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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prunes | Experimental | The 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 Comparator | The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prunes | Dietary Supplement | 12 oz of prunes daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Bowel Movement | Time to first bowel movement after surgery | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pain With Bowel Movement Measured |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Begum Ozel, MD | Keck School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles Count + USC Medical Center | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20207340 | Background | 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. | |
| 22453316 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Prunes: 12 oz of prunes daily Docusate Sodium: Oral docusate sodium twice daily |
| FG001 | Control | The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery. Docusate Sodium: Oral docusate sodium twice daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Prunes: 12 oz of prunes daily Docusate Sodium: Oral docusate sodium twice daily |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to First Bowel Movement | Time to first bowel movement after surgery | Posted | Mean | Standard Deviation | hours post surgery | 3 days |
|
The study follow up period was 5 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Prunes: 12 oz of prunes daily Docusate Sodium: Oral docusate sodium twice daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Begum Ozel, MD | University of Southern California | 562-657-2961 | ozel@usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 3, 2017 | Mar 11, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004143 | Dioctyl Sulfosuccinic Acid |
| ID | Term |
|---|---|
| D013386 | Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Docusate Sodium | Drug | Oral docusate sodium twice daily |
|
|
Likert scale from 0 to 10 in which higher values indicate more pain
| 3 days |
| Satisfaction With Bowel Regimen | Likert scale from 0 to 10 in which higher values indicate more satisfaction | 3 day |
| Satisfaction With Surgery Overall | Likert scale from 0 to 10 in which higher levels indicate more satisfaction | 3 days |
| Requirements for Laxatives | 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 | The number of participants who had a bowel movement in the post operative study follow up | 5 days |
| 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. |
| 25109788 | Background | 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. |
| 29398337 | Background | 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. |
| 21323688 | Background | 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. |
| 35732845 | Derived | 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. |
| Internally inconsistent reporting |
|
The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.
Docusate Sodium: Oral docusate sodium twice daily
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Post menopause | Count of Participants | Participants |
|
| Baseline Bristol Stool Scale | Median | Inter-Quartile Range | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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 | Posted | Median | Inter-Quartile Range | Bristol Stool Scale | 3 days |
|
|
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| Secondary | Pain With Bowel Movement Measured | Likert scale from 0 to 10 in which higher values indicate more pain | Posted | Median | Inter-Quartile Range | Likert scale 0-100 | 3 days |
|
|
|
| Secondary | Satisfaction With Bowel Regimen | Likert scale from 0 to 10 in which higher values indicate more satisfaction | Posted | Median | Inter-Quartile Range | Likert scale 0-100 | 3 day |
|
|
|
| Secondary | Satisfaction With Surgery Overall | Likert scale from 0 to 10 in which higher levels indicate more satisfaction | Posted | Median | Inter-Quartile Range | Likert scale 0-100 | 3 days |
|
|
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| Secondary | Requirements for Laxatives | The number of participants who used any laxatives (besides the prunes and stool softeners) during the study period. | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 5 days |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Control | The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery. Docusate Sodium: Oral docusate sodium twice daily | 0 | 24 | 0 | 24 | 0 | 24 |
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| D009930 |
| Organic Chemicals |