Irrigation Versus Suction in Complicated Acute Appendicitis (ISAAC)
Primary Purpose
Appendicitis, Abdominal Abscess, Acute Disease
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Irrigation
No irrigation
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis focused on measuring complicated appendicitis, laparoscopic appendectomy, irrigation, suction, abdominal abscess
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitario Virgen de La ArrixacaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Irrigation
No irrigation
Arm Description
Irrigation of the area with at least 300ml normal saline using the power suction/irrigator
Only suction with the power suction/irrigator without saline attached
Outcomes
Primary Outcome Measures
Incidence of post-operative abscess
Number of post-operative abscesses in each arm
Location of post-operative abscess
Number of abscesses in every quadrant of the abdomen
Treatment of post-operative abscess
Number of post-operative abscesses treated with a radiological drain
Secondary Outcome Measures
Operating time
Length of surgery, in minutes.
Hospital stay (Time until discharge)
Time until discharge, in days.
Postoperative pain (Visual analogic scale)
Visual analogic scale, from 1 to 10
Postoperatory fever
Body temperature in Celsius degrees
Full Information
NCT ID
NCT02688244
First Posted
December 1, 2015
Last Updated
February 17, 2016
Sponsor
Hospital Universitario Virgen de la Arrixaca
1. Study Identification
Unique Protocol Identification Number
NCT02688244
Brief Title
Irrigation Versus Suction in Complicated Acute Appendicitis
Acronym
ISAAC
Official Title
Randomized Trial Comparing Irrigation Versus Suction in Laparoscopic Appendectomy for Complicated Acute Appendicitis in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Virgen de la Arrixaca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis, Abdominal Abscess, Acute Disease, Cecal Diseases, Infection
Keywords
complicated appendicitis, laparoscopic appendectomy, irrigation, suction, abdominal abscess
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Irrigation
Arm Type
Active Comparator
Arm Description
Irrigation of the area with at least 300ml normal saline using the power suction/irrigator
Arm Title
No irrigation
Arm Type
Active Comparator
Arm Description
Only suction with the power suction/irrigator without saline attached
Intervention Type
Procedure
Intervention Name(s)
Irrigation
Other Intervention Name(s)
Washout
Intervention Description
Irrigation of the abdominal cavity with at least 300ml of normal saline using the power suction/irrigator
Intervention Type
Procedure
Intervention Name(s)
No irrigation
Other Intervention Name(s)
Suction
Intervention Description
Suction only, using suction device
Primary Outcome Measure Information:
Title
Incidence of post-operative abscess
Description
Number of post-operative abscesses in each arm
Time Frame
1 month
Title
Location of post-operative abscess
Description
Number of abscesses in every quadrant of the abdomen
Time Frame
One month
Title
Treatment of post-operative abscess
Description
Number of post-operative abscesses treated with a radiological drain
Time Frame
One month
Secondary Outcome Measure Information:
Title
Operating time
Description
Length of surgery, in minutes.
Time Frame
1 day
Title
Hospital stay (Time until discharge)
Description
Time until discharge, in days.
Time Frame
2 weeks
Title
Postoperative pain (Visual analogic scale)
Description
Visual analogic scale, from 1 to 10
Time Frame
6 days
Title
Postoperatory fever
Description
Body temperature in Celsius degrees
Time Frame
6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Universitario Virgen de La Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus Abrisqueta, Ph D
Phone
+34 968369677
First Name & Middle Initial & Last Name & Degree
Maria Teresa Soriano, MD
First Name & Middle Initial & Last Name & Degree
Juan Lujan, Ph D
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Irrigation Versus Suction in Complicated Acute Appendicitis
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