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Comparison of Tracheal Intubation vs Laryngeal Mask Airway in Laparoscopic Total Extraperitoneal Hernia Repair

Primary Purpose

Lung Functions, Pain Score

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tracheal intubation in laparoscopic extraperitoneal hernia repair
Sponsored by
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Functions

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnosis of unilateral inguinal hernia

Exclusion Criteria:

Clinical diagnosis of incarcerated inguinal hernia Clinical diagnosis of inguinal hernia with pregnancy

Sites / Locations

  • Bakirkoy Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Tracheal intubation in laparoscopic extraperitoneal hernia repair

laryngeal mask airway in laparoscopic extraperitoneal hernia repair

Arm Description

Tracheal intubation in laparoscopic extraperitoneal hernia repair

laryngeal mask airway in laparoscopic extraperitoneal hernia repair

Outcomes

Primary Outcome Measures

VAS score
Evaluation of postoperative 1th hour pain score with VAS scale
Anatomical delineation: satisfactory (n)(%)
Surgeon's evaluation at the end of the operation

Secondary Outcome Measures

Sore throat
sore throat that develops after surgery
Hoarsaness and dysphonia
Hoarsaness and dysphonia develops after surgery
seroma
postoperative seroma
scrotal edema
postoperatif scrotal edema
ventilation time
ventilation time during surgery

Full Information

First Posted
March 5, 2021
Last Updated
December 2, 2022
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04788771
Brief Title
Comparison of Tracheal Intubation vs Laryngeal Mask Airway in Laparoscopic Total Extraperitoneal Hernia Repair
Official Title
Comparison of Tracheal Intubation and Laryngeal Mask Airway in Laparoscopic Total Extraperitoneal (TEP) Repair in Patients With Unilateral Inguinal Hernia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
August 10, 2021 (Actual)
Study Completion Date
March 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Functions, Pain Score

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Tracheal intubation
Masking
Investigator
Masking Description
laryngeal mask airway
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tracheal intubation in laparoscopic extraperitoneal hernia repair
Arm Type
Sham Comparator
Arm Description
Tracheal intubation in laparoscopic extraperitoneal hernia repair
Arm Title
laryngeal mask airway in laparoscopic extraperitoneal hernia repair
Arm Type
Active Comparator
Arm Description
laryngeal mask airway in laparoscopic extraperitoneal hernia repair
Intervention Type
Procedure
Intervention Name(s)
Tracheal intubation in laparoscopic extraperitoneal hernia repair
Intervention Description
laryngeal mask airway in laparoscopic extraperitoneal hernia repair
Primary Outcome Measure Information:
Title
VAS score
Description
Evaluation of postoperative 1th hour pain score with VAS scale
Time Frame
postoperative 1th hour vas score
Title
Anatomical delineation: satisfactory (n)(%)
Description
Surgeon's evaluation at the end of the operation
Time Frame
up to 2 hour
Secondary Outcome Measure Information:
Title
Sore throat
Description
sore throat that develops after surgery
Time Frame
up to 2 hour
Title
Hoarsaness and dysphonia
Description
Hoarsaness and dysphonia develops after surgery
Time Frame
up to 2 hour
Title
seroma
Description
postoperative seroma
Time Frame
up to 30 day
Title
scrotal edema
Description
postoperatif scrotal edema
Time Frame
up to 30 day
Title
ventilation time
Description
ventilation time during surgery
Time Frame
up to 2 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of unilateral inguinal hernia Exclusion Criteria: Clinical diagnosis of incarcerated inguinal hernia Clinical diagnosis of inguinal hernia with pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Turgut Donmez
Organizational Affiliation
Bakırkoy Dr. Sadi Konuk Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bakirkoy Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34300
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31613680
Citation
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.
Results Reference
result
PubMed Identifier
28194529
Citation
Nagahisa 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.
Results Reference
result

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Comparison of Tracheal Intubation vs Laryngeal Mask Airway in Laparoscopic Total Extraperitoneal Hernia Repair

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