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Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy

Phase 4
Completed
Conditions
Post-Op Complication
Constipation
Interventions
Registration Number
NCT04197869
Lead Sponsor
Northwell Health
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
71
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ExperimentalPolyethylene Glycol PowderThe experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date.
Primary Outcome Measures
NameTimeMethod
First Bowel Movement7 days post-operatively

Time to first post-operative bowel movement will be evaluated.

Secondary Outcome Measures
NameTimeMethod
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 Scale1 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 PainAveraged 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.

Trial Locations

Locations (1)

Northwell Health

🇺🇸

Bay Shore, New York, United States

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