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

Primary Purpose

Postoperative Nausea and Vomiting, Abdominal Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bisacodyl
placebo
Sponsored by
The Cooper Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring laxative, postoperative care, ob-Gyn population, post-operative patients, obstetrical and gynecological surgery

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cooper University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bisacodyl

empty opague capsule

Arm Description

Outcomes

Primary Outcome Measures

Incidence of nausea and vomiting in the 2 groups

Secondary Outcome Measures

Time to flatus
Length of hospitalization
Incidence of postoperative ileus
Difference in pain scale in the 2 groups (Side-effects)

Full Information

First Posted
November 7, 2009
Last Updated
January 16, 2014
Sponsor
The Cooper Health System
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1. Study Identification

Unique Protocol Identification Number
NCT01011426
Brief Title
Bisacodyl Use in the Post-operative Care of Obstetrical/Gynecological (OB/GYN) Patients
Official Title
Bisacodyl Use in the Post-operative Care of Obstetrical/Gynecological (OB/GYN) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cooper Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting, Abdominal Pain
Keywords
laxative, postoperative care, ob-Gyn population, post-operative patients, obstetrical and gynecological surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
285 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bisacodyl
Arm Type
Active Comparator
Arm Title
empty opague capsule
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bisacodyl
Other Intervention Name(s)
Dulcolax
Intervention Description
5mg po 6 hours postoperatively, repeat in 12 hours if no flatus
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
1 capsule po 6 hours after surgery; repeat in 12 hours if no flatus
Primary Outcome Measure Information:
Title
Incidence of nausea and vomiting in the 2 groups
Time Frame
3-5 days
Secondary Outcome Measure Information:
Title
Time to flatus
Time Frame
2-5 days
Title
Length of hospitalization
Time Frame
2-5 days
Title
Incidence of postoperative ileus
Time Frame
2-5 days
Title
Difference in pain scale in the 2 groups (Side-effects)
Time Frame
2-5 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meena Khandelwal, MD
Organizational Affiliation
Cooper University Hospital, NJ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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