Outside the Cage (OTC) Robotic Lobectomy

Lung Cancer Stage I Clinical Trial

— OTC-RATS  

Official title:

Outside the Cage (OTC) Robotic Lobectomy, Single Center Human Phase I Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05832112
• Other study ID #: 22.228
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 22, 2023
• Est. completion date: June 9, 2024

Study information

• Verified date: September 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 9, 2024
• Est. primary completion date: June 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer Stage I

Intervention

Procedure:
• VATS/RATS lobectomy
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.

Locations

Country	Name	City	State
Canada	CHUM	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion rate	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
Primary	30-day mortality	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	Length of stay	Length of hospital stay	Through study completion, an average of 1 year
Secondary	Operative time	Surgical operative time including robot positioning	Intraoperative
Secondary	Estimated blood loss	Registered by the OR nurse team	Intraoperative
Secondary	Postoperative pain	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
Secondary	Quality of recovery	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
Secondary	Analgesic complementation requirement	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
Secondary	Serious adverse events	Complications derived from the operation that altered the pathway	Through study completion, an average of 1 year
Secondary	Perioperative complications	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
Secondary	Evaluate Chronic Pain	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