Bisacodyl Use in the Post-operative Care of Obstetrical/Gynecological (OB/GYN) Patients



Status:Completed
Conditions:Hospital, Pain
Therapuetic Areas:Musculoskeletal, Other
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:April 2009
End Date:June 2012
Contact:Meena Khandelwal, MD
Email:khandelwal-meena@cooperhealth.edu

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The purpose of this study is to determine whether Bisacodyl, 5 mg usage decreases the
incidence of nausea and abdominal pain after surgery, and also decreases the number of
hospitalization days.


Postoperative ileus is defined as a disturbance in bowel motility, clinically
indistinguishable from bowel obstruction, and resulting from noxious or injurious bowel
insult. During abdominal surgery, this could be due to bowel manipulation or its exposure to
irritants like blood or pus. This contributes to post-operative morbidity resulting in
significant patient discomfort and prolonged hospital stay. The clinical picture can be
variable in presentation and severity. Patients can be asymptomatic or complain of
anorexia, cramping, abdominal pain, nausea and vomiting, and bloating. Severe cases can
have bilious vomiting. No diagnostic test can exclude the diagnosis with certainty and
presence or absence of bowel sounds on exam is unreliable. Therefore, symptoms are
primarily relied on for clinical management to promote patient comfort. Postoperative ileus
can increase postoperative morbidity and lengthen hospital stay.

Traditionally, patients are given nothing-by-mouth (NPO) after major abdominal or pelvic
surgery to allow rest for the dysfunctional bowel because of the concern of precipitating
postoperative ileus. Patients are started on a clear liquid diet and advanced accordingly
when there is documentation of bowel function such as passing flatus, presence of bowel
sounds, or no obvious evidence of bowel obstruction such as nausea and vomiting. This was
based on the fact that colonic motility is the last to recover after abdominal surgery
(usually 3-5 days) and this is less precise in patients who develop constipation. However,
the small bowel returns to normal peristaltic activity within 12-24 hours and the stomach
within 24-48 hours. In addition, large body of evidence indicates that early feedings and
early ambulation stimulates gastrointestinal motility, reduces overall complication rates as
well as improves patient comfort and satisfaction. Laxatives also increase GI motility,
will permit passage of flatus and/or stool, making the surgeon more comfortable in
permitting early oral feeds. This will increase patient satisfaction, increase comfort by
decreasing bloating and allow faster recovery. Bisacodyl is a mild laxative and so greatly
suited for study in the post-operative period. However, laxative use can itself cause
cramping, abdominal pain, and bloating.

There are several studies found in the literature about the effect of early bowel
stimulation in postoperative care. However, there are only three studies related to the
benefit of using laxatives during postoperative care to improve bowel function and decrease
incidence of postoperative ileus. The Department of OB/GYN at Ohio showed earlier return to
bowel function and a decrease in hospital stay while using Fleets Phosphorate Soda (66%
sodium phosphate) in patients having a radical hysterectomy. Another study was done at
Hvidovre University (Demark) to identify the benefit of using Magnesium Oxide and Disodium
Phosphate immediately postoperatively in patients undergoing a hysterectomy. This study
showed no difference on postoperative nausea, vomiting, or pain, but decreased the length of
hospitalization by one day (N = 20). In July 2007, the Department of Surgery at Mahidol
University (Thailand) used Bisacodyl suppositories on the third postoperative day in
patients who underwent a colectomy for colon cancer. This study showed an increase
incidence of postoperative ileus. All these studies are limited by their small number of
patient enrollment, and none were blinded.

Bisacodyl (Dulcolax) is an over-the-counter laxative. It is coated with a protective
coating so that it will not be digested in the stomach and small intestine. Therefore,
Dulcolax only takes effect in the large intestine, where the coating is dissolved. Dulcolax
is metabolized by the liver with CYP450 mechanism and excreted by stool and urine. Dulcolax
works in the large intestine by stimulating the nerve endings, causing muscles to contract
and the contents of the bowel to empty. Dulcolax is not used as the first treatment of
bowel stimulation due to the concern about imbalance of electrolytes as well as dependency.
There are few studies that document any adverse effect of Dulcolax. There are several
studies showing Dulcolax as one the best choices of bowel prep agents without significant
discomfort or imbalance of electrolytes.

Inclusion Criteria:

- Obstetrical and gynecological patients undergoing abdominal surgery.

Exclusion Criteria:

- Subjects undergoing a bowel resection.

- Subjects who have a nasogastric tube for bowel decompression.

- Subjects allergic to Bisacodyl.

- Subjects with mechanical bowel obstruction undergoing bowel resection.
We found this trial at
1
site
1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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mi
from
Camden, NJ
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