- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00571896
The Use of SennaS for Prevention of Post-operative Constipation After Urogynecologic Surgery
January 3, 2012 updated by: Hartford Hospital
The Use of SennaS for Prevention of Post-operative Constipation After Urogynecologic Surgery: a Randomized Double Blinded Placebo Controlled Trial
We are doing this study to see if using an over the counter mild laxative, SennaS, there is a difference in time required to have a bowel movement in women who are having surgery for prolapse (when your uterus and/or vagina drop after childbirth or with age) and/or incontinence (when you leak urine or stool without your control) as compared to a sugar pill or placebo.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Right now, doctors use mild laxatives and stool softeners to help you have a bowel movement earlier and with less pain after surgery.
Sometimes if the stool softener or mild laxatives do not work, you may need to use stronger laxatives or enemas.
We want to see if specifically using SennaS is better for having a bowel movement soon after surgery and with less pain.
SennaS is FDA approved for constipation.
It has a stool softener and a mild laxative and has been shown to be safe and effective for treating constipation.
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Connecticut
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Hartford, Connecticut, United States, 06106
- Hartford Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Women undergoing pelvic reconstructive surgery, including any combination of:
- Posterior/rectocele repair
- Paravaginal repair
- Anterior/cystocele repair
- Suburethral sling
- Abdominal sacrocolpopexy
- Midurethral sling (obturator pass)
- Burch urethropexy
- Midurethral sling (retropubic pass)
- Colpocleisis/colpectomy
- Uterosacral ligament suspension
- Sacrospinous ligament fixation
- Enterocele repair
- Anal sphincter repair
- Perineorrhaphy
- Use of graft material (synthetic or biologic) of any form/size does not affect inclusion, use of laparoscopy or robotic-assisted laparoscopy does not affect inclusion
Exclusion Criteria:
- Male
- Pregnancy (based on positive urine or serum ß-HCG measurement preoperatively in women who are not menopausal or have prior hysterectomy)
- Concurrent bowel resection,
- Hirschsprung's Disease or gastroparesis,
- Irritable & inflammatory bowel disease (Crohn's Disease/ulcerative colitis) formally diagnosed,
- Clostridium difficile colitis during present hospitalization
- Inability to understand written study material,
- Inability to give consent
- Rectal bleeding or presently diagnosed colorectal cancer,
- Documented preoperative daily use of SennaS for more than 3 weeks,
- Known allergy to SennaS
- Inability to use suppositories/enemas
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SennaS
This group of participants will receive SennaS to use after surgery.
|
Senna+Docusate: dose will be 8.6 mg senna concentrate with 50 mg docusate.
The participants will take the medication as follows: 1. Drink 4-6 glasses of fluid a day for the first two weeks after surgery 2. Take 2 SennaS tabs at bedtime the first night home from the hospital 3.
If no bowel movement that next morning, take 2 tabs after breakfast.
4. If no bowel movement by evening, take 3 tabs at bedtime 5.
If no bowel movement that next morning, take 3 tabs after breakfast 6.
Once you do have a bowel movement, use the regimen described in the step two steps prior to the last one you used as your daily regimen.
So, if you had a BM the morning after 3 tabs at bedtime, use steps 2 & 3 (2 tabs at night and in the morning) until the first-postoperative visit.
Other Names:
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Placebo Comparator: Placebo
This group of participants will receive placebo pills to use after surgery.
|
Placebo pill: The participants will use the placebo pills in the following manner: 1. Drink 4-6 glasses of fluid a day for the first two weeks after surgery 2. Take 2 SennaS tabs at bedtime the first night home from the hospital 3.
If no bowel movement that next morning, take 2 tabs after breakfast.
4. If no bowel movement by evening, take 3 tabs at bedtime 5.
If no bowel movement that next morning, take 3 tabs after breakfast 6.
Once you do have a bowel movement, use the regimen described in the step two steps prior to the last one you used as your daily regimen.
So, if you had a BM the morning after 3 tabs at bedtime, use steps 2 & 3 (2 tabs at night and in the morning) until the first-postoperative visit.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1. Time to first bowel movement after surgery. 2. Need for magnesium citrate or enemas in the immediate post-operative period.
Time Frame: 7 weeks post-operatively
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7 weeks post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Straining and pain with bowel movements in the immediate post-operative period
Time Frame: First post-operative week
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First post-operative week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christine A LaSala, MD, Hartford Hospital, Division of Urogynecology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999 Sep;34(9):870-7. doi: 10.1080/003655299750025327.
- Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.
- Jewell DJ, Young G. Interventions for treating constipation in pregnancy. Cochrane Database Syst Rev. 2001;(2):CD001142. doi: 10.1002/14651858.CD001142.
- Kochen MM, Wegscheider K, Abholz HH. Prophylaxis of constipation by wheat bran: a randomized study in hospitalized patients. Digestion. 1985;31(4):220-4. doi: 10.1159/000199203.
- Schmelzer M. Effectiveness of wheat bran in preventing constipation of hospitalized orthopaedic surgery patients. Orthop Nurs. 1990 Nov-Dec;9(6):55-9. doi: 10.1097/00006416-199011000-00010.
- Kacmaz Z, Kasici M. Effectiveness of bran supplement in older orthopaedic patients with constipation. J Clin Nurs. 2007 May;16(5):928-36. doi: 10.1111/j.1365-2702.2006.01766.x.
- Franneby U, Gunnarsson U, Wollert S, Sandblom G. Discordance between the patient's and surgeon's perception of complications following hernia surgery. Hernia. 2005 May;9(2):145-9. doi: 10.1007/s10029-004-0310-x. Epub 2005 Feb 10.
- Corman ML. Management of postoperative constipation in anorectal surgery. Dis Colon Rectum. 1979 Apr;22(3):149-51. doi: 10.1007/BF02586804.
- Jelovsek JE, Barber MD, Paraiso MF, Walters MD. Functional bowel and anorectal disorders in patients with pelvic organ prolapse and incontinence. Am J Obstet Gynecol. 2005 Dec;193(6):2105-11. doi: 10.1016/j.ajog.2005.07.016.
- Arya LA, Novi JM, Shaunik A, Morgan MA, Bradley CS. Pelvic organ prolapse, constipation, and dietary fiber intake in women: a case-control study. Am J Obstet Gynecol. 2005 May;192(5):1687-91. doi: 10.1016/j.ajog.2004.11.032.
- Bradley CS, Brown MB, Cundiff GW, Goode PS, Kenton KS, Nygaard IE, Whitehead WE, Wren PA, Weber AM; Pelvic Floor Disorders Network. Bowel symptoms in women planning surgery for pelvic organ prolapse. Am J Obstet Gynecol. 2006 Dec;195(6):1814-9. doi: 10.1016/j.ajog.2006.07.008. Epub 2006 Sep 25.
- da Silva GM, Gurland B, Sleemi A, Levy G. Posterior vaginal wall prolapse does not correlate with fecal symptoms or objective measures of anorectal function. Am J Obstet Gynecol. 2006 Dec;195(6):1742-7. doi: 10.1016/j.ajog.2006.07.034.
- Mahony R, Behan M, O'Herlihy C, O'Connell PR. Randomized, clinical trial of bowel confinement vs. laxative use after primary repair of a third-degree obstetric anal sphincter tear. Dis Colon Rectum. 2004 Jan;47(1):12-7. doi: 10.1007/s10350-003-0009-6. Epub 2004 Jan 14.
- Griffenberg L, Morris M, Atkinson N, Levenback C. The effect of dietary fiber on bowel function following radical hysterectomy: a randomized trial. Gynecol Oncol. 1997 Sep;66(3):417-24. doi: 10.1006/gyno.1997.4797.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
December 10, 2007
First Submitted That Met QC Criteria
December 11, 2007
First Posted (Estimate)
December 12, 2007
Study Record Updates
Last Update Posted (Estimate)
January 5, 2012
Last Update Submitted That Met QC Criteria
January 3, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PATE002472HE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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