Gastric DilationNCT07097129
Effect of Mask Ventilation on Surgical Field View in Robotic Colorectal Surgery
A study testing Mask Ventilation in people with Gastric Dilation and Bowel Distention, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to demonstrate the effects of pressure-controlled mask ventilation and non-mask ventilation during anaesthesia induction on gastric insufflation, gastric dilatation, increased bowel movements and bowel distension and to demonstrate its effect on surgical vision in robotic colorectal… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Dilation, Bowel Distention, Surgical Procedure, Unspecified
- What is being tested?
- Mask Ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 20 Oct 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18 and 80 who are scheduled to undergo robotic colorectal surgery will be included in the study.
Who cannot join
- Patients with preoperative prediction of possible difficult intubation
- Presence of restrictive/obstructive lung disease requiring CPAP application for treatment in preoperative anaesthesia evaluation
- Patients with cardiovascular diseases (EF < 20%, advanced aortic stenosis, decompensated heart failure) that require change of at least one of the drugs to be used for anaesthesia induction
- Presence of allergy to any of the drugs to be used in anaesthesia induction and maintenance
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Koç University Hospital
Istanbul, Zeytinburnu, 34010
About this study
Official title: Effect of Mask Ventilation on Surgical Field View in Robotic Colorectal Surgery: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to demonstrate the effects of pressure-controlled mask ventilation and non-mask ventilation during anaesthesia induction on gastric insufflation, gastric dilatation, increased bowel movements and bowel distension and to demonstrate its effect on surgical vision in robotic colorectal surgeries. The main questions it aims to answer are:
How will non-mask ventilation during anaesthesia induction effect surgical vision in robotic colorectal surgeries compared to mask ventilation? How will non-mask ventilation during anaesthesia induction effect gastric dilatation and bowel movements in robotic colorectal surgeries compared to mask ventilation?
Read more
If there is a comparison group: Researchers will compare mask ventilation and non-mask ventilation during anaesthesia induction to see if the surgical vision, gastric dilatation and bowel movements are effected.
Participants will be divided in two groups:
No mask ventilation group: Outside of spontaneous breathing during preoxygenation, orotracheal intubation will be performed at the 60th second after anesthesia induction without ventilation, using video laryngoscopy. Mask ventilation group: After anesthesia induction, mask ventilation will be performed with a respiratory rate of 10 and 15 cmH2O pressure, followed by orotracheal intubation using video laryngoscopy at the 60th second.
Researchers will compare the results between the groups to see the surgical vision, gastric dilatation and bowel movements.
The hypothesis of this study is that non-mask ventilation will provide better surgical vision, less gastric dilatation and less bowel movements in robotic colorectal surgeries.
Read the detailed description
Following anaesthesia induction, mask ventilation is a technique applied until successful tracheal intubation is achieved. It is known that with mask ventilation, air can also enter the stomach as well as the trachea. If mask ventilation is not performed with the correct technique during robotic surgery, excessive dilation of the stomach will impair the surgical team's vision, causing the operation to be more difficult and longer. In this study, we aimed to demonstrate the effects of mask ventilation and non-mask ventilation on gastric dilatation, increased bowel movements, bowel distension and surgical vision in robotic colorectal surgeries.
In our anaesthesia practice, patients will be premedicated with 0.03 mg/kg midazolam in the preoperative area and then taken to the operating room. After standard monitorization in the operating room, preoxygenation will be applied with end tidal oxygen (EtO2) monitoring. Patients whose EtO2 value reached 90% will be divided into two groups and the following protocol will be applied; No mask ventilation group: 2 mcg/kg fentanyl, 1 - 2 mg/kg propofol, 1 mg/kg rocuronium will be administered for anaesthesia induction. Orotracheal intubation will be performed at 60 seconds with video laryngoscopy without ventilation other than spontaneous breathing.
Mask ventilation group: 2 mcg/kg fentanyl, 1 - 2 mg/kg propofol, 1 mg/kg rocuronium will be administered for anesthesia induction. Mask ventilation will be performed with mechanical ventilator set to pressure controlled ventilation, 15 cmH20 peak pressure, 10 respiratory rates per minute. Orotracheal intubation will be performed at the 60th second with video laryngoscopy.
The surgical team, who is blinded to the anesthesia induction groups, will mark the Likert scale prepared for the presence of gastric distension, presence of intestinal distension, status of bowel movements and surgical vision regarding the intraoperative process. Surgical time will also be recorded at the end of the operation.
- Being tested
- Mask Ventilation
- Keywords
- robotic colorectal surgery, gastric dilation, bowel distention, surgical view
- Medical subject headings
- Gastric Dilatation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mask VentilationProcedure or surgery
Mask ventilation with mechanical ventilator set to pressure controlled ventilation, 15 cmH20 peak pressure, 10 respiratory rates per minute
| Study group | Role | What they receive |
|---|---|---|
| No Mask Ventilation | Active comparator | 2 mcg/kg fentanyl, 1 - 2 mg/kg propofol, 1 mg/kg rocuronium will be administered for anaesthesia induction. Orotracheal intubation will be performed at 60 seconds with video laryngoscopy without ventilation other than spontaneous breathing. Receives: Procedure: Mask Ventilation |
| Mask Ventilation | No intervention | 2 mcg/kg fentanyl, 1 - 2 mg/kg propofol, 1 mg/kg rocuronium will be administered for anaesthesia induction. Mask ventilation will be performed with mechanical ventilator set to pressure controlled ventilation, 15 cmH20 peak pressure, 10 respiratory rates per minute. Orotracheal intubation will be performed at the 60th second with video laryngoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Vision
Likert scale Surgical field visibility is very poor: 1 point Surgical field visibility is poor: 2 points Surgical field visibility is moderate: 3 points Surgical field visibility is good: 4 points Surgical field visibility is very good: 5 points
Higher scores on this scale mean a better outcome.
Measured: 5 minutes after the end of the surgical procedure
Gastric Dilatation
Likert Scale Gastric dilatation was severe enough to complicate the surgical technique: 1 point Gastric dilatation was present but did not complicate the surgery: 2 points Stomach was not dilated: 3 points
Higher scores on this scale mean a better outcome.
Measured: 5 minutes after the end of the surgical procedure
Bowel distension
Likert Scale Bowel distension is quite significant: 1 point Bowel distension is significant: 2 points Bowel distension is moderate: 3 points Bowel distension is mild: 4 points No bowel distension: 5 points
Higher scores on this scale mean a better outcome.
Measured: 5 minutes after the end of the surgical procedure
Bowel movement
Likert Scale Bowel movements are quite frequent: 1 point Bowel movements are frequent: 2 points Bowel movements are moderate: 3 points Bowel movements are mild: 4 points No bowel movements: 5 points
Higher scores on this scale mean a better outcome.
Measured: 5 minutes after the end of the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Aug 2025
- Primary completion10 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric DilationStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamil Darcin, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097129
- Sponsor's protocol ID
- 2024.286.IRB1.036
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Jung YK, Kim CL, Jeong MA, Sung JM, Lee KG, Kim NY, Kang L, Lim H. Gastric insufflation and surgical view according to mask ventilation method for laparoscopic cholecystectomy: a randomized controlled study. BMC Anesthesiol. 2023 Sep 20;23(1):321. doi: 10.1186/s12871-023-02269-9.
PubMed 37730575Bouvet L, Albert ML, Augris C, Boselli E, Ecochard R, Rabilloud M, Chassard D, Allaouchiche B. Real-time detection of gastric insufflation related to facemask pressure-controlled ventilation using ultrasonography of the antrum and epigastric auscultation in nonparalyzed patients: a prospective, randomized, double-blind study. Anesthesiology. 2014 Feb;120(2):326-34. doi: 10.1097/ALN.0000000000000094.
PubMed 24317204
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mask Ventilation on Surgical Field View in Robotic Colorectal Surgery: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07097129
- Acronym / sponsor ID
- 2024.286.IRB1.036
- Keywords
- robotic colorectal surgery, gastric dilation, bowel distention, surgical view
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 31 Jul 2025 (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.
The goal of this clinical trial is to demonstrate the effects of pressure-controlled mask ventilation and non-mask ventilation during anaesthesia induction on gastric insufflation, gastric dilatation, increased bowel movements and bowel distension and to demonstrate its effect on surgical vision in robotic colorectal surgeries. The main questions it aims to answer are:
How will non-mask ventilation during anaesthesia induction effect surgical vision in robotic colorectal surgeries compared to mask ventilation? How will non-mask ventilation during anaesthesia induction effect gastric dilatation and bowel movements in robotic colorectal surgeries compared to mask ventilation?
If there is a comparison group: Researchers will compare mask ventilation and non-mask ventilation during anaesthesia induction to see if the surgical vision, gastric dilatation and bowel movements are effected.
Participants will be divided in two groups:
No mask ventilation group: Outside of spontaneous breathing during preoxygenation, orotracheal intubation will be performed at the 60th second after anesthesia induction without ventilation, using video laryngoscopy. Mask ventilation group: After anesthesia induction, mask ventilation will be performed with a respiratory rate of 10 and 15 cmH2O pressure, followed by orotracheal intubation using video laryngoscopy at the 60th second.
Researchers will compare the results between the groups to see the surgical vision, gastric dilatation and bowel movements.
The hypothesis of this study is that non-mask ventilation will provide better surgical vision, less gastric dilatation and less bowel movements in robotic colorectal surgeries.
Detailed description
Following anaesthesia induction, mask ventilation is a technique applied until successful tracheal intubation is achieved. It is known that with mask ventilation, air can also enter the stomach as well as the trachea. If mask ventilation is not performed with the correct technique during robotic surgery, excessive dilation of the stomach will impair the surgical team's vision, causing the operation to be more difficult and longer. In this study, we aimed to demonstrate the effects of mask ventilation and non-mask ventilation on gastric dilatation, increased bowel movements, bowel distension and surgical vision in robotic colorectal surgeries.
In our anaesthesia practice, patients will be premedicated with 0.03 mg/kg midazolam in the preoperative area and then taken to the operating room. After standard monitorization in the operating room, preoxygenation will be applied with end tidal oxygen (EtO2) monitoring. Patients whose EtO2 value reached 90% will be divided into two groups and the following protocol will be applied; No mask ventilation group: 2 mcg/kg fentanyl, 1 - 2 mg/kg propofol, 1 mg/kg rocuronium will be administered for anaesthesia induction. Orotracheal intubation will be performed at 60 seconds with video laryngoscopy without ventilation other than spontaneous breathing.
Mask ventilation group: 2 mcg/kg fentanyl, 1 - 2 mg/kg propofol, 1 mg/kg rocuronium will be administered for anesthesia induction. Mask ventilation will be performed with mechanical ventilator set to pressure controlled ventilation, 15 cmH20 peak pressure, 10 respiratory rates per minute. Orotracheal intubation will be performed at the 60th second with video laryngoscopy.
The surgical team, who is blinded to the anesthesia induction groups, will mark the Likert scale prepared for the presence of gastric distension, presence of intestinal distension, status of bowel movements and surgical vision regarding the intraoperative process. Surgical time will also be recorded at the end of the operation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Mask Ventilation | Active comparator | Procedure: Mask Ventilation2 mcg/kg fentanyl, 1 - 2 mg/kg propofol, 1 mg/kg rocuronium will be administered for anaesthesia induction. Orotracheal intubation will be performed at 60 seconds with video laryngoscopy without ventilation other than spontaneous breathing. |
| Mask Ventilation | No intervention | –2 mcg/kg fentanyl, 1 - 2 mg/kg propofol, 1 mg/kg rocuronium will be administered for anaesthesia induction. Mask ventilation will be performed with mechanical ventilator set to pressure controlled ventilation, 15 cmH20 peak pressure, 10 respiratory rates per minute. Orotracheal intubation will be performed at the 60th second with video laryngoscopy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between the ages of 18 and 80 who are scheduled to undergo robotic colorectal surgery will be included in the study.
Key exclusion criteria (4 listed)
- Patients with preoperative prediction of possible difficult intubation
- Presence of restrictive/obstructive lung disease requiring CPAP application for treatment in preoperative anaesthesia evaluation
- Patients with cardiovascular diseases (EF < 20%, advanced aortic stenosis, decompensated heart failure) that require change of at least one of the drugs to be used for anaesthesia induction
- Presence of allergy to any of the drugs to be used in anaesthesia induction and maintenance
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 |
|---|---|---|
| Mask VentilationMask ventilation with mechanical ventilator set to pressure controlled ventilation, 15 cmH20 peak pressure, 10 respiratory rates per minute | Procedure or surgery | No Mask Ventilation |
Primary outcome
Surgical Vision
Time frame: 5 minutes after the end of the surgical procedure
Likert scale Surgical field visibility is very poor: 1 point Surgical field visibility is poor: 2 points Surgical field visibility is moderate: 3 points Surgical field visibility is good: 4 points Surgical field visibility is very good: 5 points Higher scores on this scale mean a better outcome.
Gastric Dilatation
Time frame: 5 minutes after the end of the surgical procedure
Likert Scale Gastric dilatation was severe enough to complicate the surgical technique: 1 point Gastric dilatation was present but did not complicate the surgery: 2 points Stomach was not dilated: 3 points Higher scores on this scale mean a better outcome.
Bowel distension
Time frame: 5 minutes after the end of the surgical procedure
Likert Scale Bowel distension is quite significant: 1 point Bowel distension is significant: 2 points Bowel distension is moderate: 3 points Bowel distension is mild: 4 points No bowel distension: 5 points Higher scores on this scale mean a better outcome.
Bowel movement
Time frame: 5 minutes after the end of the surgical procedure
Likert Scale Bowel movements are quite frequent: 1 point Bowel movements are frequent: 2 points Bowel movements are moderate: 3 points Bowel movements are mild: 4 points No bowel movements: 5 points Higher scores on this scale mean a better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 37730575Jung YK, Kim CL, Jeong MA, Sung JM, Lee KG, Kim NY, Kang L, Lim H. Gastric insufflation and surgical view according to mask ventilation method for laparoscopic cholecystectomy: a randomized controlled study. BMC Anesthesiol. 2023 Sep 20;23(1):321. doi: 10.1186/s12871-023-02269-9.
- Background: PubMed 24317204Bouvet L, Albert ML, Augris C, Boselli E, Ecochard R, Rabilloud M, Chassard D, Allaouchiche B. Real-time detection of gastric insufflation related to facemask pressure-controlled ventilation using ultrasonography of the antrum and epigastric auscultation in nonparalyzed patients: a prospective, randomized, double-blind study. Anesthesiology. 2014 Feb;120(2):326-34. doi: 10.1097/ALN.0000000000000094.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mask Ventilation in people with Gastric Dilation and Bowel Distention, run by Koç University at 1 site 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Vision (time frame: 5 minutes after the end of the surgical procedure). The study lists 4 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 NCT07097129, which also lists 2 linked publications.
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 30 Apr 2026.