UMIN ID: UMIN000000960
Registered date:11/01/2008
Randomized Clinical Trial of Roux-en-Y versus rho-Roux-en-Y Reconstruction after Distal Gastrectomy for Gastric Cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Distal Gastrectomy for Gastric Cancer |
| Date of first enrollment | 2004/05/01 |
| Target sample size | 70 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | rho-RY reconstruction (rRY) standard RY reconstruction |
Outcome(s)
| Primary Outcome | To determine the frequency of DGE (delayed gastric emptying) |
|---|---|
| Secondary Outcome | The length of post-operative stay, post-operative complications, and some nutritional status after operation. |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 90years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Patients were excluded if they had active infection, severe heart disease, pregnancy, active synchronous carcinoma, interstitial pneumonia or pulmonary fibrosis, carcinoma in the remnant stomach, Borrmann type 4 (linitis plastica), non-curative factors, such as peritoneal dissemination, hepatic metastasis, and severe invasion to other organs by the pre-operative diagnosis, an anamnesis of laparotomy for upper gastrointestinal diseases. Written informed consent was obtained from all patients. |
Related Information
| Primary Sponsor | Osaka national hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Osaka national hospital |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Motohiro Hirao |
| Address | Japan |
| Telephone | |
| hiraom@onh.go.jp | |
| Affiliation | Osaka national hospital surgery |
| scientific contact | |
| Name | Motohiro Hirao |
| Address | 2-1-14 Hoenzaka, Osaka city, Japan Japan |
| Telephone | |
| Affiliation | Osaka national hospital surgery |