Does Simethicone Improve Operative Field in Gynecological Operations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03009604
Recruitment Status : Unknown
Verified January 2017 by Altayeb Abd alal Mostafa Mohammad, Assiut University.
Recruitment status was:  Recruiting
First Posted : January 4, 2017
Last Update Posted : January 4, 2017
Information provided by (Responsible Party):
Altayeb Abd alal Mostafa Mohammad, Assiut University

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

Condition or disease Intervention/treatment Phase
Benign Gynecologic Neoplasm Drug: Simethicone Drug: Enema Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2017
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Simethicone

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

Primary Outcome Measures :
  1. the degree of small & large bowel preparation [ Time Frame: intraoperative ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03009604

Contact: Altayeb Mostafa, MBBCh 00201003722811

Assiut University Recruiting
Assiut, Egypt
Contact: Altayeb Mostafa         
Sponsors and Collaborators
Assiut University

Responsible Party: Altayeb Abd alal Mostafa Mohammad, Dr, Assiut University Identifier: NCT03009604     History of Changes
Other Study ID Numbers: SIM
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Antifoaming Agents
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents