Water And Saline Head-to-head In The Blinded Evaluation Study Trial (WASHITBEST)

October 10, 2018 updated by: University of Missouri-Columbia
Patients who are diagnosed with acute appendicitis consented and then randomized into two arms of the trial. In one arm, patients receive irrigation of the abdomen during surgery with normal saline, or salt water. In the other arm, patients receive irrigation of the abdomen during surgery with sterile water. Sometimes patients receive no irrigation if none is determined to be needed at the time of operation by the surgeon. We then followed patients after surgery for 30 days. The hypothesis of this study was that the use of sterile water as irrigation fluid during surgery in patients who have acute appendicitis will decrease the chance of a post-operative abscess or infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients, aged 6 and above, who present for an emergent or interval appendectomy to any one of the participating surgeons will potentially be enrolled in the study. Prior to surgery, the patient or the patient's guardian if a minor, will be informed of the study and consent (assent of minors will be obtained) will be requested. If consent is obtained, the patient's name and medical record number will then be sent to the inpatient pharmacy. They will be randomly assigned using a master list to either water or saline arm. The pharmacy will then send the correct solution to the operating room in the form of 3 one Liter bags. This will be ordered prior to going to the operating room. Next, a laparoscopic or open appendectomy will be performed according to the current standard of care. The surgeon will also be free to convert a laparoscopic procedure to an open procedure if deemed appropriate by his or her clinical judgment. The type of irrigant used during the case, however, will be blinded to the surgeon. The surgeon will use as much irrigation solution as they deem necessary based on an intra-operative decision. This will likely not have any affect on the study, as there is no standard amount of irrigation that is needed during appendectomies, and we do not wish to change the current practices of our surgeons. Additionally, the study question of if sterile water will decrease infectious rates will not be affected either. The science of this study will remain the same whether 10 mL or 3000 mL of irrigation solution is utilized. The surgeon may use more irrigation if deemed necessary to adequately wash the abdomen and remove all particulate matter and blood clots. At the end of the case, the surgeon will record the amount of irrigant used along with surgery date, duration of symptoms, surgery start and finish time, preoperative antibiotics, height and weight. The patient will be followed in the study for 30 days after surgery. There is usually a follow up office visit one to two weeks after the procedure. A chart review after the case will capture the length of stay, post-operative antibiotic, pathology report results, and complications consisting such as prolonged ileus (>2 days), bowel obstruction, prolonged fever (> 2 days), post-operative abscess, irrigation volume, and wound infection.

Study Type

Interventional

Enrollment (Actual)

241

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients, age 6 and older, who present for an emergent or interval appendectomy to any one of the participating surgeons, meet the inclusion criteria for the study. Assent from all minors (under age 18) was obtained.

Exclusion Criteria:

  • Pregnant patients, patients with mental handicap, Veterans, patients under 6 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Normal Saline
Patients were randomized to receive normal saline as an irrigation solution during appendectomy.
Procedure: Normal Saline
Intra-operative irrigation with normal saline
Active Comparator: Sterile Water
Patients were randomized to receive sterile water as an irrigation solution during appendectomy.
Procedure: Sterile Water
Intra-operative irrigation with sterile water
No Intervention: No irrigation used
Patients who do not receive any irrigation at time of operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative deep space organ infection as defined by the Surgical Infection Society
Time Frame: 30 days
Infection after surgery within the peritoneal space
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temperature greater than 38.5 degree Celsius
Time Frame: 30 days
Chart review for evidence of prolonged fever >38.5 for >2 days
30 days
Greater than 2 days to return of bowel function as evident by either flatus or bowel movement
Time Frame: 30 days
Chart review for evidence of prolonged ileus for >2days
30 days
Length of Hospital Stay
Time Frame: 30 days
Medical record will be reviewed for hospital length of stay following surgery
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Arthur Rawlings, MD, University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2012

Primary Completion (Actual)

September 10, 2015

Study Completion (Actual)

November 29, 2017

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (Estimate)

March 21, 2016

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1201672

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Abscess

Clinical Trials on Normal Saline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe