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Completed

NCT Number: NCT04197869

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

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.

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Key information

Conditions

Constipation Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Op Complication Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Northwell Health

Bay Shore, New York, 11706, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. First Bowel Movement

    Time frame: 7 days post-operatively

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

Secondary outcomes

  1. Post Operative Pain With First Bowel Movement as Measured by the VAS Scale.

    Time frame: 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.

  2. Post Operative Pain at Day 1 as Measured by the VAS Scale

    Time frame: 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.

  3. Median Postoperative Pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 13, 2019
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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