AppendicitisNCT05430633
Laparoscopic Versus Open Appendectomy in Pregnancy
An observational study of Appendicitis and Pregnancy Loss, run by North Estonia Medical Centre at 1 site in Estonia.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Appendicitis, Pregnancy Loss, Pregnancy Preterm
- What is being tested?
- Appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 109 participants
- Where
- 1 siteEstonia
- Study dates
- 1 Nov 2021to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
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.
Who may be able to join
- Women with confirmed pregnancy who underwent appendectomy for acute appendicitis.
Who cannot join
- Women who were not pregnant when having an appendectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Versus Open Appendectomy in Pregnancy. 10 Year Results of Estonian Population.
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.
Read the 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.
- Conditions
- Appendicitis, Pregnancy Loss, Pregnancy Preterm
- Being tested
- Appendectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppendectomyProcedure or surgery
Appendectomy - laparoscopic or open
| Study group | Role | What they receive |
|---|---|---|
| Pregnant patients who underwent laparoscopic appendectomy | Pregnant patients who underwent laparoscopic appendectomy Receives: Procedure: Appendectomy | |
| Pregnant patients who underwent open appendectomy | Pregnant patients who underwent open appendectomy Receives: Procedure: Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstetrical outcomes
Pregnancy loss (fetal demise) - rate of cessation of pregnancy before scheduled delivery
Measured: Pregnancy loss within 9 months from appendectomy
Secondary outcomes (1)
Surgical outcomes
Surgical complications - rate of infectious complications within 30 days after appendectomy
Measured: 30 days after appendectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Nov 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Estonia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edgar Lipping, North Estonia Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430633
- Sponsor's protocol ID
- 345T-2
- Status last verified
- Jun 2022
- First submitted
- 12 Jun 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31023289Prodromidou 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.
PubMed 29656140Zeng 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.
PubMed 33935257
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Open Appendectomy in Pregnancy. 10 Year Results of Estonian Population.
- ClinicalTrials.gov ID
- NCT05430633
- Acronym / sponsor ID
- 345T-2
- Conditions
- Appendicitis, Pregnancy Loss, Pregnancy Preterm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- North Estonia Medical CentreUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant patients who underwent laparoscopic appendectomy | – | Procedure: AppendectomyPregnant patients who underwent laparoscopic appendectomy |
| Pregnant patients who underwent open appendectomy | – | Procedure: AppendectomyPregnant patients who underwent open appendectomy |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Women with confirmed pregnancy who underwent appendectomy for acute appendicitis.
Key exclusion criteria (1 listed)
- Women who were not pregnant when having an appendectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AppendectomyAppendectomy - laparoscopic or open | Procedure or surgery | Pregnant patients who underwent laparoscopic appendectomy, Pregnant patients who underwent open appendectomy |
Primary outcome
Obstetrical outcomes
Time frame: Pregnancy loss within 9 months from appendectomy
Pregnancy loss (fetal demise) - rate of cessation of pregnancy before scheduled delivery
1 secondary outcome
Surgical outcomes
Time frame: 30 days after appendectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Background: PubMed 31023289Lee 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.
- Background: PubMed 29656140Prodromidou 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.
- Background: PubMed 33935257Zeng 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis and Pregnancy Loss, run by North Estonia Medical Centre at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstetrical outcomes (time frame: Pregnancy loss within 9 months from appendectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05430633, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.