Lung FunctionsNCT04788771
Comparison of Tracheal Intubation vs Laryngeal Mask Airway in Laparoscopic Total Extraperitoneal Hernia Repair
A study testing Tracheal intubation in laparoscopic extraperitoneal hernia repair in people with Lung Functions and Pain Score, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patient comfort and satisfaction of inguinal hernia repairs can be affected by the anesthesia technique chosen in addition to the surgical method. In our study, we aimed to compare the anesthesia method used in patients during laparoscopic total extraperitoneal hernia repair, which is a minimally invasive method.It… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Functions, Pain Score
- What is being tested?
- Tracheal intubation in laparoscopic extraperitoneal hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2021to 10 Mar 2022
- 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
- Clinical diagnosis of unilateral inguinal hernia
Who cannot join
- Clinical diagnosis of incarcerated inguinal hernia Clinical diagnosis of inguinal hernia with pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Training and Research Hospital
Istanbul, 34300
About this study
Official title: Comparison of Tracheal Intubation and Laryngeal Mask Airway in Laparoscopic Total Extraperitoneal (TEP) Repair in Patients With Unilateral Inguinal Hernia
Patient comfort and satisfaction of inguinal hernia repairs can be affected by the anesthesia technique chosen in addition to the surgical method. In our study, we aimed to compare the anesthesia method used in patients during laparoscopic total extraperitoneal hernia repair, which is a minimally invasive method.It was planned to evaluate the patients' quality of life, pain conditions, additional medical support needs for pain, length of hospital stay, duration of surgery, complications during and after surgery and recurrence rates.In addition, it was planned to compare the effects of the anesthesia method used on the lung capacity of the patients. The most important achievement of the study will be to show that laparoscopic hernia repair, which is frequently performed by intubation, can be performed safely with the Laryngeal mask.
Read the detailed description
The study was designed as a prospective randomized study, and a total of 100 patients were planned to be evaluated. Laparoscopic total extraperitoneal hernia repair will be performed by anesthesia with laryngeal mask and treceal intubation. Patients with a lariyngeal mask will be named as "group 1", and patients who undergo tracheal intubation will be named as "group 2".
Patients diagnosed with inguinal hernia radiologically and diagnosed with ultrasound will be operated. Patients between the ages of 18 and 75 years will be included in the study. Patients with relapse will be excluded. All patients will be evaluated for preoperative anesthesia and their suitability for laryngeal mask or tracheal intubation will be examined. Patients considered unsuitable for anyone will not be included in the study.
All patients will be explained in two methods before surgery and their patients will be randomized. Randomization will be done on the website www.randomizer.org. All patients will be entered on the website by numbering and the method chosen by the website will be applied according to the order of arrival.
Patients will be placed in the supine position under operating room conditions and anesthesia will be appropriate. After anesthesia, the surgical procedure will begin. The first incision time will be accepted as the surgery start time, and the end time of skin suturization will be recorded as the end of the surgery.
VAS scores of the patients at the 1st, 2nd, 4th, 6th and 12th hours after surgery will be learned and recorded by the service nurses. Additional medical needs of patients due to pain will be recorded.
Demographic data and additional diseases of the patients will be recorded. Operation times, hospitalization times, wound infections, seroma, scrotal edema and pain scores will be recorded. Complications developed during the operation will be recorded. After surgery, patients' nausea, vomiting, headache, shoulder pain and pain scores will be compared. Patients will be called to the general surgery outpatient clinic in the first week, first month, third month, and sixth month after the operation.
- Conditions
- Lung Functions, Pain Score
- Being tested
- Tracheal intubation in laparoscopic extraperitoneal hernia repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheal intubation in laparoscopic extraperitoneal hernia repairProcedure or surgery
laryngeal mask airway in laparoscopic extraperitoneal hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Tracheal intubation in laparoscopic extraperitoneal hernia repair | Sham comparator | Tracheal intubation in laparoscopic extraperitoneal hernia repair Receives: Procedure: Tracheal intubation in laparoscopic extraperitoneal hernia repair |
| laryngeal mask airway in laparoscopic extraperitoneal hernia repair | Active comparator | laryngeal mask airway in laparoscopic extraperitoneal hernia repair Receives: Procedure: Tracheal intubation in laparoscopic extraperitoneal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
Evaluation of postoperative 1th hour pain score with VAS scale
Measured: postoperative 1th hour vas score
Anatomical delineation: satisfactory (n)(%)
Surgeon's evaluation at the end of the operation
Measured: up to 2 hour
Secondary outcomes (5)
Sore throat
sore throat that develops after surgery
Measured: up to 2 hour
Hoarsaness and dysphonia
Hoarsaness and dysphonia develops after surgery
Measured: up to 2 hour
seroma
postoperative seroma
Measured: up to 30 day
scrotal edema
postoperatif scrotal edema
Measured: up to 30 day
ventilation time
ventilation time during surgery
Measured: up to 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start10 Feb 2021
- Primary completion10 Aug 2021
- Study completion10 Mar 2022
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 Lung FunctionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Tracheal intubation
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Turgut Donmez, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Turgut Donmez, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788771
- Sponsor's protocol ID
- BakirkoyEAH LMA
- Status last verified
- Dec 2022
- First submitted
- 5 Mar 2021
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nevescanin A, Vickov J, Elezovic Baloevic S, Pogorelic Z. Laryngeal Mask Airway Versus Tracheal Intubation for Laparoscopic Hernia Repair in Children: Analysis of Respiratory Complications. J Laparoendosc Adv Surg Tech A. 2020 Jan;30(1):76-80. doi: 10.1089/lap.2019.0382. Epub 2019 Oct 15.
PubMed 31613680Nagahisa Y, Hashida K, Matsumoto R, Kawashima R, Okabe M, Kawamoto K. A randomized clinical study on postoperative pain comparing between the supraglottic airway device and endotracheal tubing in transabdominal preperitoneal repair (TAPP). Hernia. 2017 Jun;21(3):391-396. doi: 10.1007/s10029-017-1586-y. Epub 2017 Feb 13.
PubMed 28194529
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tracheal Intubation and Laryngeal Mask Airway in Laparoscopic Total Extraperitoneal (TEP) Repair in Patients With Unilateral Inguinal Hernia
- ClinicalTrials.gov ID
- NCT04788771
- Acronym / sponsor ID
- BakirkoyEAH LMA
- Conditions
- Lung Functions, Pain Score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 9 Mar 2021 (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.
Patient comfort and satisfaction of inguinal hernia repairs can be affected by the anesthesia technique chosen in addition to the surgical method. In our study, we aimed to compare the anesthesia method used in patients during laparoscopic total extraperitoneal hernia repair, which is a minimally invasive method.It was planned to evaluate the patients' quality of life, pain conditions, additional medical support needs for pain, length of hospital stay, duration of surgery, complications during and after surgery and recurrence rates.In addition, it was planned to compare the effects of the anesthesia method used on the lung capacity of the patients. The most important achievement of the study will be to show that laparoscopic hernia repair, which is frequently performed by intubation, can be performed safely with the Laryngeal mask.
Detailed description
The study was designed as a prospective randomized study, and a total of 100 patients were planned to be evaluated. Laparoscopic total extraperitoneal hernia repair will be performed by anesthesia with laryngeal mask and treceal intubation. Patients with a lariyngeal mask will be named as "group 1", and patients who undergo tracheal intubation will be named as "group 2".
Patients diagnosed with inguinal hernia radiologically and diagnosed with ultrasound will be operated. Patients between the ages of 18 and 75 years will be included in the study. Patients with relapse will be excluded. All patients will be evaluated for preoperative anesthesia and their suitability for laryngeal mask or tracheal intubation will be examined. Patients considered unsuitable for anyone will not be included in the study.
All patients will be explained in two methods before surgery and their patients will be randomized. Randomization will be done on the website www.randomizer.org. All patients will be entered on the website by numbering and the method chosen by the website will be applied according to the order of arrival.
Patients will be placed in the supine position under operating room conditions and anesthesia will be appropriate. After anesthesia, the surgical procedure will begin. The first incision time will be accepted as the surgery start time, and the end time of skin suturization will be recorded as the end of the surgery.
VAS scores of the patients at the 1st, 2nd, 4th, 6th and 12th hours after surgery will be learned and recorded by the service nurses. Additional medical needs of patients due to pain will be recorded.
Demographic data and additional diseases of the patients will be recorded. Operation times, hospitalization times, wound infections, seroma, scrotal edema and pain scores will be recorded. Complications developed during the operation will be recorded. After surgery, patients' nausea, vomiting, headache, shoulder pain and pain scores will be compared. Patients will be called to the general surgery outpatient clinic in the first week, first month, third month, and sixth month after the operation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Tracheal intubation
| Arm | Type | Receives |
|---|---|---|
| Tracheal intubation in laparoscopic extraperitoneal hernia repair | Sham comparator | Procedure: Tracheal intubation in laparoscopic extraperitoneal hernia repairTracheal intubation in laparoscopic extraperitoneal hernia repair |
| laryngeal mask airway in laparoscopic extraperitoneal hernia repair | Active comparator | Procedure: Tracheal intubation in laparoscopic extraperitoneal hernia repairlaryngeal mask airway in laparoscopic extraperitoneal hernia repair |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of unilateral inguinal hernia
Key exclusion criteria (1 listed)
- Clinical diagnosis of incarcerated inguinal hernia Clinical diagnosis of inguinal hernia with pregnancy
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 |
|---|---|---|
| Tracheal intubation in laparoscopic extraperitoneal hernia repairlaryngeal mask airway in laparoscopic extraperitoneal hernia repair | Procedure or surgery | Tracheal intubation in laparoscopic extraperitoneal hernia repair, laryngeal mask airway in laparoscopic extraperitoneal hernia repair |
Primary outcome
VAS score
Time frame: postoperative 1th hour vas score
Evaluation of postoperative 1th hour pain score with VAS scale
Anatomical delineation: satisfactory (n)(%)
Time frame: up to 2 hour
Surgeon's evaluation at the end of the operation
5 secondary outcomes
Sore throat
Time frame: up to 2 hour
Hoarsaness and dysphonia
Time frame: up to 2 hour
seroma
Time frame: up to 30 day
scrotal edema
Time frame: up to 30 day
ventilation time
Time frame: up to 2 hour
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 5 Dec 2022.
- Results publication: PubMed 31613680Nevescanin A, Vickov J, Elezovic Baloevic S, Pogorelic Z. Laryngeal Mask Airway Versus Tracheal Intubation for Laparoscopic Hernia Repair in Children: Analysis of Respiratory Complications. J Laparoendosc Adv Surg Tech A. 2020 Jan;30(1):76-80. doi: 10.1089/lap.2019.0382. Epub 2019 Oct 15.
- Results publication: PubMed 28194529Nagahisa Y, Hashida K, Matsumoto R, Kawashima R, Okabe M, Kawamoto K. A randomized clinical study on postoperative pain comparing between the supraglottic airway device and endotracheal tubing in transabdominal preperitoneal repair (TAPP). Hernia. 2017 Jun;21(3):391-396. doi: 10.1007/s10029-017-1586-y. Epub 2017 Feb 13.
- Individual participant dataSharing planned: No
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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.
Turgut Donmez principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheal intubation in laparoscopic extraperitoneal hernia repair in people with Lung Functions and Pain Score, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital 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 1 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 5 Dec 2022. 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. Some participants in this study may receive a placebo. 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?
VAS score (time frame: postoperative 1th hour vas score). The study lists 2 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 NCT04788771, 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 5 Dec 2022.