Postoperative Passage of FlatusPhase 4NCT03800745
Reduction of Postoperative Gastrointestinal Dysmotility Following Total Laparoscopic Hysterectomy.
A Phase 4 study testing Colace 100Mg Capsule and Miralax in people with Postoperative Passage of Flatus and Postoperative Bowel Movement, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Return of bowel function is an integral component of postoperative recovery following minimally invasive gynecologic surgery. To date, there is no standardized regimen to optimize bowel motility postoperatively. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Passage of Flatus, Postoperative Bowel Movement
- What is being tested?
- Colace 100Mg Capsule and Miralax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2018to 5 May 2020
- 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 18 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18-85 undergoing minimally invasive gynecologic surgery in the form of total laparoscopic hysterectomy.
Who cannot join
- an underlying gynecologic malignancy, pre-existing gastrointestinal disorders, history of bowel resection, insulin-dependent diabetes or gastroparesis, known gastric dysmotility, chronic use of pain medications, or anticipated bowel surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Postoperative Gastrointestinal Dysmotility Following Total Laparoscopic Hysterectomy: a Randomized Control Trial.
Return of bowel function is an integral component of postoperative recovery following minimally invasive gynecologic surgery. To date, there is no standardized regimen to optimize bowel motility postoperatively. Clinical practices vary in the medications prescribed to facilitate this process, as well as what is considered the norm for return of flatus and time to first bowel movement.
This study is a randomized control trial. The primary outcome of the study is to assess the effect of a standardized postoperative bowel care regimen on return of bowel function by assessing the time to first bowel movement; a secondary outcome is to assess the effect of such a regimen on time to first flatus. The hypothesis is that the prescription of a laxative, rather than a stool softener or no agent, will expedite the time to first bowel movement and first flatus. Other secondary outcomes and endpoints are assessing narcotic use measured in total oral morphine equivalents in the first five days postoperatively, as well as the constipation score and the PAC-SYM questionnaire.
Read the detailed description
Patients undergoing minimally invasive hysterectomy at Cleveland Clinic Florida Department of Minimally Invasive Gynecologic Surgery will be recruited at their preoperative visit or over the phone. Inclusion criteria will be patients aged 18-85 undergoing minimally invasive gynecologic surgery in the form of total laparoscopic hysterectomy. Exclusion criteria are an underlying gynecologic malignancy, pre-existing gastrointestinal disorders, history of bowel resection, insulin-dependent diabetes or gastroparesis, known gastric dysmotility, chronic use of pain medications, or anticipated bowel surgery. Subjects that routinely take laxatives will be included in a sub-analysis. Randomization will occur in the immediate postoperative period. Enrolled subjects will be randomized using a computer generator. A total sample size of 72 subjects, with 24 subjects in each arm, is needed to attain a significance level of 95% at a power of 80% to demonstrate a reduction of 24 hours or more to first postoperative bowel movement. Accounting for a 10% attrition rate, we will aim to recruit 81 patients total with 27 subjects in each arm. The control group, arm A, will be not be prescribed any postoperative bowel care regimen. The first study group, arm B, will be prescribed docusate sodium(Colace) 100mg twice daily orally, and will be instructed to begin taking this the evening of surgery through postoperative day five. One dose will be taken with breakfast every morning, and the second dose will be taken with dinner every evening. The second study group, arm C, will be prescribed Miralax 17 grams oral powder pack daily with breakfast, and will be instructed to begin taking this the morning after surgery through postoperative day five. Prescriptions will be given at the time of randomization immediately postoperatively and prior to discharge home. At Cleveland Clinic Florida, a majority of patients are discharged the day of surgery.
In addition, the presence of preoperative constipation will be assessed prior to surgery based on the Rome IV criteria along with baseline stool consistency as per the Bristol Stool Chart. Postoperatively, patients will be asked to record the time of first flatus and time first bowel movement. Each subject will complete the Patient Assessment of Constipation Symptoms (PAC-SYM) validated questionnaire on postoperative day 5, and a constipation score will also be calculated. Compliance with postoperative medications will also be assessed as defined by the number of medications taken as prescribed. Patients will record medications taken each day in a medication diary.
- Being tested
- Colace 100Mg Capsule, Miralax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colace 100Mg CapsuleDrug
Prescribed to Arm B
MiralaxDrug
Prescribed to Arm C
| Study group | Role | What they receive |
|---|---|---|
| No Medication | No intervention | No intervention is assigned in Arm A. |
| Colace | Experimental | This is Arm B. Docusate sodium(Colace) is prescribed as100mg twice daily orally. Patients will be instructed to begin taking this the evening of surgery through postoperative day five. Receives: Drug: Colace 100Mg Capsule |
| Miralax | Experimental | This is Arm C. Miralax 17 grams oral powder pack daily is prescribed to be taken with breakfast. Patients will be instructed to begin taking this the morning after surgery through postoperative day five. Receives: Drug: Miralax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Bowel Movement
The primary outcome of the study is to assess the effect of a standardized postoperative bowel care regimen on return of bowel function by assessing the date and time of first BM after surgery.
Measured: Patients will be followed for the first 5 days after surgery.
Secondary outcomes (4)
Time to First Flatus
Secondary outcomes include the time to first flatus. This will be calculated as the difference between the date and end time of the subject's surgery and the date and time of first BM after surgery.
Measured: Patients will be followed for the first 5 days after surgery.
Narcotic Use
Postoperative narcotic use in oral morphine equivalents in the first five days postoperatively will be measured.
Measured: Patients will be followed for the first 5 days after surgery.
PAC-SYM Questionnaire
To assess for opioid-induced constipation. Postoperatively, the Patient Assessment of Constipation-Symptom Questionnaire will be administered on postoperative day 5 to assess 12 different symptoms regarding bowel function.The 12-item questionnaire is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden. Historically, a reduction in total score of 1 point or more has been used as the cut-off to define a positive response to treatment, 2 implying that this is a meaningful improvement.
Measured: Patients will be followed for the first 5 days after surgery.
Constipation Score
A postoperative constipation score is calculated based on preoperative stool frequency, postoperative days to first BM, stool consistency, percentage of straining, and sensation of incomplete evacuation. Constipation scores are calculated basedon: days to first BM (2 points if >4 days, 0 points if 1-3 days); stool consistency (1 point if types 1 or 2, 0 points for types 3-7); strain rating (0.5 points if for ≥5 on ≥25% of the BMs; 0 points for ≤4 on 0-25%); 0.5 point for rating of mild, moderate, or severe for sense of incomplete evacuation to the question: "Have you experienced incomplete bowel movement, like you did not finish?" with 0 point for rating of none). The Straining Scale is a single-item questionnaire assessing straining on a 5 point Likert scale ranging from 1 to 5 in the following order: no straining, mild, moderate, severe, or very severe straining. A constipation score of 2 or more is consistent with constipation based on the Rome III criteria.
Measured: The first 5 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start9 Nov 2018
- Primary completion5 May 2020
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Passage of FlatusStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- randomized control trial
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Michael Sprague MD, Pamela Frazzini-Padilla MD, Katherine Smith MD, Jennifer Afton Cooper MD
- Responsible party
- Principal investigator, Mehandru, Natasha, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800745
- Sponsor's protocol ID
- FLA 18-069
- Status last verified
- Jun 2020
- First submitted
- 8 Jan 2019
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Postoperative Gastrointestinal Dysmotility Following Total Laparoscopic Hysterectomy: a Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT03800745
- Acronym / sponsor ID
- FLA 18-069
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Michael Sprague MD, Pamela Frazzini-Padilla MD, Katherine Smith MD, Jennifer Afton Cooper MD
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 11 Jan 2019 (actual)
- 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.
Return of bowel function is an integral component of postoperative recovery following minimally invasive gynecologic surgery. To date, there is no standardized regimen to optimize bowel motility postoperatively. Clinical practices vary in the medications prescribed to facilitate this process, as well as what is considered the norm for return of flatus and time to first bowel movement.
This study is a randomized control trial. The primary outcome of the study is to assess the effect of a standardized postoperative bowel care regimen on return of bowel function by assessing the time to first bowel movement; a secondary outcome is to assess the effect of such a regimen on time to first flatus. The hypothesis is that the prescription of a laxative, rather than a stool softener or no agent, will expedite the time to first bowel movement and first flatus. Other secondary outcomes and endpoints are assessing narcotic use measured in total oral morphine equivalents in the first five days postoperatively, as well as the constipation score and the PAC-SYM questionnaire.
Detailed description
Patients undergoing minimally invasive hysterectomy at Cleveland Clinic Florida Department of Minimally Invasive Gynecologic Surgery will be recruited at their preoperative visit or over the phone. Inclusion criteria will be patients aged 18-85 undergoing minimally invasive gynecologic surgery in the form of total laparoscopic hysterectomy. Exclusion criteria are an underlying gynecologic malignancy, pre-existing gastrointestinal disorders, history of bowel resection, insulin-dependent diabetes or gastroparesis, known gastric dysmotility, chronic use of pain medications, or anticipated bowel surgery. Subjects that routinely take laxatives will be included in a sub-analysis. Randomization will occur in the immediate postoperative period. Enrolled subjects will be randomized using a computer generator. A total sample size of 72 subjects, with 24 subjects in each arm, is needed to attain a significance level of 95% at a power of 80% to demonstrate a reduction of 24 hours or more to first postoperative bowel movement. Accounting for a 10% attrition rate, we will aim to recruit 81 patients total with 27 subjects in each arm. The control group, arm A, will be not be prescribed any postoperative bowel care regimen. The first study group, arm B, will be prescribed docusate sodium(Colace) 100mg twice daily orally, and will be instructed to begin taking this the evening of surgery through postoperative day five. One dose will be taken with breakfast every morning, and the second dose will be taken with dinner every evening. The second study group, arm C, will be prescribed Miralax 17 grams oral powder pack daily with breakfast, and will be instructed to begin taking this the morning after surgery through postoperative day five. Prescriptions will be given at the time of randomization immediately postoperatively and prior to discharge home. At Cleveland Clinic Florida, a majority of patients are discharged the day of surgery.
In addition, the presence of preoperative constipation will be assessed prior to surgery based on the Rome IV criteria along with baseline stool consistency as per the Bristol Stool Chart. Postoperatively, patients will be asked to record the time of first flatus and time first bowel movement. Each subject will complete the Patient Assessment of Constipation Symptoms (PAC-SYM) validated questionnaire on postoperative day 5, and a constipation score will also be calculated. Compliance with postoperative medications will also be assessed as defined by the number of medications taken as prescribed. Patients will record medications taken each day in a medication diary.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized control trial
| Arm | Type | Receives |
|---|---|---|
| No Medication | No intervention | –No intervention is assigned in Arm A. |
| Colace | Experimental | Drug: Colace 100Mg CapsuleThis is Arm B. Docusate sodium(Colace) is prescribed as100mg twice daily orally. Patients will be instructed to begin taking this the evening of surgery through postoperative day five. |
| Miralax | Experimental | Drug: MiralaxThis is Arm C. Miralax 17 grams oral powder pack daily is prescribed to be taken with breakfast. Patients will be instructed to begin taking this the morning after surgery through postoperative day five. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged 18-85 undergoing minimally invasive gynecologic surgery in the form of total laparoscopic hysterectomy.
Key exclusion criteria (1 listed)
- an underlying gynecologic malignancy, pre-existing gastrointestinal disorders, history of bowel resection, insulin-dependent diabetes or gastroparesis, known gastric dysmotility, chronic use of pain medications, or anticipated bowel surgery
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 |
|---|---|---|
| Colace 100Mg CapsulePrescribed to Arm B | Drug | Colace |
| MiralaxPrescribed to Arm C | Drug | Miralax |
Primary outcome
Time to First Bowel Movement
Time frame: Patients will be followed for the first 5 days after surgery.
The primary outcome of the study is to assess the effect of a standardized postoperative bowel care regimen on return of bowel function by assessing the date and time of first BM after surgery.
4 secondary outcomes
Time to First Flatus
Time frame: Patients will be followed for the first 5 days after surgery.
Narcotic Use
Time frame: Patients will be followed for the first 5 days after surgery.
PAC-SYM Questionnaire
Time frame: Patients will be followed for the first 5 days after surgery.
Constipation Score
Time frame: The first 5 days after surgery.
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 2 Jun 2020.
- Individual participant dataSharing planned: No
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 Colace 100Mg Capsule and Miralax in people with Postoperative Passage of Flatus and Postoperative Bowel Movement, run by The Cleveland Clinic 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 1 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 2 Jun 2020. 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?
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?
Time to First Bowel Movement (time frame: Patients will be followed for the first 5 days after surgery.). 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 2 Jun 2020.