Colorectal CancerNCT05961969
Robotic Top-down Intersphincteric Resection
An observational study of Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The present study is to develop the novel robotic surgical technique and enhance the surgery quality for the treatment of distal rectal cancer. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Robotic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Feb 2022to Aug 2025
- Phase
- Observational
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients diagnosed as rectal cancer and met with the above inclusion and exclusion criteria will be recruited.
Who may be able to join
- cT1-3 or yT 1-3 rectal adenocarcinoma whose low border was located below the anorectal sling (4 cm from anal verge), in which the required surgery meets the definition of ISR;
- Clinically Tumor-Node-Metastasis (TNM) stage I-III rectal adenocarcinoma;
- Curative and elective surgery;
- American Society of Anesthesiology (ASA) class Ⅰ to Ⅲ patients;
- Age between 20 and 75 years.
Who cannot join
- cT4 adenocarcinoma, i.e., the rectal cancer invaded to external sphincter or adjacent pelvic organs;
- Evidence of distant metastasis;
- Primary tumor mass≧8 cm in diameter;
- Morbidly obese patients, i.e., body mass index (BMI) ≧ 40 kg/m2 ;
- Previous major surgery of low upper abdomen;
- The adenocarcinoma has invaded to lateral pelvic side wall requiring a lateral pelvic lymph node dissection. (7) Patients with poor anorectal function (Wexner incontinence Score≧ 10)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Jin-Tung LIANG
Taipei, 886
Jin-Tung LIANG, PhD, +886-9-72-651432, jintung@ntu.edu.tw
About this study
Official title: A Feasibility Study of Robotic Transabdominal Top-down Intersphincteric Resection With Double-stapling Coloanal Anastomosis for Distal Rectal Cancer
The present study is to develop the novel robotic surgical technique and enhance the surgery quality for the treatment of distal rectal cancer.
Read the detailed description
The intersphincteric resection (ISR) for the treatment of distal rectal cancer has been a complex two-step surgical procedure consisting of transabdominal mobilization of the anorectum and transanal bowel resection with handsewn coloanal anastomosis. The availability of robotic systems may facilitate the transabdominal approach, simplify the surgical procedures, and achieve better anorectal function for patients with distal rectal cancer requiring an ISR. Consecutive 40 patients with distal rectal cancer undergoing the single-step robotic transabdominal ISR with the intent-to-treat principle will be recruited. The risk factors for a failed transabdominal ISR were identified from the prospectively maintained clinicopathologic data using univariate and multivariate analysis. The surgical outcomes, the anorectal function, and the tumor recurrence were compared between patients with a successful or failed robotic transabdominal ISR. The investigators believe that the present project can facilitate the development of the novel robotic surgical technique and enhance the surgery quality for the treatment of distal rectal cancer in our hospital and even in Taiwan.
- Conditions
- Colorectal Cancer
- Being tested
- Robotic surgery
- Keywords
- Intersphincteric resection (ISR), Transabdominal ISR, Top-down ISR, Transanal ISR, Rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic surgeryProcedure or surgery
- Patients with rectal cancer.
- Patients will undergo robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection | Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis Receives: Procedure: Robotic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of transabdominal ISR
- The total mobilization and transection of anorectum was performed in the transabdominal down sequence, followed by the double-stapling technique for the coloanal anastomosis;
- the proximal and distal stapled tissue doughnuts recovered from EEA device were intact;
- A variable length of muscular cuff of proximal internal anal sphincter was removed with a TME specimen;
- To define a successful transabdominal total ISR, besides the above-mentioned three criteria, the anastomotic site should be checked by immediate anoscopy to confirm the stapling line is approximately at the level of anal intersphincteric groove.
Measured: About one week
Secondary outcomes (12)
Circumferential resection margin (CRM)
The radicality of CRM will be evaluated by a pathologist for any tumor invasion
Measured: About one week
Distal and proximal resection margin
The radicality of distal and proximal margin
Measured: About one week
Length of operation time
The duration between skin incision and wound dressing
Measured: Through the completion of surgery, an average of 5 hours
Length of postoperative ileus
One of the most common postoperative complication
Measured: 30 days
Hospitalization
The total days of stay in hospital during postoperative period
Measured: After patients' discharge from hospital, an average of 7 days
Degree of postoperative pain
The visual analogue scale
Measured: After patients' discharge from hospital, an average of 7 days
Intraoperative complications
Any adverse effect will be recorded.
Measured: Within 5 hours
The wound infection
the presence of thin discharge or local abscess in the operative wound, followed by the confirmation with Gram stains or bacterial cultures.
Measured: 30 days
Acute anastomotic leakage
The presence of clinical features of peritonitis and bowel contents in the drainage during hospitalization.
Measured: 30 days
Chronic anastomotic leakage
a defect at the anastomotic site that results in a communication with the bowel lumen.
Measured: 6 months
Questionnaire to assess disability
Standardized questionnaire was given to patients to assess disability that included the number of days until return to partial activity, full activity, and work on the basis of their subjective responses.
Measured: 6 months
Fecal incontinence
Wexner score, also known as Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) is a fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start21 Feb 2022
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin-Tung LIANG, PhD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961969
- Sponsor's protocol ID
- 202107066RINA
- Status last verified
- Sep 2024
- First submitted
- 9 Jul 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Robotic Transabdominal Top-down Intersphincteric Resection With Double-stapling Coloanal Anastomosis for Distal Rectal Cancer
- ClinicalTrials.gov ID
- NCT05961969
- Acronym / sponsor ID
- 202107066RINA
- Conditions
- Colorectal Cancer
- Keywords
- Intersphincteric resection (ISR), Transabdominal ISR, Top-down ISR, Transanal ISR, Rectal cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 27 Jul 2023 (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.
The present study is to develop the novel robotic surgical technique and enhance the surgery quality for the treatment of distal rectal cancer.
Detailed description
The intersphincteric resection (ISR) for the treatment of distal rectal cancer has been a complex two-step surgical procedure consisting of transabdominal mobilization of the anorectum and transanal bowel resection with handsewn coloanal anastomosis. The availability of robotic systems may facilitate the transabdominal approach, simplify the surgical procedures, and achieve better anorectal function for patients with distal rectal cancer requiring an ISR. Consecutive 40 patients with distal rectal cancer undergoing the single-step robotic transabdominal ISR with the intent-to-treat principle will be recruited. The risk factors for a failed transabdominal ISR were identified from the prospectively maintained clinicopathologic data using univariate and multivariate analysis. The surgical outcomes, the anorectal function, and the tumor recurrence were compared between patients with a successful or failed robotic transabdominal ISR. The investigators believe that the present project can facilitate the development of the novel robotic surgical technique and enhance the surgery quality for the treatment of distal rectal cancer in our hospital and even in Taiwan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection | – | Procedure: Robotic surgeryPatients undergoing robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients diagnosed as rectal cancer and met with the above inclusion and exclusion criteria will be recruited.
Key inclusion criteria (5 listed)
- cT1-3 or yT 1-3 rectal adenocarcinoma whose low border was located below the anorectal sling (4 cm from anal verge), in which the required surgery meets the definition of ISR;
- Clinically Tumor-Node-Metastasis (TNM) stage I-III rectal adenocarcinoma;
- Curative and elective surgery;
- American Society of Anesthesiology (ASA) class Ⅰ to Ⅲ patients;
- Age between 20 and 75 years.
Key exclusion criteria (6 listed)
- cT4 adenocarcinoma, i.e., the rectal cancer invaded to external sphincter or adjacent pelvic organs;
- Evidence of distant metastasis;
- Primary tumor mass≧8 cm in diameter;
- Morbidly obese patients, i.e., body mass index (BMI) ≧ 40 kg/m2 ;
- Previous major surgery of low upper abdomen;
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 surgery1. Patients with rectal cancer. 2. Patients will undergo robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis | Procedure or surgery | Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection |
Primary outcome
Completion of transabdominal ISR
Time frame: About one week
1. The total mobilization and transection of anorectum was performed in the transabdominal down sequence, followed by the double-stapling technique for the coloanal anastomosis; 2. the proximal and distal stapled tissue doughnuts recovered from EEA device were intact; 3. A variable length of muscular cuff of proximal internal anal sphincter was removed with a TME specimen; 4. To define a successful transabdominal total ISR, besides the above-mentioned three criteria, the anastomotic site should be checked by immediate anoscopy to confirm the stapling line is approximately at the level of anal intersphincteric groove.
12 secondary outcomes
Circumferential resection margin (CRM)
Time frame: About one week
Distal and proximal resection margin
Time frame: About one week
Length of operation time
Time frame: Through the completion of surgery, an average of 5 hours
Length of postoperative ileus
Time frame: 30 days
Hospitalization
Time frame: After patients' discharge from hospital, an average of 7 days
Degree of postoperative pain
Time frame: After patients' discharge from hospital, an average of 7 days
Intraoperative complications
Time frame: Within 5 hours
The wound infection
Time frame: 30 days
Acute anastomotic leakage
Time frame: 30 days
Chronic anastomotic leakage
Time frame: 6 months
Questionnaire to assess disability
Time frame: 6 months
Fecal incontinence
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Toripalimab Plus Cetuximab and Irinotecan for Second-Line Right-Sided RAS/BRAF Wild-Type Advanced Colon Cancer Phase II Study
Colorectal Cancer (CRC)
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
Not yet recruiting
A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.
NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer)
Not yet recruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Advanced or Metastatic Breast Cancer
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.
Jin-Tung LIANG, PhD study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 inclusion and 6 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 20 Sep 2024. 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 Taiwan. 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 Jin-Tung LIANG, PhD (+886-9-72-651432, jintung@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of transabdominal ISR (time frame: About one week). 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 20 Sep 2024.