Gastric CancerFTSlapAGNCT01955096
Fast Track Surgery With Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer: a Randomized Controlled Trial
A study testing fast-track surgery and conventional postoperative care in people with Gastric Cancer, run by Quan Wang.
Trial summary
The purpose of this study is to to investigate the feasibility and safety of fast-track surgery when combined with laparoscopic-assisted gastrectomy for advanced gastric cancer patients. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- fast-track surgery and conventional postoperative care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Oct 2012
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of advanced gastric cancer, elective laparoscopic surgery and age under 75.
Who cannot join
- Patients with early gastric cancer, received neoadjuvant chemotherapy, had pyloric obstruction or with distant metastasis were excluded from the study.
About this study
Official title: Fast Track Surgery With Laparoscopic-assisted Gastrectomy for Advanced Gastric
The purpose of this study is to to investigate the feasibility and safety of fast-track surgery when combined with laparoscopic-assisted gastrectomy for advanced gastric cancer patients.
Read the detailed description
Methods: We designed a prospective randomized, controlled clinical trial then recruited 61 consecutive advanced gastric cancer patients. (Trial registration number: JLUFHC1722013) Further divide into a fast-track surgery group (n=30) and a conventional surgery group (n=31). Surgical technique in both groups is same laparoscopic-assisted gastrectomy with D2 lymphadenectomy. Compare outcomes includes length of hospital stay, return to normal diet and postoperative complications.Results: Recovery parameters such as the length of time to return to normal diet; to the first defection; start of ambulation time ;the mean hospital stay will be all less in patients assigned to the fast track surgery protocol compared with those in the conventional care programme. Conclusion: We will consider fast-track rehabilitation to be safe and feasible in advanced gastric cancer patients. Moreover, it will result in decreased hospital stay.
- Conditions
- Gastric Cancer
- Being tested
- fast-track surgery, conventional postoperative care
- Keywords
- fast-track surgery, laparoscopic gastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fast-track surgeryProcedure or surgery
The included patients will be randomly divided to two groups :30 that will undergo LAG with FTS rehabilitation programme and 31 that also will undergo LAG but receive conventional postoperative care.Laparoscopy-assisted gastrectomy will be carried out in this approach.There will be no difference in the surgical procedures of both groups.The criteria for discharge are: tolerance of solid diet, return of bowel habits and ability to walk on their own.
conventional postoperative careProcedure or surgery
The included patients will be randomly divided to two groups :30 that will undergo LAG with FTS rehabilitation programme and 31 that also will undergo LAG but receive conventional postoperative care.Laparoscopy-assisted gastrectomy will be carried out in this approach.There will be no difference in the surgical procedures of both groups.The criteria for discharge are: tolerance of solid diet, return of bowel habits and ability to walk on their own.
| Study group | Role | What they receive |
|---|---|---|
| fast-track surgery | Experimental | The included patients will be randomly divided to two groups :30 that will undergo LAG with FTS rehabilitation programme and 31 that also will undergo LAG but receive conventional postoperative care.Laparoscopy-assisted gastrectomy will be carried out in this approach.There will be no difference in the surgical procedures of both groups.The criteria for discharge are: tolerance of solid diet, return of bowel habits and ability to walk on their own. Receives: Procedure: fast-track surgery |
| conventional postoperative care | Other | The included patients will be randomly divided to two groups :30 that will undergo LAG with FTS rehabilitation programme and 31 that also will undergo LAG but receive conventional postoperative care.Laparoscopy-assisted gastrectomy will be carried out in this approach.There will be no difference in the surgical procedures of both groups.The criteria for discharge are: tolerance of solid diet, return of bowel habits and ability to walk on their own. Receives: Procedure: conventional postoperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulation time
Measured: within the first 30 days (plus or minus 3 days) after surgery
defection time
Measured: within the first 30 days (plus or minus 3 days) after surgery
food intake time
Measured: within the first 30 days (plus or minus 3 days) after surgery
Secondary outcomes (2)
Complications
Measured: one year
readmission
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startSep 2010
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quan Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Quan Wang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955096
- Sponsor's protocol ID
- 2013-172
- Other IDs
- 2013-172
- Acronym
- FTSlapAG
- Status last verified
- Oct 2013
- First submitted
- 25 Sep 2013
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Track Surgery With Laparoscopic-assisted Gastrectomy for Advanced Gastric
- ClinicalTrials.gov ID
- NCT01955096
- Acronym / sponsor ID
- FTSlapAG / 2013-172
- Conditions
- Gastric Cancer
- Keywords
- fast-track surgery, laparoscopic gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Quan WangUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 7 Oct 2013 (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.
The purpose of this study is to to investigate the feasibility and safety of fast-track surgery when combined with laparoscopic-assisted gastrectomy for advanced gastric cancer patients.
Detailed description
Methods: We designed a prospective randomized, controlled clinical trial then recruited 61 consecutive advanced gastric cancer patients. (Trial registration number: JLUFHC1722013) Further divide into a fast-track surgery group (n=30) and a conventional surgery group (n=31). Surgical technique in both groups is same laparoscopic-assisted gastrectomy with D2 lymphadenectomy. Compare outcomes includes length of hospital stay, return to normal diet and postoperative complications.Results: Recovery parameters such as the length of time to return to normal diet; to the first defection; start of ambulation time ;the mean hospital stay will be all less in patients assigned to the fast track surgery protocol compared with those in the conventional care programme. Conclusion: We will consider fast-track rehabilitation to be safe and feasible in advanced gastric cancer patients. Moreover, it will result in decreased hospital stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fast-track surgery | Experimental | Procedure: fast-track surgeryThe included patients will be randomly divided to two groups :30 that will undergo LAG with FTS rehabilitation programme and 31 that also will undergo LAG but receive conventional postoperative care.Laparoscopy-assisted gastrectomy will be carried out in this approach.There will be no difference in the surgical procedures of both groups.The criteria for discharge are: tolerance of solid diet, return of bowel habits and ability to walk on their own. |
| conventional postoperative care | Other | Procedure: conventional postoperative careThe included patients will be randomly divided to two groups :30 that will undergo LAG with FTS rehabilitation programme and 31 that also will undergo LAG but receive conventional postoperative care.Laparoscopy-assisted gastrectomy will be carried out in this approach.There will be no difference in the surgical procedures of both groups.The criteria for discharge are: tolerance of solid diet, return of bowel habits and ability to walk on their own. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of advanced gastric cancer, elective laparoscopic surgery and age under 75.
Key exclusion criteria (1 listed)
- Patients with early gastric cancer, received neoadjuvant chemotherapy, had pyloric obstruction or with distant metastasis were excluded from 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 |
|---|---|---|
| fast-track surgeryThe included patients will be randomly divided to two groups :30 that will undergo LAG with FTS rehabilitation programme and 31 that also will undergo LAG but receive conventional postoperative care.Laparoscopy-assisted gastrectomy will be carried out in this approach.There will be no difference in the surgical procedures of both groups.The criteria for discharge are: tolerance of solid diet, return of bowel habits and ability to walk on their own. | Procedure or surgery | fast-track surgery |
| conventional postoperative careThe included patients will be randomly divided to two groups :30 that will undergo LAG with FTS rehabilitation programme and 31 that also will undergo LAG but receive conventional postoperative care.Laparoscopy-assisted gastrectomy will be carried out in this approach.There will be no difference in the surgical procedures of both groups.The criteria for discharge are: tolerance of solid diet, return of bowel habits and ability to walk on their own. | Procedure or surgery | conventional postoperative care |
Primary outcome
Ambulation time
Time frame: within the first 30 days (plus or minus 3 days) after surgery
defection time
Time frame: within the first 30 days (plus or minus 3 days) after surgery
food intake time
Time frame: within the first 30 days (plus or minus 3 days) after surgery
2 secondary outcomes
Complications
Time frame: one year
readmission
Time frame: one year
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 9 Oct 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing fast-track surgery and conventional postoperative care in people with Gastric Cancer, run by Quan Wang.
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: finished, as of the sponsor's last update on 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Ambulation time (time frame: within the first 30 days (plus or minus 3 days) after surgery). The study lists 3 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 9 Oct 2013.