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

NCT04788771 | Completed

• 1 other identifier: BakirkoyEAH LMA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Functions; Pain Score

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Sore throat

  up to 2 hour

• Hoarsaness and dysphonia

  up to 2 hour

• seroma

  up to 30 day

• scrotal edema

  up to 30 day

• ventilation time

  up to 2 hour

Study Arms (2)

Tracheal intubation in laparoscopic extraperitoneal hernia repair

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

Interventions

Tracheal intubation in laparoscopic extraperitoneal hernia repair PROCEDURE

laryngeal mask airway in laparoscopic extraperitoneal hernia repair

Tracheal intubation in laparoscopic extraperitoneal hernia repair; laryngeal mask airway in laparoscopic extraperitoneal hernia repair

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of unilateral inguinal hernia

You may not qualify if:

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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakirkoy Training and Research Hospital

Istanbul, 34300, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 31613680 RESULT

• 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.

  PMID: 28194529 RESULT

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Turgut Donmez

  Bakırkoy Dr. Sadi Konuk Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: laryngeal mask airway
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bakirkoy EAH

Model Details: Tracheal intubation

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 9, 2021
• Study Start: February 10, 2021
• Primary Completion: August 10, 2021
• Study Completion: March 10, 2022
• Last Updated: December 5, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)