Reduction of Postoperative Gastrointestinal Dysmotility Following Total Laparoscopic Hysterectomy.

NCT ID: NCT03800745

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-09
• Study Completion Date: 2020-05-05

Brief 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.

Detailed Description

Patients undergoing minimally invasive hysterectomy at Cleveland Clinic Florida Department of Minimally Invasive Gynecologic Surgery will be recruited at their preoperative visit or over the phone. Inclusion criteria will be patients aged 18-85 undergoing minimally invasive gynecologic surgery in the form of total laparoscopic hysterectomy. Exclusion criteria are 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. Subjects that routinely take laxatives will be included in a sub-analysis. Randomization will occur in the immediate postoperative period. Enrolled subjects will be randomized using a computer generator. A total sample size of 72 subjects, with 24 subjects in each arm, is needed to attain a significance level of 95% at a power of 80% to demonstrate a reduction of 24 hours or more to first postoperative bowel movement. Accounting for a 10% attrition rate, we will aim to recruit 81 patients total with 27 subjects in each arm. The control group, arm A, will be not be prescribed any postoperative bowel care regimen. The first study group, arm B, will be prescribed docusate sodium(Colace) 100mg twice daily orally, and will be instructed to begin taking this the evening of surgery through postoperative day five. One dose will be taken with breakfast every morning, and the second dose will be taken with dinner every evening. The second study group, arm C, will be prescribed Miralax 17 grams oral powder pack daily with breakfast, and will be instructed to begin taking this the morning after surgery through postoperative day five. Prescriptions will be given at the time of randomization immediately postoperatively and prior to discharge home. At Cleveland Clinic Florida, a majority of patients are discharged the day of surgery.

In addition, the presence of preoperative constipation will be assessed prior to surgery based on the Rome IV criteria along with baseline stool consistency as per the Bristol Stool Chart. Postoperatively, patients will be asked to record the time of first flatus and time first bowel movement. Each subject will complete the Patient Assessment of Constipation Symptoms (PAC-SYM) validated questionnaire on postoperative day 5, and a constipation score will also be calculated. Compliance with postoperative medications will also be assessed as defined by the number of medications taken as prescribed. Patients will record medications taken each day in a medication diary.

Conditions

Postoperative Passage of Flatus; Postoperative Bowel Movement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

No Medication

No intervention is assigned in Arm A.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Colace

This is Arm B. Docusate sodium(Colace) is prescribed as100mg twice daily orally. Patients will be instructed to begin taking this the evening of surgery through postoperative day five.

Group Type: EXPERIMENTAL

Colace 100Mg Capsule

Intervention Type: DRUG

Prescribed to Arm B

Miralax

This is Arm C. Miralax 17 grams oral powder pack daily is prescribed to be taken with breakfast. Patients will be instructed to begin taking this the morning after surgery through postoperative day five.

Group Type: EXPERIMENTAL

Miralax

Intervention Type: DRUG

Prescribed to Arm C

Interventions

Colace 100Mg Capsule

Prescribed to Arm B

Intervention Type: DRUG

Miralax

Prescribed to Arm C

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Michael Sprague MD

UNKNOWN

Sponsor Role: collaborator

Pamela Frazzini-Padilla MD

UNKNOWN

Sponsor Role: collaborator

Katherine Smith MD

UNKNOWN

Sponsor Role: collaborator

Jennifer Afton Cooper MD

UNKNOWN

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mehandru, Natasha

Sub-Investigator; Study Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cleveland Clinic Florida

Weston, Florida, United States

Countries

United States

Other Identifiers

FLA 18-069

Identifier Type: -

Identifier Source: org_study_id