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.
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
- Conditions the study is for
- Postoperative Nausea and Vomiting, Abdominal Pain
- 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
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.
- Conditions
- Postoperative Nausea and Vomiting, Abdominal Pain
- 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 group | Role | What they receive |
|---|---|---|
| Bisacodyl | Active comparator | Not described Receives: Drug: Bisacodyl |
| empty opague capsule | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of nausea and vomiting in the 2 groups
Measured: 3-5 days
Secondary outcomes (4)
Time to flatus
Measured: 2-5 days
Length of hospitalization
Measured: 2-5 days
Incidence of postoperative ileus
Measured: 2-5 days
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.
- First posted11 Nov 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meena Khandelwal, MD, Principal investigator, Cooper University Hospital, NJ
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bisacodyl Use in the Post-operative Care of Obstetrical/Gynecological (OB/GYN) Patients
- ClinicalTrials.gov ID
- NCT01011426
- Acronym / sponsor ID
- 08-148
- Conditions
- Postoperative Nausea and Vomiting, Abdominal Pain
- Keywords
- laxative, postoperative care, ob-Gyn population, post-operative patients, obstetrical and gynecological surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bisacodyl | Active comparator | Drug: Bisacodyl |
| empty opague capsule | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Obstetrical and gynecological patients undergoing abdominal surgery.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BisacodylAlso: Dulcolax5mg po 6 hours postoperatively, repeat in 12 hours if no flatus | Drug | Bisacodyl |
| placebo1 capsule po 6 hours after surgery; repeat in 12 hours if no flatus | Drug | empty opague capsule |
Primary outcome
Incidence of nausea and vomiting in the 2 groups
Time frame: 3-5 days
4 secondary outcomes
Time to flatus
Time frame: 2-5 days
Length of hospitalization
Time frame: 2-5 days
Incidence of postoperative ileus
Time frame: 2-5 days
Difference in pain scale in the 2 groups (Side-effects)
Time frame: 2-5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meena Khandelwal, MD principal investigator
Cooper University Hospital, NJ
1 site in 1 country: see every site and its status.
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.