Colorectal CancerNCT04646915
Evaluation of Short-term Outcomes of Day Surgery for Patients With CuRC
An observational study of Colorectal Cancer, run by West China Hospital at 1 site in China.
Trial summary
To evaluate the feasibility and safety of laparoscopic colectomy and anterior resection for patients with colon/upper rectal cancer (CuRC) in day surgery center. Patients with colon or upper rectal cancer who meet the standards of day surgery will be enrolled, and laparoscopic radical resection of tumor will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Day surgery
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2019to 28 Feb 2022
- How long will I take part?
- 3 Months
- 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: Patients with CuRC undergoning laparoscopic radical colectomy or anterior resection in day surgery center.
Who may be able to join
- Patients under 65 years old with colorectal cancer or patients older than 65 years assessed by anesthesiologist that their physical conditions were excellent;
- Tumor located higher than 10cm by colonoscopy, and It is expected that the distal resection margin is above the peritoneal reflexes;
- Tumor location was diagnosed clearly by abdominal CT, no severe local invasion required extensive resection, and no intraoperative colonoscopy was needed to determine the tumor site;
- No distant metastasis assessed by preoperative imaging examination ；
- There was no special abnormality in blood routine, blood biochemistry, blood coagulation, electrocardiogram and pulmonary function, and anesthesiologist assessed that the patient was safe for day surgery
Who cannot join
- Patients with distant metastasis
- Patients with ASA grade >Ⅲ and high risk in perioperative period are expected
- Tumor was too small to clearly showed by abdominal CT, and Intraoperative colonoscopy is needed.
- Patients who need neoadjuvant therapy (preoperative chemoradiotherapy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Short-term Outcomes of Laparoscopic Radical Resection for Patients With Colon and Upper Rectum in Day Surgery Center
To evaluate the feasibility and safety of laparoscopic colectomy and anterior resection for patients with colon/upper rectal cancer (CuRC) in day surgery center. Patients with colon or upper rectal cancer who meet the standards of day surgery will be enrolled, and laparoscopic radical resection of tumor will be performed in day surgery center. Perioperative outcomes of these patients and reasons for transferring to inpatient ward will be recorded prospectively.
Read the detailed description
At present, with the development of laparoscopic surgery and the application of rapid rehabilitation, colorectal surgery has made great progress . At the same time, the application of evidence-based surgery and multimodal anesthesia in postoperative rehabilitation has accelerated the postoperative recovery. Moreover, several previous studies have shown that the implementation of ambulatory colorectal surgery can reduce the incidence of postoperative complications and shorten hospital stay. With the continuous development of rehabilitation surgery, the hospitalization time of colorectal surgery has been gradually shortened. In addition, studies had preliminarily proved the feasibility, safety and repeatability of outpatient colectomy and showed that 30% of patients with elective colectomy can be completed in outpatient department.
Therefore, the investigators designed the clinical pathway of day surgery for patients screened by outpatient department, so that these patients can complete laparoscopic radical resection of colon cancer or high rectal cancer in the day surgery center.
The aim of this study is to evaluate the feasibility and safety of day surgery center for patients with colon/upper rectal cancer (CuRC). Patients meet the inclusion criteria and exclusion criteria will be assigned to day surgery center to perform radically laparoscopic colectomy or anterior resection. Outcomes of interests including incidence of transfer to inpatient ward, readmission, perioperative adverse events will be recorded prospectively.
- Conditions
- Colorectal Cancer
- Being tested
- Day surgery
- Keywords
- day surgery, laparoscopic colectomy, laparoscopic anterior resection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day surgeryOther
Patients with CuRC who meet the standards will be assigned to day surgery center for surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with CuRC undergoing day surgery | Patients with CuRC undergoing laparoscopic colectomy or anterior resection in day surgery center. Receives: Other: Day surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of transfer to inpatient ward
The incidence of patients who did not transfer to community hospital according to the plan after operation, and the causes of this situation.
Measured: one month after operation
Secondary outcomes (7)
operation duration time
From the beginning of the skin incision to the end of the last incision was From the beginning of the skin incision to the end of the suture of last incision
Measured: during the operation
Blood loss
intraoperative blood loss
Measured: during the operation
Postoperative complications
including incision infection，anastomotic leakage，respiratory infection, postoperative bleeding, and so on.
Measured: 3 months after the surgery
Length of Hospital stay (LOS)
Time from admission to discharge
Measured: 3 months after admission
Costs of hospital expense
Expense for disease treatment during hospitalization
Measured: 3 months after admission
Readmission rate
The proportion of patients who are re-hospitalized for postoperative adverse events within 90 days after discharge in all subjects.
Measured: 90 days after surgery
Mortality
Death rate within 90 days after surgery in all patients after operation
Measured: 90 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 posted30 Nov 2020
- Study start15 Dec 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion28 Feb 2022 (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 West China 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
- 120 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziqiang Wang,MD, West China Hospital
- Investigators
- Ziqiang Wang, Study chair, Department of Gastrointestinal Surgery, West China Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646915
- Sponsor's protocol ID
- DS-CuRC-2020
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Short-term Outcomes of Laparoscopic Radical Resection for Patients With Colon and Upper Rectum in Day Surgery Center
- ClinicalTrials.gov ID
- NCT04646915
- Acronym / sponsor ID
- DS-CuRC-2020
- Conditions
- Colorectal Cancer
- Keywords
- day surgery, laparoscopic colectomy, laparoscopic anterior resection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 30 Nov 2020 (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.
To evaluate the feasibility and safety of laparoscopic colectomy and anterior resection for patients with colon/upper rectal cancer (CuRC) in day surgery center. Patients with colon or upper rectal cancer who meet the standards of day surgery will be enrolled, and laparoscopic radical resection of tumor will be performed in day surgery center. Perioperative outcomes of these patients and reasons for transferring to inpatient ward will be recorded prospectively.
Detailed description
At present, with the development of laparoscopic surgery and the application of rapid rehabilitation, colorectal surgery has made great progress . At the same time, the application of evidence-based surgery and multimodal anesthesia in postoperative rehabilitation has accelerated the postoperative recovery. Moreover, several previous studies have shown that the implementation of ambulatory colorectal surgery can reduce the incidence of postoperative complications and shorten hospital stay. With the continuous development of rehabilitation surgery, the hospitalization time of colorectal surgery has been gradually shortened. In addition, studies had preliminarily proved the feasibility, safety and repeatability of outpatient colectomy and showed that 30% of patients with elective colectomy can be completed in outpatient department.
Therefore, the investigators designed the clinical pathway of day surgery for patients screened by outpatient department, so that these patients can complete laparoscopic radical resection of colon cancer or high rectal cancer in the day surgery center.
The aim of this study is to evaluate the feasibility and safety of day surgery center for patients with colon/upper rectal cancer (CuRC). Patients meet the inclusion criteria and exclusion criteria will be assigned to day surgery center to perform radically laparoscopic colectomy or anterior resection. Outcomes of interests including incidence of transfer to inpatient ward, readmission, perioperative adverse events will be recorded prospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with CuRC undergoing day surgery | – | Other: Day surgeryPatients with CuRC undergoing laparoscopic colectomy or anterior resection in day surgery center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CuRC undergoning laparoscopic radical colectomy or anterior resection in day surgery center.
Key inclusion criteria (5 listed)
- Patients under 65 years old with colorectal cancer or patients older than 65 years assessed by anesthesiologist that their physical conditions were excellent;
- Tumor located higher than 10cm by colonoscopy, and It is expected that the distal resection margin is above the peritoneal reflexes;
- Tumor location was diagnosed clearly by abdominal CT, no severe local invasion required extensive resection, and no intraoperative colonoscopy was needed to determine the tumor site;
- No distant metastasis assessed by preoperative imaging examination ；
- There was no special abnormality in blood routine, blood biochemistry, blood coagulation, electrocardiogram and pulmonary function, and anesthesiologist assessed that the patient was safe for day surgery
Key exclusion criteria (4 listed)
- Patients with distant metastasis
- Patients with ASA grade >Ⅲ and high risk in perioperative period are expected
- Tumor was too small to clearly showed by abdominal CT, and Intraoperative colonoscopy is needed.
- Patients who need neoadjuvant therapy (preoperative chemoradiotherapy)
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 |
|---|---|---|
| Day surgeryPatients with CuRC who meet the standards will be assigned to day surgery center for surgery | Other | Patients with CuRC undergoing day surgery |
Primary outcome
Incidence of transfer to inpatient ward
Time frame: one month after operation
The incidence of patients who did not transfer to community hospital according to the plan after operation, and the causes of this situation.
7 secondary outcomes
operation duration time
Time frame: during the operation
Blood loss
Time frame: during the operation
Postoperative complications
Time frame: 3 months after the surgery
Length of Hospital stay (LOS)
Time frame: 3 months after admission
Costs of hospital expense
Time frame: 3 months after admission
Readmission rate
Time frame: 90 days after surgery
Mortality
Time frame: 90 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 30 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
Ziqiang Wang study chair
Department of Gastrointestinal Surgery, West China Hospital, Sichuan University
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 West China 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 5 inclusion and 4 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 30 Nov 2020. 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?
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 transfer to inpatient ward (time frame: one month after operation). 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 30 Nov 2020.