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NCT05667181
The Application Value of da Vinci Linear Cutting Stapler SureForm in Robotic Anus Preserving Surgery for Rectal Cancer
Conditions: Rectal Cancer, Robotic, Anastomotic Leak, Laparoscopic
Sex: All
Ages: 18 Years – 80 Years
Phase: NA
Enrollment: 276
Sponsor: Nanchang University
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.
Eligibility Criteria
Inclusion Criteria:The age is more than 18 years old and less than or equal to 75 years oldPathological diagnosis of rectal adenocarcinoma by colonoscopy biopsyThe distance between the tumor and the anal margin diagnosed by colonoscopy and pelvic MRI before operation is less than or equal to 15cmNo distant metastasis (including pelvic cavity, peritoneum, liver, lung, brain, bone, distant lymph node metastasis, etc.) is judged by ultrasound, CT, PET-CT, etcNo local complications before operation (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, abscess formation, no local invasion)Robot surgeryVoluntary participation and signing of informed consentExclusion Criteria:Previous history of malignant colorectal tumorsSimultaneous diagnosis of multiple primary colorectal tumorsThose who have performed abdominal and pelvic surgery for many times or have extensive abdominal adhesionsPatients with familial adenomatous polyposis, Lynch syndrome associated rectal cancer, and inflammatory bowel disease at active stageDiagnosis of other malignant tumors in recent 5 yearsASA grade ≥ IV and/or ECOG physical status score ≥ 2Patients with severe liver and kidney function, heart and lung function, blood coagulation dysfunction or combined with severe basic diseases can not tolerate surgeryPreventive ileostomyPatients undergoing combined abdominal and perineal resection
Source: ClinicalTrials.gov (NCT05667181). StuddyBuddy aggregates publicly available trial information.