Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04647006
Status:
COMPLETED
Last Update Posted:
2020-11-30
First Post:
2020-10-06
Brief Title:
Comparison of TOETVA and Conventional Thyroidectomy
Sponsor:
MUnlu
Organization:
Başakşehir Çam Sakura City Hospital
Study Overview
Official Title:
Comparison of Transoral Endoscopic Thyroidectomy Vestibular Approach and Open Conventional Thyroidectomy for Inflammatory Responses Pain and Patient Satisfaction A Prospective Study
Status:
COMPLETED
Status Verified Date:
2020-11
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:
TOETVA
Brief Summary:
Introduction-Objective
The application of transoral endoscopic thyroidectomy vestibular approach TOETVA is gradually increasing recently However it is not clear whether TOETVA is a true minimally invasive thyroidectomy compared to open conventional thyroidectomy
In this study we aimed to evaluate the TOETVA and open conventional thyroidectomy techniques in terms of postoperative inflammatory response pain and patient satisfaction
Material and Method
In this prospective study 40 female patients between the ages of 18-65 were divided into 2 groups of 20 patients TOETVA 20 patients open thyroidectomy 20 patients Operation time inflammatory response with IL-6 white blood cell WBC and C-reactive protein CRP postoperative pain postoperative complications and patient satisfaction were evaluated in both groups
The application of transoral endoscopic thyroidectomy vestibular approach TOETVA is gradually increasing recently However it is not clear whether TOETVA is a true minimally invasive thyroidectomy compared to open conventional thyroidectomy
In this study we aimed to evaluate the TOETVA and open conventional thyroidectomy techniques in terms of postoperative inflammatory response pain and patient satisfaction
Material and Method
In this prospective study 40 female patients between the ages of 18-65 were divided into 2 groups of 20 patients TOETVA 20 patients open thyroidectomy 20 patients Operation time inflammatory response with IL-6 white blood cell WBC and C-reactive protein CRP postoperative pain postoperative complications and patient satisfaction were evaluated in both groups
Detailed Description:
The application of transoral endoscopic thyroidectomy vestibular approach TOETVA is gradually increasing recently However it is not clear whether TOETVA is a true minimally invasive thyroidectomy compared to open conventional thyroidectomy
In this study we aimed to evaluate the TOETVA and open conventional thyroidectomy techniques in terms of postoperative inflammatory response pain and patient satisfaction
This non-randomized prospective clinical study was performed in our clinic between September 2019 and January 2020 with the approval of the Sisli Hamidiye Etfal Training and Research Hospital Ethics Committee Ethics committee date 19032019 number 2313
In the study it was planned to form 2 groups with 20 patients in each performing conventional open thyroidectomy OTG Group 1 or transoral endoscopic thyroidectomy vestibular approach TOETVA TTG Group 2 All patients who agreed to participate in the study were informed about both surgical techniques and complications and their written consent was obtained Patients took part in Group 1 or Group 2 according to their own preferences
During this study 43 patients underwent thyroidectomy Patients who did not comply with the study criteria were excluded from the study 43 female patients were selected from these patients who were eligible for the study Of these patients 3 patients who were converted to open surgery in the TTG group were excluded from the study and a total of 40 patients were included in the study
All surgeries were performed by an experienced endocrine surgeon
Conventional thyroidectomy After neck extension with a thyroid pillow and patient positioning thyroidectomy andor central neck dissection was performed using a 4 to 6cm collar transverse incision Subplatysmal flap dissection was applied up to the sternal notch inferiorly and to the thyroid cartilage superiorly and through the mid line of the strap muscles the thyroid gland was reached After receiving a vagus nerve impulse upper pole dissection was performed under the guidance of IONM Identification and monitoring of recurrent laryngeal nerves RLNs and external branch of the superior laryngeal nerves EBSLNs were carried out systematically
TOETVA All patients received preoperative chlorhexidine mouthwash and preoperative intravenous amoxicillinclavulanic acid was administered for prophylaxis Orotracheal intubation was performed A slight extension posture was given to the neck with a pillow placed under the shoulder and the patients were placed in 15 degrees of Trendelenburg position Skin and oral cavity were wiped with povidone iodine A central 15-2 cm transverse incision was performed in the middle of the distance between the first vermillion inner edge and the inferior labial frenulum in the oral vestibule Through the peripheral fibers of the submucosa and orbicularis oris muscle the jaw tip was reached with a monopolar electrocautery between the two mentalis muscles deep in the subdermal layer From this incision 50 cc of 1500000 adrenaline-saline solution was applied to the anterior neck with a Veress needle A surgical field was created from this incision by dissection of thyroid cartilage with Kelly forceps The surgical field was formed by blunt dissection from the incision in the subplatysmal area up to both sternocleidomastoid muscles SCMs leading edge and to the sternal notch in the inferiorly with the blunt type tunnel probe For the 30 camera from the central incision 10 mm blunt tipped port was entered and operation was performed under 6 mmHg CO 2 pressure and 15 Lmin CO 2 flow rate In addition with 3-4 silk sutures placed on the front neck the skin is mechanically hung and an optimal working area is provided A vertical 5 mm incision was made from the lateral side of the canine tooth and edge of vermillion at both sides and two working channels were created parallel to the 10 mm port Subplatysmal workspace was opened completely with Hook cautery and Harmonic scalpel Strap muscles were opened in midline and dissected over thyroid gland The strap muscles were retracted by a transcutaneous 20 silk suture Thyroid isthmus is divided The upper pole was dissected controlled with the EBSLN monitoring probe and the thyroid vessels were separated from the thyroid capsule with Ultracision The superior parathyroids are identified and dissected and protected The recurrent laryngeal nerve was viewed at the entrance of the larynx and introduced towards proximally The Berry region was separated close to the thyroid capsule to protect RLN Inferior parathyroids have been identified and protected The thyroid gland was separated from the trachea The thyroid gland was placed in the endobag placed through the 10 mm port and extracted The same surgical procedures were applied to the opposite lobe in total thyroidectomy Following bleeding control RLN R2 and vagus V2 signals were measured with IONM probe and recorded Surgicel was placed into the surgical field The midline was closed with 30 polyglactin sutures No drain was used in any patient Intraoral incisions were sutured with 40 polyglactin 24-hour pressure dressing was applied to the chin
The upper pole vessels were separated on the thyroid capsule with bipolar cautery In lateral dissection of the thyroid lobe RLN was identified in the region where it crosses with the inferior thyroid artery ITA Then RLN was fully dissected up to its entry through the larynx under the cricopharyngeal muscle CP muscle Preserving parathyroids ITA branches were separated from the capsule R2 and V2 signals were measured after bleeding control Surgicel was placed in the surgical field and strap muscles were reapproximated with 30 polyglactin The subcutaneous tissue was sutured separately with polyglactin The skin was reapproximated subcutaneously with polyglactin
Inflammatory Response Preoperative postoperative 2nd hour 1st day and 2nd day CRP C-reactive protein WBC White blood cell IL-6 Interleukin 6 levels were measured to evaluate the inflammatory response in all patients To measure IL-6 blood samples were collected from patients centrifuged then stored at -80oC After all the serum were collected they were evaluated using the Human IL-6 ELISA kit To evaluate postoperative hypoparathyroidism postoperative first day calcium phosphorus and parathormone values were checked Hypocalcemic patients were controlled weekly and evaluated clinically and with laboratory values
Postoperative pain and analgesia As a standard in terms of pain palliation all patients received 41 500 mg paracetamol intravenously and 31 100 mg tramadol HCl on the first day 31 500 mg paracetamol intravenously on the second day in the postoperative period
Pain intensity of the patients was evaluated with the Visual Analogue Scale VAS score 0 to 10 on the 2nd and 12th hour 1st and 2nd days postoperatively Lower lip lower chin and anterior neck area pain were evaluated separately with VAS score VAS scores were determined by patients by marking the intensity of pain on the ruler which was marked as 0 for the absence of pain and as 10 for the most severe pain sensation
Patient satisfaction was evaluated on postoperative 15th and 30th days in both groups Patients were asked to evaluate and score the operation in general and in terms of cosmesis 1 bad and 4 very good In addition the patients were asked which surgery TOETVA or conventional thyroidectomy they would prefer if they would have the operation again
Vocal cord examination with fiberoptic laryngoscopy was performed to all patients in the preoperative period and within the first 2 days postoperatively by an independent otorhinolaryngologist Control examinations were planned for patients with vocal cord paralysis at the 15th day 1st 2nd 4th and 6th months postoperatively
Intraoperative and postoperative complications of patients were recorded
In this study we aimed to evaluate the TOETVA and open conventional thyroidectomy techniques in terms of postoperative inflammatory response pain and patient satisfaction
This non-randomized prospective clinical study was performed in our clinic between September 2019 and January 2020 with the approval of the Sisli Hamidiye Etfal Training and Research Hospital Ethics Committee Ethics committee date 19032019 number 2313
In the study it was planned to form 2 groups with 20 patients in each performing conventional open thyroidectomy OTG Group 1 or transoral endoscopic thyroidectomy vestibular approach TOETVA TTG Group 2 All patients who agreed to participate in the study were informed about both surgical techniques and complications and their written consent was obtained Patients took part in Group 1 or Group 2 according to their own preferences
During this study 43 patients underwent thyroidectomy Patients who did not comply with the study criteria were excluded from the study 43 female patients were selected from these patients who were eligible for the study Of these patients 3 patients who were converted to open surgery in the TTG group were excluded from the study and a total of 40 patients were included in the study
All surgeries were performed by an experienced endocrine surgeon
Conventional thyroidectomy After neck extension with a thyroid pillow and patient positioning thyroidectomy andor central neck dissection was performed using a 4 to 6cm collar transverse incision Subplatysmal flap dissection was applied up to the sternal notch inferiorly and to the thyroid cartilage superiorly and through the mid line of the strap muscles the thyroid gland was reached After receiving a vagus nerve impulse upper pole dissection was performed under the guidance of IONM Identification and monitoring of recurrent laryngeal nerves RLNs and external branch of the superior laryngeal nerves EBSLNs were carried out systematically
TOETVA All patients received preoperative chlorhexidine mouthwash and preoperative intravenous amoxicillinclavulanic acid was administered for prophylaxis Orotracheal intubation was performed A slight extension posture was given to the neck with a pillow placed under the shoulder and the patients were placed in 15 degrees of Trendelenburg position Skin and oral cavity were wiped with povidone iodine A central 15-2 cm transverse incision was performed in the middle of the distance between the first vermillion inner edge and the inferior labial frenulum in the oral vestibule Through the peripheral fibers of the submucosa and orbicularis oris muscle the jaw tip was reached with a monopolar electrocautery between the two mentalis muscles deep in the subdermal layer From this incision 50 cc of 1500000 adrenaline-saline solution was applied to the anterior neck with a Veress needle A surgical field was created from this incision by dissection of thyroid cartilage with Kelly forceps The surgical field was formed by blunt dissection from the incision in the subplatysmal area up to both sternocleidomastoid muscles SCMs leading edge and to the sternal notch in the inferiorly with the blunt type tunnel probe For the 30 camera from the central incision 10 mm blunt tipped port was entered and operation was performed under 6 mmHg CO 2 pressure and 15 Lmin CO 2 flow rate In addition with 3-4 silk sutures placed on the front neck the skin is mechanically hung and an optimal working area is provided A vertical 5 mm incision was made from the lateral side of the canine tooth and edge of vermillion at both sides and two working channels were created parallel to the 10 mm port Subplatysmal workspace was opened completely with Hook cautery and Harmonic scalpel Strap muscles were opened in midline and dissected over thyroid gland The strap muscles were retracted by a transcutaneous 20 silk suture Thyroid isthmus is divided The upper pole was dissected controlled with the EBSLN monitoring probe and the thyroid vessels were separated from the thyroid capsule with Ultracision The superior parathyroids are identified and dissected and protected The recurrent laryngeal nerve was viewed at the entrance of the larynx and introduced towards proximally The Berry region was separated close to the thyroid capsule to protect RLN Inferior parathyroids have been identified and protected The thyroid gland was separated from the trachea The thyroid gland was placed in the endobag placed through the 10 mm port and extracted The same surgical procedures were applied to the opposite lobe in total thyroidectomy Following bleeding control RLN R2 and vagus V2 signals were measured with IONM probe and recorded Surgicel was placed into the surgical field The midline was closed with 30 polyglactin sutures No drain was used in any patient Intraoral incisions were sutured with 40 polyglactin 24-hour pressure dressing was applied to the chin
The upper pole vessels were separated on the thyroid capsule with bipolar cautery In lateral dissection of the thyroid lobe RLN was identified in the region where it crosses with the inferior thyroid artery ITA Then RLN was fully dissected up to its entry through the larynx under the cricopharyngeal muscle CP muscle Preserving parathyroids ITA branches were separated from the capsule R2 and V2 signals were measured after bleeding control Surgicel was placed in the surgical field and strap muscles were reapproximated with 30 polyglactin The subcutaneous tissue was sutured separately with polyglactin The skin was reapproximated subcutaneously with polyglactin
Inflammatory Response Preoperative postoperative 2nd hour 1st day and 2nd day CRP C-reactive protein WBC White blood cell IL-6 Interleukin 6 levels were measured to evaluate the inflammatory response in all patients To measure IL-6 blood samples were collected from patients centrifuged then stored at -80oC After all the serum were collected they were evaluated using the Human IL-6 ELISA kit To evaluate postoperative hypoparathyroidism postoperative first day calcium phosphorus and parathormone values were checked Hypocalcemic patients were controlled weekly and evaluated clinically and with laboratory values
Postoperative pain and analgesia As a standard in terms of pain palliation all patients received 41 500 mg paracetamol intravenously and 31 100 mg tramadol HCl on the first day 31 500 mg paracetamol intravenously on the second day in the postoperative period
Pain intensity of the patients was evaluated with the Visual Analogue Scale VAS score 0 to 10 on the 2nd and 12th hour 1st and 2nd days postoperatively Lower lip lower chin and anterior neck area pain were evaluated separately with VAS score VAS scores were determined by patients by marking the intensity of pain on the ruler which was marked as 0 for the absence of pain and as 10 for the most severe pain sensation
Patient satisfaction was evaluated on postoperative 15th and 30th days in both groups Patients were asked to evaluate and score the operation in general and in terms of cosmesis 1 bad and 4 very good In addition the patients were asked which surgery TOETVA or conventional thyroidectomy they would prefer if they would have the operation again
Vocal cord examination with fiberoptic laryngoscopy was performed to all patients in the preoperative period and within the first 2 days postoperatively by an independent otorhinolaryngologist Control examinations were planned for patients with vocal cord paralysis at the 15th day 1st 2nd 4th and 6th months postoperatively
Intraoperative and postoperative complications of patients were recorded
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