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Postoperative Nausea and VomitingPhase 2NCT01011426

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

A Phase 2 study testing Bisacodyl in people with Postoperative Nausea and Vomiting and Abdominal Pain, run by Cooper Norcross Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older, women only
What is being tested?
Bisacodyl
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
285 participants
Where
1 siteUnited States
Study dates
Apr 2009to Jun 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Obstetrical and gynecological patients undergoing abdominal surgery.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cooper University Hospital

    Camden, New Jersey, 08103

Other trials in United States

About this study

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.

Read the 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.

Being tested
Bisacodyl, placebo
Keywords
laxative, postoperative care, ob-Gyn population, post-operative patients, obstetrical and gynecological surgery
Medical subject headings
Postoperative Nausea and Vomiting, Abdominal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BisacodylDrug

    Also called Dulcolax

    5mg po 6 hours postoperatively, repeat in 12 hours if no flatus

  • placeboDrug

    1 capsule po 6 hours after surgery; repeat in 12 hours if no flatus

Study groups in NCT01011426
Study groupRoleWhat they receive
BisacodylActive comparatorNot described
Receives: Drug: Bisacodyl
empty opague capsulePlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of nausea and vomiting in the 2 groups

    Measured: 3-5 days

Secondary outcomes (4)
  1. Time to flatus

    Measured: 2-5 days

  2. Length of hospitalization

    Measured: 2-5 days

  3. Incidence of postoperative ileus

    Measured: 2-5 days

  4. Difference in pain scale in the 2 groups (Side-effects)

    Measured: 2-5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
285 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01011426
Sponsor's protocol ID
08-148
Status last verified
Jan 2014
First submitted
7 Nov 2009
Last updated
20 Jan 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bisacodyl in people with Postoperative Nausea and Vomiting and Abdominal Pain, run by Cooper Norcross Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of nausea and vomiting in the 2 groups (time frame: 3-5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2014.

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