Uncut Roux-en-YNCT03349398
Uncut Roux-en-Y vs Roux-en-Y
A study testing Uncut Roux-en-Y reconstruction and Roux-en-Y reconstruction in people with Uncut Roux-en-Y and Roux-en-Y, run by Jilin University at 1 site in China.
Trial summary
Uncut Roux-en-Y vs Roux-en-Y reconstruction after distal gastrectomy for gastric cancer Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uncut Roux-en-Y, Roux-en-Y, Gastric Cancer
- What is being tested?
- Uncut Roux-en-Y reconstruction and Roux-en-Y reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2017to 2 Jun 2020
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of distal gastric cancer
- underwent laparoscopy-assisted distal gastrectomy
Who cannot join
- have simultaneously other cancer
- have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
- have upper gastrointestinal surgery
- can't bear the gastric tube
- the period is too late or the tumor is too large to carry on a laparoscopy assisted radical distal gastrectomy
Trial locations and contacts
1 site in 1 country.
Dong Yang, Master contact
China1 site, 1 recruiting
- Recruiting
the First Hospital of Jilin University
Ch’ang-ch’un, Jilin, 130021
Quan Wang, Professor, 18844097668@163.com
About this study
Official title: Uncut Roux-en-Y vs Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer
Uncut Roux-en-Y vs Roux-en-Y reconstruction after distal gastrectomy for gastric cancer
Read the detailed description
To search which is the better reconstructions by comparing and analyzing the advantages and disadvantages between Uncut Roux-en-Y and Roux-en-Y reconstructions after laparoscopy-assisted distal gastrectomy for gastric cancer.
Method: It's a prospective study including all patients underwent laparoscopy-assisted distal gastrectomy (LADG) in the First Hospital of Jilin University. All surgical procedures will be performed by the single surgery team, which is leaded by professor Wang Quan. The reconstruction method will be selected randomly from Uncut Roux-en-Y and Roux-en-Y anastomosis preoperatively without distinct indications. All clinical data, operation data, perioperative complications and related physiological indexes after surgery will be compared.
- Conditions
- Uncut Roux-en-Y, Roux-en-Y, Gastric Cancer
- Being tested
- Uncut Roux-en-Y reconstruction, Roux-en-Y reconstruction
- Keywords
- Uncut Roux-en-Y, Roux-en-Y
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uncut Roux-en-Y reconstructionProcedure or surgery
Uncut Roux-en-Y Reconstruction All surgical procedures will be performed by the single surgery team ,which is leaded by professor Wang Quan. Uncut Roux-en-Y construction will be used in this group.
Roux-en-Y reconstructionProcedure or surgery
Roux-en-Y Reconstruction All surgical procedures will be performed by the single surgery team ,which is leaded by professor Wang Quan. Roux-en-Y construction will be used in this group.
| Study group | Role | What they receive |
|---|---|---|
| the group of Roux-en-Y | Active comparator | Not described Receives: Procedure: Roux-en-Y reconstruction |
| the group of Uncut Roux-en-Y | Experimental | Not described Receives: Procedure: Uncut Roux-en-Y reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of Roux stasis syndrome
the incidence of Roux stasis syndrome after Roux-en-Y reach an incidence of over 30% which involve nausea, vomiting, and abdominal distension. So the incidence of both reconstructions should be compared.
Measured: 3 month after surgery
Secondary outcomes (2)
the incidence of other complications after operation
Measured: one month after surgery
the quility of life according to the RGB standards
the RGB standards in Terms of Gastritis, Bile Reflux, and Gastric Residue
Measured: 12 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start10 Nov 2017
- Primary completion1 Jun 2020 (estimated)
- Study completion2 Jun 2020 (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 Uncut Roux-en-YStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Yang, Jilin University
- Investigators
- Quan Wang, Doctor, Study director, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349398
- Sponsor's protocol ID
- 130000
- Status last verified
- Apr 2020
- First submitted
- 12 Nov 2017
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cai Z, Mu M, Ma Q, Liu C, Jiang Z, Liu B, Ji G, Zhang B. Uncut Roux-en-Y reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2024 Feb 29;2(2):CD015014. doi: 10.1002/14651858.CD015014.pub2.
PubMed 38421211
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncut Roux-en-Y vs Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT03349398
- Acronym / sponsor ID
- 130000
- Conditions
- Uncut Roux-en-Y, Roux-en-Y, Gastric Cancer
- Keywords
- Uncut Roux-en-Y, Roux-en-Y
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Jilin UniversityUniversity, hospital or other
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 2 Jun 2020 (estimated)
- First posted
- 21 Nov 2017 (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.
Uncut Roux-en-Y vs Roux-en-Y reconstruction after distal gastrectomy for gastric cancer
Detailed description
To search which is the better reconstructions by comparing and analyzing the advantages and disadvantages between Uncut Roux-en-Y and Roux-en-Y reconstructions after laparoscopy-assisted distal gastrectomy for gastric cancer.
Method: It's a prospective study including all patients underwent laparoscopy-assisted distal gastrectomy (LADG) in the First Hospital of Jilin University. All surgical procedures will be performed by the single surgery team, which is leaded by professor Wang Quan. The reconstruction method will be selected randomly from Uncut Roux-en-Y and Roux-en-Y anastomosis preoperatively without distinct indications. All clinical data, operation data, perioperative complications and related physiological indexes after surgery will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the group of Roux-en-Y | Active comparator | Procedure: Roux-en-Y reconstruction |
| the group of Uncut Roux-en-Y | Experimental | Procedure: Uncut Roux-en-Y reconstruction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of distal gastric cancer
- underwent laparoscopy-assisted distal gastrectomy
Key exclusion criteria (5 listed)
- have simultaneously other cancer
- have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
- have upper gastrointestinal surgery
- can't bear the gastric tube
- the period is too late or the tumor is too large to carry on a laparoscopy assisted radical distal gastrectomy
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 |
|---|---|---|
| Uncut Roux-en-Y reconstructionUncut Roux-en-Y Reconstruction All surgical procedures will be performed by the single surgery team ,which is leaded by professor Wang Quan. Uncut Roux-en-Y construction will be used in this group. | Procedure or surgery | the group of Uncut Roux-en-Y |
| Roux-en-Y reconstructionRoux-en-Y Reconstruction All surgical procedures will be performed by the single surgery team ,which is leaded by professor Wang Quan. Roux-en-Y construction will be used in this group. | Procedure or surgery | the group of Roux-en-Y |
Primary outcome
the incidence of Roux stasis syndrome
Time frame: 3 month after surgery
the incidence of Roux stasis syndrome after Roux-en-Y reach an incidence of over 30% which involve nausea, vomiting, and abdominal distension. So the incidence of both reconstructions should be compared.
2 secondary outcomes
the incidence of other complications after operation
Time frame: one month after surgery
the quility of life according to the RGB standards
Time frame: 12 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Derived from this study: PubMed 38421211Cai Z, Mu M, Ma Q, Liu C, Jiang Z, Liu B, Ji G, Zhang B. Uncut Roux-en-Y reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2024 Feb 29;2(2):CD015014. doi: 10.1002/14651858.CD015014.pub2.
- Individual participant dataSharing planned: No
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.
Dong Yang, Master contact
Quan Wang, Doctor study director
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uncut Roux-en-Y reconstruction and Roux-en-Y reconstruction in people with Uncut Roux-en-Y and Roux-en-Y, run by 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 2 inclusion and 5 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 16 Apr 2020. 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, Professor (18844097668, 18844097668@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of Roux stasis syndrome (time frame: 3 month after surgery). 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 NCT03349398, 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 16 Apr 2020.