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

Not Applicable

Completed

• Conditions: Pain Score; Lung Functions
• Interventions: Procedure: Tracheal intubation in laparoscopic extraperitoneal hernia repair

• Registration Number: NCT04788771
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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.

Study Timeline

• Study Start: 2021-02-10
• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-09
• Primary Completion: 2021-08-10
• Study Completion: 2022-03-10
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-02
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Clinical diagnosis of unilateral inguinal hernia

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tracheal intubation in laparoscopic extraperitoneal hernia repair	Tracheal intubation in laparoscopic extraperitoneal hernia repair	Tracheal intubation in laparoscopic extraperitoneal hernia repair
laryngeal mask airway in laparoscopic extraperitoneal hernia repair	Tracheal intubation in laparoscopic extraperitoneal hernia repair	laryngeal mask airway in laparoscopic extraperitoneal hernia repair

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bakirkoy Training and Research Hospital; 🇹🇷 Istanbul, Turkey