NCT03009604

Brief Summary

Mechanical bowel preparation aims to decrease the volume fecal content in the colon, which thereby decreases the total colony count of bacteria, thus, decreasing peritoneal contamination in case of bowel injury, improving the access to the surgical field and facilitating intraoperative bowel manipulation

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

January 2, 2017

Last Update Submit

January 2, 2017

Conditions

Benign Gynecologic Neoplasm

Outcome Measures

Primary Outcomes (1)

  • the degree of small & large bowel preparation

    intraoperative

Study Arms (2)

Simethicone

EXPERIMENTAL

women take 6 tablets (2 tablets after each meal) and to fast overnight before the operation

Drug: Simethicone

Enema

ACTIVE COMPARATOR

women take 3 rectal Enema (8:00 pm, 12:00 am \& 8:00 am) and to fast over night before the operation.

Drug: Enema

Interventions

SimethiconeDRUG

Simethicone 40mg oral tablets

Simethicone
EnemaDRUG

sodium dihydrogen phosphate dihydrate 19.2 gram \& disodium hydrogen phosphate dodecahydrate 7.2 gram, in addition to purified water

Enema

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Gynecological operations for benign conditions as hysterectomy, ovarian cystectomy and myomectomy.

You may not qualify if:

  • History of allergic reaction to study drugs.
  • More than one scar of previous operation.
  • Suspicious of malignancy.
  • Psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

RECRUITING

MeSH Terms

Interventions

SimethiconeEnema

Intervention Hierarchy (Ancestors)

DimethylpolysiloxanesSiliconesSiloxanesOrganosilicon CompoundsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureDrug TherapyTherapeutics

Central Study Contacts

Altayeb Mostafa, MBBCh

CONTACT

00201003722811

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 2, 2017

First Posted

January 4, 2017

Study Start

January 1, 2017

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

January 4, 2017

Record last verified: 2017-01

Locations

EG(1)