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

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.

Study Overview

• Status: Recruiting
• Conditions: Patient Preference; Patient Safety
• Intervention / Treatment: Other: Mechanical Bowel Preparation; Dietary supplement: Low fibre diet; Other: MBP plus low-fibre diet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Uzeyir Kalkan, M.D.; Phone Number: +905428102539; Email: uzekal@hotmail.com

Study Locations

• Turkey
  • Aydin, Turkey
    • Recruiting
    • EgeMed Hospital
    • Contact: Uzeyir Kalkan, M.D.
    • Principal Investigator: Uzeyir Kalkan, M.D.
  • Samsun, Turkey
    • Recruiting
    • Samsun Medical Faculty
    • Contact: Kadir Bakay, Assoc.Prof.
    • Principal Investigator: Kadir Bakay, Assoc.Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mechanical Bowel Preparation; 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.	Other: Mechanical Bowel Preparation; oral sodium phosphate (NaP) enema
Active Comparator: Low fibre diet; 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.	Dietary supplement: Low fibre diet; 3 days
Active Comparator: MBP plus low fibre diet; This group will receive both mechanical bowel preparation and 3-days low fibre diet.	Other: MBP plus low-fibre diet; 3 days low fibre diet preoperative mechanical bowel preparation
No Intervention: Control; Control subjects will receive no instructions about the pre-operative diet (free diet).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The surgical visibility of abdomen	A scale title as "Objective Visual Indexing (OVI)" will be used for assessing the visibility of the Douglas pouch and adnexa. The assessment of the visibility of Douglas pouch and adnexa will be performed under standard pneumoperitoneum pressure (12mmHg) and Trendelenburg inclincation angle (30). After the first Inspection, scale of VI scoring will be calculated by adding up the points obtained from optical inspection. Higher scores mean better visuality of the surgical field.	After the introduce of first left lateral port
The lowest pneumoperitoneum pressure (PP) at standard Trendelenburg inclination angle (TIA).	The PP will be increased to 15 mmHg while keeping the TIA same, at 30o. The surgeon will displace the bowel beginning from the cecum followed by the last ileal loop above the sacral promontory. Once the bowel was displaced out of the pelvis, the PP will be stepwise decreased by 1 mmHg during 1 min intervals to the lowest pressure where the bowel is to descend towards the pelvis over the pelvic brim and/or where the surgical workspace is not adequate to proceed safely with the planned operation. This value will be recorded as the lowest PP adequate to proceed safely with the planned surgery at standard TIA (30 degree).	In the initial phase of the surgery
The lowest Trendelenburg inclination angle (TIA) at standard pneumoperitoneum pressure (PP) adequate to proceed with the planned operation.	The PP obtained in outcome 2 will be readjusted to the standard 12 mmHg keeping the TIA same, at 300. Then, the surgeon will replace the bowel beginning from the cecum followed by the last ileal loop above the sacral promontory. Once the bowel is displaced out of the pelvis, the TIA will be gradually decreased by 1o with 15 seconds intervals to the degree where the bowel is to descend towards the pelvis over the pelvic brim. This value will be recorded as the lowest TIA adequate to proceed safely with the planned surgery at standard PP (12 mmHg).	In the initial phase of the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative patient symptomatology	Patients will be interviewed in the preoperative holding area or in the patient's room about the acceptability of the intervention (MBP / diet) and adverse pre-operative events, including: nausea, insomnia, headache, thirst, weakness, tiredness, discomfort, abdominal cramps, sleep disturbances. These symptoms will be scored with using a 10-cm "Visual Analog Score" (VAS). Higher scores mean worse outcome.	Right before the surgery
Postoperative pain	The intensity of the postoperative pain was measured by an independent investigator at 24th hours with a 10-cm Visual Analog Score (VAS). Higher scores mean worse outcome.	at 24th hours
Complications	Intraoperative complications, at 1st week and 6th week postoperatively, between the groups.	At 1st week and 6th week postoperatively or whenever it occurred.

Collaborators and Investigators

• Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
• Collaborators: Ondokuz Mayıs University
• Investigators: Principal Investigator: Kadir Bakay, Assoc Prof, Ondokuz Mayis Universitesi

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2020
• Primary Completion (Anticipated): November 5, 2021
• Study Completion (Anticipated): November 20, 2021

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: mechanical bowel preparation; gynecological surgery; Enema; Minimally invasive gynecological procedures; Trendelenburg angle; Pneumoperitoneum pressure
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: MBP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Raw data (for meta-analysis), statistical analyses and study protocol can be shared upon request. Processed data can be shared after completion of the study.
• IPD Sharing Time Frame: After the completion of the study, for 10 years.
• IPD Sharing Access Criteria: Access will be granted right after establishing a contact.
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No