Trial Outcomes & Findings for Bowel Function After Minimally Invasive Urogynecologic Surgery (NCT NCT01044212)

Results Overview

The time to first post-operative bowel movement was measured in hours after surgery.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

72 participants

Primary outcome timeframe

Within 1 week of surgery

Results posted on

2015-10-21

Participant Flow

Candidates meeting criteria were offered participation at their preoperative visit.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	35	37
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bowel Function After Minimally Invasive Urogynecologic Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bowel Medications n=35 Participants 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 n=37 Participants Docusate is the standard of care regimen Docusate sodium : Docusate 100mg BID	Total n=72 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	29 Participants n=7 Participants	48 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	8 Participants n=7 Participants	24 Participants n=5 Participants
Age, Continuous	58 years STANDARD_DEVIATION 10 • n=5 Participants	63 years STANDARD_DEVIATION 9 • n=7 Participants	61 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	37 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	37 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 1 week of surgery

Population: Power analysis

The time to first post-operative bowel movement was measured in hours after surgery.

Outcome measures

Outcome measures
Measure	Bowel Medications n=30 Participants 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 n=30 Participants Docusate is the standard of care regimen Docusate sodium : Docusate 100mg BID
Time to First Post-op Bowel Movement	64 hours Standard Deviation 21	77 hours Standard Deviation 24

SECONDARY outcome

Timeframe: Within 1 week of surgery

The pain level experienced with the first post-operative bowel movement was recorded and measured on visual analog score with range 0 to 10 in units on scale. 0 being no pain at all. 10 being worst pain.

Outcome measures

Outcome measures
Measure	Bowel Medications n=35 Participants 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 n=37 Participants Docusate is the standard of care regimen Docusate sodium : Docusate 100mg BID
Pain Level Associated With First Postoperative Bowel Movement	3.6 VAS pain score Standard Deviation 3.2	3.7 VAS pain score Standard Deviation 2.8

SECONDARY outcome

Timeframe: Within 1 week of surgery

The consistency of the first post-operative bowel movement was rated using the Bristol Stool Scale. This is a validated scale that is widely used. It is given to patients as a chart. The chart can be seen here: http://en.wikipedia.org/wiki/Bristol\_stool\_scale. The seven types of stool are: Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid

Outcome measures

Outcome measures
Measure	Bowel Medications n=35 Participants 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 n=37 Participants Docusate is the standard of care regimen Docusate sodium : Docusate 100mg BID
Consistency of First Postoperative Bowel Movement	3.13 Bristol Stool Scale Standard Deviation 1.22	3.40 Bristol Stool Scale Standard Deviation 1.07

Adverse Events

Bowel Medications

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Docusate Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gunhilde Buchsbaum, Division Director Urogynecology

University of Rochester

Phone: 585-273-3233

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place