Evaluation of Surgical and Obstetric Outcomes in Pregnant... | NCT05271877

Studies
Evaluation of Surgical and Obstetric Outcomes in Pregnant Women Undergoing Operative Laparoscopy

NCT05271877

Sponsor

Università degli Studi dell'Insubria

Status

Unknown status

Last Update Posted

Mar 9, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Pregnancy Related
Laparoscopy

Interventions

Laparoscopy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2022Estimated

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Feb 27, 2022

First Submission Date that Met QC Criteria

Feb 27, 2022

First Posted Date

Mar 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2022

Last Update Posted Date

Mar 9, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Antonio Simone Laganà, M.D. Ph.D., Università degli Studi dell'InsubriaPrincipal Investigator

Lead Sponsor

Università degli Studi dell'InsubriaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 (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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnant women		Pregnant women, regardless of the gestational age.	Procedure: Laparoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopy	Procedure	Diagnostic/operative laparoscopic procedure	Pregnant women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intraoperative complication	Any complication during laparoscopy	From the beginning to the end of laparoscopy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women (regardless of gestational age)
At least one indication for laparoscopic surgery

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Pregnant women undergoing laparoscopy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Antonio Simone Laganà, M.D., Ph.D.	Contact	3296279579		antoniosimone.lagana@uninsubria.it

Overall Officials

Name	Affiliation	Role
Antonio Simone Laganà, M.D., Ph.D.	Università degli Studi dell'Insubria	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010535	Laparoscopy

Ancestor Terms

ID	Term
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided