Prunes for Gastrointestinal Function After Gynecologic Surgery

University of Southern California

Status and phase: Terminated; Phase 4

Conditions: Constipation

Treatments: Dietary Supplement: Prunes; Drug: Docusate Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT03523715

HS-17-00548

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. Age 18 or greater
3. Able to give informed consent
4. No contraindications to docusate or prune consumption

Exclusion criteria

1. Unable to give informed consent
2. Unwilling to follow protocol
3. Active malignancy
4. Emergency surgery
5. Diabetes mellitus
6. Inflammatory bowel disease, gastroparesis, or other bowel disorder
7. History of bowel resection or presence of colostomy
8. Dependence on regular laxative use prior to surgery
9. Baseline frequency of bowel movements less than weekly
10. Intraoperative enterotomy or any bowel surgery performed at the time of surgery
11. Patient unable to initiate oral intake on post op day 1 for any reason
12. Allergy to docusate or prunes

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 2 patient groups, including a placebo group

Prunes

Experimental group

Description:

The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.

Treatment:

Drug: Docusate Sodium

Dietary Supplement: Prunes

Control

Placebo Comparator group

Description:

The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.

Treatment:

Drug: Docusate Sodium