NCT05430633

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 24, 2022

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

7 months

First QC Date

June 12, 2022

Last Update Submit

June 18, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Obstetrical outcomes

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

    Pregnancy loss within 9 months from appendectomy

Secondary Outcomes (1)

  • Surgical outcomes

    30 days after appendectomy

Study Arms (2)

Pregnant patients who underwent laparoscopic appendectomy

Pregnant patients who underwent laparoscopic appendectomy

Procedure: Appendectomy

Pregnant patients who underwent open appendectomy

Pregnant patients who underwent open appendectomy

Procedure: Appendectomy

Interventions

AppendectomyPROCEDURE

Appendectomy - laparoscopic or open

Pregnant patients who underwent laparoscopic appendectomyPregnant patients who underwent open appendectomy

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population consists of pregnant women who were pregnant during appendectomy confirmed either before or after the surgical procedure. The population was derived from the billing information from years 2010-2020 of the national health insurance fund of Estonia.

You may qualify if:

  • Women with confirmed pregnancy who underwent appendectomy for acute appendicitis.

You may not qualify if:

  • Women who were not pregnant when having an appendectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Estonia Medical Centre

Tallinn, Estonia

Location

Related Publications (3)

  • Lee SH, Lee JY, Choi YY, Lee JG. Laparoscopic appendectomy versus open appendectomy for suspected appendicitis during pregnancy: a systematic review and updated meta-analysis. BMC Surg. 2019 Apr 25;19(1):41. doi: 10.1186/s12893-019-0505-9.

    PMID: 31023289BACKGROUND
  • Prodromidou A, Machairas N, Kostakis ID, Molmenti E, Spartalis E, Kakkos A, Lainas GT, Sotiropoulos GC. Outcomes after open and laparoscopic appendectomy during pregnancy: A meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2018 Jun;225:40-50. doi: 10.1016/j.ejogrb.2018.04.010. Epub 2018 Apr 9.

    PMID: 29656140BACKGROUND
  • Zeng Q, Aierken A, Gu SS, Yao G, Apaer S, Anweier N, Wu J, Zhao JM, Li T, Tuxun T. Laparoscopic Versus Open Appendectomy for Appendicitis in Pregnancy: Systematic Review and Meta-Analysis. Surg Laparosc Endosc Percutan Tech. 2021 May 3;31(5):637-644. doi: 10.1097/SLE.0000000000000943.

    PMID: 33935257BACKGROUND

MeSH Terms

Conditions

Appendicitis

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, general surgeon, MD

Study Record Dates

First Submitted

June 12, 2022

First Posted

June 24, 2022

Study Start

November 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

June 24, 2022

Record last verified: 2022-06

Locations