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NCT05430633 Clinical Trial

Laparoscopic Versus Open Appendectomy in Pregnancy

Appendicitis Clinical Trial

Official title:
Laparoscopic Versus Open Appendectomy in Pregnancy. 10 Year Results of Estonian Population.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05430633
Other study ID # 345T-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date June 1, 2022

Study information
Verified date June 2022
Source North Estonia Medical Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 109
Est. completion date June 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Appendectomy
Appendectomy - laparoscopic or open

Locations
Country Name City State
Estonia North Estonia Medical Centre Tallin

Sponsors (1)
Lead Sponsor Collaborator
North Estonia Medical Centre

Country where clinical trial is conducted

Estonia, 

References & 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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Obstetrical outcomes Pregnancy loss (fetal demise) - rate of cessation of pregnancy before scheduled delivery Pregnancy loss within 9 months from appendectomy
Secondary Surgical outcomes Surgical complications - rate of infectious complications within 30 days after appendectomy 30 days after appendectomy
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Completed NCT04365491 - European Society for Trauma and Emergency Surgery (ESTES) Cohort Study Snapshot Audit 2020 - Acute Appendicitis
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Completed NCT02507674 - Point of Care 3D Ultrasound for Pediatric Appendicitis: a Pilot Study
Active, not recruiting NCT01718275 - Non-operative Management of Early Appendicitis in Children
Terminated NCT01575028 - Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies Phase 2