Clinical Trial: Irrigation Versus Suction in Complicated Acute Appendicitis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Randomized Trial Comparing Irrigation Versus Suction in Laparoscopic Appendectomy for Complicated Acute Appendicitis in Adults
Brief Summary: 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.
Detailed Summary:
Despite the available literature for and against the irrigation of the abdominal cavity in complicated acute appendicitis, in the current practice of this and other centres, the irrigation and no irrigation is made equally depending on the surgeon who performs the intervention.
Those who systematically irrigate the abdominal cavity in laparoscopic appendectomies do it as an inherited act from open surgery and those who systematically do not irrigate the abdominal cavity base their choice in theories such as abscess migration due to the irrigation and difficulty of the suction of all the irrigated fluid, spreading, therefore, the infection.
The intention of the investigators is to provide evidence about this technique in order to either systematize peritoneal irrigation in laparoscopic appendectomy for complicated appendicitis or avoid an unnecessary gesture, if it were established so.
This will be a prospective, randomized clinical trial involving patients who present to the hospital with complicated acute appendicitis. Power calculation was based on abscess rate in the investigators' hospital calculated retrospectively (15%) Subjects will be those patients above 18 y.o. who are found to have complicated acute appendicitis (defined as perforated appendicitis before or during surgery, gangrenous appendicitis and/or purulent peritonitis).
The final decision to include a patient in the study will made after complication has been visually confirmed during surgery. The randomization assignment will be made known at the initiation of the operation, and confirmation of complication will confirm the patient will utilize the next randomization slot.
The irrigation group will have suct
Sponsor: Hospital Universitario Virgen de la Arrixaca
Current Primary Outcome:
- Incidence of post-operative abscess [ Time Frame: 1 month ]Number of post-operative abscesses in each arm
- Location of post-operative abscess [ Time Frame: One month ]Number of abscesses in every quadrant of the abdomen
- Treatment of post-operative abscess [ Time Frame: One month ]Number of post-operative abscesses treated with a radiological drain
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Operating time [ Time Frame: 1 day ]Length of surgery, in minutes.
- Hospital stay (Time until discharge) [ Time Frame: 2 weeks ]Time until discharge, in days.
- Postoperative pain (Visual analogic scale) [ Time Frame: 6 days ]Visual analogic scale, from 1 to 10
- Postoperatory fever [ Time Frame: 6 days ]Body temperature in Celsius degrees
Original Secondary Outcome: Same as current
Information By: Hospital Universitario Virgen de la Arrixaca
Dates:
Date Received: December 1, 2015
Date Started: November 2015
Date Completion: October 2017
Last Updated: February 17, 2016
Last Verified: February 2016
