drugset / Trial / NCT00571896
The Use of SennaS for Prevention of Post-operative Constipation After Urogynecologic Surgery
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2008-01
- Primary completion
- 2009-06
- Completion
- 2009-06
Publications
- Background Jewell DJ, Young G. Interventions for treating constipation in pregnancy. Cochrane Database Syst Rev. 2001;(2):CD001142. doi: 10.1002/14651858.CD001142.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background Corman ML. Management of postoperative constipation in anorectal surgery. Dis Colon Rectum. 1979 Apr;22(3):149-51. doi: 10.1007/BF02586804.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docusate Sodium | Unknown | 50 mg | — |
| Subject | Senna | Traditional medicine (herbal / TCM) | 8.6 mg | — |