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Prunes for Gastrointestinal Function After Gynecologic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523715
Recruitment Status : Unknown
Verified July 2018 by Begum Ozel, University of Southern California.
Recruitment status was:  Recruiting
First Posted : May 14, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Begum Ozel, University of Southern California

Brief 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.

Condition or disease Intervention/treatment Phase
Constipation Dietary Supplement: Prunes Drug: Docusate Sodium Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Prunes on Gastrointestinal Function After Gynecological Surgery: A Randomized Controlled Trial
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


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 Name: Dried plums

Drug: Docusate Sodium
Oral docusate sodium twice daily
Other Name: 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 Name: Colace




Primary Outcome Measures :
  1. Time to first bowel movement [ Time Frame: 3 days ]
    Time to first bowel movement after surgery


Secondary Outcome Measures :
  1. 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

  2. Pain with bowel movement measured [ Time Frame: 3 days ]
    Likert scale from 0 to 10 in which higher values indicate more pain

  3. Satisfaction with bowel regimen [ Time Frame: 3 day ]
    Likert scale from 0 to 10 in which higher values indicate more satisfaction

  4. Satisfaction with surgery overall [ Time Frame: 3 days ]
    Likert scale from 0 to 10 in which higher levels indicate more satisfaction

  5. Requirements for laxatives [ Time Frame: 3 days ]
    Yes or No



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523715


Contacts
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Contact: Begum Ozel, MD 3234093385 ozel@usc.edu
Contact: Christina Dancz, MD 3234093385 Christina.Dancz@med.usc.edu

Locations
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United States, California
Los Angeles Count + USC Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Begum Ozel, M.D.    323-409-3385    ozel@usc.edu   
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Begum Ozel, MD Keck School of Medicine
Publications:
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Responsible Party: Begum Ozel, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT03523715    
Other Study ID Numbers: HS-17-00548
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Bismuth subsalicylate
Antidiarrheals
Gastrointestinal Agents