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

Last updated: February 11, 2021
Sponsor: Martyr Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04400669
MBP
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 AmericanSociety for Reproductive Medicine)
  • Psychiatric disorders precluding consent

Study Design

Total Participants: 160
Study Start date:
June 05, 2020
Estimated Completion Date:
November 20, 2021

Study 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.

Connect with a study center

  • Egemed Hospital

    Aydin,
    Turkey

    Active - Recruiting

  • Samsun Medical Faculty

    Samsun,
    Turkey

    Active - Recruiting

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