Other Specified Complications of PregnancyNCT04753502
Laparoscopic Treatment for Appendicitis During Pregnancy
An observational study of Other Specified Complications of Pregnancy, run by Austral University, Argentina at 1 site in Argentina.
Trial summary
Acute appendicitis is the most frequent non-obstetric surgical emergency during pregnancy. The benefits of laparoscopy during pregnancy are well known, but complications can occur, and these can affect both the mother and/or the foetus. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Other Specified Complications of Pregnancy
- What is being tested?
- Laparoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 63 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Sep 2005to 30 Nov 2020
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant patients of 18 or more years of age admitted to our institution between September 2005 and July 2020 with diagnosis of acute appendicitis.
Who may be able to join
- pregnant women 18 years or above
- preoperative diagnosis of acute appendicitis
- Diagnosed, operated and followed in Austral University Hospital
- Signed informed consent for surgery and inclusion in databases for further research
Who cannot join
- Patients operated in another hospital and sent to our institution for postoperative controls.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Treatment for Appendicitis During Pregnancy: Retrospective Cohort Study
Acute appendicitis is the most frequent non-obstetric surgical emergency during pregnancy. The benefits of laparoscopy during pregnancy are well known, but complications can occur, and these can affect both the mother and/or the foetus.
Objective: Evaluate results of laparoscopic surgical treatment of acute appendicitis in pregnant women, to analyse the occurrence of adverse postoperative, obstetric and foetal outcomes Methods: Retrospective cohort single-centred observational study on pregnant women with a preoperative diagnosis of acute appendicitis,using computerized medical records' information of pregnant patients admitted to our institution between September 2005 and July 2020
Read the detailed description
Construction and analysis of the database and study protocol were authorized by the Institutional Evaluation Committee under N° B20-010 and P20-070, respectively.
Assuming a 3: 1 relationship between surgery within 48 hours of symptom onset and surgery after 48 hours of 3: 1, we have an 80% power to find a difference in postoperative morbidity between groups of 30% with error type I of .05.
Analysed variables include: demographic characteristics, gestational age, clinical presentation, symptom duration from onset until surgical resolution, complementary studies, ASA score (Classification of the American Society of Anaesthesiology), intraoperative findings, type of surgery performed, intra and postoperative complications, length of stay, readmissions, use of tocolytics, preterm delivery, birth weight, Apgar score, maternal and foetal mortality, and obstetric and perinatological complications in pregnant patients with a preoperative diagnosis of acute appendicitis.
Any surgery in which the exploratory laparoscopy did not reveal intra-abdominal pathology and the appendix was macroscopically and microscopically normal was classified as a "negative laparoscopy". An "intraoperative complication" was defined as any unexpected intraoperative event, excluding conversion to conventional surgery, which was analysed as an independent event. A "postoperative complication" was defined as any deviation from the usual postoperative course within 30 days of surgery. An "obstetric complication" was one that occurred from the appendectomy until the end of the pregnancy, including foetal death and excluding preterm delivery. Spontaneous abortion and foetal demise were included within the same "foetal loss" outcome. "Preterm labour" was considered to be deliveries or caesarean sections that occurred prior to the 37th week of gestation.
For continuous variables, mean, standard deviation and / or minimum and maximum, or median and interquartile interval (IQR) were used, according to distribution. For categorical variables the number and corresponding percentages were reported. Continuous parameter comparisons were made using the test for independent samples or Wilcoxon-rank test; and when there were more than two groups, Anova or Kruskal Wallis were applied. For the comparison of categorical variables, Chi-square or Fisher's exact test were used, as appropriate. A p <0.05 was considered statistically significant. Likewise, a multivariate analysis was performed for the presence of postoperative and obstetric complications, contemplating possible confounders.
- Being tested
- Laparoscopy
- Keywords
- acute appendicitis, pregnancy, complications
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyProcedure or surgery
laparoscopic removal of pathologic appendix
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complication
Number of participants that present any deviation from the usual postoperative course within 30 days of surgery
Measured: within 30 days of surgery
Secondary outcomes (1)
obstetric complication
Number of participants that present an obstetric complication from the appendectomy until the end of the pregnancy, including foetal death and excluding preterm delivery
Measured: since the appendectomy until date of pregancy termination by vaginal delivery, cesarean section, or foetal death, assesed up to July 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Sep 2005
- Primary completion1 Jul 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Specified Complications of PregnancyStudies 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austral University, Argentina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carina Chwat, Austral University, Argentina
- Investigators
- Carina M Chwat, MD, Principal investigator, Austral University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753502
- Sponsor's protocol ID
- P20-070
- Status last verified
- Feb 2021
- First submitted
- 2 Feb 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Treatment for Appendicitis During Pregnancy: Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04753502
- Acronym / sponsor ID
- P20-070
- Keywords
- acute appendicitis, pregnancy, complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Austral University, ArgentinaUniversity, hospital or other
- Study start
- 1 Sep 2005 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 15 Feb 2021 (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.
Acute appendicitis is the most frequent non-obstetric surgical emergency during pregnancy. The benefits of laparoscopy during pregnancy are well known, but complications can occur, and these can affect both the mother and/or the foetus.
Objective: Evaluate results of laparoscopic surgical treatment of acute appendicitis in pregnant women, to analyse the occurrence of adverse postoperative, obstetric and foetal outcomes Methods: Retrospective cohort single-centred observational study on pregnant women with a preoperative diagnosis of acute appendicitis,using computerized medical records' information of pregnant patients admitted to our institution between September 2005 and July 2020
Detailed description
Construction and analysis of the database and study protocol were authorized by the Institutional Evaluation Committee under N° B20-010 and P20-070, respectively.
Assuming a 3: 1 relationship between surgery within 48 hours of symptom onset and surgery after 48 hours of 3: 1, we have an 80% power to find a difference in postoperative morbidity between groups of 30% with error type I of .05.
Analysed variables include: demographic characteristics, gestational age, clinical presentation, symptom duration from onset until surgical resolution, complementary studies, ASA score (Classification of the American Society of Anaesthesiology), intraoperative findings, type of surgery performed, intra and postoperative complications, length of stay, readmissions, use of tocolytics, preterm delivery, birth weight, Apgar score, maternal and foetal mortality, and obstetric and perinatological complications in pregnant patients with a preoperative diagnosis of acute appendicitis.
Any surgery in which the exploratory laparoscopy did not reveal intra-abdominal pathology and the appendix was macroscopically and microscopically normal was classified as a "negative laparoscopy". An "intraoperative complication" was defined as any unexpected intraoperative event, excluding conversion to conventional surgery, which was analysed as an independent event. A "postoperative complication" was defined as any deviation from the usual postoperative course within 30 days of surgery. An "obstetric complication" was one that occurred from the appendectomy until the end of the pregnancy, including foetal death and excluding preterm delivery. Spontaneous abortion and foetal demise were included within the same "foetal loss" outcome. "Preterm labour" was considered to be deliveries or caesarean sections that occurred prior to the 37th week of gestation.
For continuous variables, mean, standard deviation and / or minimum and maximum, or median and interquartile interval (IQR) were used, according to distribution. For categorical variables the number and corresponding percentages were reported. Continuous parameter comparisons were made using the test for independent samples or Wilcoxon-rank test; and when there were more than two groups, Anova or Kruskal Wallis were applied. For the comparison of categorical variables, Chi-square or Fisher's exact test were used, as appropriate. A p <0.05 was considered statistically significant. Likewise, a multivariate analysis was performed for the presence of postoperative and obstetric complications, contemplating possible confounders.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant patients of 18 or more years of age admitted to our institution between September 2005 and July 2020 with diagnosis of acute appendicitis.
Key inclusion criteria (4 listed)
- pregnant women 18 years or above
- preoperative diagnosis of acute appendicitis
- Diagnosed, operated and followed in Austral University Hospital
- Signed informed consent for surgery and inclusion in databases for further research
Key exclusion criteria (1 listed)
- Patients operated in another hospital and sent to our institution for postoperative controls.
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 |
|---|---|---|
| Laparoscopylaparoscopic removal of pathologic appendix | Procedure or surgery | – |
Primary outcome
Postoperative complication
Time frame: within 30 days of surgery
Number of participants that present any deviation from the usual postoperative course within 30 days of surgery
1 secondary outcome
obstetric complication
Time frame: since the appendectomy until date of pregancy termination by vaginal delivery, cesarean section, or foetal death, assesed up to July 2020
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 15 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Other Specified Complications of Pregnancy
RecruitingPhase 3
Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
Other Specified Disorders of Kidney and Ureter, Benign Neoplasm of Ureter
Active, not recruitingPhase 2
Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients with PD1-high MRNA Expressing Tumors
MSI-H Colorectal Cancer, Melanoma
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.
Carina M Chwat, MD principal investigator
Austral University Hospital
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 Other Specified Complications of Pregnancy, run by Austral University, Argentina at 1 site in Argentina.
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 4 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 15 Feb 2021. 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 Argentina. 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?
Postoperative complication (time frame: within 30 days of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2021.