Reduction of Postoperative Gastrointestinal Dysmotility Following Total Laparoscopic Hysterectomy.
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 1/13/2019 |
| Start Date: | November 9, 2018 |
| End Date: | September 5, 2019 |
| Contact: | Natasha Mehandru, MD |
| Email: | mehandn@ccf.org |
| Phone: | 954-766-5710 |
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.
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.
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.
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.
Inclusion Criteria:
- aged 18-85 undergoing minimally invasive gynecologic surgery in the form of total
laparoscopic hysterectomy.
Exclusion Criteria:
- 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
We found this trial at
1
site
2950 Cleveland Clinic Blvd.
Weston, Florida 33331
Weston, Florida 33331
866.293.7866
Phone: 954-766-5710
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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