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Phase 4 N=71 Randomized Treatment

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

Constipation · Post-Op Complication

Bottom Line

View on ClinicalTrials.gov: NCT04197869 ↗
Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: First Bowel Movement — 1.96; 2.32 days

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Polyethylene Glycol Powder (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Northwell Health
Primary completion
Jun 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
First Bowel Movement		 1.96; 2.32 —
SECONDARY
Post Operative Pain With First Bowel Movement as Measured by the VAS Scale.		 1; 4 —
SECONDARY
Post Operative Pain at Day 1 as Measured by the VAS Scale		 4; 2 —
SECONDARY
Median Postoperative Pain		 1.3; 3.2 —

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04197869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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