Trials / Completed
CompletedNCT01065688
A Trial of Reconstruction After Distal Gastrectomy for Gastric Cancer
A Prospective Randomized Controlled Trial Comparing Billroth-I Reconstruction With Roux-en Y Reconstruction After Distal Gastrectomy for Gastric Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Wakayama Medical University · Academic / Other
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the quality of life (QOL) after Billroth-I reconstruction (B-I) following distal gastrectomy, compared with Roux-en Y reconstruction (R-Y) in patients with gastric cancer.
Detailed description
The purpose of this study is to evaluate the quality of life (QOL) after Billroth-I reconstruction (B-I) following distal gastrectomy, compared with Roux-en Y reconstruction (R-Y) in patients with gastric cancer. There is no prospective randomized study of the two operative procedures focusing on postoperative QOL. The investigators conducted a prospective randomized trial on 120 patients who underwent distal gastrectomy comparing Billroth-I reconstruction and Roux-en Y reconstruction. The primary endpoint was the postoperative QOL. The secondary endpoints were the incidence of postoperative complications, nutritional status, and the incidence of the remnant gastritis and the reflux esophagitis. Patients were recruited into this study before surgery, on the basis of whether distal gastrectomy was anticipated at Wakayama Medical University Hospital(WMUH) for gastric cancer, and appropriate informed consent was obtained. Exclusion criteria was 1) patients with severe complications which were possible to prolong hospital stay, 2) patients with history of other organ malignancies, 3) patients who were diagnosed inadequacy for this study by a physician, and 4) patients without an informed consent.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Roux-en Y reconstruction | surgical procedure |
| PROCEDURE | Billroth-I reconstruction | surgical procedure |
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2013-09-01
- Completion
- 2013-11-01
- First posted
- 2010-02-09
- Last updated
- 2018-10-09
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01065688. Inclusion in this directory is not an endorsement.