RecruitingACTRN12622001386729

Clinical Trial assessing the safety and feasibility of major soft tissue abdominal resections using the da Vinci Xi surgical robot.

Clinical Trial assessing the safety and feasibility of performing robotic-assisted multivisceral complete soft tissue extended resections (CSTER) in adults with advanced or recurrent abdominal tumours.

Sponsor

Sydney Local Health District

Enrollment

20 participants

Start Date

Oct 16, 2023

Study Type

Interventional

Conditions

Recurrent abdominal cancers Advanced abdominal cancers

Summary

RoboSTER is a prospective cohort trial designed to evaluate the outcomes following robotic removal of pelvic tumours and attached organs during multivisceral complete soft tissue extended resections (STER). The procedure is split into three parts, Firstly, there is removal of the bowel, then removal of the bladder, +/- prostate (male) or gynaecological organs (female) as well as lymph nodes. The second part involves reconstruction of a new urinary tract (urinary diversion) using a section of small bowel attached to the ureters to drain urine produced by the kidneys. The third part involves construction of a faecal diversion, ileostomoy/colostomy, using a section in the bowel to drain faecal matter produced in the intestines. The main objective is to investigate whether performing the operation inside the body (via a "keyhole surgery approach") with robotic assistance (using the da Vinci Xi surgical robot) is safe and feasible. Who is it for? You may be eligible for this study if you are aged over 18 years, and are undergoing an elective robotic multivisceral complete soft tissue extended resections for pelvic cancers. Study details All participants will undergo a multivisceral complete soft tissue extended resection using robotic surgical techniques. This will involve using the robotic equipment to perform the resection, and is anticipated to take approximately 13 hours to complete. For all participants conversion to traditional approach rates, quality of life measures, morbidity data and other clinical data (ie: blood loss, oncological outcomes etc) will be recorded to test the safety and feasibility of the approach. It is hoped that this study may demonstrate that intracorporeal pelvic tumour removal following robotic multivisceral complete STER is a safe and feasible approach and may result in better patient outcomes.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

The RoboSTER trial is investigating whether using robotic-assisted "keyhole" surgery to remove complex pelvic tumours is a safe and practical approach. The procedure, called a multivisceral soft tissue extended resection, involves removing the bowel, bladder, and sometimes reproductive organs when a pelvic cancer has grown to involve multiple structures. It is a major operation that has traditionally required open surgery with a large incision, but robotic tools now make it possible to perform the procedure entirely inside the body with much smaller cuts. The study will evaluate outcomes such as how often surgeons need to switch from robotic to open surgery, recovery time, blood loss, complication rates, and quality of life after the procedure. All participants will undergo the robotic-assisted version of this surgery as part of their standard cancer care. You may be eligible if you are 18 or older and have been assessed by a specialist multidisciplinary team as suitable for this type of robotic pelvic surgery, which may be recommended for primary pelvic cancers, locally recurrent central cancers, or certain types of fistulas between pelvic organs. You would not be eligible if you have had multiple complex previous abdominal surgeries, or if your surgery would require bone removal or major blood vessel reconstruction as part of the procedure.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The intervention in the RoboSTER trial is the use of the da Vinci Xi surgical robot to resect advanced or recurrent abdominal tumours (intervention name: robot-assisted multivisceral complete soft tissue extended resection). Intra-corporeal abdominal tumour resection (ICATR) involves performing resection using the Da Vinci Xi Surgical Robot's arms internally, within the body. The majority of the surgery is performed by a colorectal surgeon, however urological surgeons and gynaecological surgeons are often involved and perform specialty specific procedures as parts of the overall surgery (ie: a urologist may perform a radical cystectomy). Abdominal tumour resection involves excision of the tumour and associated attached viscera, this may include bowel, and genitourinary organs. The surgical approach for ICATR follows standardised oncological principles to obtain clear surgical margins and appropriate resection of draining lymph node tissue, as performed for the traditional open approach (please see Comparator/Control Treatment section). The use of the robotic device will be confined to the instrument’s limitations, all remaining components of the surgery will be performed via routine practice. Reconstruction of gastrointestinal and urinary systems will be undertaken using a minimally invasive approach. The approximate duration of the intervention will be 13 hours, however this depends on each individual case. Adherence to the intervention is monitored by patient surgical case reports within electronic medical records and intra-operative surgical forms.

Locations(2)

Royal Prince Alfred Hospital - Camperdown

NSW, Australia

The Chris O’Brien Lifehouse - Camperdown

NSW, Australia

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ACTRN12622001386729