C20 C21
Conditions
Interventions
Group 1: Patients treated at the center who underwent guideline-based, interdisciplinary planned (certified tumor board) robotic abdominoperineal resection for colorectal carcinoma or another malignan
Sponsors
Vivantes Humboldt-Klinikum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Surgery (APR & rVRAM) performed by an experienced colorectal and robotic surgeon (>100 cases). 2. Participation in a case-observation or workshop/ lecture on the standardized rVRAM technique. 3. Completion of proctoring by an experienced rVRAM surgeon (>20 cases) for standardized rVRAM training. 4. Guideline-based surgical indication (abdominoperineal resection) confirmed by a certified interdisciplinary tumor board. 5. Planned abdominoperineal resection or exenteration with the option of interdisciplinary consultation (oncology, radiotherapy, surgery, gastroenterology, psycho-oncology, stoma therapy). 6. Presence of an intact rectus abdominis muscle with preserved inferior vascular supply. 7. Full patient information and written informed consent for study participation and data processing. 8. Registration in a clinical data registry.
Exclusion criteria
Exclusion criteria: 1. Surgeon does not meet the defined qualification requirements (lack of experience in colorectal surgery, no completed observership and/or no proctoring in the rVRAM technique). 2. Refusal to participate in the study or absence of written informed consent. 3. Lack of guideline-based surgical indication. 4. General contraindications to extensive reconstructive procedures (e.g., severe cardiac or pulmonary comorbidities). 5. Contraindications to minimally invasive surgical techniques (e.g., extensive adhesions, uncontrolled coagulopathies). 6. Patients not capable of giving informed consent (including minors). 7. Active systemic infection. 8. Relevant pre-existing abdominal wall defects or unavailability of the VRAM flap (e.g., due to prior surgery or vascular injury). 9. Concurrent participation in another clinical trial that may influence the study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of perineal wound healing complications (defined as Clavien–Dindo grade I-V) within 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall mortality, reoperation rate, conversion rate, length of hospital stay, abdominal wall complications, rate of initiation of adjuvant therapy, incidence of perineal hernia, donor-site morbidity, operative times (total, console, and harvest), R0 resection rate, and local recurrence rate. | — |
Countries
Germany
Contacts
Public ContactSkander Bouassida
Vivantes Humboldt-Klinikum, Klinik für Koloproktologie
Outcome results
None listed