Water And Saline Head-to-head In The Blinded Evaluation Study Trial
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 6 - Any |
| Updated: | 10/17/2018 |
| Start Date: | October 10, 2012 |
| End Date: | November 29, 2017 |
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.
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.
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.
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.
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
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University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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