This is a prospective, randomized control trial that randomizes patients post-operatively into standard care versus standard care plus prunes. Patients in the control arm will take 100 mg docusate twice per day for 3 days (standard care). Participants in the treatment arm will consume 4 oz prunes daily and take 100 mg docusate twice per day for 3 days. The primary objective is to determine the time to first bowel movement after surgery.
A major postoperative complaint among benign gynecological surgery patients is constipation. Improved management of constipation among these patients has the potential to both alleviate pain and for significant savings for health care systems. This is a prospective, randomized control trial that randomizes patients post-operatively into standard care versus standard care plus prunes. The primary objective is to determine the time to first bowel movement after surgery. Secondary objectives are pain associated with first bowel movement, stool consistency using Bristol stool form scale, compliance and patient satisfaction. The study population includes women over the age of 18 undergoing benign gynecologic surgery with overnight stay. Patients in the control arm will take 100 mg docusate twice per day for 3 days (standard care). Participants in the treatment arm will consume 4 oz prunes daily and take 100 mg docusate twice per day for 3 days. Follow-up phone calls will be made 3 and 5 days postoperatively to inquire about primary and secondary outcomes. Participants will be randomized to the treatment or control group at a 1:1 ratio and using randomization blocks of 6. Participant characteristics will be presented as means and standard deviations for continuous variables and counts and percentages for categorical variables. The primary and secondary outcomes will be assessed using two-sample t-tests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
77
12 oz of prunes daily
Oral docusate sodium twice daily
Los Angeles Count + USC Medical Center
Los Angeles, California, United States
Time to First Bowel Movement
Time to first bowel movement after surgery
Time frame: 3 days
Stool Consistency of the First Bowel Movement
Bristol Stool chart in which stool consistency is described as type 1 to 7 with higher values indicating more liquid stool
Time frame: 3 days
Pain With Bowel Movement Measured
Likert scale from 0 to 10 in which higher values indicate more pain
Time frame: 3 days
Satisfaction With Bowel Regimen
Likert scale from 0 to 10 in which higher values indicate more satisfaction
Time frame: 3 day
Satisfaction With Surgery Overall
Likert scale from 0 to 10 in which higher levels indicate more satisfaction
Time frame: 3 days
Requirements for Laxatives
The number of participants who used any laxatives (besides the prunes and stool softeners) during the study period.
Time frame: 3 days
Bowel Movement in the Study Period
The number of participants who had a bowel movement in the post operative study follow up
Time frame: 5 days
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