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

Not Applicable

Recruiting

• Conditions: Advanced abdominal cancers; Recurrent abdominal cancers; Cancer - Bladder; Cancer - Bowel - Back passage (rectum) or large bowel (colon); Cancer - Bowel - Small bowel (duodenum and ileum); Cancer - Bowel - Anal; Cancer - Cervical (cervix); Cancer - Womb (Uterine or endometrial cancer); Cancer - Neuroendocrine tumour (NET); Cancer - Penile (penis)

• Registration Number: ACTRN12622001386729
• Lead Sponsor: Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-28
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Adults aged 18 years or older
2. Cognitively able to give written informed consent for participation
3. Patients who have one of the following pathologies, and who are deemed by the Pelvic Exenteration MDT as being suitable for robotic multivisceral complete soft tissue extended resection:
a. Primary pelvic malignancy
b. Locally recurrent cancer of the central compartment
c. Colovesical, rectourethral or rectovaginal fistulae
4. Elective procedures

Exclusion Criteria

1. Patients unable or unwilling to undergo pre and post-operative evaluation as per the study protocol
2. Patient and/or disease factors precluding robotic assisted multivisceral soft tissue extended resections such as:
a. Previous multiple complex abdominal surgeries
b. Bony resection required as part of the extended resection
c. Vascular reconstruction required as part of the extended resection
d. Other factors as determined by the treating surgeon or Pelvic Exenteration MDT

Study & Design

• Study Type: Interventional
• Study Design: Not specified