Prunes for Gastrointestinal Function After Gynecologic Surgery

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03523715
• Other study ID #: HS-17-00548
• Status: Terminated
• Phase: Phase 4
• Start date: November 30, 2017
• Est. completion date: July 31, 2020

Study information

• Verified date: March 2021
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. completion date: July 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation

Intervention

Dietary Supplement:
• Prunes
12 oz of prunes daily

Drug:
• Docusate Sodium
Oral docusate sodium twice daily

Locations

Country	Name	City	State
United States	Los Angeles Count + USC Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (5)

Attaluri A, Donahoe R, Valestin J, Brown K, Rao SS. Randomised clinical trial: dried plums (prunes) vs. psyllium for constipation. Aliment Pharmacol Ther. 2011 Apr;33(7):822-8. doi: 10.1111/j.1365-2036.2011.04594.x. Epub 2011 Feb 15. — View Citation

Lever E, Cole J, Scott SM, Emery PW, Whelan K. Systematic review: the effect of prunes on gastrointestinal function. Aliment Pharmacol Ther. 2014 Oct;40(7):750-8. doi: 10.1111/apt.12913. Epub 2014 Aug 11. Review. — View Citation

Lever E, Scott SM, Louis P, Emery PW, Whelan K. The effect of prunes on stool output, gut transit time and gastrointestinal microbiota: A randomised controlled trial. Clin Nutr. 2019 Feb;38(1):165-173. doi: 10.1016/j.clnu.2018.01.003. Epub 2018 Feb 15. — View Citation

McNanley A, Perevich M, Glantz C, Duecy EE, Flynn MK, Buchsbaum G. Bowel function after minimally invasive urogynecologic surgery: a prospective randomized controlled trial. Female Pelvic Med Reconstr Surg. 2012 Mar-Apr;18(2):82-5. doi: 10.1097/SPV.0b013e3182455529. — View Citation

Patel M, Schimpf MO, O'Sullivan DM, LaSala CA. The use of senna with docusate for postoperative constipation after pelvic reconstructive surgery: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 2010 May;202(5):479.e1-5. doi: 10.1016/j.ajog.2010.01.003. Epub 2010 Mar 6. — View Citation

Outcome

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