rectal cancer, rectosigmoid cancer, sigmoid diverticulosis
Conditions
Interventions
The investigational product is the Implican Anastomotic Device, a sterile, implantable medical device. It consists of an applicator that places two compression rings at the anastomotic site to create
Sponsors
Implican B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with a primary diagnosis of radiologically confirmed non-metastatic, non-locally advanced rectal cancer or non-metastatic, non-locally advanced rectosigmoid cancer; OR patients with a primary diagnosis of diverticulosis or diverticulitis of the sigmoid;Indication for a low anterior resection or sigmoid resection with the inferior border of the anastomosis estimated between 5-15 cm from the anorectal junction on MRI;Planned to undergo robot-assisted minimally invasive surgery;Aged 18 years or older;ASA class I/II;Body mass index < 30;Elective surgery;Oral and written informed consent.
Exclusion criteria
Exclusion criteria: Previous rectal surgery (e.g. transanal endoscopic microsurgery, transanal minimally invasive surgery);Indication for neoadjuvant therapy;Confirmed or suspected abscess or fistula (e.g. colovesical, coloenteral or colocolic) related to the diverticulitisHistory of malignancies in the previous 5 years, with the exception of skin cancers other than melanoma;History of inflammatory bowel disease, ulcerative colitis, or Crohn’s disease;Previous pelvic surgery;Pregnancy or a planned pregnancy during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the successful creation of a colorectal anastomosis using the Implican Anastomotic Device without the occurrence of device- or procedure-related serious adverse events (SAEs), serious adverse device effects (SADEs), adverse events (AEs), or adverse device effects (ADEs) within 30 days postoperatively. Successful anastomosis creation is defined according to pre-established clinical criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include total time required for anastomosis creation, time to first flatus and first defecation, timing and nature of compression ring expulsion, anastomotic integrity at 90 days and 1 year, incidence of anastomosis-related complications (such as leakage, stenosis, hemorrhage, or pelvic sepsis), and functional bowel outcomes assessed using the Low Anterior Resection Syndrome (LARS) score. | — |
Countries
Netherlands
Contacts
Public ContactK Havenga
Implican B.V.
Outcome results
None listed