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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714023
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

Tracking Information
First Submitted Date  ICMJE March 8, 2016
First Posted Date  ICMJE March 21, 2016
Last Update Posted Date October 15, 2018
Actual Study Start Date  ICMJE October 10, 2012
Actual Primary Completion Date September 10, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
Post-operative deep space organ infection as defined by the Surgical Infection Society [ Time Frame: 30 days ]
Infection after surgery within the peritoneal space
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2017)
  • Temperature greater than 38.5 degree Celsius [ Time Frame: 30 days ]
    Chart review for evidence of prolonged fever >38.5 for >2 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
  • Length of Hospital Stay [ Time Frame: 30 days ]
    Medical record will be reviewed for hospital length of stay following surgery
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
  • Temperature greater than 38.5 degree Celsius [ Time Frame: 30 days ]
  • Greater than 2 days to return of bowel function as evident by either flatus or bowel movement [ Time Frame: 30 days ]
  • Length of Hospital Stay [ Time Frame: 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Water And Saline Head-to-head In The Blinded Evaluation Study Trial
Official Title  ICMJE Water And Saline Head-to-head In The Blinded Evaluation Study Trial
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Appendicitis
  • Abscess
Intervention  ICMJE
  • Procedure: Normal Saline
    Intra-operative irrigation with normal saline
  • Procedure: Sterile Water
    Intra-operative irrigation with sterile water
Study Arms  ICMJE
  • Active Comparator: Normal Saline
    Patients were randomized to receive normal saline as an irrigation solution during appendectomy.
    Intervention: Procedure: Normal Saline
  • Active Comparator: Sterile Water
    Patients were randomized to receive sterile water as an irrigation solution during appendectomy.
    Intervention: Procedure: Sterile Water
  • No Intervention: No irrigation used
    Patients who do not receive any irrigation at time of operation.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2018)
241
Original Actual Enrollment  ICMJE
 (submitted: March 15, 2016)
240
Actual Study Completion Date  ICMJE November 29, 2017
Actual Primary Completion Date September 10, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02714023
Other Study ID Numbers  ICMJE 1201672
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Missouri-Columbia
Study Sponsor  ICMJE University of Missouri-Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arthur Rawlings, MD University of Missouri-Columbia
PRS Account University of Missouri-Columbia
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP