The Application Value of da Vinci Linear Cutting Stapler SureForm in Robotic Anus Preserving Surg… (NCT05667181) | Clinical Trial Compass
CompletedNot Applicable
The Application Value of da Vinci Linear Cutting Stapler SureForm in Robotic Anus Preserving Surgery for Rectal Cancer
China276 participantsStarted 2022-12-29
Plain-language summary
Anastomotic complications are serious complications after anus preserving surgery for rectal cancer,the instrument anastomosis technology are one of the factors that influence the occurrence of anastomotic complications after surgery,the laparoscopic linear cutting closure device used in robotic rectal cancer may increase the occurrence of anastomotic complications,but the robot linear cutting stapler (SureForm) may reduce the incidence of postoperative anastomotic complications due to the technical advantages,therefore,the aim of this study is to evaluate the impact of robotic linear cutting stapler SureForm and laparoscopic linear cutting stapler on the incidence of anastomotic complications after robotic rectal cancer anus preserving surgery.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. The age is more than 18 years old and less than or equal to 80 years old
✓. Pathological diagnosis of rectal adenocarcinoma by colonoscopy biopsy
✓. The distance between the tumor and the anal margin diagnosed by colonoscopy and pelvic MRI before operation is less than or equal to 15cm
✓. No distant metastasis (including pelvic cavity, peritoneum, liver, lung, brain, bone, distant lymph node metastasis, etc.) is judged by ultrasound, CT, PET-CT, etc
✓. No local complications before operation (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, abscess formation, no local invasion)
✓. Robot surgery
✓. Voluntary participation and signing of informed consent
Exclusion criteria
✕. Previous history of malignant colorectal tumors
✕. Simultaneous diagnosis of multiple primary colorectal tumors
✕. Those who have performed abdominal and pelvic surgery for many times or have extensive abdominal adhesions
✕. Patients with familial adenomatous polyposis, Lynch syndrome associated rectal cancer, and inflammatory bowel disease at active stage
✕. Diagnosis of other malignant tumors in recent 5 years
✕. ASA grade ≥ IV and/or ECOG physical status score ≥ 2
✕. Patients with severe liver and kidney function, heart and lung function, blood coagulation dysfunction or combined with severe basic diseases can not tolerate surgery