Clinical trial NCT04197869: Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy
Official title: Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Post-Op Complication
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: First Bowel Movement
timeFrame: 7 days post-operatively
Secondary outcomes:
measure: Post Operative Pain With First Bowel Movement as Measured by the VAS Scale.
timeFrame: 7 days post-operatively
measure: Post Operative Pain at Day 1 as Measured by the VAS Scale
timeFrame: 1 day post-operatively
measure: Median Postoperative Pain
timeFrame: Averaged over 7 days post-operatively
Other outcomes:
Locations:
city: Bay Shore
country: United States
facility: Northwell Health
state: New York
Study officials:
References: