Rectal CancerNCT05667181
The Application Value of da Vinci Linear Cutting Stapler SureForm in Robotic Anus Preserving Surgery for Rectal Cancer
A study testing Surform in people with Rectal Cancer and Robotic, run by Nanchang University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer, Robotic, Anastomotic Leak
- What is being tested?
- Surform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2022to 29 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Anastomotic complications are serious complications after anus preserving surgery for rectal cancer, including anastomotic leakage, anastomotic bleeding, and anastomotic stenosis, with a incidence rate of 1.6% - 20.5% . The occurrence of anastomotic complications increases the perioperative mortality, hospital stay, and hospital costs of patients, and even some patients with severe anastomotic complications need to be re operated after surgery, which seriously affects the quality of life of patients. More research shows that , The complications of anastomotic stoma lead to the delay of postoperative adjuvant therapy, which increases the local recurrence rate of tumor. Therefore, how to reduce the occurrence of anastomotic complications in anus preserving surgery for rectal cancer has always been the focus of surgeons.
A variety of factors are involved in the occurrence of anastomotic complications after surgery, including gender, patient's general condition, tumor size and distance from anal margin, and instrument anastomosis technology . It is believed that , when using a closer to break the rectum during radical resection of rectal cancer, the use of multiple nail cages will increase the incidence of postoperative anastomotic complications. In the past, laparoscopic rectal cutting staplers were used in robotic radical resection of rectal cancer, and most of them were completed with the cooperation of assistants. In difficult cases, the mechanical arm needed to be removed and the main knife was used to perform rectal resection. In addition, the laparoscopic linear cutting closure device was cumbersome and complicated, and it often needed to use multiple nail silos to cut rectum in a narrow pelvic cavity, resulting in uneven anastomosis quality, Increase the occurrence of anastomotic complications. In recent years, the robot company has developed a new software driven robot assisted stapler (SureForm). The stapler can be directly loaded onto the mechanical arm. When the rectum is broken, the main knife can independently control it on the console. It has a joint head that rotates 60 ° from top to bottom, left to right, a 120 ° cone range of motion, and a 540 ° wrist joint design of the rod body, so that the stapler jaws can be vertically placed and separated from the rectum, The utility model can reduce the use of the nail bin when the rectum is transected, thereby reducing the incidence of postoperative anastomotic complications.
At present, only a few foreign studies have reported the application of robot linear cutting stapler SureForm in anus preserving surgery for rectal cancer, and the studies are retrospective, with a small sample size. There is no report in China. Therefore, this study adopts a prospective randomized controlled study method 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, so as to provide a reference for the application of robotic linear cutting stapler SureForm in robotic anus preserving surgery.
- Conditions
- Rectal Cancer, Robotic, Anastomotic Leak, Laparoscopic
- Being tested
- Surform
- Medical subject headings
- Rectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurformDevice
Da Vinci linear cutting stapler
| Study group | Role | What they receive |
|---|---|---|
| robotic group | Experimental | Robot linear cutting stapler Receives: Device: Surform |
| laparocaopic group | Active comparator | laparoscopic linear cutting stapler Receives: Device: Surform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of anastomotic complications
Anastomotic leakage and anastomotic bleeding
Measured: 1 month after surgery
Secondary outcomes (7)
The number of stapler cartridges required for rectal transection
number per each surgery
Measured: 1 month after surgery
operative time
minute
Measured: 1 month after surgery
operative blood loss
milliliter
Measured: 1 month after surgery
Time to first flatus
days
Measured: 1 month after surgery
Postoperative length of stay
days
Measured: 1 month after surgery
Distal resection margin
centimeter
Measured: 1 month after surgery
proximal resection margin
centimeter
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start29 Dec 2022
- Primary completion11 Nov 2024
- Study completion29 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taiyuan Li, Nanchang University
- Investigators
- li taiyuan, doctor, Study chair, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667181
- Sponsor's protocol ID
- IIT2022155
- Status last verified
- May 2025
- First submitted
- 10 Dec 2022
- Last updated
- 28 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05667181
- Acronym / sponsor ID
- IIT2022155
- Conditions
- Rectal Cancer, Robotic, Anastomotic Leak, Laparoscopic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Nanchang UniversityUniversity, hospital or other
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 29 Dec 2024 (actual)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Anastomotic complications are serious complications after anus preserving surgery for rectal cancer, including anastomotic leakage, anastomotic bleeding, and anastomotic stenosis, with a incidence rate of 1.6% - 20.5% . The occurrence of anastomotic complications increases the perioperative mortality, hospital stay, and hospital costs of patients, and even some patients with severe anastomotic complications need to be re operated after surgery, which seriously affects the quality of life of patients. More research shows that , The complications of anastomotic stoma lead to the delay of postoperative adjuvant therapy, which increases the local recurrence rate of tumor. Therefore, how to reduce the occurrence of anastomotic complications in anus preserving surgery for rectal cancer has always been the focus of surgeons.
A variety of factors are involved in the occurrence of anastomotic complications after surgery, including gender, patient's general condition, tumor size and distance from anal margin, and instrument anastomosis technology . It is believed that , when using a closer to break the rectum during radical resection of rectal cancer, the use of multiple nail cages will increase the incidence of postoperative anastomotic complications. In the past, laparoscopic rectal cutting staplers were used in robotic radical resection of rectal cancer, and most of them were completed with the cooperation of assistants. In difficult cases, the mechanical arm needed to be removed and the main knife was used to perform rectal resection. In addition, the laparoscopic linear cutting closure device was cumbersome and complicated, and it often needed to use multiple nail silos to cut rectum in a narrow pelvic cavity, resulting in uneven anastomosis quality, Increase the occurrence of anastomotic complications. In recent years, the robot company has developed a new software driven robot assisted stapler (SureForm). The stapler can be directly loaded onto the mechanical arm. When the rectum is broken, the main knife can independently control it on the console. It has a joint head that rotates 60 ° from top to bottom, left to right, a 120 ° cone range of motion, and a 540 ° wrist joint design of the rod body, so that the stapler jaws can be vertically placed and separated from the rectum, The utility model can reduce the use of the nail bin when the rectum is transected, thereby reducing the incidence of postoperative anastomotic complications.
At present, only a few foreign studies have reported the application of robot linear cutting stapler SureForm in anus preserving surgery for rectal cancer, and the studies are retrospective, with a small sample size. There is no report in China. Therefore, this study adopts a prospective randomized controlled study method 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, so as to provide a reference for the application of robotic linear cutting stapler SureForm in robotic anus preserving surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robotic group | Experimental | Device: SurformRobot linear cutting stapler |
| laparocaopic group | Active comparator | Device: Surformlaparoscopic linear cutting stapler |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurformDa Vinci linear cutting stapler | Device | laparocaopic group, robotic group |
Primary outcome
Incidence of anastomotic complications
Time frame: 1 month after surgery
Anastomotic leakage and anastomotic bleeding
7 secondary outcomes
The number of stapler cartridges required for rectal transection
Time frame: 1 month after surgery
operative time
Time frame: 1 month after surgery
operative blood loss
Time frame: 1 month after surgery
Time to first flatus
Time frame: 1 month after surgery
Postoperative length of stay
Time frame: 1 month after surgery
Distal resection margin
Time frame: 1 month after surgery
proximal resection margin
Time frame: 1 month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
li taiyuan, doctor study chair
The First Affiliated Hospital of Nanchang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surform in people with Rectal Cancer and Robotic, run by Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of anastomotic complications (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.