Clinical trial NCT00571896: The Use of SennaS for Prevention of Post-operative Constipation After Urogynecologic Surgery
Official title: The Use of SennaS for Prevention of Post-operative Constipation After Urogynecologic Surgery: a Randomized Double Blinded Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Constipation
Keywords: constipation
SennaS
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2007-12-12
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1. Time to first bowel movement after surgery. 2. Need for magnesium citrate or enemas in the immediate post-operative period.
timeFrame: 7 weeks post-operatively
Secondary outcomes:
measure: Straining and pain with bowel movements in the immediate post-operative period
timeFrame: First post-operative week
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital, Division of Urogynecology
name: Christine A LaSala, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jewell DJ, Young G. Interventions for treating constipation in pregnancy. Cochrane Database Syst Rev. 2001;(2):CD001142. doi: 10.1002/14651858.CD001142.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Corman ML. Management of postoperative constipation in anorectal surgery. Dis Colon Rectum. 1979 Apr;22(3):149-51. doi: 10.1007/BF02586804.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.