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NCT Number: NCT04788771

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

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.

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Key information

Conditions

Lung Functions Pain Score

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bakirkoy Training and Research Hospital

Istanbul, 34300, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of unilateral inguinal hernia

Exclusion criteria

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

Treatment and study plan

Tracheal intubation in laparoscopic extraperitoneal hernia repair

Procedure

laryngeal mask airway in laparoscopic extraperitoneal hernia repair

Primary outcomes

  1. VAS score

    Time frame: postoperative 1th hour vas score

    Evaluation of postoperative 1th hour pain score with VAS scale

  2. Anatomical delineation: satisfactory (n)(%)

    Time frame: up to 2 hour

    Surgeon's evaluation at the end of the operation

Secondary outcomes

  1. Sore throat

    Time frame: up to 2 hour

    sore throat that develops after surgery

  2. Hoarsaness and dysphonia

    Time frame: up to 2 hour

    Hoarsaness and dysphonia develops after surgery

  3. seroma

    Time frame: up to 30 day

    postoperative seroma

  4. scrotal edema

    Time frame: up to 30 day

    postoperatif scrotal edema

  5. ventilation time

    Time frame: up to 2 hour

    ventilation time during surgery

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Comparison of Tracheal Intubation and Laryngeal Mask Airway in Laparoscopic Total Extraperitoneal (TEP) Repair in Patients With Unilateral Inguinal Hernia

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 9, 2021
Registry last updated
Dec 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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