Constipation, Post-Op Complication
Conditions
Brief 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. 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.
Interventions
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.
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing a robotic assisted sacrocolpopexy with or without hysterectomy and with or without anti-incontinence procedures
Exclusion criteria
* 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 * Inability to take medication by mouth * Chronic kidney disease (Cr \> 1.2) * Esophageal strictures * Persistent nausea and vomiting * Bowel obstruction * Inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Bowel Movement | 7 days post-operatively | Time to first post-operative bowel movement will be evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Pain With First Bowel Movement as Measured by the VAS Scale. | 7 days post-operatively | 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. |
| Post Operative Pain at Day 1 as Measured by the VAS Scale | 1 day post-operatively | 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. |
| Median Postoperative Pain | Averaged over 7 days post-operatively | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date.
Polyethylene Glycol Powder: 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. | 24 |
| Control The control group will not be given any intervention preoperatively. | 25 |
| Total | 49 |
Baseline characteristics
| Characteristic | Experimental | Control | Total |
|---|---|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 6.8 | 60.4 years STANDARD_DEVIATION 8.7 | 62.6 years STANDARD_DEVIATION 7.8 |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Unknown/not reported | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 21 Participants | 21 Participants | 42 Participants |
| Sex: Female, Male Female | 24 Participants | 25 Participants | 49 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 25 |
| other Total, other adverse events | 3 / 24 | 0 / 25 |
| serious Total, serious adverse events | 0 / 24 | 0 / 25 |
Outcome results
Primary
First Bowel Movement
Time to first post-operative bowel movement will be evaluated.
Time frame: 7 days post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | First Bowel Movement | 1.96 days | Standard Deviation 1 |
| Control | First Bowel Movement | 2.32 days | Standard Deviation 0.99 |
Secondary
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.
Time frame: Averaged over 7 days post-operatively
Population: One patient did not report this data point therefore there were fewer patients analyzed than were described in the Participant Flow
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental | Median Postoperative Pain | 1.3 units on a scale |
| Control | Median Postoperative Pain | 3.2 units on a scale |
Secondary
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.
Time frame: 1 day post-operatively
Population: Some patients did not report this data point therefore there were fewer patients analyzed than were described in the Participant Flow
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental | Post Operative Pain at Day 1 as Measured by the VAS Scale | 4 units on a scale |
| Control | Post Operative Pain at Day 1 as Measured by the VAS Scale | 2 units on a scale |
Secondary
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.
Time frame: 7 days post-operatively
Population: one experimental patient did not report this data point therefore there were 23, not 24, patients analyzed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental | Post Operative Pain With First Bowel Movement as Measured by the VAS Scale. | 1 units on a scale |
| Control | Post Operative Pain With First Bowel Movement as Measured by the VAS Scale. | 4 units on a scale |