Clinical trial NCT02714023: Water And Saline Head-to-head In The Blinded Evaluation Study Trial
Official title: Water And Saline Head-to-head In The Blinded Evaluation Study Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Appendicitis
Abscess
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 241
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Post-operative deep space organ infection as defined by the Surgical Infection Society
timeFrame: 30 days
Secondary outcomes:
measure: Temperature greater than 38.5 degree Celsius
timeFrame: 30 days
measure: Greater than 2 days to return of bowel function as evident by either flatus or bowel movement
timeFrame: 30 days
measure: Length of Hospital Stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Arthur Rawlings, MD
role: PRINCIPAL_INVESTIGATOR
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