An interventional study of Irrigation and No irrigation in Appendicitis, Abdominal Abscess and Acute Disease, sponsored by Hospital Universitario Virgen de la Arrixaca. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-23.
Sponsored by Hospital Universitario Virgen de la Arrixaca · Not applicable, Interventional, and Treatment
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.
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 suction irrigator set up with a 1 liter bag of normal saline. The surgeon must use at least 300 ml of this bag but may use as much as they choose.
The no irrigation group will have the suction irrigator set up without the saline attachment. This will leave them with the capacity for suction only. Since several suction devices exist, this will assure the same type of suction for both groups.
After the operation, both groups will be managed in the same manner. When the patient is tolerating a regular diet, on oral pain medication and has been afebrile for over 12 hours, they will be discharged on oral antibiotics to complete a course of 7 days. If the participants stay until the 5th post-operative day, a white blood cell count will be checked, which if it is normal, they will be discharged to home without antibiotics.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's planned enrollment of 210 is above the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Hospital Universitario Virgen de la Arrixaca is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Irrigation of the area with at least 300ml normal saline using the power suction/irrigator
Procedure: Irrigation
Only suction with the power suction/irrigator without saline attached
Procedure: No irrigation
Irrigation of the abdominal cavity with at least 300ml of normal saline using the power suction/irrigator
Also known as: Washout
Suction only, using suction device
Also known as: Suction
Incidence of post-operative abscess
Number of post-operative abscesses in each arm
Time frame: 1 month
Location of post-operative abscess
Number of abscesses in every quadrant of the abdomen
Time frame: One month
Treatment of post-operative abscess
Number of post-operative abscesses treated with a radiological drain
Time frame: One month
Operating time
Length of surgery, in minutes.
Time frame: 1 day
Hospital stay (Time until discharge)
Time until discharge, in days.
Time frame: 2 weeks
Postoperative pain (Visual analogic scale)
Visual analogic scale, from 1 to 10
Time frame: 6 days
Postoperatory fever
Body temperature in Celsius degrees
Time frame: 6 days
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Nov 2015, a primary completion of Oct 2016 and a completion of Oct 2017. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Virgen de la Arrixaca