Infection Clinical Trial
— ISAACOfficial title:
Randomized Trial Comparing Irrigation Versus Suction in Laparoscopic Appendectomy for Complicated Acute Appendicitis in Adults
This study evaluates the intraabdominal abscess rate after laparoscopic appendectomy in complicated acute appendicitis performing irrigation of the abdominal cavity or only suction without lavage.
Status | Recruiting |
Enrollment | 210 |
Est. completion date | October 2017 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with complicated acute appendiccitis - Laparoscopic approach Exclusion Criteria: - Open approach - Medical or psychiatric condition of the patient that compromises the informed consent authorisation - Non complicated acute appendicitis - Underage patients (<18) - Refusal to participate in the study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Virgen de La Arrixaca | Murcia |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario Virgen de la Arrixaca |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of post-operative abscess | Number of post-operative abscesses in each arm | 1 month | Yes |
Primary | Location of post-operative abscess | Number of abscesses in every quadrant of the abdomen | One month | Yes |
Primary | Treatment of post-operative abscess | Number of post-operative abscesses treated with a radiological drain | One month | No |
Secondary | Operating time | Length of surgery, in minutes. | 1 day | No |
Secondary | Hospital stay (Time until discharge) | Time until discharge, in days. | 2 weeks | No |
Secondary | Postoperative pain (Visual analogic scale) | Visual analogic scale, from 1 to 10 | 6 days | No |
Secondary | Postoperatory fever | Body temperature in Celsius degrees | 6 days | No |
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