Clinical trial NCT02694081: The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric
Official title: The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: reflux
residue
Gastric stasis
Emptying time
Lead sponsor: Jilin University
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 100
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The time of reconstruction during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction
timeFrame: within 2 hours after surgery
measure: change of potential of hydrogen ( pH) in remnant stomach
timeFrame: 1-6 days after surgery
measure: the amount of blood loss during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction
timeFrame: within 2 hours after surgery
Secondary outcomes:
measure: the number of patients with the complication of Residual food
timeFrame: 6 month after surgery
measure: the number of patients with the complication of Reflux esophagitis
timeFrame: 6 month after surgery
Other outcomes:
measure: the number of patients with the complication of gastroesophageal reflux disease(GERD)
timeFrame: 6 month after surgery
Locations:
city: Changchun
country: China
facility: the first hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Quan Wang, professor
role: STUDY_DIRECTOR
References: