Postoperative ComplicationsTLDGNCT05556980
Totally Laparoscopic Distal Gastrectomy for Gastric Cancer
A study testing totally laparoscopic distal gastrectomy in people with Postoperative Complications, run by Liu Liu at 1 site in China.
Trial summary
This study was designed as a randomized clinical trial comparing the totally laparoscopic distal gastrectomy with laparoscopy-assisted distal gastroectomy for patients with gastric cancer, in terms of short-term and long-term outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- totally laparoscopic distal gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 31 Dec 2023
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-80 years old, no gender limitation;
- primary gastric cancer and planed for distal gastrectomy;
Who cannot join
- patients with total or proximal gastrectomy;
- patients with distant metastasis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing the Outcomes of Totally Laparoscopic Distal Gastrectomy and Laparoscopy-assisted Gastrectomy for Gastric Cancer
This study was designed as a randomized clinical trial comparing the totally laparoscopic distal gastrectomy with laparoscopy-assisted distal gastroectomy for patients with gastric cancer, in terms of short-term and long-term outcomes.
Read the detailed description
When one patient was enrolled, he will be randomly divided into experimental group (totally laparoscopic distal gastrectomy) or control group (laparoscopy-assisted distal gastrectomy). When he receives surgery, intraoperative parameters would be recorded. when the patient discharges, the routine follow-up would be regularly performed for the survival.
- Conditions
- Postoperative Complications
- Being tested
- totally laparoscopic distal gastrectomy
- Keywords
- laparoscopy-assisted gastrectomy, totally laparoscopic gastrectomy, distal gastroectomy, postoperative hospital stay, survival, complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
totally laparoscopic distal gastrectomyProcedure or surgery
all the surgical procedure would be finished under laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| totally laparoscopic distal gastrectomy | Experimental | patients in this arm will receive totally laparoscopic distal gastrectomy Receives: Procedure: totally laparoscopic distal gastrectomy |
| laparoscopy-assisted distal gastrectomy | No intervention | patients in this group will receive laparoscopy-assisted distal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative stay
the time from the finish of surgery to discharge
Measured: about one week to one month from the finish of surgery
Secondary outcomes (1)
Survival
the survival rate at the third year from the finish of surgery
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Sep 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liu Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Liu, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556980
- Sponsor's protocol ID
- TLDG
- Acronym
- TLDG
- Status last verified
- Oct 2022
- First submitted
- 18 Sep 2022
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is a plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Outcomes of Totally Laparoscopic Distal Gastrectomy and Laparoscopy-assisted Gastrectomy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT05556980
- Acronym / sponsor ID
- TLDG / TLDG
- Conditions
- Postoperative Complications
- Keywords
- laparoscopy-assisted gastrectomy, totally laparoscopic gastrectomy, distal gastroectomy, postoperative hospital stay, survival, complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Liu LiuUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Sep 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 study was designed as a randomized clinical trial comparing the totally laparoscopic distal gastrectomy with laparoscopy-assisted distal gastroectomy for patients with gastric cancer, in terms of short-term and long-term outcomes.
Detailed description
When one patient was enrolled, he will be randomly divided into experimental group (totally laparoscopic distal gastrectomy) or control group (laparoscopy-assisted distal gastrectomy). When he receives surgery, intraoperative parameters would be recorded. when the patient discharges, the routine follow-up would be regularly performed for the survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| totally laparoscopic distal gastrectomy | Experimental | Procedure: totally laparoscopic distal gastrectomypatients in this arm will receive totally laparoscopic distal gastrectomy |
| laparoscopy-assisted distal gastrectomy | No intervention | –patients in this group will receive laparoscopy-assisted distal gastrectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 18-80 years old, no gender limitation;
- primary gastric cancer and planed for distal gastrectomy;
Key exclusion criteria (2 listed)
- patients with total or proximal gastrectomy;
- patients with distant metastasis.
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 |
|---|---|---|
| totally laparoscopic distal gastrectomyall the surgical procedure would be finished under laparoscopy | Procedure or surgery | totally laparoscopic distal gastrectomy |
Primary outcome
postoperative stay
Time frame: about one week to one month from the finish of surgery
the time from the finish of surgery to discharge
1 secondary outcome
Survival
Time frame: 3 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 25 Sep 2024.
- Individual participant dataSharing planned: No. there is a plan to make individual participant data (IPD) available to other researchers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing totally laparoscopic distal gastrectomy in people with Postoperative Complications, run by Liu Liu 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 2 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: finished, as of the sponsor's last update on 25 Sep 2024. 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?
postoperative stay (time frame: about one week to one month from the finish of surgery). 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 25 Sep 2024.