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

NCT ID: NCT04788771

Last Updated: 2022-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-10
• Study Completion Date: 2022-03-10

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.

Conditions

Lung Functions; Pain Score

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Tracheal intubation in laparoscopic extraperitoneal hernia repair

Tracheal intubation in laparoscopic extraperitoneal hernia repair

Group Type: SHAM_COMPARATOR

Tracheal intubation in laparoscopic extraperitoneal hernia repair

Intervention Type: PROCEDURE

laryngeal mask airway in laparoscopic extraperitoneal hernia repair

laryngeal mask airway in laparoscopic extraperitoneal hernia repair

laryngeal mask airway in laparoscopic extraperitoneal hernia repair

Group Type: ACTIVE_COMPARATOR

Tracheal intubation in laparoscopic extraperitoneal hernia repair

Intervention Type: PROCEDURE

laryngeal mask airway in laparoscopic extraperitoneal hernia repair

Interventions

Tracheal intubation in laparoscopic extraperitoneal hernia repair

laryngeal mask airway in laparoscopic extraperitoneal hernia repair

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Turgut Donmez

Bakirkoy EAH

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Turgut Donmez

Role: PRINCIPAL_INVESTIGATOR

Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Locations

Bakirkoy Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 31613680 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28194529 (View on PubMed)

Other Identifiers

BakirkoyEAH LMA

Identifier Type: -

Identifier Source: org_study_id