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

Patient Safety Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04400669
• Other study ID #: MBP
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: November 20, 2021

Study information

• Verified date: February 2021
• Source: Martyr Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
• Contact: Uzeyir Kalkan, M.D.
• Phone: +905428102539
• Email: uzekal[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: November 20, 2021
• Est. primary completion date: November 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Preference
• Patient Safety
• Pneumoperitoneum

Intervention

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

Locations

Country	Name	City	State
Turkey	Egemed Hospital	Aydin
Turkey	Samsun Medical Faculty	Samsun

Sponsors (2)

Lead Sponsor	Collaborator
Martyr Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital	Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The surgical visibility of abdomen	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.	After the introduce of first left lateral port
Primary	The lowest pneumoperitoneum pressure (PP) at standard Trendelenburg inclination angle (TIA).	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).	In the initial phase of the surgery
Primary	The lowest Trendelenburg inclination angle (TIA) at standard pneumoperitoneum pressure (PP) adequate to proceed with the planned operation.	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).	In the initial phase of the surgery
Secondary	Preoperative patient symptomatology	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.	Right before the surgery
Secondary	Postoperative pain	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.	at 24th hours
Secondary	Complications	Intraoperative complications, at 1st week and 6th week postoperatively, between the groups.	At 1st week and 6th week postoperatively or whenever it occurred.