Uncut Roux-en-Y vs Roux-en-Y
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|ClinicalTrials.gov Identifier: NCT03349398|
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : November 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Uncut Roux-en-Y Roux-en-Y Gastric Cancer||Procedure: Uncut Roux-en-Y reconstruction Procedure: Roux-en-Y reconstruction||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Uncut Roux-en-Y vs Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer|
|Actual Study Start Date :||November 10, 2017|
|Estimated Primary Completion Date :||November 10, 2018|
|Estimated Study Completion Date :||August 30, 2019|
|Active Comparator: the group of Roux-en-Y||
Procedure: Roux-en-Y reconstruction
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.
|Experimental: the group of Uncut Roux-en-Y||
Procedure: Uncut Roux-en-Y reconstruction
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.
- 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.
- 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 ]the RGB standards in Terms of Gastritis, Bile Reflux, and Gastric Residue
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349398
|Contact: Quan Wang, Professorfirstname.lastname@example.org|
|Contact: Dong Yang, Masteremail@example.com|
|China, JI Lin|
|the First Hospital of Jilin University||Recruiting|
|Ch'ang-ch'un, JI Lin, China, 130021|
|Contact: Quan Wang, Professor firstname.lastname@example.org|
|Study Director:||Quan Wang, Doctor||First Hospital of Jilin University|