Prunes for Gastrointestinal Function After Gynecologic Surgery
Primary Purpose
Constipation
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prunes
Docusate Sodium
Sponsored by
About this trial
This is an interventional prevention trial for Constipation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Los Angeles Count + USC Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Prunes
Control
Arm Description
The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.
The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.
Outcomes
Primary Outcome Measures
Time to First Bowel Movement
Time to first bowel movement after surgery
Secondary Outcome Measures
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
Pain With Bowel Movement Measured
Likert scale from 0 to 10 in which higher values indicate more pain
Satisfaction With Bowel Regimen
Likert scale from 0 to 10 in which higher values indicate more satisfaction
Satisfaction With Surgery Overall
Likert scale from 0 to 10 in which higher levels indicate more satisfaction
Requirements for Laxatives
The number of participants who used any laxatives (besides the prunes and stool softeners) during the study period.
Bowel Movement in the Study Period
The number of participants who had a bowel movement in the post operative study follow up
Full Information
NCT ID
NCT03523715
First Posted
May 1, 2018
Last Updated
March 11, 2021
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT03523715
Brief Title
Prunes for Gastrointestinal Function After Gynecologic Surgery
Official Title
Effect of Prunes on Gastrointestinal Function After Gynecological Surgery: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruiting participants
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prunes
Arm Type
Experimental
Arm Description
The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.
Intervention Type
Dietary Supplement
Intervention Name(s)
Prunes
Other Intervention Name(s)
Dried plums
Intervention Description
12 oz of prunes daily
Intervention Type
Drug
Intervention Name(s)
Docusate Sodium
Other Intervention Name(s)
Colace
Intervention Description
Oral docusate sodium twice daily
Primary Outcome Measure Information:
Title
Time to First Bowel Movement
Description
Time to first bowel movement after surgery
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Stool Consistency of the First Bowel Movement
Description
Bristol Stool chart in which stool consistency is described as type 1 to 7 with higher values indicating more liquid stool
Time Frame
3 days
Title
Pain With Bowel Movement Measured
Description
Likert scale from 0 to 10 in which higher values indicate more pain
Time Frame
3 days
Title
Satisfaction With Bowel Regimen
Description
Likert scale from 0 to 10 in which higher values indicate more satisfaction
Time Frame
3 day
Title
Satisfaction With Surgery Overall
Description
Likert scale from 0 to 10 in which higher levels indicate more satisfaction
Time Frame
3 days
Title
Requirements for Laxatives
Description
The number of participants who used any laxatives (besides the prunes and stool softeners) during the study period.
Time Frame
3 days
Title
Bowel Movement in the Study Period
Description
The number of participants who had a bowel movement in the post operative study follow up
Time Frame
5 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Begum Ozel, MD
Organizational Affiliation
Keck School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles Count + USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20207340
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.
Results Reference
background
PubMed Identifier
22453316
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.
Results Reference
background
PubMed Identifier
25109788
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.
Results Reference
background
PubMed Identifier
29398337
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.
Results Reference
background
PubMed Identifier
21323688
Citation
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.
Results Reference
background
PubMed Identifier
35732845
Citation
Rasouli 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.
Results Reference
derived
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Prunes for Gastrointestinal Function After Gynecologic Surgery
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