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Prunes for Gastrointestinal Function After Gynecologic Surgery
Effect of Prunes on Gastrointestinal Function After Gynecological Surgery: A Randomized Controlled Trial
1 other identifier
interventional
77
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2017
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2017
CompletedFirst Submitted
Initial submission to the registry
May 1, 2018
CompletedFirst Posted
Study publicly available on registry
May 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedResults Posted
Study results publicly available
April 8, 2021
CompletedApril 8, 2021
March 1, 2021
2.6 years
May 1, 2018
March 11, 2021
March 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Time to First Bowel Movement
Time to first bowel movement after surgery
3 days
Secondary Outcomes (6)
Stool Consistency of the First Bowel Movement
3 days
Pain With Bowel Movement Measured
3 days
Satisfaction With Bowel Regimen
3 day
Satisfaction With Surgery Overall
3 days
Requirements for Laxatives
3 days
- +1 more secondary outcomes
Study Arms (2)
Prunes
EXPERIMENTALThe study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.
Control
PLACEBO COMPARATORThe placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Age 18 or greater
- Able to give informed consent
- No contraindications to docusate or prune consumption
You may not qualify if:
- Unable to give informed consent
- Unwilling to follow protocol
- Active malignancy
- Emergency surgery
- Diabetes mellitus
- Inflammatory bowel disease, gastroparesis, or other bowel disorder
- History of bowel resection or presence of colostomy
- Dependence on regular laxative use prior to surgery
- Baseline frequency of bowel movements less than weekly
- Intraoperative enterotomy or any bowel surgery performed at the time of surgery
- Patient unable to initiate oral intake on post op day 1 for any reason
- Allergy to docusate or prunes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Los Angeles Count + USC Medical Center
Los Angeles, California, 90033, United States
Related Publications (6)
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.
PMID: 20207340BACKGROUNDMcNanley 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.
PMID: 22453316BACKGROUNDLever 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.
PMID: 25109788BACKGROUNDLever 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.
PMID: 29398337BACKGROUNDAttaluri 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.
PMID: 21323688BACKGROUNDRasouli MA, Dancz CE, Dahl M, Volpe KA, Horton CJ, Ozel BZ. Effect of prunes on gastrointestinal function after benign gynecological surgery: a randomized control trial. Langenbecks Arch Surg. 2022 Dec;407(8):3803-3810. doi: 10.1007/s00423-022-02584-8. Epub 2022 Jun 22.
PMID: 35732845DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Begum Ozel, MD
- Organization
- University of Southern California
Study Officials
- PRINCIPAL INVESTIGATOR
Begum Ozel, MD
Keck School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 1, 2018
First Posted
May 14, 2018
Study Start
November 30, 2017
Primary Completion
June 30, 2020
Study Completion
July 31, 2020
Last Updated
April 8, 2021
Results First Posted
April 8, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share