Overview

Reduction of Postoperative Gastrointestinal Dysmotility Following Total Laparoscopic Hysterectomy.

Status:
Completed
Trial end date:
2020-05-05
Target enrollment:
0
Participant gender:
Female
Summary
Return of bowel function is an integral component of postoperative recovery following minimally invasive gynecologic surgery. To date, there is no standardized regimen to optimize bowel motility postoperatively. Clinical practices vary in the medications prescribed to facilitate this process, as well as what is considered the norm for return of flatus and time to first bowel movement. This study is a randomized control trial. The primary outcome of the study is to assess the effect of a standardized postoperative bowel care regimen on return of bowel function by assessing the time to first bowel movement; a secondary outcome is to assess the effect of such a regimen on time to first flatus. The hypothesis is that the prescription of a laxative, rather than a stool softener or no agent, will expedite the time to first bowel movement and first flatus. Other secondary outcomes and endpoints are assessing narcotic use measured in total oral morphine equivalents in the first five days postoperatively, as well as the constipation score and the PAC-SYM questionnaire.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
The Cleveland Clinic
Collaborators:
Jennifer Afton Cooper MD
Katherine Smith MD
Michael Sprague MD
Pamela Frazzini-Padilla MD
Treatments:
Bismuth subsalicylate
Polyethylene glycol 3350
Criteria
Inclusion Criteria:

- aged 18-85 undergoing minimally invasive gynecologic surgery in the form of total
laparoscopic hysterectomy.

Exclusion Criteria:

- an underlying gynecologic malignancy, pre-existing gastrointestinal disorders, history
of bowel resection, insulin-dependent diabetes or gastroparesis, known gastric
dysmotility, chronic use of pain medications, or anticipated bowel surgery