Prunes for Gastrointestinal Function After Gynecologic Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Constipation |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/14/2018 |
| Start Date: | November 30, 2017 |
| End Date: | July 31, 2019 |
| Contact: | Begum Ozel, MD |
| Email: | ozel@usc.edu |
| Phone: | 3234093385 |
Effect of Prunes on Gastrointestinal Function After Gynecological Surgery: A Randomized Controlled Trial
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.
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.
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.
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
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