Laparoscopic Hysterectomy and/or Laparoscopic Sacrocolpopexy
Conditions
Keywords
Laparoscopic hysterectomy,laparoscopic sacrocolpopexy,bowel prep
Brief summary
The purpose of this study is to learn about bowel preparation (cleansing) before laparoscopic hysterectomy and/or sacrocolpopexy. We are most interested in the ability of the surgeon to view necessary anatomy for the surgery, which will be assessed by a questionnaire completed at the end of your operation by the surgeon. We hypothesize that bowel preparation before laparoscopic hysterectomy will result in improved ability of the surgeon to view necessary anatomy for the surgery.
Interventions
DRUGFleet Enema (sodium biphosphate and sodium phosphate)
Those assigned to the mechanical bowel prep group will be asked to administer a single sodium phosphate enema rectally before going to bed the night before surgery. If stool is not clear in the morning, mechanical bowel prep subjects will administer one additional enema the morning of surgery
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women undergoing planned laparoscopic hysterectomy, with or without concomitant sacrocolpopexy, for benign indications with members of the Advanced Laparoscopy & Pelvic Pain division and the Urogynecology division at UNC.
Exclusion criteria
* Patients with known or suspected malignancy and those with severe endometriosis of the posterior cul-de-sac where bowel resection * Pregnant women. * Women under 18 years old. * Women who cannot provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgeon's assessment of surgical field visual quality | immediately after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon evaluation of patient outcomes | immediately after surgery | Survey will include questions regarding operative time, operative complications, postoperative complications, and length of hospitalization. |
| Patient reported satisfaction | immediately prior to surgery | Participants will complete questionnaires regarding their relative comfort in the preoperative period. Participants will also be asked if they were able to complete the regimen and if they would be willing to perform the same preparation before a future surgery. |
Countries
United States
Outcome results
None listed