Patient PreferenceNCT04400669
The Effect of Mechanical Bowel Preparation Prior to Gynaecological Laparoscopic Surgeries on the Surgical Conditions
A study testing Mechanical Bowel Preparation, Low fibre diet and MBP plus low-fibre diet in people with Patient Preference and Patient Safety, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patient Preference, Patient Safety
- What is being tested?
- Mechanical Bowel Preparation, Low fibre diet and MBP plus low-fibre diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 Jun 2020to 20 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years and older
- Able to provide informed consent
- Undergo laparoscopic gynecological surgery for a benign condition
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Egemed Hospital
Aydin
Uzeyir Kalkan, M.D.
Uzeyir Kalkan, M.D.
- Recruiting
Samsun Medical Faculty
Samsun
Kadir Bakay, Assoc.Prof.
Kadir Bakay, Assoc.Prof.
About this study
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
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.
Read the 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.
- Conditions
- Patient Preference, Patient Safety
- Being tested
- Mechanical Bowel Preparation, Low fibre diet, MBP plus low-fibre diet
- Keywords
- mechanical bowel preparation, gynecological surgery, Minimally invasive gynecological procedures, Enema, Trendelenburg angle, Pneumoperitoneum pressure
- Medical subject headings
- Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Bowel PreparationOther
oral sodium phosphate (NaP) enema
Low fibre dietDietary supplement
3 days
MBP plus low-fibre dietOther
3 days low fibre diet preoperative mechanical bowel preparation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: MBP plus low-fibre diet |
| Control | No intervention | Control subjects will receive no instructions about the pre-operative diet (free diet). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: In the initial phase of the surgery
Secondary outcomes (3)
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.
Measured: Right before the surgery
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.
Measured: at 24th hours
Complications
Intraoperative complications, at 1st week and 6th week postoperatively, between the groups.
Measured: At 1st week and 6th week postoperatively or whenever it occurred.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start5 Jun 2020
- Primary completion5 Nov 2021 (estimated)
- Study completion20 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient PreferenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Responsible party
- Principal investigator, Kadir Bakay, Ondokuz Mayıs University
- Investigators
- Kadir Bakay, Assoc Prof, Principal investigator, Ondokuz Mayis Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400669
- Sponsor's protocol ID
- MBP
- Status last verified
- Feb 2021
- First submitted
- 19 May 2020
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data (for meta-analysis), statistical analyses and study protocol can be shared upon request. Processed data can be shared after completion of the study.
Publications
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.
PubMed 28650683
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04400669
- Acronym / sponsor ID
- MBP
- Conditions
- Patient Preference, Patient Safety
- Keywords
- mechanical bowel preparation, gynecological surgery, Minimally invasive gynecological procedures, Enema, Trendelenburg angle, Pneumoperitoneum pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 5 Nov 2021 (estimated)
- Study completion
- 20 Nov 2021 (estimated)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mechanical Bowel Preparation | Experimental | Other: Mechanical Bowel PreparationPatients 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. |
| Low fibre diet | Active comparator | Dietary Supplement: Low fibre dietPatients 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 | Active comparator | Other: MBP plus low-fibre dietThis group will receive both mechanical bowel preparation and 3-days low fibre diet. |
| Control | No intervention | –Control subjects will receive no instructions about the pre-operative diet (free diet). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years and older
- Able to provide informed consent
- Undergo laparoscopic gynecological surgery for a benign condition
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical Bowel Preparationoral sodium phosphate (NaP) enema | Other | Mechanical Bowel Preparation |
| Low fibre diet3 days | Dietary supplement | Low fibre diet |
| MBP plus low-fibre diet3 days low fibre diet preoperative mechanical bowel preparation | Other | MBP plus low fibre diet |
Primary outcome
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.
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).
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).
3 secondary outcomes
Preoperative patient symptomatology
Time frame: Right before the surgery
Postoperative pain
Time frame: at 24th hours
Complications
Time frame: At 1st week and 6th week postoperatively or whenever it occurred.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Results publication: PubMed 28650683Bakay 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.
- Individual participant dataSharing planned: Yes. Raw data (for meta-analysis), statistical analyses and study protocol can be shared upon request. Processed data can be shared after completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kadir Bakay, Assoc Prof principal investigator
Ondokuz Mayis Universitesi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Bowel Preparation, Low fibre diet and MBP plus low-fibre diet in people with Patient Preference and Patient Safety, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uzeyir Kalkan, M.D. (+905428102539, uzekal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The surgical visibility of abdomen (time frame: After the introduce of first left lateral port). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04400669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.