Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04788771
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2021-03-05
Brief Title:
Comparison of Tracheal Intubation vs Laryngeal Mask Airway in Laparoscopic Total Extraperitoneal Hernia Repair
Sponsor:
Bakirkoy Dr Sadi Konuk Research and Training Hospital
Organization:
Bakirkoy Dr Sadi Konuk Research and Training Hospital
Study Overview
Official Title:
Comparison of Tracheal Intubation and Laryngeal Mask Airway in Laparoscopic Total Extraperitoneal TEP Repair in Patients With Unilateral Inguinal Hernia
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 methodIt 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 ratesIn 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 wwwrandomizerorg 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
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 wwwrandomizerorg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None