Bowel Function After Minimally Invasive Hysterectomy

The University of Chicago

Status and phase: Completed; Phase 4

Conditions: Constipation

Treatments: Drug: Polyethylene Glycol 3350

Study type: Interventional

Funder types: Other

Identifiers

NCT04263896

IRB19-0436

Details and patient eligibility

About

Postoperative constipation affects up to a third of women undergoing minimally invasive (MIS) gynecologic surgery and is a major source of anxiety and discomfort. The average time to first bowel movement after gynecologic surgery is about 2 to 4 days and some factors responsible for this include anesthesia inhibitory effect on gastrointestinal motility, opioid pain medication use, chronic nonsteroidal anti-inflammatory drugs (NSAID) use and anatomic manipulation.

There are no established regimens to manage postoperative constipation after minimally invasive gynecologic surgery. Two studies evaluating the implementation of postoperative bowel regimen with polyethylene glycol (PEG) and with Senna and Docusate found no significant impact on postoperative bowel function. There have been no studies looking at the effect of preoperative bowel regimens on postoperative bowel function.

The purpose of this study is to evaluate postoperative bowel function after minimally invasive hysterectomy in women receiving a preoperative 10-day bowel regimen of PEG daily.

Full description

Following enrollment subjects will be randomized into the intervention/treatment arm and control arm. All subjects will be asked to complete a baseline demographic form and three questionnaires (Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Constipation Quality of Life (PAC- QOL), Wexner Constipation score). Additional demographic information will be obtained from chart review. This information will include past medical history, use of constipating medications, use of daily pain medications, chronic pain history, use of daily fiber supplementation.

Subjects in the intervention arm will be given 10-day supply of Miralax and instructed on its use. They will take this medication for the 10 days prior to surgery. Subjects in the control arm will continue with standard care prior to surgery.

Post operatively, all subjects will complete a diary for 7 days. In this diary they will record details about their bowel movements (time of movement, discomfort, texture of stool). They will also report average daily pain levels ( with a visual analog scale), daily pain medication use (time, medication, total number of pills).

At the end of the 7th day all subjects will complete the same PAC questionnaires as they did pre-operatively.

Enrollment: 97 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Any woman ≥ 18 years of age undergoing a minimally invasive hysterectomy (Laparoscopic, robotic, vaginal)
• Able to understand the consenting process and willing to participate in study

Exclusion criteria

• Planned laparotomy
• Emergent surgery
• Regular preoperative use of PEG 3350, laxatives, enemas or suppositories
• Planned bowel surgery
• Presence of colostomy
• Inability to consent
• Medical problems as follows:
• Chronic Kidney Disease (Cr: > 1.2 mg/dL)
• Insulin-Dependent Diabetes Mellitus
• Cardiac disease
• Gastric ulcers
• Difficulty swallowing or esophageal stricture
• Persistent nausea or vomiting
• Signs or symptoms of a small bowel obstruction

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

Participants receiving pre-operative laxative

Experimental group

Description:

Participants will receive 10 doses, 17g each, of polyethylene glycol 3350. They will be instructed to take 1 dose/packet each day for 10 days leading up to their surgery.

Treatment:

Drug: Polyethylene Glycol 3350

Participants not receiving pre-operative laxative

No Intervention group

Description:

Participants will not be given any laxatives.