Rectum CancerNCT05245565
Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer
An observational study of Rectum Cancer and Stoma Colostomy, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
RATIONALE: Colorectal cancer is one of the most common cancers. However, approaches to minimize surgical trauma, preserve anal function, avoid abdominal stoma, and improve quality of life for patients with ultralow rectal cancers were limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectum Cancer, Stoma Colostomy, Faecal Incontinence
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 May 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our study population is the patients who diagnosed as low-lying rectal adenocarcinoma cases by preoperative pathology and meet the eligibility criteria.
Who may be able to join
- Histological proof of newly diagnosed primary adenocarcinoma of the rectum
- The lower edge of tumor < 3 cm from the dentate line
- Clinical T stage ≤ T3
Who cannot join
- The lower edge of tumor < 1 cm from the dentate line
- Locally advanced stage of tumor
- Presence of metastatic disease or recurrent rectal tumor
- Concomitant malignancies
- Concurrent uncontrolled medical conditions
- Impaired anal function before surgery
- Presence of acute bowel obstruction or bowel perforation caused by cancer
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Cheng-Le Zhuang, MD, PhD, zhuangchengle@tongji.edu.cn
Cheng-Le Zhuang, MD, PhD
About this study
Official title: Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer: A Multicenter Prospective Cohort Study
RATIONALE: Colorectal cancer is one of the most common cancers. However, approaches to minimize surgical trauma, preserve anal function, avoid abdominal stoma, and improve quality of life for patients with ultralow rectal cancers were limited. Thus, new technologies are urgently needed to improve the anal preservation rate, reduce the incidence of anastomotic leakage and improve postoperative anal function in patients with ultralow rectal cancer.
PURPOSE: This one-arm multicenter prospective cohort study aims to collect the data of patients with ultralow rectal cancer who undergo sphincter-preserving surgeries, including modified PPS and conventional surgeries, then compare the effects of different operations on clinical outcomes and to see the efficacy and safety of modified PPS surgery when compared with conventional procedures in the treatment of ultralow rectal cancer.
- Medical subject headings
- Rectal Neoplasms, Encopresis, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PPS surgery | Patients who undergo modified PPS surgery in order to preserve anal sphincter function under the premise of radical resection of ultralow rectal cancer. | |
| Conventional | Patients who undergo conventional sphincter-preserving surgeries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of temporary defunctioning stoma
The percentage of patients who get temporary defunctioning stoma to limit the consequences of anastomotic leakage.
Measured: Within 30 days after operation
The percentage of patients who develop anastomotic leakage
The percentage of patients who develop anastomotic leakage
Measured: Within 30 days after operation
Postoperative anal function assessed by Wexner scale
Ranging from 0 (perfect continence) to 20 (complete incontinence)
Measured: 2 years since the start of treatment
Postoperative anal function assessed by Vaizey scale
Ranging from 0 (perfect continence) to 24 (complete incontinence)
Measured: 2 years since the start of treatment
Secondary outcomes (7)
Rate of sphincter-preservation rates
The percentage of patients who preserve the anatomical structure of the anus
Measured: Within 30 days after operation
The number of short-term postoperative complications
The number of grade II and higher postoperative complications according to the Clavien-Dindo classification
Measured: Within 30 days after operation
Postoperative hospital stay
The time between the operation date and the discharge date.
Measured: Within 30 days after operation
Hospitalization costs
The total cost of hospitalization
Measured: Within 30 days after operation
30-Day Readmission Rate
Percentage of readmitted patients within 30 days after operation
Measured: Within 30 days after operation
Disease-free survival
Disease-free survival is defined as the time from surgery to recurrence of tumor or death
Measured: Up to 5 years after the last patient recruited
Overall survival
Overall survival is defined as the time from surgery until death from any cause.
Measured: Up to 5 years after the last patient recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 May 2021
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectum 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Feng-Min, Shanghai 10th People's Hospital
- Investigators
- Cheng-Le Zhuang, MD, PhD, Study chair, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245565
- Sponsor's protocol ID
- SHSY-IEC-4.1/21-311/01
- Status last verified
- Apr 2023
- First submitted
- 28 Jan 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer: A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05245565
- Acronym / sponsor ID
- SHSY-IEC-4.1/21-311/01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 18 Feb 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.
RATIONALE: Colorectal cancer is one of the most common cancers. However, approaches to minimize surgical trauma, preserve anal function, avoid abdominal stoma, and improve quality of life for patients with ultralow rectal cancers were limited. Thus, new technologies are urgently needed to improve the anal preservation rate, reduce the incidence of anastomotic leakage and improve postoperative anal function in patients with ultralow rectal cancer.
PURPOSE: This one-arm multicenter prospective cohort study aims to collect the data of patients with ultralow rectal cancer who undergo sphincter-preserving surgeries, including modified PPS and conventional surgeries, then compare the effects of different operations on clinical outcomes and to see the efficacy and safety of modified PPS surgery when compared with conventional procedures in the treatment of ultralow rectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPS surgery | – | –Patients who undergo modified PPS surgery in order to preserve anal sphincter function under the premise of radical resection of ultralow rectal cancer. |
| Conventional | – | –Patients who undergo conventional sphincter-preserving surgeries. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our study population is the patients who diagnosed as low-lying rectal adenocarcinoma cases by preoperative pathology and meet the eligibility criteria.
Key inclusion criteria (3 listed)
- Histological proof of newly diagnosed primary adenocarcinoma of the rectum
- The lower edge of tumor < 3 cm from the dentate line
- Clinical T stage ≤ T3
Key exclusion criteria (8 listed)
- The lower edge of tumor < 1 cm from the dentate line
- Locally advanced stage of tumor
- Presence of metastatic disease or recurrent rectal tumor
- Concomitant malignancies
- Concurrent uncontrolled medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of temporary defunctioning stoma
Time frame: Within 30 days after operation
The percentage of patients who get temporary defunctioning stoma to limit the consequences of anastomotic leakage.
The percentage of patients who develop anastomotic leakage
Time frame: Within 30 days after operation
The percentage of patients who develop anastomotic leakage
Postoperative anal function assessed by Wexner scale
Time frame: 2 years since the start of treatment
Ranging from 0 (perfect continence) to 20 (complete incontinence)
Postoperative anal function assessed by Vaizey scale
Time frame: 2 years since the start of treatment
Ranging from 0 (perfect continence) to 24 (complete incontinence)
7 secondary outcomes
Rate of sphincter-preservation rates
Time frame: Within 30 days after operation
The number of short-term postoperative complications
Time frame: Within 30 days after operation
Postoperative hospital stay
Time frame: Within 30 days after operation
Hospitalization costs
Time frame: Within 30 days after operation
30-Day Readmission Rate
Time frame: Within 30 days after operation
Disease-free survival
Time frame: Up to 5 years after the last patient recruited
Overall survival
Time frame: Up to 5 years after the last patient recruited
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
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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.
Cheng-Le Zhuang, MD, PhD study chair
Shanghai 10th People's 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 Rectum Cancer and Stoma Colostomy, run by Shanghai 10th People's 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 3 inclusion and 8 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 13 Apr 2023. 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 Cheng-Le Zhuang, MD, PhD (+86-19921618250, zhuangchengle@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of temporary defunctioning stoma (time frame: Within 30 days after operation). The study lists 4 primary outcomes in all. 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 13 Apr 2023.