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Bowel Function After Minimally Invasive Urogynecologic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01044212
Recruitment Status : Completed
First Posted : January 7, 2010
Results First Posted : October 21, 2015
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Functional Disorder of Intestine
Interventions: Drug: Docusate
Drug: Bowel medications

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Candidates meeting criteria were offered participation at their preoperative visit.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bowel Medications

Docusate, Miralax, Metamucil wafers, Bisacodyl suppository

Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID

Docusate Controls

Docusate is the standard of care regimen

Docusate sodium : Docusate 100mg BID


Participant Flow:   Overall Study
    Bowel Medications   Docusate Controls
STARTED   35   37 
COMPLETED   30   30 
NOT COMPLETED   5   7 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Bowel Medications

Docusate, Miralax, Metamucil wafers, Bisacodyl suppository

Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID

Docusate Controls

Docusate is the standard of care regimen

Docusate sodium : Docusate 100mg BID

Total Total of all reporting groups

Baseline Measures
   Bowel Medications   Docusate Controls   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   37   72 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   19   29   48 
>=65 years   16   8   24 
Age 
[Units: Years]
Mean (Standard Deviation)
 58  (10)   63  (9)   61  (9.5) 
Gender 
[Units: Participants]
     
Female   35   37   72 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   35   37   72 


  Outcome Measures

1.  Primary:   Time to First Post-op Bowel Movement   [ Time Frame: Within 1 week of surgery ]

2.  Secondary:   Pain Level Associated With First Postoperative Bowel Movement   [ Time Frame: Within 1 week of surgery ]

3.  Secondary:   Consistency of First Postoperative Bowel Movement   [ Time Frame: Within 1 week of surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gunhilde Buchsbaum, Division Director Urogynecology
Organization: University of Rochester
phone: 585-273-3233
e-mail: gunhilde_buchsbaum@urmc.rochester.edu



Responsible Party: Gunhilde Buchsbaum, University of Rochester
ClinicalTrials.gov Identifier: NCT01044212     History of Changes
Other Study ID Numbers: 29359
First Submitted: January 5, 2010
First Posted: January 7, 2010
Results First Submitted: September 14, 2012
Results First Posted: October 21, 2015
Last Update Posted: October 21, 2015