Prolonged Air Leak, Lung Resection
Conditions
Keywords
Prevention PAL Prolonged Air Leak (PAL), Lung Resection, Thoracic Surgery, Post-operative Thoracic Air Leak
Brief summary
The effectiveness of tissue sealants to prevent Prolonged Air Leak (PAL) after lung resection procedures remains unproved. The investigators hypothesize that one of the main reasons for that is the heterogeneity of previously studied populations. Since currently the risk of postoperative PAL can be scored with a reasonable accuracy, the aim of this research is to investigate the effect of routine application of a novel tissue sealant in patients selected on the basis of a high risk of PAL estimated before surgery.
Interventions
DEVICEHemopatch
PROCEDUREstandard preventive measures
Sponsors
Instituto de Investigación Biomédica de Salamanca
Baxter Healthcare Corporation
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled anatomical lung resection indicated for any non-infectious disease (excluding Pneumonectomy) * Patients classified in class D according estimated risk of PAL * Age between 18 and 80 years
Exclusion criteria
* Those patients that according to Investigator assessment are not going to tolerate the procedure * Clinical and anesthetic criteria that contraindicate surgery * Severe uncontrolled illness * Pregnancy * Patients that are under Investigational New Drug treatment or have participated in study with a investigational drug (authorized or not) in 30 days before randomization. * Lack of Informed Consent or patient refusal * Postsurgery mechanical ventilation or repeated surgery in follow-up month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Prolonged Air Leak (PAL) | From day of surgery to the fifth postoperative day | Prevalence of Prolonged Air Leak (PAL) measured as binary variable (YES/NO) and recorded, from day of surgery to the fifth postoperative day, in the study questionnaire. The occurrence of the outcome will be recorded if air leak exists 5 days or more after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Air Leaks | Check everyday from day of surgery up to 38 days post-operative at maximum | Measured as continuous variable (days) and recorded, from day of surgery to the day of withdraw the chest tube. (standardized criteria for pulling out chest drainage/s will be agreed among investigators) |
| Number of Participants With at Least One Chest Tube Reinsertion | From day of surgery up to 30 days thereafter | Rate of patients needing postoperative reinsertion of chest drainages due to symptomatic pneumothorax. Following daily during hospital stay and pone follow-up until 30th day post-operative. |
| Number of Participants With One or More Readmission | 30 days post-operative | Rate of readmissions due to relapsing pneumothorax (follow-up 30 days) |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis.
Hemopatch
standard preventive measures | 118 |
| Control Group Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat
standard preventive measures | 118 |
| Total | 236 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 8 |
| Overall Study | Death | 0 | 2 |
| Overall Study | Use of sealants other than Hemopatch | 5 | 3 |
Baseline characteristics
| Characteristic | Experimental Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 70.77 years | 70.76 years | 70.77 years |
| American Society of Anesthesiologists (ASA) classification ASA 2 | 54 Participants | 51 Participants | 105 Participants |
| American Society of Anesthesiologists (ASA) classification ASA 3 | 62 Participants | 65 Participants | 127 Participants |
| American Society of Anesthesiologists (ASA) classification ASA 4 | 2 Participants | 2 Participants | 4 Participants |
| Body Mass Index | 24.5 kg/m^2 | 24.27 kg/m^2 | 24.4 kg/m^2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Spain | 118 participants | 118 participants | 236 participants |
| Sex: Female, Male Female | 25 Participants | 27 Participants | 52 Participants |
| Sex: Female, Male Male | 93 Participants | 91 Participants | 184 Participants |
| Type of Surgery Bilobectomy | 5 Participants | 7 Participants | 12 Participants |
| Type of Surgery Lobectomy | 106 Participants | 107 Participants | 213 Participants |
| Type of Surgery Segmentectomy | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 118 | 2 / 118 |
| other Total, other adverse events | 0 / 118 | 0 / 118 |
| serious Total, serious adverse events | 3 / 118 | 7 / 118 |
Outcome results
Primary
Number of Participants With Prolonged Air Leak (PAL)
Prevalence of Prolonged Air Leak (PAL) measured as binary variable (YES/NO) and recorded, from day of surgery to the fifth postoperative day, in the study questionnaire. The occurrence of the outcome will be recorded if air leak exists 5 days or more after surgery
Time frame: From day of surgery to the fifth postoperative day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Group | Number of Participants With Prolonged Air Leak (PAL) | 33 Participants |
| Control Group | Number of Participants With Prolonged Air Leak (PAL) | 24 Participants |
p-value: 0.17195% CI: [0.891, 1.583]Chi-squared
Secondary
Duration of Air Leaks
Measured as continuous variable (days) and recorded, from day of surgery to the day of withdraw the chest tube. (standardized criteria for pulling out chest drainage/s will be agreed among investigators)
Time frame: Check everyday from day of surgery up to 38 days post-operative at maximum
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental Group | Duration of Air Leaks | 1 days |
| Control Group | Duration of Air Leaks | 1 days |
p-value: >0.05Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With at Least One Chest Tube Reinsertion
Rate of patients needing postoperative reinsertion of chest drainages due to symptomatic pneumothorax. Following daily during hospital stay and pone follow-up until 30th day post-operative.
Time frame: From day of surgery up to 30 days thereafter
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Group | Number of Participants With at Least One Chest Tube Reinsertion | 3 Participants |
| Control Group | Number of Participants With at Least One Chest Tube Reinsertion | 6 Participants |
p-value: 0.30795% CI: [0.657, 1.879]Chi-squared
Secondary
Number of Participants With One or More Readmission
Rate of readmissions due to relapsing pneumothorax (follow-up 30 days)
Time frame: 30 days post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Group | Number of Participants With One or More Readmission | 0 Participants |
| Control Group | Number of Participants With One or More Readmission | 0 Participants |