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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04400669
Recruitment Status : Not yet recruiting
First Posted : May 22, 2020
Last Update Posted : May 27, 2020
Sponsor:
Collaborator:
Ondokuz Mayıs University
Information provided by (Responsible Party):
Kadir Bakay, Ondokuz Mayıs University

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
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.
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Patient Safety

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).



Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Uzeyir Kalkan, M.D. +905428102539 uzekal@hotmail.com

Sponsors and Collaborators
Martyr Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Ondokuz Mayıs University
Investigators
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Principal Investigator: Kadir Bakay, Assoc Prof Ondokuz Mayis Universitesi
Publications of Results:
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Responsible Party: Kadir Bakay, Associate Professor, Ondokuz Mayıs University
ClinicalTrials.gov Identifier: NCT04400669    
Other Study ID Numbers: MBP
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Raw data (for mate-analysis), statistical analyses and study protocol can be shared upon request.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: After the completion of the study, for 10 years.
Access Criteria: Access will be granted right after establishing a contact.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kadir Bakay, Ondokuz Mayıs University:
mechanical bowel preparation
gynecological surgery
Minimally invasive gynecological procedures
Enema
Trendelenburg angle
Pneumoperitoneum pressure
Additional relevant MeSH terms:
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Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases