Colorectal NeoplasmsNCT03010813
A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery
A study testing Robotic single port surgery and NOTES in people with Colorectal Neoplasms and Urologic Neoplasms, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
This is a prospective, single center, multispecialty study that aimed to evaluate the clinical feasibility and safety of single port surgery and NOTES (mainly transanal and transoral surgery) using a novel single port robotic system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Urologic Neoplasms, Urologic Diseases
- What is being tested?
- Robotic single port surgery and NOTES
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Oct 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
GENERAL INCLUSION CRITERIA FOR ALL PROCEDURES
- Body mass index <35 kg/m2
- Suitable for minimally invasive surgery
- Willingness to participate as demonstrated by giving informed consent
GENERAL EXCLUSION CRITERIA FOR ALL PROCEDURES
- Contraindication to general anesthesia
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
- Untreated active infection
- Noncorrectable coagulopathy
- Presence of another malignancy or distant metastasis
- Emergency surgery
- Vulnerable population (e.g. mentally disabled, pregnancy)
Trial locations and contacts
1 site in 1 country.
China1 site
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
About this study
Official title: A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery: A Prospective, Single Center, Multispecialty Study
This is a prospective, single center, multispecialty study that aimed to evaluate the clinical feasibility and safety of single port surgery and NOTES (mainly transanal and transoral surgery) using a novel single port robotic system.
Read the detailed description
Background: Single port surgery and natural orifice transluminal endoscopic surgery (NOTES) are emerging minimally invasive surgery techniques which can further reduce patient trauma and enhance recovery. However, the wider adoption of these techniques is hampered by the limitation of instrumentation and technical difficulties. Robotic assistance may improve surgical capabilities during single port surgery and NOTES by providing augmented motion precision and manipulation dexterity.
Objectives: To evaluate the clinical feasibility and safety of single port surgery and NOTES (mainly transanal and transoral surgery) using a novel single port robotic system.
Design: Prospective, single center, multispecialty study consistent with a stage 1 (Innovation) study described in the Innovation, Development, Exploration, Assessment, Long-term Study (IDEAL) framework.
Subjects: Sixty consecutive patients with various benign/malignant pathologies indicated for single port colorectal/urologic surgery or transanal/transoral surgery who fulfilled all the inclusion and exclusion criteria will be recruited.
Intervention: Single port surgery and transanal/transoral surgery will be performed using the novel single port robotic system.
Study Endpoints: Primary: conversion rate and perioperative complications. Secondary: operative time, blood loss, pain scores, analgesic requirement, and length of stay.
Hypothesis: The prospective study will provide important information on the feasibility, safety, and effectiveness of the novel single port robotic system in performing single port surgery and NOTES in various surgical specialties. A positive study will provide supporting evidence for continuing development of this new technology.
- Conditions
- Colorectal Neoplasms, Urologic Neoplasms, Urologic Diseases, Nasopharyngeal Neoplasms, Oropharyngeal Neoplasms, Oral Neoplasms
- Being tested
- Robotic single port surgery and NOTES
- Medical subject headings
- Colorectal Neoplasms, Urologic Neoplasms, Urologic Diseases, Nasopharyngeal Neoplasms, Oropharyngeal Neoplasms, Mouth Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic single port surgery and NOTESProcedure or surgery
Robotic single port colorectal surgery; Robotic transanal surgery; Robotic single port urologic surgery; Transoral robotic surgery
| Study group | Role | What they receive |
|---|---|---|
| Novel single port robotic system | Experimental | A single port innovation designed to deliver an articulating 3D high definition camera and three fully articulating instruments through a single 25-mm cannula Receives: Procedure: Robotic single port surgery and NOTES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate
An emergent change in the treatment plan to conventional minimally invasive (laparoscopic/endoscopic) surgery (i.e. the use of more than one additional port), multiport robotic surgery, or to open surgery
Measured: Up to 1 month
Perioperative complications
Complications including intraoperative complications and all complications occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification
Measured: Up to 1 month
Secondary outcomes (15)
Operative time
Measured: Intraoperative
Estimated blood loss
Measured: Up to 1 month
Pain scores on a visual analog scale
Measured: Up to 1 month
Analgesic requirement
Measured: Up to 1 month
Length of hospital stay
Measured: Up to 1 month
Completeness of resection
Pathologic examination of the resected specimen for completeness of resection
Measured: Up to 1 month
Resection margins
Pathologic examination of the resected specimen for resection margins positivity
Measured: Up to 1 month
Number of lymph nodes harvested
Pathologic examination of the resected specimen (malignant cases)
Measured: Up to 1 month
Anal continence after transanal surgery
After transanal surgery; using the Cleveland Clinic Incontinence Score (Wexner's Score)
Measured: Up to 1 year
Fecal incontinence quality of life after transanal surgery
After transanal surgery; using the validated Chinese version of the Fecal Incontinence Quality of Life Scale (FIQL)
Measured: Up to 1 year
Urinary continence after radical prostatectomy
After radical prostatectomy; assessed by recording the number of pads used per day
Measured: Up to 1 year
Male sexual function after radical prostatectomy
After radical prostatectomy; using the abridged version of the International Index of Erectile Dysfunction - erectile function domain score (IIEF-EF)
Measured: Up to 1 year
Renal function after nephrectomy
After nephrectomy; using renal function blood tests for urea and creatinine
Measured: Up to 1 year
Swallowing function after transoral robotic surgery (TORS)
After TORS; using the MD Anderson Dysphagia Inventory
Measured: Up to 1 year
Voice function after TORS
After TORS; using the Voice Handicap Index (VHI) 30
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon S. M. Ng, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010813
- Sponsor's protocol ID
- CREC Ref. No.: 2016.348
- Status last verified
- Feb 2018
- First submitted
- 24 Dec 2016
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Holsinger FC, Magnuson JS, Weinstein GS, Chan JYK, Starmer HM, Tsang RKY, Wong EWY, Rassekh CH, Bedi N, Hong SSY, Orosco R, O'Malley BW Jr, Moore EJ. A Next-Generation Single-Port Robotic Surgical System for Transoral Robotic Surgery: Results From Prospective Nonrandomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2019 Nov 1;145(11):1027-1034. doi: 10.1001/jamaoto.2019.2654.
PubMed 31536129Chan JYK, Tsang RK, Holsinger FC, Tong MCF, Ng CWK, Chiu PWY, Ng SSM, Wong EWY. Prospective clinical trial to evaluate safety and feasibility of using a single port flexible robotic system for transoral head and neck surgery. Oral Oncol. 2019 Jul;94:101-105. doi: 10.1016/j.oraloncology.2019.05.018. Epub 2019 May 28.
PubMed 31178203
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery: A Prospective, Single Center, Multispecialty Study
- ClinicalTrials.gov ID
- NCT03010813
- Acronym / sponsor ID
- CREC Ref. No.: 2016.348
- Conditions
- Colorectal Neoplasms, Urologic Neoplasms, Urologic Diseases, Nasopharyngeal Neoplasms, Oropharyngeal Neoplasms, Oral Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 5 Jan 2017 (estimated)
- 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 prospective, single center, multispecialty study that aimed to evaluate the clinical feasibility and safety of single port surgery and NOTES (mainly transanal and transoral surgery) using a novel single port robotic system.
Detailed description
Background: Single port surgery and natural orifice transluminal endoscopic surgery (NOTES) are emerging minimally invasive surgery techniques which can further reduce patient trauma and enhance recovery. However, the wider adoption of these techniques is hampered by the limitation of instrumentation and technical difficulties. Robotic assistance may improve surgical capabilities during single port surgery and NOTES by providing augmented motion precision and manipulation dexterity.
Objectives: To evaluate the clinical feasibility and safety of single port surgery and NOTES (mainly transanal and transoral surgery) using a novel single port robotic system.
Design: Prospective, single center, multispecialty study consistent with a stage 1 (Innovation) study described in the Innovation, Development, Exploration, Assessment, Long-term Study (IDEAL) framework.
Subjects: Sixty consecutive patients with various benign/malignant pathologies indicated for single port colorectal/urologic surgery or transanal/transoral surgery who fulfilled all the inclusion and exclusion criteria will be recruited.
Intervention: Single port surgery and transanal/transoral surgery will be performed using the novel single port robotic system.
Study Endpoints: Primary: conversion rate and perioperative complications. Secondary: operative time, blood loss, pain scores, analgesic requirement, and length of stay.
Hypothesis: The prospective study will provide important information on the feasibility, safety, and effectiveness of the novel single port robotic system in performing single port surgery and NOTES in various surgical specialties. A positive study will provide supporting evidence for continuing development of this new technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novel single port robotic system | Experimental | Procedure: Robotic single port surgery and NOTESA single port innovation designed to deliver an articulating 3D high definition camera and three fully articulating instruments through a single 25-mm cannula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 single port surgery and NOTESRobotic single port colorectal surgery; Robotic transanal surgery; Robotic single port urologic surgery; Transoral robotic surgery | Procedure or surgery | Novel single port robotic system |
Primary outcome
Conversion rate
Time frame: Up to 1 month
An emergent change in the treatment plan to conventional minimally invasive (laparoscopic/endoscopic) surgery (i.e. the use of more than one additional port), multiport robotic surgery, or to open surgery
Perioperative complications
Time frame: Up to 1 month
Complications including intraoperative complications and all complications occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification
15 secondary outcomes
Operative time
Time frame: Intraoperative
Estimated blood loss
Time frame: Up to 1 month
Pain scores on a visual analog scale
Time frame: Up to 1 month
Analgesic requirement
Time frame: Up to 1 month
Length of hospital stay
Time frame: Up to 1 month
Completeness of resection
Time frame: Up to 1 month
Resection margins
Time frame: Up to 1 month
Number of lymph nodes harvested
Time frame: Up to 1 month
Anal continence after transanal surgery
Time frame: Up to 1 year
Fecal incontinence quality of life after transanal surgery
Time frame: Up to 1 year
Urinary continence after radical prostatectomy
Time frame: Up to 1 year
Male sexual function after radical prostatectomy
Time frame: Up to 1 year
Renal function after nephrectomy
Time frame: Up to 1 year
Swallowing function after transoral robotic surgery (TORS)
Time frame: Up to 1 year
Voice function after TORS
Time frame: Up to 1 year
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 6 Feb 2018.
- Derived from this study: PubMed 31536129Holsinger FC, Magnuson JS, Weinstein GS, Chan JYK, Starmer HM, Tsang RKY, Wong EWY, Rassekh CH, Bedi N, Hong SSY, Orosco R, O'Malley BW Jr, Moore EJ. A Next-Generation Single-Port Robotic Surgical System for Transoral Robotic Surgery: Results From Prospective Nonrandomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2019 Nov 1;145(11):1027-1034. doi: 10.1001/jamaoto.2019.2654.
- Derived from this study: PubMed 31178203Chan JYK, Tsang RK, Holsinger FC, Tong MCF, Ng CWK, Chiu PWY, Ng SSM, Wong EWY. Prospective clinical trial to evaluate safety and feasibility of using a single port flexible robotic system for transoral head and neck surgery. Oral Oncol. 2019 Jul;94:101-105. doi: 10.1016/j.oraloncology.2019.05.018. Epub 2019 May 28.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 single port surgery and NOTES in people with Colorectal Neoplasms and Urologic Neoplasms, run by Chinese University of Hong Kong 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?
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 6 Feb 2018. 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?
Conversion rate (time frame: Up to 1 month). The study lists 2 primary outcomes in all. 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 NCT03010813, which also lists 2 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 6 Feb 2018.