NCT05667181Completed
The Application Value of da Vinci Linear Cutting Stapler SureForm in Robotic Anus Preserving Surgery for Rectal Cancer
The Application Value of da Vinci Linear Cutting Stapler SureForm in Robotic Anus Preserving Surgery for Rectal Cancer: a Single Center Prospective Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 28 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 276 (actual)
- First submitted
- 10 Dec 2022
- Start date
- 29 Dec 2022
- Primary completion date
- 11 Nov 2024
- Lead sponsor
- Nanchang University
- Diseases
- Colorectal cancer
- NCT number
- NCT05667181
What you commit to
- Study type: Interventional
- Participants enrolled: 276
- From 29 Dec 2022 to the primary completion date, 11 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those who have performed abdominal and pelvic surgery for many times or have extensive abdominal adhesions
- Patients undergoing combined abdominal and perineal resection
Other illness
- Previous history of malignant colorectal tumors
- 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
- Patients with severe liver and kidney function, heart and lung function, blood coagulation dysfunction or combined with severe basic diseases can not tolerate surgery
Other
- Simultaneous diagnosis of multiple primary colorectal tumors
- ASA grade ≥ IV and/or ECOG physical status score ≥ 2
- Preventive ileostomy
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Taiyuan li Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.