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The safety and efficacy of robots in colorectal surgery

An exploratory clinical study to evaluate the safety and efficacy of split-type surgical robots in colorectal surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127541
Enrollment
Unknown
Registered
2026-07-01
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with colorectal cancer surgery

Interventions

Intervention group:Surgical operations were performed using the CarinaTM split-type surgical robot.

Sponsors

Huizhou First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age: 18 to 80 years old, gender not limited; 2.Colorectal adenocarcinoma confirmed by histology or/and cytology can be treated surgically to achieve a radical cure; 3.Agree to participate in this study and voluntarily sign the informed consent form; 4.Willing to cooperate in completing the research follow-up and related examinations, with good compliance; 5.The ECOG score is 0 to 1; 6.Preoperative chest, abdominal and pelvic CT or PET-CT were used to rule out distant metastases;

Exclusion criteria

Exclusion criteria: 1.BMI=35kg/m^2; 2.Patients with severe heart, lung, brain, liver or kidney diseases who cannot tolerate surgery or anesthesia; 3.Patients who cannot tolerate pneumoperitoneum or who, based on the researcher's judgment, have a risk of extensive and severe adhesions in the abdominal cavity, making it impossible to undergo puncture to establish pneumoperitoneum; 4.Patients with severe coagulation disorders; 5.Patients with active pulmonary tuberculosis; 6.There are severe uncontrolled diseases or acute infections; Physical exhaustion, massive ascites, internal bleeding or shock; 7.Lymph node metastases of colorectal tumors fuse and surround important blood vessels; 8.Patients with a history of abdominal and pelvic surgery or radiotherapy and chemotherapy who are not suitable for laparoscopic surgery; 9.Pregnant and lactating women; 10.Patients who are participating in clinical trials of other drugs or medical devices; 11.The researchers considered patients who were not suitable to participate in this trial;

Design outcomes

Primary

MeasureTime frame
Surgical non-reoperation rate;Incidence of perioperative complications (Clavien-Dindo classification);

Secondary

MeasureTime frame
Time of robot-assisted surgery (minutes);System preparation time (minutes);Intraoperative blood loss (ml);Evaluation of the mental workload of the chief surgeon during the operation;Postoperative mortality rate;Incidence of adverse events and serious adverse events;Pain score;Postoperative hospital stay (days);Intraoperative blood transfusion rate;Incidence of adverse events and serious adverse events related to the equipment;The incidence of postoperative complications;Evaluation of the surgeon's physiological load during the operation;Equipment performance evaluation;The time of the first ventilation after surgery;

Countries

China

Contacts

Public ContactWang Xi

Huizhou First Hospital

hwangxi@126.com+86 752 2883868

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026