Clinical trial NCT04400669: The Effect of Mechanical Bowel Preparation Prior to Gynaecological Laparoscopic Surgeries on the Surgical Conditions
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Preference
Patient Safety
Keywords: mechanical bowel preparation
gynecological surgery
Minimally invasive gynecological procedures
Enema
Trendelenburg angle
Pneumoperitoneum pressure
Lead sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Ondokuz Mayıs University
First posted: 2020-05-22
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The surgical visibility of abdomen
timeFrame: After the introduce of first left lateral port
measure: The lowest pneumoperitoneum pressure (PP) at standard Trendelenburg inclination angle (TIA).
timeFrame: In the initial phase of the surgery
measure: The lowest Trendelenburg inclination angle (TIA) at standard pneumoperitoneum pressure (PP) adequate to proceed with the planned operation.
timeFrame: In the initial phase of the surgery
Secondary outcomes:
measure: Preoperative patient symptomatology
timeFrame: Right before the surgery
measure: Postoperative pain
timeFrame: at 24th hours
measure: Complications
timeFrame: At 1st week and 6th week postoperatively or whenever it occurred.
Other outcomes:
Locations:
city: Aydin
country: Turkey
facility: Egemed Hospital
city: Samsun
country: Turkey
facility: Samsun Medical Faculty
Study officials:
affiliation: Ondokuz Mayis Universitesi
name: Kadir Bakay, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bakay K, Aytekin F. Mechanical bowel preparation for laparoscopic hysterectomy, is it really necessary? J Obstet Gynaecol. 2017 Nov;37(8):1032-1035. doi: 10.1080/01443615.2017.1318268. Epub 2017 Jun 26.