Outside the Cage (OTC) Robotic Lobectomy (OTC-RATS)
Outside the Cage (OTC) Robotic Lobectomy, Single Center Human Phase I Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Consenting patients will undergo lobectomy by OTC RATS following the exact standard steps usually done by VATS/RATS, aside from the ports that will be placed in the subcostal plane. The characteristics of both the patient and the case, will determine the number of incisions from 1-4.
The Davinci Xi® surgical system will be used to perform the lobectomy through the ports using the standard technique with an anterior approach. Once the procedure is completed, the robotic arms and ports will be removed from the chest and figure-of-8 stitches with non absorbable sutures will be placed to close the diaphragm at the site of insertion. A 24 Fr soft chest tube will be left in place, as in the standard VATS/RATS lobectomy procedure. The incision closure will be done in a standard manner.
Enrolled patients will receive standard postoperative care. Chest tube removal and discharge will be decided by the treating surgeon, following the same criteria as VATS/RATS lobectomies. Images and videos will be recorded during the procedure. The postoperative course will be monitored in case of potential complications up to the 30-day follow-up appointment. Medical records will be verified to obtain postoperative outcomes at follow-up appointments at the surgical clinic.
All data pertaining to the 1-year follow-up will be collected and analysed retrospectively. Chronic pain of OTC RATS lobectomy patients will be compared to that of VATS lobectomy patients, for which the data will also be collected and analysed retrospectively. A propensity match score will be conducted using the two groups of patients, divided by surgical approach, to adequately interpret the degree of chronic pain experienced by patients who have received surgery using an OTC approach versus the current minimally invasive thoracic approach.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H2X 0A9
- CHUM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All patients with clinical stage I tumors (≤cT2N0M0) planned to undergo a lobectomy by VATS/RATS at the CHUM
Exclusion Criteria:
- Age < 18 years old
- Inability to consent to the study
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Out of the Cage Robotic Lobectomy
Consented patients will undergo lobectomy by OTC RATS following the exact standard steps usually done by VATS/RATS, except for the incisions, that will consist in 1 to 4 subcostal ports, based on the patient and case characteristics.
|
Consenting patients will undergo lobectomy by OTC RATS following the exact standard steps usually done by VATS/RATS, aside from the ports that will be placed in the subcostal plane. The characteristics of both the patient and the case, will determine the number of incisions from 1-4. The Davinci Xi® surgical system will be used to perform the lobectomy through the ports using the standard technique with an anterior approach. Once the procedure is completed, the robotic arms and ports will be removed from the chest and figure-of-8 stitches with non absorbable sutures will be placed to close the diaphragm at the site of insertion. A 24 Fr soft chest tube will be left in place, as in the standard VATS/RATS lobectomy procedure. The incision closure will be done in a standard manner. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Conversion rate
Time Frame: Through study completion, an average of 1 year
|
Feasibility will be evaluated by completion of the procedure without conversion of the approach or technique.
Any change in the treatment plan requiring the use of intercostal ports, conversion to conventional minimally invasive thoracic surgery through intercostal incisions, or conversion to open surgery
|
Through study completion, an average of 1 year
|
|
30-day mortality
Time Frame: 30 days after discharge
|
Safety will be evaluated by 30-day mortality.
Any dead occurring during the hospital stay or within 30 days after discharge will be registered.
|
30 days after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of stay
Time Frame: Through study completion, an average of 1 year
|
Length of hospital stay
|
Through study completion, an average of 1 year
|
|
Operative time
Time Frame: Intraoperative
|
Surgical operative time including robot positioning
|
Intraoperative
|
|
Estimated blood loss
Time Frame: Intraoperative
|
Registered by the OR nurse team
|
Intraoperative
|
|
Serious adverse events
Time Frame: Through study completion, an average of 1 year
|
Complications derived from the operation that altered the pathway
|
Through study completion, an average of 1 year
|
|
Perioperative complications
Time Frame: Through study completion, an average of 1 year
|
Complications including intraoperative and postoperative occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification
|
Through study completion, an average of 1 year
|
|
Postoperative pain
Time Frame: Through study completion, an average of 1 year
|
Pain scores on a visual analog scale: Pain Rating Scale between 0 and 10 (0: better outcome and 10:Worse outcome)
|
Through study completion, an average of 1 year
|
|
Quality of recovery
Time Frame: Through study completion, an average of 1 year
|
Assessment of postoperative recovery using Quality Of Recovery (QOR-15) questionnaire between 0 and 10 (0: Better outcome and 10: Worst outcome)
|
Through study completion, an average of 1 year
|
|
Analgesic complementation requirement
Time Frame: Through study completion, an average of 1 year
|
Number of participants who need of adding analgesia medication out of the analgesic pathway used in our center for conventional RATS/VATS
|
Through study completion, an average of 1 year
|
|
Evaluate Chronic Pain
Time Frame: Through study completion, an average of 1 year
|
Pain scores on a visual analog scale: Pain Rating Scale between 0 and 10 (0: better outcome and 10:Worse outcome). Chronic pain of OTC RATS lobectomy patients will be compared to that of VATS lobectomy patients, for which the data will also be collected and analysed retrospectively. |
Through study completion, an average of 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Moishe Liberman, MD, Centre Hospitalier de l'Université de Montréal (CHUM)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22.228
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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