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

Not Applicable

• Conditions: Patient Safety; Patient Preference
• Interventions: Dietary Supplement: Low fibre diet; Other: MBP plus low-fibre diet; Other: Mechanical Bowel Preparation

• Registration Number: NCT04400669
• Lead Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

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.

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 Timeline

• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-22
• Study Start: 2020-06-05
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-02-12
• Primary Completion: 2021-11-05
• Study Completion: 2021-11-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low fibre diet	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.
MBP plus low fibre diet	MBP plus low-fibre diet	This group will receive both mechanical bowel preparation and 3-days low fibre diet.
Mechanical Bowel Preparation	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.

Primary Outcome Measures

Name	Time	Method
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 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 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

Name	Time	Method
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.
Complications	At 1st week and 6th week postoperatively or whenever it occurred.	Intraoperative complications, at 1st week and 6th week postoperatively, between the groups.
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.

Trial Locations

Locations (2)

Egemed Hospital; 🇹🇷 Aydin, Turkey

Samsun Medical Faculty; 🇹🇷 Samsun, Turkey