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

Sponsor

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04400669

Collaborator

Ondokuz Mayıs University (Other)

160

Enrollment

Locations

Arms

17.5

Anticipated Duration (Months)

Patients Per Site

4.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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

Actual Study Start Date :

Jun 5, 2020

Anticipated Primary Completion Date :

Nov 5, 2021

Anticipated Study Completion Date :

Nov 20, 2021

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

The surgical visibility of abdomen [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). [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. [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

Preoperative patient symptomatology [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 [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 [At 1st week and 6th week postoperatively or whenever it occurred.]
Intraoperative complications, at 1st week and 6th week postoperatively, between the groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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