The Effect of Mechanical Bowel Preparation Prior to Gynaecological Laparoscopic Surgeries on the Surgical Conditions
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|ClinicalTrials.gov Identifier: NCT04400669|
Recruitment Status : Not yet recruiting
First Posted : May 22, 2020
Last Update Posted : May 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Patient Preference Patient Safety||Other: Mechanical Bowel Preparation Dietary Supplement: Low fibre diet Other: MBP plus low-fibre diet||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Surgeons and the assessor will be blind. The nurse working in the gynecology setting perform the intervention to the previously randomized patients. Patient will be told for not to reveal the intervention that she undergoes.|
|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|
|Estimated Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||February 1, 2021|
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
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).
- 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.
- Complications [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400669
|Contact: Uzeyir Kalkan, M.D.||+email@example.com|
|Principal Investigator:||Kadir Bakay, Assoc Prof||Ondokuz Mayis Universitesi|