Gastrostomy ComplicationsNCT03046303
Radical Gastrectomy Within Enhanced Recovery Programs(ERAS): a Prospective Randomized Controlled Trial
A study testing ERAS in people with Gastrostomy Complications, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.ERAS is combined with the laprascopic gastrectomy to assess the efficacy and safety in patients with advanced gastric carcinoma.The hospitalized… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrostomy Complications
- What is being tested?
- ERAS
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2017to 30 Jan 2019
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) A preoperative cancer stage of T2, T3, T4, Any N, M0 without digestive obstruction confirmed by whole body CT scan, which could be treated with laparoscopic gastrectomy; (2) age 18-75 years; (3) pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy; (4) normal hematological, renal, hepatic, and cardiac parameters, ASA score < III without severe systemic disease; and (5) no history of treatment with neoadjuvant chemotherapy and/or radiotherapy.
Who cannot join
- patients requiring conversion to open gastrectomy; excessive bleeding (˃ 500 mL);and patients opting out of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Hospital of Jilin University
Changchun, Jilin, 130021
Quan Wang, MD, +86-431-81875607, wangquan5607@126.com
About this study
Official title: Radical Gastrectomy Within Enhanced Recovery Programs: a Prospective Randomized Controlled Trial
This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.ERAS is combined with the laprascopic gastrectomy to assess the efficacy and safety in patients with advanced gastric carcinoma.The hospitalized patients were randomly divided into ERAS group and conventional pathway group . Inter-group differences were evaluated for clinical recovery index, economic indicators, length of hospital stay, 3 years to 5 years long-term survival, etc.
- Conditions
- Gastrostomy Complications
- Being tested
- ERAS
- Keywords
- ERAS,gastric cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERASProcedure or surgery
optimized pain control, restricted I.V. fluids, early initiation of post-operative oral feeding and enforced mobilization
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Experimental | Patients were admitted 1-3 days prior to their respective dates of operation. A ERAS protocol was used in the ERAS group. Receives: Procedure: ERAS |
| conventional pathway group | No intervention | The conventional pathway group received conventional care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical parameters
length of post-operative stay
Measured: One week after operation
Secondary outcomes (1)
Postoperative complications
wound infection;post-opeartion bleeding;ileus;stenosis;leakage
Measured: 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start20 Feb 2017 (estimated)
- Primary completion30 Mar 2018 (estimated)
- Study completion30 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrostomy ComplicationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046303
- Sponsor's protocol ID
- ERAS for Radical gastrectomy
- Status last verified
- Feb 2017
- First submitted
- 2 Feb 2017
- Last updated
- 8 Feb 2017
- 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 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radical Gastrectomy Within Enhanced Recovery Programs: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03046303
- Acronym / sponsor ID
- ERAS for Radical gastrectomy
- Conditions
- Gastrostomy Complications
- Keywords
- ERAS,gastric cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 20 Feb 2017 (estimated)
- Primary completion
- 30 Mar 2018 (estimated)
- Study completion
- 30 Jan 2019 (estimated)
- First posted
- 8 Feb 2017 (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.
This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.ERAS is combined with the laprascopic gastrectomy to assess the efficacy and safety in patients with advanced gastric carcinoma.The hospitalized patients were randomly divided into ERAS group and conventional pathway group . Inter-group differences were evaluated for clinical recovery index, economic indicators, length of hospital stay, 3 years to 5 years long-term survival, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS group | Experimental | Procedure: ERASPatients were admitted 1-3 days prior to their respective dates of operation. A ERAS protocol was used in the ERAS group. |
| conventional pathway group | No intervention | –The conventional pathway group received conventional care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) A preoperative cancer stage of T2, T3, T4, Any N, M0 without digestive obstruction confirmed by whole body CT scan, which could be treated with laparoscopic gastrectomy; (2) age 18-75 years; (3) pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy; (4) normal hematological, renal, hepatic, and cardiac parameters, ASA score < III without severe systemic disease; and (5) no history of treatment with neoadjuvant chemotherapy and/or radiotherapy.
Key exclusion criteria (1 listed)
- patients requiring conversion to open gastrectomy; excessive bleeding (˃ 500 mL);and patients opting out of the study.
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 |
|---|---|---|
| ERASoptimized pain control, restricted I.V. fluids, early initiation of post-operative oral feeding and enforced mobilization | Procedure or surgery | ERAS group |
Primary outcome
clinical parameters
Time frame: One week after operation
length of post-operative stay
1 secondary outcome
Postoperative complications
Time frame: 30 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Gastrostomy Complications
Not yet recruitingObservational study
Comparison of Sedated and Unsedated PEG in Elderly ASA IV Patients
Percutaneous Endoscopic Gastrostomy, Enteral Nutrition Feeding
Not yet recruitingObservational study
The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 3)
Feeding Difficulties, Gastrostomy
Not yet recruitingPhase 4
The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 2)
Feeding Difficulties, Gastrostomy
RecruitingPhase 4
The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)
Feeding Difficulties, Aspiration
Recruiting
Pediatric Percutaneous Ultrasound Gastrostomy Technique
Gastrostomy, Gastrostomy Complications
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS in people with Gastrostomy Complications, run by The First Hospital of Jilin 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 1 inclusion and 1 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 8 Feb 2017. 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 Quan Wang, MD (+86-431-81875607, wangquan5607@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical parameters (time frame: One week 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 8 Feb 2017.