ISAAC: Irrigation Versus Suction in Complicated Acute Appendicitis

Sponsor

Hospital Universitario Virgen de la Arrixaca (Other)

Overall Status

Unknown status

CT.gov ID

NCT02688244

Collaborator

(none)

210

Enrollment

Location

Arms

Duration (Months)

9.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Appendicitis Abdominal Abscess Acute Disease Cecal Diseases Infection	Procedure: Irrigation Procedure: No irrigation	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Trial Comparing Irrigation Versus Suction in Laparoscopic Appendectomy for Complicated Acute Appendicitis in Adults

Study Start Date :

Nov 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2016

Anticipated Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Irrigation Irrigation of the area with at least 300ml normal saline using the power suction/irrigator	Procedure: Irrigation Irrigation of the abdominal cavity with at least 300ml of normal saline using the power suction/irrigator Other Names: Washout
Active Comparator: No irrigation Only suction with the power suction/irrigator without saline attached	Procedure: No irrigation Suction only, using suction device Other Names: Suction

Arm

Intervention/Treatment

Active Comparator: Irrigation

Irrigation of the area with at least 300ml normal saline using the power suction/irrigator

Procedure: Irrigation

Irrigation of the abdominal cavity with at least 300ml of normal saline using the power suction/irrigator

Other Names:

Washout

Active Comparator: No irrigation

Only suction with the power suction/irrigator without saline attached

Procedure: No irrigation

Suction only, using suction device

Other Names:

Suction

Outcome Measures

Primary Outcome Measures

Incidence of post-operative abscess [1 month]
Number of post-operative abscesses in each arm
Location of post-operative abscess [One month]
Number of abscesses in every quadrant of the abdomen
Treatment of post-operative abscess [One month]
Number of post-operative abscesses treated with a radiological drain

Secondary Outcome Measures

Operating time [1 day]
Length of surgery, in minutes.
Hospital stay (Time until discharge) [2 weeks]
Time until discharge, in days.
Postoperative pain (Visual analogic scale) [6 days]
Visual analogic scale, from 1 to 10
Postoperatory fever [6 days]
Body temperature in Celsius degrees

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.