General SurgeryNCT05486299
Clinical Study of the Safety of a Single-port Endoscopic Surgical System for General Surgery
A study testing Robotic assisted single-port general surgery in people with General Surgery, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a small-scale pre-clinical exploratory study to investigate the safety of a novel single-port robotic system for general surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- General Surgery
- What is being tested?
- Robotic assisted single-port general surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2022to Mar 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years < age ≤75 years
- Suitable for minimally invasive surgery
- 18.5≤BMI≤28 kg/m2
- ASA score is Ⅰ-Ⅲ
- Informed consent
- Colon and rectal resection: colon and rectal polyps, inflammatory bowel disease, intestinal diverticula, colorectal cancer diagnosed cT3N0M0 with a maximum diameter of ≤4 cm located above the peritoneal reflection.
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- Partial gastrectomy: gastric stromal tumor, gastric giant ulcer.
- Appendectomy: chronic appendicitis.
- Cholecystectomy: chronic cholecystitis combined with gallbladder stones, gallbladder polyps (> 1 cm).
Who cannot join
- With other malignancies or a previous history of other malignancies
- Undergone other major surgical treatment within 3 months prior to enrolment or planned during the trial
- With active tuberculosis
- With severe systemic disease
- With long-term use of anticoagulant and anti-platelet drugs (anti-platelet aggregation drugs discontinued less than 1 week prior to surgery), history of bleeding disorders or hematopoietic or coagulation disorders.
- With severe allergies and suspected or established alcohol, drug or substance addiction
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- Patients who are immunodeficiency virus (HIV) antibody positive; hepatitis B surface antigen (HbsAg) positive and have a hepatitis B virus DNA (HBV-DNA) copy number above the lower limit of detection or normal range; hepatitis C virus (HCV) antibody positive; syphilis spirochete antibody positive and at high risk of transmission as judged by the investigator.
- Emergency surgery
- Women who are pregnant, breastfeeding or planning to become pregnant during the trial
- Other conditions which, in the opinion of the investigator, make participation in this trial inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 201801
Kun Liu, MD, +8618121263082, lookiere@126.com
About this study
Official title: Clinical Study of the Safety of a Single-port Endoscopic Surgical System for General Surgery: An Exploratory Study of a Novel Robotic System
This is a small-scale pre-clinical exploratory study to investigate the safety of a novel single-port robotic system for general surgery.
Read the detailed description
Single-incision laparoscopic surgery is a surgical procedure in which multiple laparoscopic instruments are placed through a single small incision. It has the advantages of less surgical trauma, better cosmetic results and less postoperative pain compared with conventional laparoscopic surgery. However, the technical challenges and difficulties, including loss of triangulation, parallel coaxial effect, difficulty of achieving correct exposure, shared fulcrum, lack of ergonomic favorable position, etc. limited its widespread use. Robot-assisted laparoscopic surgery have significant advantages such as minimally invasive, delicate, and flexible, which can greatly expand the surgeon's surgical capabilities and effectively solve the various problems faced by traditional surgery. Therefore, robotic assisted single-port surgery is attracting increasing attention. This study is to investigate the safety of a novel single-port robotic system for general surgery.
- Conditions
- General Surgery
- Being tested
- Robotic assisted single-port general surgery
- Keywords
- robotic surgery, robotic assisted single-incision surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic assisted single-port general surgeryProcedure or surgery
Robot assisted single-port rectal resection, colectomy, partial gastrectomy, appendectomy and cholecystectomy via the single-port configuration
| Study group | Role | What they receive |
|---|---|---|
| Single-port Endoscopic Surgical System | Experimental | A novel robotic surgical system that can be configured for multi-port, single-port, or hybrid-port procedures. In the single-port configuration, a four-channel trocar shall be used. The surgical tools are steered through the curved access channels in the trocar to enter a patient's abdomen. Receives: Procedure: Robotic assisted single-port general surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate
The proportion of converted to laparotomy, laparoscopic surgery and added ≥ 2 trocars
Measured: intraoperative
Secondary outcomes (5)
Operative time
Operative time（minutes）
Measured: intraoperative
Intraoperative blood loss
Estimated blood loss（milliliters，ml）
Measured: intraoperative
Length of stay
The postoperative day when patients complied with the predefined discharge criteria（days after surgery）
Measured: 1-14 days after surgery
Early morbidity rate
morbidity rate 30 days after surgery
Measured: 30 days after surgery
Incision healing
Incision healing grade at discharge. Grade A: well healed; Grade B: incision with inflammatory reaction but no suppuration; Grade C: incision cracked and suppurating
Measured: 1-14 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start7 Mar 2022
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for General SurgeryStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Ren, Ruijin Hospital
- Investigators
- Ren Zhao, MD, PHD, Study chair, Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486299
- Sponsor's protocol ID
- RASIS-01
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grochola LF, Soll C, Zehnder A, Wyss R, Herzog P, Breitenstein S. Robot-assisted versus laparoscopic single-incision cholecystectomy: results of a randomized controlled trial. Surg Endosc. 2019 May;33(5):1482-1490. doi: 10.1007/s00464-018-6430-7. Epub 2018 Sep 14.
PubMed 30218263Lim MS, Melich G, Min BS. Robotic single-incision anterior resection for sigmoid colon cancer: access port creation and operative technique. Surg Endosc. 2013 Mar;27(3):1021. doi: 10.1007/s00464-012-2549-0. Epub 2012 Oct 10.
PubMed 23052525Guo Z, Shi Y, Song Z, Jia W, Wang S, Zhang Y, Ji X, Liu K, Zhang T, Cheng X, Zhao R. Single-incision robotic assisted surgery: a nonrandomized cohort pilot study on a novel surgical platform in colorectal surgery. Int J Surg. 2023 Nov 1;109(11):3417-3429. doi: 10.1097/JS9.0000000000000612.
PubMed 37526117
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Safety of a Single-port Endoscopic Surgical System for General Surgery: An Exploratory Study of a Novel Robotic System
- ClinicalTrials.gov ID
- NCT05486299
- Acronym / sponsor ID
- RASIS-01
- Conditions
- General Surgery
- Keywords
- robotic surgery, robotic assisted single-incision surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 3 Aug 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.
This is a small-scale pre-clinical exploratory study to investigate the safety of a novel single-port robotic system for general surgery.
Detailed description
Single-incision laparoscopic surgery is a surgical procedure in which multiple laparoscopic instruments are placed through a single small incision. It has the advantages of less surgical trauma, better cosmetic results and less postoperative pain compared with conventional laparoscopic surgery. However, the technical challenges and difficulties, including loss of triangulation, parallel coaxial effect, difficulty of achieving correct exposure, shared fulcrum, lack of ergonomic favorable position, etc. limited its widespread use. Robot-assisted laparoscopic surgery have significant advantages such as minimally invasive, delicate, and flexible, which can greatly expand the surgeon's surgical capabilities and effectively solve the various problems faced by traditional surgery. Therefore, robotic assisted single-port surgery is attracting increasing attention. This study is to investigate the safety of a novel single-port robotic system for general surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-port Endoscopic Surgical System | Experimental | Procedure: Robotic assisted single-port general surgeryA novel robotic surgical system that can be configured for multi-port, single-port, or hybrid-port procedures. In the single-port configuration, a four-channel trocar shall be used. The surgical tools are steered through the curved access channels in the trocar to enter a patient's abdomen. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years < age ≤75 years
- Suitable for minimally invasive surgery
- 18.5≤BMI≤28 kg/m2
- ASA score is Ⅰ-Ⅲ
- Informed consent
Key exclusion criteria (10 listed)
- With other malignancies or a previous history of other malignancies
- Undergone other major surgical treatment within 3 months prior to enrolment or planned during the trial
- With active tuberculosis
- With severe systemic disease
- With long-term use of anticoagulant and anti-platelet drugs (anti-platelet aggregation drugs discontinued less than 1 week prior to surgery), history of bleeding disorders or hematopoietic or coagulation disorders.
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 |
|---|---|---|
| Robotic assisted single-port general surgeryRobot assisted single-port rectal resection, colectomy, partial gastrectomy, appendectomy and cholecystectomy via the single-port configuration | Procedure or surgery | Single-port Endoscopic Surgical System |
Primary outcome
Conversion rate
Time frame: intraoperative
The proportion of converted to laparotomy, laparoscopic surgery and added ≥ 2 trocars
5 secondary outcomes
Operative time
Time frame: intraoperative
Intraoperative blood loss
Time frame: intraoperative
Length of stay
Time frame: 1-14 days after surgery
Early morbidity rate
Time frame: 30 days after surgery
Incision healing
Time frame: 1-14 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Background: PubMed 30218263Grochola LF, Soll C, Zehnder A, Wyss R, Herzog P, Breitenstein S. Robot-assisted versus laparoscopic single-incision cholecystectomy: results of a randomized controlled trial. Surg Endosc. 2019 May;33(5):1482-1490. doi: 10.1007/s00464-018-6430-7. Epub 2018 Sep 14.
- Background: PubMed 23052525Lim MS, Melich G, Min BS. Robotic single-incision anterior resection for sigmoid colon cancer: access port creation and operative technique. Surg Endosc. 2013 Mar;27(3):1021. doi: 10.1007/s00464-012-2549-0. Epub 2012 Oct 10.
- Derived from this study: PubMed 37526117Guo Z, Shi Y, Song Z, Jia W, Wang S, Zhang Y, Ji X, Liu K, Zhang T, Cheng X, Zhao R. Single-incision robotic assisted surgery: a nonrandomized cohort pilot study on a novel surgical platform in colorectal surgery. Int J Surg. 2023 Nov 1;109(11):3417-3429. doi: 10.1097/JS9.0000000000000612.
- 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.
Ren Zhao, MD, PHD study chair
Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic assisted single-port general surgery in people with General Surgery, run by Ruijin Hospital 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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 5 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ren Zhao, MD, PHD (+8618917762018, zhaorensurgeon@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion rate (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05486299, which also lists 3 linked publications.
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 5 Aug 2022.