Does Simethicone Improve Operative Field in Gynecological Operations

January 2, 2017 updated by: Altayeb Abd alal Mostafa Mohammad, Assiut University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Altayeb Mostafa, MBBCh
  • Phone Number: 00201003722811

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assiut University
        • Contact:
          • Altayeb Mostafa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Simethicone
women take 6 tablets (2 tablets after each meal) and to fast overnight before the operation
Drug: Simethicone
Simethicone 40mg oral tablets
Active Comparator: Enema
women take 3 rectal Enema (8:00 pm, 12:00 am & 8:00 am) and to fast over night before the operation.
Drug: Enema
sodium dihydrogen phosphate dihydrate 19.2 gram & disodium hydrogen phosphate dodecahydrate 7.2 gram, in addition to purified water

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

January 2, 2017

First Submitted That Met QC Criteria

January 2, 2017

First Posted (Estimate)

January 4, 2017

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 2, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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