients
An observational study of Endometriosis and Obesity, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Evaluation of surgical outcomes of endometriosis laparoscopic surgery in obese patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Obesity
- What is being tested?
- Laparoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 1,230 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2010to 31 Dec 2016
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Consecutive patients affected by endometriosis undergoing to laparoscopic endometriosis removal.
Who may be able to join
- Obese patients undergoing endometriosis laparoscopic treatment
- Obteined Informed Consensus
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Safety of Endometriosis Laparoscopic Removal in Obese Patients: a Propensity Score Method Analysis
Evaluation of surgical outcomes of endometriosis laparoscopic surgery in obese patients.
Read the detailed description
Obesity may influence surgical variables such as operative time, laparotomic conversion rate and intraoperative and postoperative complication rate. Moreover, it might influence the hospital length of stay. For that reason, the study aims to compare a group of obese patients with a non-obese group of patients about these topics.
- Conditions
- Endometriosis, Obesity
- Being tested
- Laparoscopy
- Keywords
- Endometriosis, Obesity, Laparoscopy
- Medical subject headings
- Endometriosis, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyProcedure or surgery
Laparoscopy for endometriosis
| Study group | Role | What they receive |
|---|---|---|
| Group A: obese patients | Obese patients undergoing laparoscopic surgery for endometriosis Receives: Procedure: Laparoscopy | |
| Group B: non-obese patients | Non-obese patients undergoing laparoscopy for endometriosis Receives: Procedure: Laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Comparison of operative time, expressed in minutes, between Group A and Group B
Measured: Intraoperative: from the skin incision to the skin suture
Secondary outcomes (4)
Laparotomic conversion rate
Comparison of laparotomic conversion rate between Group A and Group B
Measured: Intraoperative
Hospital length of stay
Comparison of hospital length of stay, expressed in days, between Group A and Group B
Measured: Postoperative: from surgery to hospitalization discharge, assessed up to 30 days after surgery.
Intraoperative complication rate
Comparison of intraoperative complication rate between Group A and Group B. Intraoperative complication rate is assessed using Clavien-Dindo Classification (from grade I to V, where I means any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions, and V means the death of a patient)
Measured: Intraoperative
Postoperative complication rate
Comparison of postoperative complication rate between Group A and Group B. Postoperative complication rate is assessed using Clavien-Dindo Classification (from grade I to V, where I means any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions, and V means the death of a patient)
Measured: Postoperative: from surgery to hospitalization discharge, assessed up to 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Jan 2010
- Primary completion30 Nov 2016
- Study completion31 Dec 2016
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.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- 1,230 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Seracchioli, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899935
- Sponsor's protocol ID
- ObesityEndometriosis
- Status last verified
- Aug 2019
- First submitted
- 31 Mar 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Endometriosis Laparoscopic Removal in Obese Patients: a Propensity Score Method Analysis
- ClinicalTrials.gov ID
- NCT03899935
- Acronym / sponsor ID
- ObesityEndometriosis
- Conditions
- Endometriosis, Obesity
- Keywords
- Endometriosis, Obesity, Laparoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,230 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 2 Apr 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.
Evaluation of surgical outcomes of endometriosis laparoscopic surgery in obese patients.
Detailed description
Obesity may influence surgical variables such as operative time, laparotomic conversion rate and intraoperative and postoperative complication rate. Moreover, it might influence the hospital length of stay. For that reason, the study aims to compare a group of obese patients with a non-obese group of patients about these topics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: obese patients | – | Procedure: LaparoscopyObese patients undergoing laparoscopic surgery for endometriosis |
| Group B: non-obese patients | – | Procedure: LaparoscopyNon-obese patients undergoing laparoscopy for endometriosis |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Consecutive patients affected by endometriosis undergoing to laparoscopic endometriosis removal.
Key inclusion criteria (2 listed)
- Obese patients undergoing endometriosis laparoscopic treatment
- Obteined Informed Consensus
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| LaparoscopyLaparoscopy for endometriosis | Procedure or surgery | Group A: obese patients, Group B: non-obese patients |
Primary outcome
Operative time
Time frame: Intraoperative: from the skin incision to the skin suture
Comparison of operative time, expressed in minutes, between Group A and Group B
4 secondary outcomes
Laparotomic conversion rate
Time frame: Intraoperative
Hospital length of stay
Time frame: Postoperative: from surgery to hospitalization discharge, assessed up to 30 days after surgery.
Intraoperative complication rate
Time frame: Intraoperative
Postoperative complication rate
Time frame: Postoperative: from surgery to hospitalization discharge, assessed up to 30 days after surgery.
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 21 Aug 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 Endometriosis and Obesity, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 2 inclusion and 0 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 21 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 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?
Operative time (time frame: Intraoperative: from the skin incision to the skin suture). 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 21 Aug 2019.