Reduction of Postoperative Gastrointestinal Dysmotility Following Total Laparoscopic Hysterectomy.
Condition: Postoperative Passage of Flatus; Postoperative Bowel Movement
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Colace 100Mg Capsule; Miralax
Intervention type(s): Drug; Drug
Intervention description(s): Prescribed to Arm B; Prescribed to Arm C
Intervention MeSH terms: Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: randomized control trial
Masking: None (Open Label)
Primary purpose: Prevention