Esophageal Cancer PatientsNCT05600335
Short-term Outcomes of ERAS Protocol in RAME for Esophageal Cancer
An observational study of Esophageal Cancer Patients, run by West China Hospital at 1 site in China.
Trial summary
This single-center, retrospective cohort study aimed to evaluate the short-term outcomes of enhanced recovery after surgery (ERAS) protocol in perioperative robotic-assisted McKeown esophagectomy (RAME) among esophageal cancer patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Esophageal Cancer Patients
- What is being tested?
- ERAS protocol
- Type of treatment
- Surgery or procedure
- How many people
- 211 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 9 Mar 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with esophageal cancer undertaking resection by RAME were included. According to different perioperative management strategies, all eligible patients were divided into the ERAS group and conventional group.
Who may be able to join
- first detected and endoscopically confirmed esophageal cancer;
- preoperative evaluation showed no distant metastases and suitable for RAME;
- preoperative clinical stage of I to III;
Who cannot join
- patients had a history of thoracic or abdominal surgery;
- patients were IV to VI in the American Society of Anesthesiologists (ASA) physical status classification system;
- patients had other malignancies;
- patients had missing clinical data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Outcomes of Enhanced Recovery After Surgery Protocol in Robotic-assisted McKeown Esophagectomy for Esophageal Cancer
This single-center, retrospective cohort study aimed to evaluate the short-term outcomes of enhanced recovery after surgery (ERAS) protocol in perioperative robotic-assisted McKeown esophagectomy (RAME) among esophageal cancer patients.
- Conditions
- Esophageal Cancer Patients
- Being tested
- ERAS protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS protocolProcedure or surgery
Patients with esophageal cancer have undergone RAME using ERAS protocol and conventional management strategy
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Not described Receives: Procedure: ERAS protocol | |
| Conventional group | Not described Receives: Procedure: ERAS protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first flatus
time to first flatus characterized by postoperative outcome
Measured: 2019-2022
time to out-of-bed activity
time to out-of-bed activity characterized by postoperative outcome
Measured: 2019-2022
time to liquid diet
time to liquid diet characterized by postoperative outcome
Measured: 2019-2022
postoperative pain score
postoperative pain score characterized by postoperative outcome and was scored according to the numeric pain rating scale (NPRS) to assess the patient's pain on the first day after surgery.
Measured: 2019-2022
duration of analgesic pump
duration of analgesic pump characterized by postoperative outcome
Measured: 2019-2022
postoperative hospital stay
postoperative hospital stay characterized by postoperative outcome
Measured: 2019-2022
ICU length of stay
ICU length of stay characterized by postoperative outcome
Measured: 2019-2022
in-hospital mortality
in-hospital mortality characterized by postoperative outcome
Measured: 2019-2022
incidence of various postoperative complications
incidence of various postoperative complications characterized by postoperative outcome
Measured: 2019-2022
Secondary outcomes (6)
postoperative chest drainage volume
postoperative chest drainage volume characterized by postoperative outcome
Measured: 2019-2022
preoperative anesthesia time
preoperative anesthesia time characterized by intraoperative outcome
Measured: 2019-2022
operation time
operation time characterized by intraoperative outcome
Measured: 2019-2022
blood loss
blood loss characterized by intraoperative outcome
Measured: 2019-2022
conversion rate
conversion rate characterized by intraoperative outcome
Measured: 2019-2022
radicality of surgery
R0 resection was defined as > 1mm from all resection margins, R1 resection was defined as microscopic residual tumor, and R2 resection was defined as macroscopic residual tumor
Measured: 2019-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Jan 2019
- Primary completion16 Aug 2021
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Cancer PatientsStudies 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
- Retrospective
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiajun Xiong, West China Hospital
- Investigators
- Yidan Lin, MD, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600335
- Sponsor's protocol ID
- HXDB-1908
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Outcomes of Enhanced Recovery After Surgery Protocol in Robotic-assisted McKeown Esophagectomy for Esophageal Cancer
- ClinicalTrials.gov ID
- NCT05600335
- Acronym / sponsor ID
- HXDB-1908
- Conditions
- Esophageal Cancer Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 31 Oct 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 single-center, retrospective cohort study aimed to evaluate the short-term outcomes of enhanced recovery after surgery (ERAS) protocol in perioperative robotic-assisted McKeown esophagectomy (RAME) among esophageal cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS group | – | Procedure: ERAS protocol |
| Conventional group | – | Procedure: ERAS protocol |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with esophageal cancer undertaking resection by RAME were included. According to different perioperative management strategies, all eligible patients were divided into the ERAS group and conventional group.
Key inclusion criteria (3 listed)
- first detected and endoscopically confirmed esophageal cancer;
- preoperative evaluation showed no distant metastases and suitable for RAME;
- preoperative clinical stage of I to III;
Key exclusion criteria (4 listed)
- patients had a history of thoracic or abdominal surgery;
- patients were IV to VI in the American Society of Anesthesiologists (ASA) physical status classification system;
- patients had other malignancies;
- patients had missing clinical data
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 |
|---|---|---|
| ERAS protocolPatients with esophageal cancer have undergone RAME using ERAS protocol and conventional management strategy | Procedure or surgery | Conventional group, ERAS group |
Primary outcome
time to first flatus
Time frame: 2019-2022
time to first flatus characterized by postoperative outcome
time to out-of-bed activity
Time frame: 2019-2022
time to out-of-bed activity characterized by postoperative outcome
time to liquid diet
Time frame: 2019-2022
time to liquid diet characterized by postoperative outcome
postoperative pain score
Time frame: 2019-2022
postoperative pain score characterized by postoperative outcome and was scored according to the numeric pain rating scale (NPRS) to assess the patient's pain on the first day after surgery.
duration of analgesic pump
Time frame: 2019-2022
duration of analgesic pump characterized by postoperative outcome
postoperative hospital stay
Time frame: 2019-2022
postoperative hospital stay characterized by postoperative outcome
ICU length of stay
Time frame: 2019-2022
ICU length of stay characterized by postoperative outcome
in-hospital mortality
Time frame: 2019-2022
in-hospital mortality characterized by postoperative outcome
incidence of various postoperative complications
Time frame: 2019-2022
incidence of various postoperative complications characterized by postoperative outcome
6 secondary outcomes
postoperative chest drainage volume
Time frame: 2019-2022
preoperative anesthesia time
Time frame: 2019-2022
operation time
Time frame: 2019-2022
blood loss
Time frame: 2019-2022
conversion rate
Time frame: 2019-2022
radicality of surgery
Time frame: 2019-2022
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 3 Nov 2022.
- 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.
Yidan Lin, MD study director
West China 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 Esophageal Cancer Patients, 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 3 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: finished, as of the sponsor's last update on 3 Nov 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?
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?
time to first flatus (time frame: 2019-2022). The study lists 9 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 3 Nov 2022.