Laparoscopic Versus Open Appendectomy in Pregnancy

Completed

• Conditions: Appendicitis; Pregnancy Loss; Pregnancy Preterm
• Interventions: Procedure: Appendectomy

• Registration Number: NCT05430633
• Lead Sponsor: North Estonia Medical Centre

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.

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 Timeline

• Study Start: 2021-11-01
• Status Verified: 2022-06
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Study First Submitted: 2022-06-12
• Study First Submitted QC: 2022-06-18
• Last Update Submitted: 2022-06-18
• Study First Posted: 2022-06-24
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 109

Inclusion Criteria

Women with confirmed pregnancy who underwent appendectomy for acute appendicitis.

Exclusion Criteria

Women who were not pregnant when having an appendectomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant patients who underwent open appendectomy	Appendectomy	Pregnant patients who underwent open appendectomy
Pregnant patients who underwent laparoscopic appendectomy	Appendectomy	Pregnant patients who underwent laparoscopic appendectomy

Primary Outcome Measures

Name	Time	Method
Obstetrical outcomes	Pregnancy loss within 9 months from appendectomy	Pregnancy loss (fetal demise) - rate of cessation of pregnancy before scheduled delivery

Secondary Outcome Measures

Name	Time	Method
Surgical outcomes	30 days after appendectomy	Surgical complications - rate of infectious complications within 30 days after appendectomy

Trial Locations

Locations (1)

North Estonia Medical Centre; 🇪🇪 Tallin, Estonia