NCT03523715

Prunes for Gastrointestinal Function After Gynecologic Surgery

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Prunes	12 oz of prunes daily
DRUG	Docusate Sodium	Oral docusate sodium twice daily

Timeline

• Start date: 2017-11-30
• Primary completion: 2020-06-30
• Completion: 2020-07-31
• First posted: 2018-05-14
• Last updated: 2021-04-08
• Results posted: 2021-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study