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Simethicone: Does it Improve Operative Field and Postoperative Pain?

Primary Purpose

Simethicone

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Simethicone Tab 40 mg

Placebo Tablets

Sponsored by

Woman's Health University Hospital, Egypt

About this trial

This is an interventional treatment trial for Simethicone focused on measuring Simethicone, Laparoscopies, Pain

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Infertile patients
aged 20 - 40 years old
scheduled for laparoscopy

Exclusion Criteria:

Women were excluded from the study if patients had one or more of the following:
- scar of previous operation, uterine mass, severe endometriosis, suspicion of malignancy, history of allergic reaction to study drugs, psychiatric disorders and patient refusal

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Simethicone

placebo

Arm Description

Arm 1 or Group I or Simethicone 40mg. 3 tablets (one tablet after each meal) and to fast overnight the day before the operation.

Arm 2 or group 2 or placebo group. 3 tablets (one tablet after each meal) and to fast overnight the day before the operation.

Outcomes

Primary Outcome Measures

five-point scale

Secondary Outcome Measures

The degree of bowel preparation

VAS

Patient satisfaction

Full Information

NCT ID

First Posted

June 28, 2016

Last Updated

December 5, 2016

Sponsor

Woman's Health University Hospital, Egypt

1. Study Identification

Unique Protocol Identification Number

NCT02984176

Brief Title

Simethicone: Does it Improve Operative Field and Postoperative Pain?

Official Title

Simethicone and Gynecological Laparoscopies: Does it Improve Operative Field and Postoperative Pain?

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Woman's Health University Hospital, Egypt

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

Simethicone is an oral anti-foaming agent that reduces bloating, abdominal discomfort, and abdominal pain by promoting the clearance of excessive gas along the gastrointestinal tract. The investigators objective is to evaluate the efficacy and safety of preoperative oral simethicone for bowel preparation in gynecological laparoscopies.

Detailed Description

Introduction: Simethicone is an oral antifoaming agent that reduces bloating, abdominal discomfort, and abdominal pain by promoting the clearance of excessive gas along the gastrointestinal tract. Objective: to evaluate the efficacy and safety of preoperative oral simethicone for bowel preparation in gynecological laparoscopies. Methods: 100 infertile women will be scheduled for laparoscopy, patients randomized to receive either Simethicone (Group I) or placebo tablets (Group II). The primary outcome measure will be the overall exposure of the surgical field and pain scoring. Assessment of the overall exposure of the surgical field was done using a five-point scale (poor, sufficient, medium, good, and excellent). Visual analog score (VAS) will be used for assessment of postoperative pain and verbal analog scoring was used for assessment of patient satisfaction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Simethicone

Keywords

Simethicone, Laparoscopies, Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Simethicone

Arm Type

Active Comparator

Arm Description

Arm 1 or Group I or Simethicone 40mg. 3 tablets (one tablet after each meal) and to fast overnight the day before the operation.

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Arm 2 or group 2 or placebo group. 3 tablets (one tablet after each meal) and to fast overnight the day before the operation.

Intervention Type

Drug

Intervention Name(s)

Simethicone Tab 40 mg

Other Intervention Name(s)

Disflatyl

Intervention Description

3 tablets of Simethicone Tab 40 mg (one tablet after each meal) and to fast overnight the day before the operation.

Intervention Type

Drug

Intervention Name(s)

Placebo Tablets

Other Intervention Name(s)

Placebo

Intervention Description

3 tablets of Placebo Tablets (one tablet after each meal) and to fast overnight the day before the operation.

Primary Outcome Measure Information:

Title

five-point scale

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

The degree of bowel preparation

Time Frame

1 hour

Title

VAS

Time Frame

24 hours

Title

Patient satisfaction

Time Frame

24 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Infertile patients aged 20 - 40 years old scheduled for laparoscopy Exclusion Criteria: Women were excluded from the study if patients had one or more of the following: scar of previous operation, uterine mass, severe endometriosis, suspicion of malignancy, history of allergic reaction to study drugs, psychiatric disorders and patient refusal

12. IPD Sharing Statement

Plan to Share IPD

Yes

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Simethicone: Does it Improve Operative Field and Postoperative Pain?

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