An interventional study of Tracheal intubation in laparoscopic extraperitoneal hernia repair in Lung Functions and Pain Score, sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-05.
Sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Not applicable, Interventional, and Prevention
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.
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.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 739 interventional studies indexed under Hernia.
Browse Hernia studies →Bakirkoy Dr. Sadi Konuk Research and Training Hospital is the lead sponsor of 118 studies on the registry; 14 are open to participants now.
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Clinical diagnosis of unilateral inguinal hernia
Exclusion Criteria:
Clinical diagnosis of incarcerated inguinal hernia Clinical diagnosis of inguinal hernia with pregnancy
Tracheal intubation in laparoscopic extraperitoneal hernia repair
Procedure: Tracheal intubation in laparoscopic extraperitoneal hernia repair
laryngeal mask airway in laparoscopic extraperitoneal hernia repair
Procedure: Tracheal intubation in laparoscopic extraperitoneal hernia repair
laryngeal mask airway in laparoscopic extraperitoneal hernia repair
VAS score
Evaluation of postoperative 1th hour pain score with VAS scale
Time frame: postoperative 1th hour vas score
Anatomical delineation: satisfactory (n)(%)
Surgeon's evaluation at the end of the operation
Time frame: up to 2 hour
Sore throat
sore throat that develops after surgery
Time frame: up to 2 hour
Hoarsaness and dysphonia
Hoarsaness and dysphonia develops after surgery
Time frame: up to 2 hour
seroma
postoperative seroma
Time frame: up to 30 day
scrotal edema
postoperatif scrotal edema
Time frame: up to 30 day
ventilation time
ventilation time during surgery
Time frame: up to 2 hour
Plan to share: No
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Bakirkoy Dr. Sadi Konuk Research and Training Hospital