Postoperative ComplicationsNCT02728973
ERAS Protocol on the Incidence of Postoperative Complications Following Intestinal Surgery
An observational study of Postoperative Complications, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
Enhanced recovery after surgery (ERAS) was first proposed by Kehlet in Copenhagen Denmark, this is a new concept for the integration of the latest study of the surgical, anesthesia, and nursing. The purpose of optimization measures, reduce patient trauma stress, promote early rehabilitation of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- ERAS program
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Mar 2017
- 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 receive elective laparotomy or laparoscopic intestinal surgery
Who may be able to join
- Elective laparotomy or laparoscopic intestinal surgery.
- Age ≥ 18 years old.
- ASA grade II - IV.
- General anesthesia.
Who cannot join
- Patients with cognitive dysfunction and uncooperative subjects.
- Failure to obtain informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first Affiliated Hospital of Chongqing Medical University
Chongqing
Juying Jin, Doctor
About this study
Official title: Effects of Enhanced Recovery After Surgery (ERAS) Protocol on the Incidence of Postoperative Complications Following Intestinal Surgery
Enhanced recovery after surgery (ERAS) was first proposed by Kehlet in Copenhagen Denmark, this is a new concept for the integration of the latest study of the surgical, anesthesia, and nursing. The purpose of optimization measures, reduce patient trauma stress, promote early rehabilitation of patients. The investigators plan to compare the feasibility, clinical effectiveness, and cost savings of an ERAS program with traditional treatment program at a major teaching hospital in China.The investigators will apply ERAS plan or traditional treatment regimens in the treatment of 100 cases of colorectal cancer patients, respectively. And data Compare the two programs about the incidence of postoperative complications, postoperative hospital stay, cost of hospitalization, and readmission rate will be collected.
Read the detailed description
Major colorectal surgery usually requires a hospital stay of more than 12 days. Inadequate pain management, intestinal dysfunction and immobilisation are the main factors associated with delay in recovery. This study aims to assess the short and medium term results achieved by an enhanced recovery program based on previously published protocols. This prospective study will be performed at a major hospital in China, involved 200 patients. All patients underwent elective colorectal resection for cancer are divided into enhanced recovery program group or conventional treatment group. The main elements of this program were: preoperative advice, no colon preparation, provision of carbohydrate-rich drinks one day prior and on the morning of surgery, goal directed fluid administration, body temperature control during surgery, avoiding drainages and nasogastric tubes, early mobilization, and the taking of oral fluids in the early postoperative period. Perioperative morbidity and mortality data will be collected and the length of hospital stay and protocol compliance recorded.
- Conditions
- Postoperative Complications
- Being tested
- ERAS program
- Keywords
- colorectal resection, enhanced recovery after surgery, Postoperative Complications, length of hospital stay
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS programOther
The main elements of this program were: preoperative advice, no colon preparation, provision of carbohydrate-rich drinks one day prior and on the morning of surgery, goal directed fluid administration, body temperature control during surgery, avoiding drainages and nasogastric tubes, early mobilization, and the taking of oral fluids in the early postoperative period.
| Study group | Role | What they receive |
|---|---|---|
| ERAS program | The main elements of this program were: preoperative advice, no colon preparation, provision of carbohydrate-rich drinks one day prior and on the morning of surgery, goal directed fluid administration, body temperature control during surgery, avoiding drainages and nasogastric tubes, early mobilization, and the taking of oral fluids in the early postoperative period. Receives: Other: ERAS program | |
| conventional treatment program | conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in postoperative morbidity rate
Measured: within postoperative 30 days
Secondary outcomes (2)
length of hospital stay
Measured: within postoperative 30 days
mortality
Measured: within postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Su, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Su Min, MD, Study chair, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728973
- Sponsor's protocol ID
- ERASCQ2016
- Status last verified
- Mar 2016
- First submitted
- 27 Mar 2016
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Peng LH, Min S, Jin JY, Wang WJ. Stratified pain management counseling and implementation improving patient satisfaction: a prospective, pilot study. Chin Med J (Engl). 2019 Dec 5;132(23):2812-2819. doi: 10.1097/CM9.0000000000000540.
PubMed 31856052
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Enhanced Recovery After Surgery (ERAS) Protocol on the Incidence of Postoperative Complications Following Intestinal Surgery
- ClinicalTrials.gov ID
- NCT02728973
- Acronym / sponsor ID
- ERASCQ2016
- Conditions
- Postoperative Complications
- Keywords
- colorectal resection, enhanced recovery after surgery, Postoperative Complications, length of hospital stay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 6 Apr 2016 (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.
Enhanced recovery after surgery (ERAS) was first proposed by Kehlet in Copenhagen Denmark, this is a new concept for the integration of the latest study of the surgical, anesthesia, and nursing. The purpose of optimization measures, reduce patient trauma stress, promote early rehabilitation of patients. The investigators plan to compare the feasibility, clinical effectiveness, and cost savings of an ERAS program with traditional treatment program at a major teaching hospital in China.The investigators will apply ERAS plan or traditional treatment regimens in the treatment of 100 cases of colorectal cancer patients, respectively. And data Compare the two programs about the incidence of postoperative complications, postoperative hospital stay, cost of hospitalization, and readmission rate will be collected.
Detailed description
Major colorectal surgery usually requires a hospital stay of more than 12 days. Inadequate pain management, intestinal dysfunction and immobilisation are the main factors associated with delay in recovery. This study aims to assess the short and medium term results achieved by an enhanced recovery program based on previously published protocols. This prospective study will be performed at a major hospital in China, involved 200 patients. All patients underwent elective colorectal resection for cancer are divided into enhanced recovery program group or conventional treatment group. The main elements of this program were: preoperative advice, no colon preparation, provision of carbohydrate-rich drinks one day prior and on the morning of surgery, goal directed fluid administration, body temperature control during surgery, avoiding drainages and nasogastric tubes, early mobilization, and the taking of oral fluids in the early postoperative period. Perioperative morbidity and mortality data will be collected and the length of hospital stay and protocol compliance recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS program | – | Other: ERAS programThe main elements of this program were: preoperative advice, no colon preparation, provision of carbohydrate-rich drinks one day prior and on the morning of surgery, goal directed fluid administration, body temperature control during surgery, avoiding drainages and nasogastric tubes, early mobilization, and the taking of oral fluids in the early postoperative period. |
| conventional treatment program | – | –conventional treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receive elective laparotomy or laparoscopic intestinal surgery
Key inclusion criteria (4 listed)
- Elective laparotomy or laparoscopic intestinal surgery.
- Age ≥ 18 years old.
- ASA grade II - IV.
- General anesthesia.
Key exclusion criteria (2 listed)
- Patients with cognitive dysfunction and uncooperative subjects.
- Failure to obtain informed consent
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 programThe main elements of this program were: preoperative advice, no colon preparation, provision of carbohydrate-rich drinks one day prior and on the morning of surgery, goal directed fluid administration, body temperature control during surgery, avoiding drainages and nasogastric tubes, early mobilization, and the taking of oral fluids in the early postoperative period. | Other | ERAS program |
Primary outcome
The difference in postoperative morbidity rate
Time frame: within postoperative 30 days
2 secondary outcomes
length of hospital stay
Time frame: within postoperative 30 days
mortality
Time frame: within postoperative 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Derived from this study: PubMed 31856052Peng LH, Min S, Jin JY, Wang WJ. Stratified pain management counseling and implementation improving patient satisfaction: a prospective, pilot study. Chin Med J (Engl). 2019 Dec 5;132(23):2812-2819. doi: 10.1097/CM9.0000000000000540.
- 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.
Su Min, MD study chair
First Affiliated Hospital of Chongqing Medical 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 Postoperative Complications, run by First Affiliated Hospital of Chongqing Medical University 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 4 inclusion and 2 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 6 Apr 2016. 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 Juying Jin, doctor (+89-13527486171, juyingjin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in postoperative morbidity rate (time frame: within postoperative 30 days). 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 NCT02728973, which also lists 1 linked publication.
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 Apr 2016.