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Reduction of Postoperative Gastrointestinal Dysmotility Following Total Laparoscopic Hysterectomy.

NCT03800745 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2020-06-02

No results posted yet for this study

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.

Conditions

  • Postoperative Passage of Flatus
  • Postoperative Bowel Movement

Interventions

DRUG

Colace 100Mg Capsule

Prescribed to Arm B

DRUG

Miralax

Prescribed to Arm C

Sponsors & Collaborators

  • Michael Sprague MD

    collaborator UNKNOWN

  • Pamela Frazzini-Padilla MD

    collaborator UNKNOWN

  • Katherine Smith MD

    collaborator UNKNOWN

  • Jennifer Afton Cooper MD

    collaborator UNKNOWN

  • The Cleveland Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-09
Primary Completion
2020-05-05
Completion
2020-05-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03800745 on ClinicalTrials.gov