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

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.

Study Overview

• Status: Completed
• Conditions: Lung Functions; Pain Score
• Intervention / Treatment: Procedure: Tracheal intubation in laparoscopic extraperitoneal hernia repair

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34300
    • Bakirkoy Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Clinical diagnosis of unilateral inguinal hernia

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Tracheal intubation in laparoscopic extraperitoneal hernia repair	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	Procedure: Tracheal intubation in laparoscopic extraperitoneal hernia repair; laryngeal mask airway in laparoscopic extraperitoneal hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS score	Evaluation of postoperative 1th hour pain score with VAS scale	postoperative 1th hour vas score
Anatomical delineation: satisfactory (n)(%)	Surgeon's evaluation at the end of the operation	up to 2 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sore throat	sore throat that develops after surgery	up to 2 hour
Hoarsaness and dysphonia	Hoarsaness and dysphonia develops after surgery	up to 2 hour
seroma	postoperative seroma	up to 30 day
scrotal edema	postoperatif scrotal edema	up to 30 day
ventilation time	ventilation time during surgery	up to 2 hour

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Investigators: Principal Investigator: Turgut Donmez, Bakırköy Dr. Sadi Konuk Training and Research Hospital

Publications and helpful links

General Publications

• Nevešćanin A, Vickov J, Elezović Baloević S, Pogorelić 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Actual): August 10, 2021
• Study Completion (Actual): March 10, 2022

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: BakirkoyEAH LMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No