Prunes for Gastrointestinal Function After Gynecologic Surgery

March 11, 2021 updated by: Begum Ozel, University of Southern California

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Los Angeles Count + USC Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prunes
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
12 oz of prunes daily
Other Names:
  • Dried plums
Drug: Docusate Sodium
Oral docusate sodium twice daily
Other Names:
  • Colace
Placebo Comparator: Control
The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.
Drug: Docusate Sodium
Oral docusate sodium twice daily
Other Names:
  • Colace

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Bowel Movement
Time Frame: 3 days
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
Time Frame: 3 days
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
Time Frame: 3 days
Likert scale from 0 to 10 in which higher values indicate more pain
3 days
Satisfaction With Bowel Regimen
Time Frame: 3 day
Likert scale from 0 to 10 in which higher values indicate more satisfaction
3 day
Satisfaction With Surgery Overall
Time Frame: 3 days
Likert scale from 0 to 10 in which higher levels indicate more satisfaction
3 days
Requirements for Laxatives
Time Frame: 3 days
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
Time Frame: 5 days
The number of participants who had a bowel movement in the post operative study follow up
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

  • Principal Investigator: Begum Ozel, MD, Keck School Of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2017

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

May 1, 2018

First Submitted That Met QC Criteria

May 1, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-17-00548

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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