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

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ClinicalTrials.gov Identifier: NCT02714023
Recruitment Status : Recruiting
First Posted : March 21, 2016
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Arthur Rawlings, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Acute Appendicitis Abscess Procedure: Normal Saline Procedure: Sterile Water Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 441 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Water And Saline Head-to-head In The Blinded Evaluation Study Trial
Actual Study Start Date : March 22, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Post-operative deep space organ infection as defined by the Surgical Infection Society [ Time Frame: 30 days ]
    Infection after surgery within the peritoneal space


Secondary Outcome Measures :
  1. Temperature greater than 38.5 degree Celsius [ Time Frame: 30 days ]
    Chart review for evidence of prolonged fever >38.5 for >2 days

  2. 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

  3. Length of Hospital Stay [ Time Frame: 30 days ]
    Medical record will be reviewed for hospital length of stay following surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714023


Contacts
Contact: Amanda E Allen, MD 573-884-2000 allenama@health.missouri.edu
Contact: Arthur Rawlings, MD 573-355-3276 RawlingsA@health.missouri.edu

Locations
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Arthur Rawlings, MD University of Missouri-Columbia

Publications of Results:
Other Publications:

Responsible Party: Arthur Rawlings, Associate Professor of Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02714023     History of Changes
Other Study ID Numbers: 1201672
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases