The Application Value of da Vinci Linear Cutting Stapler SureForm in Robotic Anus Preserving Surgery for Rectal Cancer

NCT05667181 | Completed FDA Device

• 1 other identifier: IIT2022155
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer; Robotic; Anastomotic Leak; Laparoscopic

Outcome Measures

Primary Outcomes (1)

• Incidence of anastomotic complications

  Anastomotic leakage and anastomotic bleeding

  1 month after surgery

Secondary Outcomes (7)

• The number of stapler cartridges required for rectal transection

  1 month after surgery

• operative time

  1 month after surgery

• operative blood loss

  1 month after surgery

• Time to first flatus

  1 month after surgery

• Postoperative length of stay

  1 month after surgery

Study Arms (2)

robotic group

EXPERIMENTAL

Robot linear cutting stapler

Device: Surform

laparocaopic group

ACTIVE COMPARATOR

laparoscopic linear cutting stapler

Device: Surform

Interventions

Surform DEVICE

Da Vinci linear cutting stapler

laparocaopic group; robotic group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Preventive ileostomy
• Patients undergoing combined abdominal and perineal resection

Sponsors & Collaborators

• Nanchang University: lead

Study Sites (1)

Taiyuan li

Nanchang, Jiangxi, 330000, China

Location

MeSH Terms

Conditions

Rectal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• li taiyuan, doctor

  The First Affiliated Hospital of Nanchang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: December 28, 2022
• Study Start: December 29, 2022
• Primary Completion: November 11, 2024
• Study Completion: December 29, 2024
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)