Constipation
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPrunes
12 oz of prunes daily
DRUGDocusate Sodium
Oral docusate sodium twice daily
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Bowel Movement | 3 days | Time to first bowel movement after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain With Bowel Movement Measured | 3 days | Likert scale from 0 to 10 in which higher values indicate more pain |
| Satisfaction With Bowel Regimen | 3 day | Likert scale from 0 to 10 in which higher values indicate more satisfaction |
| Stool Consistency of the First Bowel Movement | 3 days | Bristol Stool chart in which stool consistency is described as type 1 to 7 with higher values indicating more liquid stool |
| Requirements for Laxatives | 3 days | The number of participants who used any laxatives (besides the prunes and stool softeners) during the study period. |
| Bowel Movement in the Study Period | 5 days | The number of participants who had a bowel movement in the post operative study follow up |
| Satisfaction With Surgery Overall | 3 days | Likert scale from 0 to 10 in which higher levels indicate more satisfaction |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| 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 | 24 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not meet inclusion criteria | 1 | 0 |
| Overall Study | Internally inconsistent reporting | 0 | 2 |
| Overall Study | Lost to Follow-up | 11 | 14 |
Baseline characteristics
| Characteristic | Prunes | Total | Control |
|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 9.9 | 50 years STANDARD_DEVIATION 10.2 | 51.1 years STANDARD_DEVIATION 10.6 |
| Baseline Bristol Stool Scale | 4 units on a scale | 4 units on a scale | 4 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 42 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 8 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Post menopause | 9 Participants | 20 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 24 Participants | 9 Participants |
| Race (NIH/OMB) White | 7 Participants | 21 Participants | 14 Participants |
| Sex: Female, Male Female | 26 Participants | 50 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 |
| other Total, other adverse events | 0 / 26 | 0 / 24 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 |
Outcome results
Primary
Time to First Bowel Movement
Time to first bowel movement after surgery
Time frame: 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prunes | Time to First Bowel Movement | 57.6 hours post surgery | Standard Deviation 19.3 |
| Control | Time to First Bowel Movement | 53.8 hours post surgery | Standard Deviation 21.7 |
Secondary
Bowel Movement in the Study Period
The number of participants who had a bowel movement in the post operative study follow up
Time frame: 5 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prunes | Bowel Movement in the Study Period | 26 Participants |
| Control | Bowel Movement in the Study Period | 17 Participants |
Secondary
Pain With Bowel Movement Measured
Likert scale from 0 to 10 in which higher values indicate more pain
Time frame: 3 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prunes | Pain With Bowel Movement Measured | 60 Likert scale 0-100 |
| Control | Pain With Bowel Movement Measured | 40 Likert scale 0-100 |
Secondary
Requirements for Laxatives
The number of participants who used any laxatives (besides the prunes and stool softeners) during the study period.
Time frame: 3 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prunes | Requirements for Laxatives | 7 Participants |
| Control | Requirements for Laxatives | 6 Participants |
Secondary
Satisfaction With Bowel Regimen
Likert scale from 0 to 10 in which higher values indicate more satisfaction
Time frame: 3 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prunes | Satisfaction With Bowel Regimen | 100 Likert scale 0-100 |
| Control | Satisfaction With Bowel Regimen | 80 Likert scale 0-100 |
Secondary
Satisfaction With Surgery Overall
Likert scale from 0 to 10 in which higher levels indicate more satisfaction
Time frame: 3 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prunes | Satisfaction With Surgery Overall | 100 Likert scale 0-100 |
| Control | Satisfaction With Surgery Overall | 100 Likert scale 0-100 |
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
Time frame: 3 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prunes | Stool Consistency of the First Bowel Movement | 3 Bristol Stool Scale |
| Control | Stool Consistency of the First Bowel Movement | 4 Bristol Stool Scale |