ConstipationPhase 4NCT04197869
Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy
A Phase 4 study testing Polyethylene Glycol Powder in people with Constipation and Post-Op Complication, run by Northwell Health at 1 site in United States.
Trial summary
The hypothesis is that starting a bowel regimen with Polyethylene Glycol prior to robotic assisted sacrocolpopexy will decrease time to first bowel movement after surgery. The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Constipation, Post-Op Complication
- What is being tested?
- Polyethylene Glycol Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2019to 21 Jun 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 89 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing a robotic assisted sacrocolpopexy with or without hysterectomy and with or without anti-incontinence procedures
Who cannot join
- Age under 18 or over 90
- Planned laparotomy
- Planned posterior colporrhaphy
- Regular pre-operative use of stool softeners/laxatives
- Presence of colostomy
- Inability to give informed consent
Show all 12Show fewer
- Inability to take medication by mouth
- Chronic kidney disease (Cr > 1.2)
- Esophageal strictures
- Persistent nausea and vomiting
- Bowel obstruction
- Inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy: A Randomized Controlled Trial
The hypothesis is that starting a bowel regimen with Polyethylene Glycol prior to robotic assisted sacrocolpopexy will decrease time to first bowel movement after surgery. The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date. The control group will not be given any intervention preoperatively. All patients will take polyethylene glycol postoperatively.
Read the detailed description
In order to assess bowel characteristics and assess for pre-existing constipation a standardized questionnaire will be distributed to all patients prior to surgery at their pre-operative visit. The patients in the experimental group will have follow up via phone call, 3-4 days prior to surgery to assess for medication compliance or any side effects/complications. Patients will record if they are taking their Miralax as prescribed daily. They will also record their bowel movements and pain levels during evacuation. Prior to surgery, in the pre-operative area, medication compliance will be assessed once again. Post operatively all patients will take polyethylene glycol for seven days, once a day. They will maintain a bowel diary, which will record bowel movements, stool type and pain with evacuation. The primary objective is to determine if the preoperative use of polyethylene glycol decreases time to first bowel movement after robotic sacral colpopexy. Secondary outcomes include pain with first bowel movement, stool consistency and daily pain levels.
- Conditions
- Constipation, Post-Op Complication
- Being tested
- Polyethylene Glycol Powder
- Medical subject headings
- Constipation, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene Glycol PowderDrug
Polyethylene Glycol 3350 17g should be mixed in 8 ounces of fluid for administration. Polyethylene glycol is a high molecular weight, water soluble polymer which can form hydrogen bonds with water molecules. It is an osmotic laxative solution which stimulates bowel movements by increasing the amount of water absorbed in the GI tract. It decreases feces consistency and increases their volume by promoting peristalsis and evacuation. The side effects of polyethylene glycol are bloating, gas or diarrhea. The half-life of polyethylene glycol is 4-6 hours and after 18 hours the concentration declines to non-quantifiable levels.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date. Receives: Drug: Polyethylene Glycol Powder |
| Control | No intervention | The control group will not be given any intervention preoperatively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Bowel Movement
Time to first post-operative bowel movement will be evaluated.
Measured: 7 days post-operatively
Secondary outcomes (3)
Post Operative Pain With First Bowel Movement as Measured by the VAS Scale.
Patients will record their pain levels with first post-operative bowel movement using the Visual Analogue Scale (VAS) pain scale. The scale is numbered 0 through 10, with 0 being no pain and 10 being worst possible pain.
Measured: 7 days post-operatively
Post Operative Pain at Day 1 as Measured by the VAS Scale
Patients will record their pain level using the Visual Analogue Scale (VAS) pain scale. The scale is numbered 0 through 10, with 0 being no pain and 10 being worst possible pain.
Measured: 1 day post-operatively
Median Postoperative Pain
Patients will record their pain level daily for 7 days using the Visual Analogue Scale (VAS) pain scale. The scale is numbered 0 through 10, with 0 being no pain and 10 being worst possible pain. The average value over 7 days for each patient will be calculated. We will then report the median postoperative pain score averaged across 7 days for each group.
Measured: Averaged over 7 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start9 Dec 2019
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date. The control group will not be given any intervention preoperatively. All patients will take polyethylene glycol postoperatively.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197869
- Sponsor's protocol ID
- 19-0802
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2019
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Holubyeva A, Goodwin AI, O'Shaughnessy D, Pillalamarri N, Demertzis K, Rahbani AC, Stefanov DG, Finamore PS. Does a Preoperative Bowel Regimen Change Time to Bowel Movement? A Randomized Clinical Trial. Urogynecology (Phila). 2024 Mar 1;30(3):251-255. doi: 10.1097/SPV.0000000000001462. Epub 2024 Feb 26.
PubMed 38484239
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04197869
- Acronym / sponsor ID
- 19-0802
- Conditions
- Constipation, Post-Op Complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis is that starting a bowel regimen with Polyethylene Glycol prior to robotic assisted sacrocolpopexy will decrease time to first bowel movement after surgery. The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date. The control group will not be given any intervention preoperatively. All patients will take polyethylene glycol postoperatively.
Detailed description
In order to assess bowel characteristics and assess for pre-existing constipation a standardized questionnaire will be distributed to all patients prior to surgery at their pre-operative visit. The patients in the experimental group will have follow up via phone call, 3-4 days prior to surgery to assess for medication compliance or any side effects/complications. Patients will record if they are taking their Miralax as prescribed daily. They will also record their bowel movements and pain levels during evacuation. Prior to surgery, in the pre-operative area, medication compliance will be assessed once again. Post operatively all patients will take polyethylene glycol for seven days, once a day. They will maintain a bowel diary, which will record bowel movements, stool type and pain with evacuation. The primary objective is to determine if the preoperative use of polyethylene glycol decreases time to first bowel movement after robotic sacral colpopexy. Secondary outcomes include pain with first bowel movement, stool consistency and daily pain levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date. The control group will not be given any intervention preoperatively. All patients will take polyethylene glycol postoperatively.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Polyethylene Glycol PowderThe experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date. |
| Control | No intervention | –The control group will not be given any intervention preoperatively. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing a robotic assisted sacrocolpopexy with or without hysterectomy and with or without anti-incontinence procedures
Key exclusion criteria (12 listed)
- Age under 18 or over 90
- Planned laparotomy
- Planned posterior colporrhaphy
- Regular pre-operative use of stool softeners/laxatives
- Presence of colostomy
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 |
|---|---|---|
| Polyethylene Glycol PowderPolyethylene Glycol 3350 17g should be mixed in 8 ounces of fluid for administration. Polyethylene glycol is a high molecular weight, water soluble polymer which can form hydrogen bonds with water molecules. It is an osmotic laxative solution which stimulates bowel movements by increasing the amount of water absorbed in the GI tract. It decreases feces consistency and increases their volume by promoting peristalsis and evacuation. The side effects of polyethylene glycol are bloating, gas or diarrhea. The half-life of polyethylene glycol is 4-6 hours and after 18 hours the concentration declines to non-quantifiable levels. | Drug | Experimental |
Primary outcome
First Bowel Movement
Time frame: 7 days post-operatively
Time to first post-operative bowel movement will be evaluated.
3 secondary outcomes
Post Operative Pain With First Bowel Movement as Measured by the VAS Scale.
Time frame: 7 days post-operatively
Post Operative Pain at Day 1 as Measured by the VAS Scale
Time frame: 1 day post-operatively
Median Postoperative Pain
Time frame: Averaged over 7 days post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38484239Holubyeva A, Goodwin AI, O'Shaughnessy D, Pillalamarri N, Demertzis K, Rahbani AC, Stefanov DG, Finamore PS. Does a Preoperative Bowel Regimen Change Time to Bowel Movement? A Randomized Clinical Trial. Urogynecology (Phila). 2024 Mar 1;30(3):251-255. doi: 10.1097/SPV.0000000000001462. Epub 2024 Feb 26.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Polyethylene Glycol Powder in people with Constipation and Post-Op Complication, run by Northwell 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 12 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 27 Dec 2024. 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. 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?
Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
First Bowel Movement (time frame: 7 days post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04197869, which also lists 1 linked publication.
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 27 Dec 2024.