ConstipationPhase 4NCT01879605
Study About Effect of Preoperative Bowel Preparation Versus no Bowel Preparation Before Spinal Surgery
A Phase 4 study testing Docusate natrium and sorbitol and Bisacodyl in people with Constipation and Ileus, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This study investigated the effect of preoperative bowel preparations for patients undergoing spinal fusion surgery. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Constipation, Ileus, Surgery
- What is being tested?
- Docusate natrium and sorbitol and Bisacodyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2007to Dec 2009
- Phase
- Phase 4
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing spinal fusion surgery
- Age 15 years or older
- The patients had to understand oral and written Norwegian.
- Postoperative pain management via epidural catheter should have been planned.
Who cannot join
- Constipation
- Regularly use of enema
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Bowel Preparation Versus no Preparation Before Spinal Surgery: a Randomised Clinical Trial
This study investigated the effect of preoperative bowel preparations for patients undergoing spinal fusion surgery.
Read the detailed description
This was a randomised clinical trial with one control group and two treatment groups.
Forty-five elective spinal fusion patients were randomised into three groups who received preoperative treatment with either enema of sorbitol and docusat natrium, Bisacodyl suppository or no bowel preparation.
- Conditions
- Constipation, Ileus, Surgery
- Being tested
- Docusate natrium and sorbitol, Bisacodyl
- Keywords
- Spinal surgery, Bowel preparation, Ileus, Constipation, Well-being
- Medical subject headings
- Constipation, Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docusate natrium and sorbitolDrug
Also called Klyx
BisacodylDrug
Also called Dulcolax
| Study group | Role | What they receive |
|---|---|---|
| Enema | Experimental | Docusate natrium and sorbitol, 240 ml enema, the evening before surgery Receives: Drug: Docusate natrium and sorbitol |
| Suppository | Active comparator | Bisacodyl, suppository 10 mg, the evening before surgery. Receives: Drug: Bisacodyl |
| Control grup | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defecation within 72 hours postoperatively
Measured: The study's outcome measures were recorded every evening between 17.00 and 21.00 hours
Secondary outcomes (1)
Postoperative constipation
Measured: The study's outcome measures were recorded every evening between 17.00 and 21.00 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startDec 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ida T Bjork, MNSc, PhD,, Principal investigator, University of Oslo, Institute of Health and society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879605
- Sponsor's protocol ID
- v57e4nbn
- Status last verified
- Jun 2013
- First submitted
- 13 Jun 2013
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Bowel Preparation Versus no Preparation Before Spinal Surgery: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT01879605
- Acronym / sponsor ID
- v57e4nbn
- Conditions
- Constipation, Ileus, Surgery
- Keywords
- Spinal surgery, Bowel preparation, Ileus, Constipation, Well-being
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 18 Jun 2013 (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.
This study investigated the effect of preoperative bowel preparations for patients undergoing spinal fusion surgery.
Detailed description
This was a randomised clinical trial with one control group and two treatment groups.
Forty-five elective spinal fusion patients were randomised into three groups who received preoperative treatment with either enema of sorbitol and docusat natrium, Bisacodyl suppository or no bowel preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enema | Experimental | Drug: Docusate natrium and sorbitolDocusate natrium and sorbitol, 240 ml enema, the evening before surgery |
| Suppository | Active comparator | Drug: BisacodylBisacodyl, suppository 10 mg, the evening before surgery. |
| Control grup | No intervention | –No intervention |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing spinal fusion surgery
- Age 15 years or older
- The patients had to understand oral and written Norwegian.
- Postoperative pain management via epidural catheter should have been planned.
Key exclusion criteria (2 listed)
- Constipation
- Regularly use of enema
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 |
|---|---|---|
| Docusate natrium and sorbitolAlso: Klyx | Drug | Enema |
| BisacodylAlso: Dulcolax | Drug | Suppository |
Primary outcome
Defecation within 72 hours postoperatively
Time frame: The study's outcome measures were recorded every evening between 17.00 and 21.00 hours
1 secondary outcome
Postoperative constipation
Time frame: The study's outcome measures were recorded every evening between 17.00 and 21.00 hours
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 18 Jun 2013.
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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.
Ida T Bjork, MNSc, PhD, principal investigator
University of Oslo, Institute of Health and society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Docusate natrium and sorbitol and Bisacodyl in people with Constipation and Ileus, run by Oslo University Hospital at 1 site in Norway.
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 4 inclusion and 2 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 18 Jun 2013. 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 Norway. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Defecation within 72 hours postoperatively (time frame: The study's outcome measures were recorded every evening between 17.00 and 21.00 hours). 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 18 Jun 2013.