NCT04400669

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

The Effect of Mechanical Bowel Preparation Prior to Gynaecological Laparoscopic Surgeries on the Pressure of Pneumoperitoneum and Trendelenburg Inclination Angle During the Surgery: A Novel Perspective for Patient Safety

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Patient Preference
• Patient Safety

Interventions

Type	Name	Description
OTHER	Mechanical Bowel Preparation	oral sodium phosphate (NaP) enema
DIETARY_SUPPLEMENT	Low fibre diet	3 days
OTHER	MBP plus low-fibre diet	3 days low fibre diet preoperative mechanical bowel preparation

Timeline

• Start date: 2020-06-05
• Primary completion: 2021-11-05
• Completion: 2021-11-20
• First posted: 2020-05-22
• Last updated: 2021-02-12

Locations

2 sites across 1 country: Turkey (Türkiye)