Clinical trial NCT05832112: Outside the Cage (OTC) Robotic Lobectomy
Official title: Outside the Cage (OTC) Robotic Lobectomy, Single Center Human Phase I Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer Stage I
Keywords: Out of the Cage
Lobectomy
Robotic
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study consists in a prospective pilot study evaluating the feasibility and safety of OTC RATS lobectomies in patients treated for lung cancer. All patients with clinical stage I tumors (≤cT2N0M0) planned to undergo a VATS or RATS lobectomy at the CHUM will be approached. At our institution, lobectomies are either performed open by thoracotomy or by MIS, including VATS and RATS. The technique is selected based on tumor size, tumor location and patient characteristics. Only patients already planned for a VATS or RATS lobectomy will be approached. They will be identified through the operation request forms and will be approached either in the preoperative clinic or the day before surgery, when admitted. The investigators aim to recruit 20 patients.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Conversion rate
timeFrame: Through study completion, an average of 1 year
measure: 30-day mortality
timeFrame: 30 days after discharge
Secondary outcomes:
measure: Length of stay
timeFrame: Through study completion, an average of 1 year
measure: Operative time
timeFrame: Intraoperative
measure: Estimated blood loss
timeFrame: Intraoperative
measure: Postoperative pain
timeFrame: Through study completion, an average of 1 year
measure: Quality of recovery
timeFrame: Through study completion, an average of 1 year
measure: Analgesic complementation requirement
timeFrame: Through study completion, an average of 1 year
measure: Serious adverse events
timeFrame: Through study completion, an average of 1 year
measure: Perioperative complications
timeFrame: Through study completion, an average of 1 year
measure: Evaluate Chronic Pain
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHUM
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Moishe Liberman, MD
role: PRINCIPAL_INVESTIGATOR
References: