Irrigation Versus Suction in Complicated Acute Appendicitis (ISAAC)

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Disease; Appendicitis; Abdominal Abscess; Cecal Diseases; Infection
• Intervention / Treatment: Procedure: Irrigation; Procedure: No irrigation

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 Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30120
    • Recruiting
    • Hospital Universitario Virgen de la Arrixaca
    • Contact: Jesus Abrisqueta, Ph D; Phone Number: +34 968369677
    • Sub-Investigator: Juan Lujan, Ph D
    • Sub-Investigator: Maria Teresa Soriano, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of post-operative abscess	Number of post-operative abscesses in each arm	1 month
Location of post-operative abscess	Number of abscesses in every quadrant of the abdomen	One month
Treatment of post-operative abscess	Number of post-operative abscesses treated with a radiological drain	One month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitario Virgen de la Arrixaca

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: December 1, 2015
• First Submitted That Met QC Criteria: February 17, 2016
• First Posted (Estimate): February 23, 2016

Study Record Updates

• Last Update Posted (Estimate): February 23, 2016
• Last Update Submitted That Met QC Criteria: February 17, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: complicated appendicitis; suction; laparoscopic appendectomy; irrigation; abdominal abscess
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Inflammation; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Suppuration; Intraabdominal Infections; Abscess; Acute Disease; Appendicitis; Abdominal Abscess; Cecal Diseases
• Other Study ID Numbers: AAC-2015-HCUVA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED