NCT01011426

Brief Summary

The purpose of this study is to determine whether Bisacodyl, 5 mg usage decreases the incidence of nausea and abdominal pain after surgery, and also decreases the number of hospitalization days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

3.2 years

First QC Date

November 7, 2009

Last Update Submit

January 16, 2014

Conditions

Postoperative Nausea and VomitingAbdominal Pain

Keywords

laxativepostoperative careob-Gyn populationpost-operative patientsobstetrical and gynecological surgery

Outcome Measures

Primary Outcomes (1)

  • Incidence of nausea and vomiting in the 2 groups

    3-5 days

Secondary Outcomes (4)

  • Time to flatus

    2-5 days

  • Length of hospitalization

    2-5 days

  • Incidence of postoperative ileus

    2-5 days

  • Difference in pain scale in the 2 groups (Side-effects)

    2-5 days

Study Arms (2)

Bisacodyl

ACTIVE COMPARATOR
Drug: Bisacodyl

empty opague capsule

PLACEBO COMPARATOR
Drug: placebo

Interventions

BisacodylDRUG

5mg po 6 hours postoperatively, repeat in 12 hours if no flatus

Also known as: Dulcolax
Bisacodyl
placeboDRUG

1 capsule po 6 hours after surgery; repeat in 12 hours if no flatus

empty opague capsule

Eligibility Criteria

Age12 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Obstetrical and gynecological patients undergoing abdominal surgery.

You may not qualify if:

  • Subjects undergoing a bowel resection.
  • Subjects who have a nasogastric tube for bowel decompression.
  • Subjects allergic to Bisacodyl.
  • Subjects with mechanical bowel obstruction undergoing bowel resection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and VomitingAbdominal Pain

Interventions

Bisacodyl

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomitingPainNeurologic Manifestations

Intervention Hierarchy (Ancestors)

CresolsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Meena Khandelwal, MD

    Cooper University Hospital, NJ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2009

First Posted

November 11, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

January 20, 2014

Record last verified: 2014-01

Locations

US(1)