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 Title of Study: “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
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Other
- Masking: Double (Investigator, Outcomes Assessor)
- Study Primary Completion Date: January 1, 2021
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.
- 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
Arms, Groups and Cohorts
- 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.
- 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.
- Active Comparator: MBP plus low fibre diet
- This group will receive both mechanical bowel preparation and 3-days low fibre diet.
- No Intervention: Control
- Control subjects will receive no instructions about the pre-operative diet (free diet).
Clinical Trial Outcome Measures
- The surgical visibility of abdomen
- Time Frame: After the introduce of first left lateral port
- 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.
- The lowest pneumoperitoneum pressure (PP) at standard Trendelenburg inclination angle (TIA).
- Time Frame: In the initial phase of the surgery
- 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).
- The lowest Trendelenburg inclination angle (TIA) at standard pneumoperitoneum pressure (PP) adequate to proceed with the planned operation.
- Time Frame: In the initial phase of the surgery
- 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).
- Preoperative patient symptomatology
- Time Frame: Right before the surgery
- 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.
- Postoperative pain
- Time Frame: at 24th hours
- 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.
- Time Frame: At 1st week and 6th week postoperatively or whenever it occurred.
- Intraoperative complications, at 1st week and 6th week postoperatively, between the groups.
Participating in This Clinical Trial
- Aged 18 years and older
- Able to provide informed consent
- Undergo laparoscopic gynecological surgery for a benign condition
- 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
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Martyr Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Ondokuz Mayıs University
- Provider of Information About this Clinical Study
- Principal Investigator: Kadir Bakay, Associate Professor – Ondokuz Mayıs University
- Overall Official(s)
- Kadir Bakay, Assoc Prof, Principal Investigator, Ondokuz Mayis Universitesi
- Overall Contact(s)
- Uzeyir Kalkan, M.D., +905428102539, email@example.com
Citations Reporting on Results
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.
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