Laparoscopic Versus Open Appendectomy in Pregnancy

Sponsor
North Estonia Medical Centre (Other)
Overall Status
Completed
CT.gov ID
NCT05430633
Collaborator
(none)
109
1
7
15.6

Study Details

Study Description

Brief Summary

The aim of this retrospective trial is to compare surgical and pregnancy outcomes of pregnant patients who underwent laparoscopic or open appendectomy for acute appendicitis.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Appendectomy

Detailed Description

The aim of this retrospective trial is to compare surgical and pregnancy outcomes of pregnant patients who underwent laparoscopic or open appendectomy for acute appendicitis.

Patients' medical records from 2010-2020 were extracted using billing information of the national health insurance fund of Estonia and ICD-10 codes (pregnancy, appendicitis).

Collected data was stored on RedCap electronic database and analyzed with R Studio.

Two group of patients were compared: pregnant patients who had laparoscopic appendectomy and pregnant patients who had open appendectomy.

Study Design

Study Type:
Observational
Actual Enrollment :
109 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Laparoscopic Versus Open Appendectomy in Pregnancy. 10 Year Results of Estonian Population.
Actual Study Start Date :
Nov 1, 2021
Actual Primary Completion Date :
Jun 1, 2022
Actual Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Pregnant patients who underwent laparoscopic appendectomy

Pregnant patients who underwent laparoscopic appendectomy

Procedure: Appendectomy
Appendectomy - laparoscopic or open

Pregnant patients who underwent open appendectomy

Pregnant patients who underwent open appendectomy

Procedure: Appendectomy
Appendectomy - laparoscopic or open

Outcome Measures

Primary Outcome Measures

  1. Obstetrical outcomes [Pregnancy loss within 9 months from appendectomy]

    Pregnancy loss (fetal demise) - rate of cessation of pregnancy before scheduled delivery

Secondary Outcome Measures

  1. Surgical outcomes [30 days after appendectomy]

    Surgical complications - rate of infectious complications within 30 days after appendectomy

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Inclusion Criteria:

Women with confirmed pregnancy who underwent appendectomy for acute appendicitis.

Exclusion Criteria:

Women who were not pregnant when having an appendectomy

Contacts and Locations

Locations

Site City State Country Postal Code
1 North Estonia Medical Centre Tallin Estonia

Sponsors and Collaborators

  • North Estonia Medical Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Edgar Lipping, Principal investigator, general surgeon, MD, North Estonia Medical Centre
ClinicalTrials.gov Identifier:
NCT05430633
Other Study ID Numbers:
  • 345T-2
First Posted:
Jun 24, 2022
Last Update Posted:
Jun 24, 2022
Last Verified:
Jun 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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 24, 2022