Irrigation Versus Suction in Complicated Acute Appendicitis
NCT ID: NCT02688244
Last Updated: 2016-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
210 participants
INTERVENTIONAL
2015-11-30
2017-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Irrigation
Irrigation of the area with at least 300ml normal saline using the power suction/irrigator
Irrigation
Irrigation of the abdominal cavity with at least 300ml of normal saline using the power suction/irrigator
No irrigation
Only suction with the power suction/irrigator without saline attached
No irrigation
Suction only, using suction device
Interventions
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Irrigation
Irrigation of the abdominal cavity with at least 300ml of normal saline using the power suction/irrigator
No irrigation
Suction only, using suction device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Laparoscopic approach
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Hospital Universitario Virgen de la Arrixaca
OTHER
Responsible Party
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Jesus Abrisqueta Carrion
PhD
Locations
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Hospital Universitario Virgen de La Arrixaca
Murcia, Murcia, Spain
Countries
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Facility Contacts
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Jesus Abrisqueta, Ph D
Role: primary
Other Identifiers
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AAC-2015-HCUVA
Identifier Type: -
Identifier Source: org_study_id
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