The Effect of Mechanical Bowel Preparation Prior to Gynaecological Laparoscopic Surgeries on the Surgical Conditions

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Status: Unknown

Conditions: Patient Safety; Patient Preference

Treatments: Dietary Supplement: Low fibre diet; Other: MBP plus low-fibre diet; Other: Mechanical Bowel Preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT04400669

MBP

Details and patient eligibility

About

This RCT aims to investigate the real surgical effects of MBP prior to the gynecological laparoscopic surgeries. Those effects include lowest pneumoperitoneum pressure, lowest Trendelenburg inclination angle, the ease of the surgical view and the preferences of the patients with objective measures.

Full description

Mechanical bowel preparation (MBP) has been routinely used prior to minimally invasive gynaecologic procedures (MIGP) hypothetically to improve intraoperative bowel handling and visualization of the surgical field, and also to reduce faecal contamination in the setting of bowel injury and/or resection.

The studies investigating the effect of MBP on MIGP are limited and most of existing data are extrapolated from the reports of colorectal and urological surgery studies.

Besides, evaluation of the surgical workspace visualization and intraoperative bowel handling are far from being objective since they were mostly measured by a 4/5/10-point Likert scales or rated verbally on scales of excellent to poor by the operating surgeons.

In contrary, it is planned to use objective visualize index, and objective surgical conditions to measure whether MBP has any effect or not.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 18 years and older
• Able to provide informed consent
• Undergo laparoscopic gynecological surgery for a benign condition

Exclusion criteria

• History of previous abdominal surgery
• Clinically significant present or past systemic diseases
• Inability to perform mechanical bowel preparation
• Suspicion of malignancy
• Association with non-gynaecological surgical pathologies
• Severe endometriosis (stage ≥ III according to the classification of the American Society for Reproductive Medicine)
• Psychiatric disorders precluding consent

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 4 patient groups

Mechanical Bowel Preparation

Experimental group

Description:

Patients will have only clear liquids after a normal breakfast and lunch on the day before surgery and subsequently fasten for 7-9 hours prior to surgery. Patients will ingest first dose of 45 ml oral sodium phosphate (NaP) enema (BT ORAL SOLUSYON 45 ML®, Yenisehir Lab. Tic. San. Ltd. Sti, Turkey) at 4 p.m. and a second dose at 8 p.m. in the evening before the scheduled surgery.

Treatment:

Other: Mechanical Bowel Preparation

Low fibre diet

Active Comparator group

Description:

Patients will be given detailed instructions about the pre-operative diet (total daily Fibre intake inferior to 10 g) to be used for 3 days prior to surgery.

Treatment:

Dietary Supplement: Low fibre diet

MBP plus low fibre diet

Active Comparator group

Description:

This group will receive both mechanical bowel preparation and 3-days low fibre diet.

Treatment:

Other: MBP plus low-fibre diet

Control

No Intervention group

Description:

Control subjects will receive no instructions about the pre-operative diet (free diet).