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

NCT04400669 | Unknown

• 1 other identifier: MBP
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Patient Preference; Patient Safety

Keywords

mechanical bowel preparation; gynecological surgery; Minimally invasive gynecological procedures; Enema; Trendelenburg angle; Pneumoperitoneum pressure

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Preoperative patient symptomatology

  Right before the surgery

• Postoperative pain

  at 24th hours

• Complications

  At 1st week and 6th week postoperatively or whenever it occurred.

Study Arms (4)

Mechanical Bowel Preparation

EXPERIMENTAL

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

Low fibre diet

ACTIVE COMPARATOR

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

MBP plus low fibre diet

ACTIVE COMPARATOR

This group will receive both mechanical bowel preparation and 3-days low fibre diet.

Other: MBP plus low-fibre diet

Control

NO INTERVENTION

Control subjects will receive no instructions about the pre-operative diet (free diet).

Interventions

Mechanical Bowel Preparation OTHER

oral sodium phosphate (NaP) enema

Mechanical Bowel Preparation

Low fibre diet DIETARY_SUPPLEMENT

3 days

Low fibre diet

MBP plus low-fibre diet OTHER

3 days low fibre diet preoperative mechanical bowel preparation

MBP plus low fibre diet

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years and older
• Able to provide informed consent
• Undergo laparoscopic gynecological surgery for a benign condition

You may not qualify if:

• 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

Sponsors & Collaborators

• Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital: lead
• Ondokuz Mayıs University: collaborator

Study Sites (2)

Egemed Hospital

Aydin, Turkey (Türkiye)

RECRUITING

Samsun Medical Faculty

Samsun, Turkey (Türkiye)

RECRUITING

Related 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.

  PMID: 28650683 RESULT

MeSH Terms

Conditions

Patient Preference

Condition Hierarchy (Ancestors)

Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Kadir Bakay, Assoc Prof

  Ondokuz Mayis Universitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uzeyir Kalkan, M.D.

CONTACT

+905428102539; uzekal@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: June 5, 2020
• Primary Completion: November 5, 2021
• Study Completion: November 20, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After the completion of the study, for 10 years.
• Access Criteria: Access will be granted right after establishing a contact.

Locations

TU (2)