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

• Sponsor: Università degli Studi dell'Insubria (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05271877
• Collaborator: (none)
• Enrollment: 100
• Anticipated Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related; Laparoscopy	Procedure: Laparoscopy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Evaluation of Surgical and Obstetric Outcomes in Pregnant Women Undergoing Operative Laparoscopy
• Anticipated Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Pregnant women Pregnant women, regardless of the gestational age.	Procedure: Laparoscopy; Diagnostic/operative laparoscopic procedure

Outcome Measures

Primary Outcome Measures

1. Intraoperative complication [From the beginning to the end of laparoscopy]

   Any complication during laparoscopy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pregnant women (regardless of gestational age)

• At least one indication for laparoscopic surgery

Exclusion Criteria:

• None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Università degli Studi dell'Insubria

Investigators

• Principal Investigator: Antonio Simone Laganà, M.D., Ph.D., Università degli Studi dell'Insubria

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Antonio Simone Laganà, M.D. Ph.D., Università degli Studi dell'Insubria
• ClinicalTrials.gov Identifier: NCT05271877
• Other Study ID Numbers: LAPRE-1
• First Posted: Mar 9, 2022
• Last Update Posted: Mar 9, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Antonio Simone Laganà, M.D. Ph.D., Università degli Studi dell'Insubria: Pregnancy; Laparoscopy

Study Results

No Results Posted as of Mar 9, 2022