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The Use of SennaS for Prevention of Post-operative Constipation After Urogynecologic Surgery

Primary Purpose

Constipation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Senna+ docusate
placebo
Sponsored by
Hartford Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring constipation, SennaS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hartford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SennaS

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

1. Time to first bowel movement after surgery. 2. Need for magnesium citrate or enemas in the immediate post-operative period.

Secondary Outcome Measures

Straining and pain with bowel movements in the immediate post-operative period

Full Information

First Posted
December 10, 2007
Last Updated
January 3, 2012
Sponsor
Hartford Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00571896
Brief Title
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

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
constipation, SennaS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SennaS
Arm Type
Experimental
Arm Description
This group of participants will receive SennaS to use after surgery.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group of participants will receive placebo pills to use after surgery.
Intervention Type
Drug
Intervention Name(s)
Senna+ docusate
Other Intervention Name(s)
SennaS or Senokot-S
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Blank pill
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Straining and pain with bowel movements in the immediate post-operative period
Time Frame
First post-operative week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine A LaSala, MD
Organizational Affiliation
Hartford Hospital, Division of Urogynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States

12. IPD Sharing Statement

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The Use of SennaS for Prevention of Post-operative Constipation After Urogynecologic Surgery

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