Robot-assisted surgery for advanced pelvic cancer
Laparoscopic Robot-assisted Pelvic Exenteration for Pelvic Primary and Recurrent Cancers
This study is testing if robot-assisted surgery can help people with advanced pelvic cancers have better outcomes and recoveries compared to traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Oslo) |
| Trial ID | NCT05186493 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of laparoscopic robot-assisted pelvic exenteration in patients with locally advanced pelvic cancers, including rectal and sigmoid cancers, as well as recurrent cervical and endometrial cancers. The study aims to achieve R0 resection, which is defined as having more than 1 mm of healthy tissue surrounding the tumor, thereby improving patient outcomes. It will assess various endpoints such as conversion rates to open surgery, postoperative complications, hospital stay duration, and quality of life over a follow-up period of five years. The trial is open-label and observational, focusing on the surgical approach and its implications for patient survival and recovery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with locally advanced pelvic cancer requiring pelvic exenteration and who are eligible for robot-assisted minimally invasive surgery.
Not a fit: Patients who are not suited for robot-assisted surgery or have contraindications as determined by the investigator may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes and survival rates for patients with advanced pelvic cancers.
How similar studies have performed: While robot-assisted surgeries have shown promise in various contexts, this specific approach for pelvic exenteration is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (\>18 years) * locally advanced pelvic cancer that require pelvic exenteration * eligible for robot- assisted minimally invasive surgery by the respective multidisciplinary teams, may be included in the study. Exclusion Criteria: * Any reason why the patient in the investigator's opinion is not suited for inclusion.
Where this trial is running
Oslo
- Oslo University Hospital The Radium Hospital — Oslo, Norway (Recruiting)
Study contacts
- Study coordinator: Ebbe B Thorgersen, MD PhD
- Email: ebbtho@rr-research.no
- Phone: +4748144121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.