- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02694081
The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric
The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To search which is the better reconstructions by comparing and analyzing the advantages and disadvantages between Uncut Roux-en-Y and Billroth II 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, from February 2016 to February 2017. 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 Billroth II anastomosis by drawing lots preoperatively without distinct indications. Clinical data, operation data and perioperative complications and related physiological indexes of differences.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Dong Yang, postgraduate
- Phone Number: 18243052038
- Email: 714488468@qq.com
Study Locations
-
-
Jilin
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Changchun, Jilin, China, 130021
- Recruiting
- The First Hospital of Jilin University
-
Contact:
- Quan Wang, proffessor
- Email: 18844097668@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of distal gastric cancer
- underwent laparoscopy-assisted distal gastrectomy
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Uncut Roux-en-Y Reconstruction
Uncut Roux-en-Y Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer.
|
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.
|
ACTIVE_COMPARATOR: Billroth II Reconstruction
Billroth II Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The time of reconstruction during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction
Time Frame: within 2 hours after surgery
|
The time of reconstruction operation will be recorded in the operating note by nurses in minutes.
|
within 2 hours after surgery
|
change of potential of hydrogen ( pH) in remnant stomach
Time Frame: 1-6 days after surgery
|
In the morning of 1-6 days after operation , monitor the number of gastric juice's potential of hydrogen ( pH) value through gastric tube and write down the data.
So if the data is greater than 7,the complication of bile reflux happened
|
1-6 days after surgery
|
the amount of blood loss during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction
Time Frame: within 2 hours after surgery
|
During the operation the amount of blood loss will be recorded in the operating note by nurses in milliliters.
|
within 2 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the number of patients with the complication of Residual food
Time Frame: 6 month after surgery
|
During the upper gastrointestinal radiography,if there is residual food,the meglumine diatrizoate will be separate and then write down the number.
|
6 month after surgery
|
the number of patients with the complication of Reflux esophagitis
Time Frame: 6 month after surgery
|
During the upper gastrointestinal radiography,if there is meglumine diatrizoate refluxing to esophagus,it will be observed and written down in number.
|
6 month after surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the number of patients with the complication of gastroesophageal reflux disease(GERD)
Time Frame: 6 month after surgery
|
all patients of this clinical trial will be investigated by Gastroesophageal reflux disease questionnaire(GerdQ),and all patients whose score is beyond 8 will be collected.
|
6 month after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Quan Wang, professor, The First Hospital of Jilin University
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 130021
- 714488468 (OTHER: Department of Gastrointestinal and Anal Surgery)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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