Prunes for Gastrointestinal Function After Gynecologic Surgery

Phase 4

Terminated

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Female patients seen in the Gynecology or Urogynecology clinics at LAC+USC Medical Center who are planned for surgery requiring at least 24 hour stay
Age 18 or greater
Able to give informed consent
No contraindications to docusate or prune consumption

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Control	Docusate Sodium	The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.
Prunes	Prunes	The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.
Prunes	Docusate Sodium	The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.

Primary Outcome Measures

Name	Time	Method
Time to First Bowel Movement	3 days	Time to first bowel movement after surgery

Secondary Outcome Measures

Name	Time	Method
Stool Consistency of the First Bowel Movement	3 days	Bristol Stool chart in which stool consistency is described as type 1 to 7 with higher values indicating more liquid stool
Pain With Bowel Movement Measured	3 days	Likert scale from 0 to 10 in which higher values indicate more pain
Satisfaction With Bowel Regimen	3 day	Likert scale from 0 to 10 in which higher values indicate more satisfaction
Satisfaction With Surgery Overall	3 days	Likert scale from 0 to 10 in which higher levels indicate more satisfaction
Requirements for Laxatives	3 days	The number of participants who used any laxatives (besides the prunes and stool softeners) during the study period.
Bowel Movement in the Study Period	5 days	The number of participants who had a bowel movement in the post operative study follow up

Locations (1): Los Angeles Count + USC Medical Center
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Los Angeles, California, United States