Pregnancy RelatedNCT05271877
Evaluation of Surgical and Obstetric Outcomes in Pregnant Women Undergoing Operative Laparoscopy
An observational study of Pregnancy Related and Laparoscopy, run by Università degli Studi dell'Insubria.
Trial summary
Laparoscopy, when applicable, is the current gold standard management for abdominal and pelvic surgery. Although accumulating evidence suggests that laparoscopy is associated with reduced intraoperative and postoperative morbidity, reduced hospital stay, better recovery and cosmesis compared with open surgery… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy Related, Laparoscopy
- What is being tested?
- Laparoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Dec 2024
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women undergoing laparoscopy
Who may be able to join
- Pregnant women (regardless of gestational age)
- At least one indication for laparoscopic surgery
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
Laparoscopy, when applicable, is the current gold standard management for abdominal and pelvic surgery. Although accumulating evidence suggests that laparoscopy is associated with reduced intraoperative and postoperative morbidity, reduced hospital stay, better recovery and cosmesis compared with open surgery (laparotomy), the use of this technique in pregnant women is still debated. Considering this point, we aimed to collect retrospectively cases of laparoscopic surgery during pregnancy, regardless of the indication and gestational age, in order to analyze both surgical and obstetric outcomes during and after the procedure.
- Conditions
- Pregnancy Related, Laparoscopy
- Being tested
- Laparoscopy
- Keywords
- Pregnancy, Laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyProcedure or surgery
Diagnostic/operative laparoscopic procedure
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Pregnant women, regardless of the gestational age. Receives: Procedure: Laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative complication
Any complication during laparoscopy
Measured: From the beginning to the end of laparoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study startDec 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Simone Laganà, Università degli Studi dell'Insubria
- Investigators
- Antonio Simone Laganà, M.D., Ph.D., Principal investigator, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271877
- Sponsor's protocol ID
- LAPRE-1
- Status last verified
- Feb 2022
- First submitted
- 27 Feb 2022
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surgical and Obstetric Outcomes in Pregnant Women Undergoing Operative Laparoscopy
- ClinicalTrials.gov ID
- NCT05271877
- Acronym / sponsor ID
- LAPRE-1
- Conditions
- Pregnancy Related, Laparoscopy
- Keywords
- Pregnancy, Laparoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Mar 2022 (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.
Laparoscopy, when applicable, is the current gold standard management for abdominal and pelvic surgery. Although accumulating evidence suggests that laparoscopy is associated with reduced intraoperative and postoperative morbidity, reduced hospital stay, better recovery and cosmesis compared with open surgery (laparotomy), the use of this technique in pregnant women is still debated. Considering this point, we aimed to collect retrospectively cases of laparoscopic surgery during pregnancy, regardless of the indication and gestational age, in order to analyze both surgical and obstetric outcomes during and after the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Procedure: LaparoscopyPregnant women, regardless of the gestational age. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women undergoing laparoscopy
Key inclusion criteria (2 listed)
- Pregnant women (regardless of gestational age)
- At least one indication for laparoscopic surgery
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| LaparoscopyDiagnostic/operative laparoscopic procedure | Procedure or surgery | Pregnant women |
Primary outcome
Intraoperative complication
Time frame: From the beginning to the end of laparoscopy
Any complication during laparoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- 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.
Antonio Simone Laganà, M.D., Ph.D. principal investigator
Università degli Studi dell'Insubria
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Laparoscopy, run by Università degli Studi dell'Insubria.
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 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: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Antonio Simone Laganà, M.D., Ph.D. (3296279579, antoniosimone.lagana@uninsubria.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative complication (time frame: From the beginning to the end of laparoscopy). 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 9 Mar 2022.