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

NCT05271877 | Unknown DMC

• 1 other identifier: LAPRE-1
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy Related; Laparoscopy

Keywords

Pregnancy; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Intraoperative complication

  Any complication during laparoscopy

  From the beginning to the end of laparoscopy

Study Arms (1)

Pregnant women

Pregnant women, regardless of the gestational age.

Procedure: Laparoscopy

Interventions

Laparoscopy PROCEDURE

Diagnostic/operative laparoscopic procedure

Pregnant women

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women undergoing laparoscopy

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Antonio Simone Laganà, M.D., Ph.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Simone Laganà, M.D., Ph.D.

CONTACT

3296279579; antoniosimone.lagana@uninsubria.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Ph.D.

Study Record Dates

• First Submitted: February 27, 2022
• First Posted: March 9, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: March 9, 2022

Record last verified: 2022-02