Does Simethicone Improve Operative Field in Gynecological... | NCT03009604

Studies
Does Simethicone Improve Operative Field in Gynecological Operations

NCT03009604

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jan 4, 2017Estimated

Enrollment

90Estimated

Phase

Phase 3

Conditions

Benign Gynecologic Neoplasm

Interventions

Simethicone
Enema

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Apr 2017Estimated

Completion Date

May 2017Estimated

First Submitted Date

Jan 2, 2017

First Submission Date that Met QC Criteria

Jan 2, 2017

First Posted Date

Jan 4, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2017

Last Update Posted Date

Jan 4, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Simethicone	Drug	Simethicone 40mg oral tablets	Simethicone
Enema

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the degree of small & large bowel preparation		intraoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Altayeb Mostafa, MBBCh	Contact	00201003722811

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University	Recruiting	Asyut			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012841	Simethicone
D004733	Enema

Ancestor Terms

ID	Term
D004129	Dimethylpolysiloxanes
D012828	Silicones
D012833	Siloxanes
D017646	Organosilicon Compounds

Browse Leaves

Not provided

Browse Branches

Not provided