Prunes for Gastrointestinal Function After Gynecologic Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Prunes on Gastrointestinal Function After Gynecological Surgery: A Randomized Controlled Trial

Conditions
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Constipation

Intervention / Treatment
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* Dietary Supplement: Prunes
* Drug: Docusate Sodium


Participation Criteria
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Eligibility Criteria
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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: Unable to give informed consent Unwilling to follow protocol Active malignancy Emergency surgery Diabetes mellitus Inflammatory bowel disease, gastroparesis, or other bowel disorder History of bowel resection or presence of colostomy Dependence on regular laxative use prior to surgery Baseline frequency of bowel movements less than weekly Intraoperative enterotomy or any bowel surgery performed at the time of surgery Patient unable to initiate oral intake on post op day 1 for any reason Allergy to docusate or prunes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prunes<br>The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery. | Dietary Supplement: Prunes<br>* 12 oz of prunes daily<br>* Other names: Dried plums;Drug: Docusate Sodium<br>* Oral docusate sodium twice daily<br>* Other names: Colace;|
| Placebo Comparator: Control<br>The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery. | Drug: Docusate Sodium<br>* Oral docusate sodium twice daily<br>* Other names: Colace;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Bowel Movement | Time to first bowel movement after surgery | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 days | 
| Pain With Bowel Movement Measured | Likert scale from 0 to 10 in which higher values indicate more pain | 3 days | 
| Satisfaction With Bowel Regimen | Likert scale from 0 to 10 in which higher values indicate more satisfaction | 3 day | 
| Satisfaction With Surgery Overall | Likert scale from 0 to 10 in which higher levels indicate more satisfaction | 3 days | 
| Requirements for Laxatives | The number of participants who used any laxatives (besides the prunes and stool softeners) during the study period. | 3 days | 
| Bowel Movement in the Study Period | The number of participants who had a bowel movement in the post operative study follow up | 5 days |