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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | The 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene Glycol Powder | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| First Bowel Movement | Time to first post-operative bowel movement will be evaluated. | 7 days post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwell Health | Bay Shore | New York | 11706 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38484239 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control | The control group will not be given any intervention preoperatively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | First Bowel Movement | Time to first post-operative bowel movement will be evaluated. | Posted | Mean | Standard Deviation | days | 7 days post-operatively |
|
through study completion, an average of 1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| loose stool | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexandra Goodwin | UCLA Health | 917-969-1654 | zangoodwin@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2022 | Oct 2, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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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.
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|
| 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. |
| 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. | Averaged over 7 days post-operatively |
| BG001 | Control | The control group will not be given any intervention preoperatively. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Control | The control group will not be given any intervention preoperatively. |
|
|
| 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. | one experimental patient did not report this data point therefore there were 23, not 24, patients analyzed | Posted | Median | Inter-Quartile Range | units on a scale | 7 days post-operatively |
|
|
|
| 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. | Some patients did not report this data point therefore there were fewer patients analyzed than were described in the Participant Flow | Posted | Median | Inter-Quartile Range | units on a scale | 1 day post-operatively |
|
|
|
| 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. | One patient did not report this data point therefore there were fewer patients analyzed than were described in the Participant Flow | Posted | Median | Inter-Quartile Range | units on a scale | Averaged over 7 days post-operatively |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 3 |
| 24 |
| EG001 | Control | The control group will not be given any intervention preoperatively. | 0 | 25 | 0 | 25 | 0 | 25 |
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