Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04753502 |
| Other study ID # |
P20-070 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2005 |
| Est. completion date |
November 30, 2020 |
Study information
| Verified date |
February 2021 |
| Source |
Austral University, Argentina |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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
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.
