Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Lung Neoplasms

Pain, Postoperative

Postoperative Complications

Pain

Neurologic Manifestations

For postoperative pleural space drainage a silicone coaxial drain of size French 24 (Redax Coaxial Drain, Redax S.p.A., Poggio Rusco Mantova, Italy) was used

For postoperative pleural space drainage a standard polyvinyl chloride drain of size French 24 (Argyle, Covidien, Mansfield, USA) was used

Silicone chest tube used for pleural space drainage after VATS lobectomy

SIL drain

Polyvinyl chloride chest tube used for pleural space drainage after VATS lobectomy

PVC drain

Boris Greif

The goal of this prospective randomized clinical trial is to compare the impact of the chest tube type on pain, chest drainage efficacy and early postoperative outcome following VATS lobectomy for lung cancer.

The main questions it aims to answer are:

* silicone chest drains are less painful compared to standard PVC drains?
* is there any difference in chest drainage efficacy and short term outcome between the two groups? Researchers will compare silicone chest drain group with PVC chest drain group to see if there is any difference in postoperative pain, chest drainage efficacy and short term outcome.

A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy

The Impact of Chest Drain Type on Pain, Drainage Efficacy and Short Term Outcome Following VATS Lobectomy for Lung Cancer: A Prospective Randomized Study Comparing Silicone Versus PVC Drains

Amount of analgesics used first two days after the surgery was analyzed and reported in milligrams. Higher scores mean a worse outcome.

Need for peroral analgesia at first, second and fourth week after chest tube removal was assessed and reported as frequency in number. Higher scores mean a worse outcome.

Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal inspiratory pressure (MIP) in cmH2O. Higher scores mean a better outcome.

Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal expiratory pressure (MEP) in cmH2O. Higher scores mean a better outcome.

Post-operative pain during the first two days after the surgery was analyzed by using the visual analogue scale (VAS). Scale tittle was Visual Analogue Scale. Minimum value on a scale was 0 and maximum value was 10. Higher scores mean a worse outcome.

The effectiveness of chest drainage was analyzed by assessing the duration of chest drainage in days. Higher scores mean a worse outcome.

The effectiveness of chest drainage was analyzed by assessing the rate of pneumothorax (frequency in number) on chest x-ray on the day of surgery. Higher scores mean a worse outcome.

The effectiveness of chest drainage was analyzed by assessing the rate of pneumothorax (frequency in number) on chest x-ray after removal of the drain. Higher scores mean a worse outcome.

The effectiveness of chest drainage was analyzed by assessing the rate of pleural effusion (frequency in number) on chest x-ray on the day of surgery. Higher scores mean a worse outcome.

The effectiveness of chest drainage was analyzed by assessing the rate of pleural effusion (frequency in number) on chest x-ray after removal of the drain. Higher scores mean a worse outcome.

The effectiveness of chest drainage was analyzed by assessing the rate of clinically expressed subcutaneous emphysema (frequency in number). Higher scores mean a worse outcome.

The effectiveness of chest drainage was analyzed by assessing the rate of prolonged air leak over 5 days (frequency in number). Higher scores mean a worse outcome.

The effectiveness of chest drainage was analyzed by assessing the rate of reintervention (thoracentesis or chest drainage) after chest tube removal (frequency in number). Higher scores mean a worse outcome.

Early postoperative course was analyzed by assessing the duration of hospital stay (in days). Higher scores mean a worse outcome.

Early postoperative course was analyzed by assessing the rate of respiratory complications (frequency in number). Higher scores mean a worse outcome.

Early postoperative course was analyzed by assessing the rate of readmission in the first month after drain removal (frequency in number). Higher scores mean a worse outcome.

University Medical Centre Ljubljana

Head of Thoracic Surgery

Behaviors and Mental Disorders

Delirium

Confusion

Neurobehavioral Manifestations

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Antipyretics

Analgesics

Anti-Inflammatory Agents

Antirheumatic Agents

Anesthetics

Acetaminophen

Ibuprofen

Analgesics, Non-Narcotic

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Patients in the Maxigesic group will be administered a total of 5 doses of the drug (20mg/kg, maximum dose per serving: 1g) every 6 h from immediately after anesthetic induction.

Acetaminophen and Ibuprofen

Patients in the control group will be administered equal amounts of normal saline at the same time points.

Normal saline

Heezoo KIM, MD, PhD

Hye Bin KIM, MD, PhD

Hye Bin Kim, MD, PhD

Heezoo Kim, MD, PhD

The primary aim of this interventional study is to investigate the impact of perioperative administration of Maxigesic (combination of acetaminophen and ibuprofen) on delirium after minimally invasive lung surgery in elderly patients. The Maxigesic group receives a total of 5 doses of Maxigesic (20mg/kg, maximum dose per serving: 1g) every 6 h from immediately after anesthesia induction. The control group receives the same volume of normal saline. Researchers compare the incidence and severity of postoperative delirium for 5 days after surgery.

Impact of Maxigesic on Delirium After Minimally Invasive Lung Surgery in Elderly Patients

The Impact of Intravenous Administration of Perioperative Acetaminophen and Ibuprofen Combination (Maxigesic®) on Postoperative Delirium in Elderly Patients Undergoing Minimally Invasive Lung Segmentectomy or Lobectomy

The investigators have no plans yet to share individual participant data (IPD) with other researchers.

Confusion assessment method(CAM)/Confusion Assessment Method for the ICU (CAM-ICU) or delirium record on electrical medical record(EMR) will be used for the evaluation of POD.

CAM-S(severity) will be utilized to assess the severity of POD. (\*CAM-S is measured on 0-7 (short form) and 0-19 (long form) scale, and the higher the score, the greater the POD severity.)

CAM/CAM-ICU or delirium record on EMR will be used to estimate the duration of POD.

Mini-mental state examination(MMSE) will be used to evaluate the participants' preoperative cognition. (\*MMSE is measured on 0-30 scale, and the lower the score, the more cognitively impaired the patient is.)

Montreal cognitive assessment(MoCA) will be used to evaluate the participants' preoperative cognition. (\*MoCA is measured on 0-30 scale, and the lower the score, the more cognitively impaired the patient is.)

Clinical frailty scale(CFS) will be utilized to assess the preoperative frailty (\*CFS is used to determine comprehensive geriatric assessment. It is measured on 1-9 scale, and the higher the scale, the more frail the patient is.)

Numerical rating scale (NRS) or Visual analogue scale (VAS) will be used to determine the postoperative pain severity (\*NRS and VAS are measured on a 0-10 scale, and the higher the score, the more severe the patient's pain. If the patient can verbalize their pain, use the NRS; otherwise, use the VAS to assess pain).

Opioid consumption is measured by converting them into morphine equivalents.

Nausea is measured by scoring on a scale of 0-10. The higher the score, the more severe the symptom. Whether the patients vomit or not is observed and recorded.

Determine how many days the participant stays in the ICU.

Determine how many days the participant stays in the hospital.

Investigate all kinds of complications that occur after surgery.

Investigate complications suspected to be side effects caused by the study drug.

Kyongbo Pharmaceutical Co.,Ltd

Korea University Guro Hospital

Professor

Vasoconstrictor Agents

Respiratory System Agents

Herbal and Botanical

Bupivacaine

Morphine

Epinephrine

Racepinephrine

Epinephryl borate

* uniportal VATS lobectomy
* thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour)
* ketoprofene 100 mg i.v every 12 hours
* paracetamol 1000 mg i.v every 8 hours
* rescue doses of morphine in PCA system (bolus dose 2 mg i.v)
* pain intensity measured in VAS scale

* two-ports VATS lobectomy
* thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour)
* ketoprofene 100 mg i.v every 12 hours
* paracetamol 1000 mg i.v every 8 hours
* rescue doses of morphine in PCA system (bolus dose 2 mg i.v)
* pain intensity measured in VAS scale

* three-ports VATS lobectomy
* thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour)
* ketoprofene 100 mg i.v every 12 hours
* paracetamol 1000 mg i.v every 8 hours
* rescue doses of morphine in PCA system (bolus dose 2 mg i.v)
* pain intensity measured in VAS scale

Pain intensity in 0-100 mm VAS scale is measured every 4 hours on standard ruler beginning from the end of the surgery.

pain intensity measured in VAS scale

Sylweriusz Kosiński, PhD

Sylweriusz Kosiński

Marcin Zieliński, PhD

This single-center, prospective, randomized controlled trial was designed to assess and compare the postoperative pain after VATS lobectomy performed though one, two and three incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary outcome measure is cumulative morphine consumption up to 72 hours after surgery

The best VATS technique for lobectomy has not been well defined yet. Most of the authors describe the VATS approach to lobectomy via 2 to even 4 incisions. The final step in the evolution of the technique is the use of a single-port approach. If conventional multiportal VATS is superior to open thoracotomy by virtue of minimizing surgical access trauma, then further reduction in such access trauma should yield even greater benefits. Therefore, reducing the number of wounds from three or four to just one, should, in theory, lead to less pain, paresthesia, and morbidity as well as faster recovery. However, critics of the uniportal VATS approach may raise concerns about whether this most minimally invasive surgical approach for lung surgery may compromise safety and treatment efficacy. In addition, there's the concern about true invasiveness of the procedure. This prospective, randomized controlled trial was designed to compare the postoperative pain after VATS lobectomy performed through one, two and three incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary outcome measures are cumulative morphine consumption up to 72 hours after surgery in 4-hour intervals and dynamic spirometry (PEF, FEV1 and FVC) measured daily at the bedside up to 72 hours after surgery. All patients will receive the same regimen of postoperative analgesia based on thoracic epidural block, non-steroidal anti-inflammatory drugs and rescue doses of morphine in PCA system. The side effects and complications including atelectasis, pneumonia, atrial fibrillation, urine retention, hypotension, respiratory depression and sedation will be analysed.

Postoperative Pain After Single Port, Two Ports and Three Ports VATS Lobectomy

Postoperative Pain After Single Port, Two Ports and Three Ports Video-assisted Thoracic Surgery Lobectomy in Cancer Patients: A Randomized Controlled Trial

0-100 mm VAS scale measured every 4 hours on standard ruler beginning from the end of the surgery

cumulative rescue morphine consumtion (PCA) in miligrams

frequency of postoperative complications (atelectasis, pneumonia, atrial fibrillation, urine retention, hypotension, respiatory depression, sedation)

Pulmonary Hospital Zakopane

Lung lobectomy with ipsilateral lymphadenectomy

Lung lobectomy combined with video-assisted mediastinal lymphadenectomy through the neck (VAMLA). The approach is similar to transcervical mediastinoscopy and allows for a radical bloc dissection of all mediastinal lymph node stations. Besides the benefit of bilateral lung ventilation during this phase of the operation a bilateral mediastinal lymphadenectomy offers improved surgical radicality.

radical bloc dissection of all mediastinal lymph node stations

Lymphadenectomy

Mohamed SALAMA, MD, PhD

Micheal Mueller, MD

Mohamed Salama, MD, PhD

Any kind of anatomical lung resection for lung cancer with curative intent has to be accompanied by formal mediastinal lymph node dissection. Video-assisted mediastinoscopic lymphadenectomy through a cervical access (VAMLA) along with thoracoscopic lobectomies in the same setting offers improved radicality through bilateral mediastinal dissection, provide accurate staging, does not require single lung ventilation and hence ideally supports the concept of minimally invasive surgery.

Due to the VAMLA associated radicality, the investigator believes that using of VAMLA along with lobectomy could improve the oncological outcome of lung cancer patients. Furthermore, the absence of single lung ventilation during VAMLA could attenuate the surgically induced immunosuppression.

Any kind of anatomical lung resection for lung cancer with curative intent has to be accompanied by formal mediastinal lymph node dissection. Video-assisted mediastinoscopic lymphadenectomy through a cervical access (VAMLA) along with thoracoscopic lobectomies in the same setting offers improved radicality through bilateral mediastinal dissection, provide accurate staging, does not require single lung ventilation and hence ideally supports the concept of minimally invasive surgery.

Due to the VAMLA associated radicality, the investigator believes that using VAMLA along with lobectomy could improve the oncological outcome of lung cancer patients. Furthermore, the absence of single lung ventilation during VAMLA could attenuate the surgically induced immunosuppression.

The present study aims at:

1. The current project primarily aims at identifying the effect of reduced single lunge ventilation time during VAMLA-VATS lobectomy on the intraoperative production of oxygen radicals as well as its effect on the immune competence of patients undergoing VAMLA-VATS lobectomy as compared to those receiving VATS lobectomy Along with conventional unilateral lymphadenectomy.
2. Secondary, in line with the hypothesis that radical bilateral lymphadenectomy might results in a more complete oncological staging as compared to unilateral lymphadenectomy or lymph node sampling. The current project aims to compare the pre- and postoperative staging in patients undergoing VAMLA, as VAMLA enables a proper examination of all bilateral mediastinal lymph nodes.
3. Patient Follow-up will be continued for at least 5 years postoperatively in order to compare the oncological outcome namely local and distant recurrence, tumor-associated and overall survival in patients undergoing VAMLA-VATS Lobectomy as compared to those with VATS lobectomy. This issue is, however, a second endpoint of this study and will be independent of the primary endpoint.

Compare the oncological outcome and immune competence between patients who undergo lung lobectomy with standard lymphadenectomy and those who undergo combined lobectomy and video assisted bilateral mediastinal lymphadenectomy

Immune Response Following Lobectomy Along With or Without Bilateral Transcervical Mediastinal Lymphadenectomy

Immune Response of Patients Following Thoracoscopic Lobectomy Along With Bilateral Transcervical Mediastinal Lymphadenectomy and Patients Receiving VATSLOB Together With Standard Unilateral Mediastinal Lymphadenectomy

Interleukin (IL) 6 serum concentration on the 1st postoperative day

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy	NCT06425601	Postoperative P... Postoperative C...	SIL drain PVC drain	18 Years -	University Medical Centre Ljubljana
A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy	NCT06425601	Postoperative P... Postoperative C...	SIL drain PVC drain	18 Years -	University Medical Centre Ljubljana
Impact of Maxigesic on Delirium After Minimally Invasive Lung Surgery in Elderly Patients	NCT05834569	Delirium Aged Lung Neoplasms Robotic Surgica... Thoracic Surger...	Acetaminophen a... Normal saline	65 Years -	Korea University Guro Hospital
Postoperative Pain After Single Port, Two Ports and Three Ports VATS Lobectomy	NCT03228056	Lung Cancer	pain intensity ...	-	Pulmonary Hospital Zakopane
Immune Response Following Lobectomy Along With or Without Bilateral Transcervical Mediastinal Lymphadenectomy	NCT04778826	Lung Neoplasm M...	Lymphadenectomy	18 Years -	Otto Wagner Hospital

Spots Global Cancer Trial Database for lung lobectomy