The Use of SennaS for Prevention of Post-Operative Constipation After Urogynecologic Surgery - Full Text View

Sponsored by:	Hartford Hospital
Information provided by:	Hartford Hospital
ClinicalTrials.gov Identifier:	NCT00571896

Purpose

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.

Condition	Intervention	Phase
Constipation	Drug: Senna+ docusate Drug: placebo	Phase II Phase III

MedlinePlus related topics: Constipation

Drug Information available for: Bismuth subsalicylate Dioctyl sulfosuccinic acid Docusate calcium Kaopectate Amphetamine Methamphetamine Senna

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Use of SennaS for Prevention of Post-Operative Constipation After Urogynecologic Surgery: a Randomized Double Blinded Placebo Controlled Trial

Further study details as provided by Hartford Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Straining and pain with bowel movements in the immediate post-operative period [ Time Frame: First post-operative week ] [ Designated as safety issue: No ]

Estimated Enrollment:	102
Study Start Date:	December 2007
Estimated Study Completion Date:	May 2009

Arms	Assigned Interventions
SennaS: Experimental This group of participants will receive SennaS to use after surgery.	Drug: Senna+ docusate 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.
Placebo: Placebo Comparator This group of participants will receive placebo pills to use after surgery.	Drug: placebo 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.

Arms

Assigned Interventions

SennaS: Experimental

This group of participants will receive SennaS to use after surgery.

Drug: Senna+ docusate

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.

Placebo: Placebo Comparator

This group of participants will receive placebo pills to use after surgery.

Drug: placebo

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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571896

Contacts

Contact: Minita Patel, MD	860-545-1908	mpatel@harthosp.org
Contact: Christine A. LaSala, MD	860-545-4638	clasala@harthosp.org

Locations

United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06106

Sponsors and Collaborators

Hartford Hospital

Investigators

Principal Investigator:

Christine A LaSala, MD

Hartford Hospital, Division of Urogynecology

More Information

Publications:

Jewell DJ, Young G. Interventions for treating constipation in pregnancy. Cochrane Database Syst Rev. 2001;(2):CD001142. Review.

Kochen MM, Wegscheider K, Abholz HH. Prophylaxis of constipation by wheat bran: a randomized study in hospitalized patients. Digestion. 1985;31(4):220-4.

Schmelzer M. Effectiveness of wheat bran in preventing constipation of hospitalized orthopaedic surgery patients. Orthop Nurs. 1990 Nov-Dec;9(6):55-9.

Kaçmaz Z, Kaşiçi M. Effectiveness of bran supplement in older orthopaedic patients with constipation. J Clin Nurs. 2007 May;16(5):928-36.

Fränneby 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. Epub 2005 Feb 10.

Corman ML. Management of postoperative constipation in anorectal surgery. Dis Colon Rectum. 1979 Apr;22(3):149-51.

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.

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.

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. 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.

Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4.

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. 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.

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.

Responsible Party:	Division of Urogynecology, Hartford Hospital ( Minita Patel, MD )
Study ID Numbers:	2472
Study First Received:	December 10, 2007
Last Updated:	December 11, 2007
ClinicalTrials.gov Identifier:	NCT00571896
Health Authority:	United States: Institutional Review Board

Keywords provided by Hartford Hospital:

constipation
SennaS

Study placed in the following topic categories:

Signs and Symptoms
Methamphetamine
Signs and Symptoms, Digestive
Sennoside A&B

Constipation
Amphetamine
Senna Extract
Bismuth subsalicylate

ClinicalTrials.gov processed this record on January 13, 2009