Does Simethicone Improve Operative Field in Gynecological Operations

Assiut University

Status and phase: Unknown; Phase 3

Conditions: Benign Gynecologic Neoplasm

Treatments: Drug: Simethicone; Drug: Enema

Study type: Interventional

Funder types: Other

Identifiers

NCT03009604

SIM

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Simethicone

Experimental group

Description:

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

Treatment:

Drug: Simethicone

Enema

Active Comparator group

Description:

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

Treatment:

Drug: Enema