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Reduction of Postoperative Gastrointestinal Dysmotility Following Total Laparoscopic Hysterectomy.

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ClinicalTrials.gov Identifier: NCT03800745
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Collaborators:
Michael Sprague MD
Pamela Frazzini-Padilla MD
Katherine Smith MD
Jennifer Afton Cooper MD
Information provided by (Responsible Party):
Mehandru, Natasha, The Cleveland Clinic

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.


Condition or disease Intervention/treatment Phase
Postoperative Passage of Flatus Postoperative Bowel Movement Drug: Colace 100Mg Capsule Drug: Miralax Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: randomized control trial
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Reduction of Postoperative Gastrointestinal Dysmotility Following Total Laparoscopic Hysterectomy: a Randomized Control Trial.
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : September 5, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: No Medication
No intervention is assigned in Arm A.
Experimental: 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.
Drug: Colace 100Mg Capsule
Prescribed to Arm B

Experimental: 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.
Drug: Miralax
Prescribed to Arm C




Primary Outcome Measures :
  1. Time to First Bowel Movement [ Time Frame: Patients will be followed for the first 5 days after surgery. ]
    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.


Secondary Outcome Measures :
  1. Time to First Flatus [ Time Frame: Patients will be followed for the first 5 days after surgery. ]
    Secondary outcomes include the time to first flatus. This will be calculated as the difference between the date and end time of the subject's surgery and the date and time of first BM after surgery.

  2. Narcotic Use [ Time Frame: Patients will be followed for the first 5 days after surgery. ]
    Postoperative narcotic use in oral morphine equivalents in the first five days postoperatively will be measured.

  3. PAC-SYM Questionnaire [ Time Frame: Patients will be followed for the first 5 days after surgery. ]
    To assess for opioid-induced constipation. Postoperatively, the Patient Assessment of Constipation-Symptom Questionnaire will be administered on postoperative day 5 to assess 12 different symptoms regarding bowel function.The 12‐item questionnaire is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5‐point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0‐4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden. Historically, a reduction in total score of 1 point or more has been used as the cut‐off to define a positive response to treatment, 2 implying that this is a meaningful improvement.

  4. Constipation Score [ Time Frame: The first 5 days after surgery. ]
    A postoperative constipation score is calculated based on preoperative stool frequency, postoperative days to first BM, stool consistency, percentage of straining, and sensation of incomplete evacuation. Constipation scores are calculated basedon: days to first BM (2 points if >4 days, 0 points if 1-3 days); stool consistency (1 point if types 1 or 2, 0 points for types 3-7); strain rating (0.5 points if for ≥5 on ≥25% of the BMs; 0 points for ≤4 on 0-25%); 0.5 point for rating of mild, moderate, or severe for sense of incomplete evacuation to the question: "Have you experienced incomplete bowel movement, like you did not finish?" with 0 point for rating of none). The Straining Scale is a single-item questionnaire assessing straining on a 5 point Likert scale ranging from 1 to 5 in the following order: no straining, mild, moderate, severe, or very severe straining. A constipation score of 2 or more is consistent with constipation based on the Rome III criteria.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800745


Contacts
Contact: Natasha Mehandru, MD 954-766-5710 mehandn@ccf.org
Contact: Michael Sprague, MD 954-999-3215 SPRAGUM2@ccf.org

Locations
United States, Florida
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Natasha Mehandru, MD    954-766-5710    mehandn@ccf.org   
Contact: Michael Sprague, MD    954-999-3215    spragum2@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Michael Sprague MD
Pamela Frazzini-Padilla MD
Katherine Smith MD
Jennifer Afton Cooper MD

Responsible Party: Mehandru, Natasha, Sub-Investigator; Study Coordinator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03800745     History of Changes
Other Study ID Numbers: FLA 18-069
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Polyethylene glycol 3350
Bismuth subsalicylate
Laxatives
Gastrointestinal Agents
Antidiarrheals