Clinical trial

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

NCT04197869

Name

19-0802

Description

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.

Trial arms

Trial start

2019-12-09

Estimated PCD

2023-06-21

Trial end

2023-06-21

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Experimental

Size

Primary endpoint

First bowel movement

7 days post-operatively

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}

Updated at

2023-09-21

1 organization

1 product

2 indications

Organization

Northwell Health

Product

Polyethylene Glycol

Indication

Constipation

Indication

Postoperative Complication