Reduction of Postoperative Gastrointestinal Dysmotility Following Total Laparoscopic Hysterectomy.

NCT03800745 | Completed Phase 4 FDA Drug

• 1 other identifier: FLA 18-069
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Passage of Flatus; Postoperative Bowel Movement

Outcome Measures

Primary Outcomes (1)

• Time to First Bowel Movement

  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 date and time of first BM after surgery.

  Patients will be followed for the first 5 days after surgery.

Secondary Outcomes (4)

• Time to First Flatus

  Patients will be followed for the first 5 days after surgery.

• Narcotic Use

  Patients will be followed for the first 5 days after surgery.

• PAC-SYM Questionnaire

  Patients will be followed for the first 5 days after surgery.

• Constipation Score

  The first 5 days after surgery.

Study Arms (3)

No Medication

NO INTERVENTION

No intervention is assigned in Arm A.

Colace

EXPERIMENTAL

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.

Drug: Colace 100Mg Capsule

Miralax

EXPERIMENTAL

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.

Drug: Miralax

Interventions

Colace 100Mg Capsule DRUG

Prescribed to Arm B

Colace

Miralax DRUG

Prescribed to Arm C

Miralax

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Michael Sprague MD: collaborator
• Pamela Frazzini-Padilla MD: collaborator
• Katherine Smith MD: collaborator
• Jennifer Afton Cooper MD: collaborator

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

MeSH Terms

Interventions

Dioctyl Sulfosuccinic Acid; polyethylene glycol 3350

Intervention Hierarchy (Ancestors)

Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants are randomized to their arm on the day of surgery. A manila envelope with the arm written on a paper inside the envelope is opened in the post-anesthesia care unit (PACU) following surgery. A computerized random number generator was used to assign arms.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sub-Investigator; Study Coordinator

Model Details: randomized control trial

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 11, 2019
• Study Start: November 9, 2018
• Primary Completion: May 5, 2020
• Study Completion: May 5, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)