Laparoscopic Treatment for Appendicitis During Pregnancy

NCT04753502 | Completed DMC

• 1 other identifier: P20-070
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Other Specified Complications of Pregnancy

Keywords

acute appendicitis; pregnancy; complications

Outcome Measures

Primary Outcomes (1)

• Postoperative complication

  Number of participants that present any deviation from the usual postoperative course within 30 days of surgery

  within 30 days of surgery

Secondary Outcomes (1)

• obstetric complication

  since the appendectomy until date of pregancy termination by vaginal delivery, cesarean section, or foetal death, assesed up to July 2020

Other Outcomes (3)

• negative laparoscopy

  during laparoscopic abdominal exploration

• foetal loss

  since the appendectomy until date of pregancy termination by vaginal delivery, cesarean section, or foetal death, assesed up to July 2020

• Preterm labour

  until 37th week of gestation

Interventions

Laparoscopy PROCEDURE

laparoscopic removal of pathologic appendix

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: participants were pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• pregnant women 18 years or above
• preoperative diagnosis of acute appendicitis
• Diagnosed, operated and followed in Austral University Hospital

You may not qualify if:

• \- Patients operated in another hospital and sent to our institution for postoperative controls.

Sponsors & Collaborators

• Austral University, Argentina: lead

Study Sites (1)

Austral University Hospital

Buenos Aires, 1629, Argentina

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Carina M Chwat, MD

  Austral University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 15, 2021
• Study Start: September 1, 2005
• Primary Completion: July 1, 2020
• Study Completion: November 30, 2020
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)