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

Northwell Health

Status and phase: Completed; Phase 4

Conditions: Post-Op Complication; Constipation

Treatments: Drug: Polyethylene Glycol Powder

Study type: Interventional

Funder types: Other

Identifiers

NCT04197869

19-0802

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: Female

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Experimental

Experimental group

Description:

The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date.

Treatment:

Drug: Polyethylene Glycol Powder

Control

No Intervention group

Description:

The control group will not be given any intervention preoperatively.