Evaluation of Four Reconstructions After Total Gastrectomy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Tang-Du Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Tang-Du Hospital
Collaborator:
Fourth Military Medical University
Information provided by:
Tang-Du Hospital
ClinicalTrials.gov Identifier:
NCT00677456
First received: May 12, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
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Purpose
There are four capital reconstructions after total gastrectomy which is widely used in China. Life quality is the only standard to evaluate postoperative results of different reconstructions. In order to determine the best reconstruction after total gastrectomy, we designed this study to compare life qualities of four reconstructions.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer Nutrition |
Procedure: R-Y reconstruction after total gastrectomy Procedure: P-Y reconstruction after total gastrectomy Procedure: Pouch reconstruction after total gastrectomy Procedure: P-I reconstruction after total gastrectomy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Postoperative Life Quality Evaluation of Four Reconstructions After Total Gastrectomy |
Resource links provided by NLM:
MedlinePlus related topics:
Plastic and Cosmetic Surgery
Drug Information available for:
Sodium polystyrene sulfonate
U.S. FDA Resources
Further study details as provided by Tang-Du Hospital:
Primary Outcome Measures:
- Patients should live for 6 months at least, and with acceptable life quality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- There are significant differences among life qualities of the four reconstructions [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Patients will receive R-Y reconstruction after total gastrectomy as intervention
|
Procedure: R-Y reconstruction after total gastrectomy
Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. The distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the R-Y.
Other Name: R-Y reconstruction
|
|
Active Comparator: 2
Patients will receive P-Y reconstruction after total gastrectomy as intervention
|
Procedure: P-Y reconstruction after total gastrectomy
Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. The distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the P-Y.
Other Name: P-Y reconstruction
|
|
Active Comparator: 3
Patients will receive Pouch reconstruction after total gastrectomy as intervention.
|
Procedure: Pouch reconstruction after total gastrectomy
Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. To make the jejunal pouch, jejunojejunostomy was done with a linear stapler at the antimesenteric border, the distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the R-Y.
Other Name: Pouch reconstruction
|
|
Active Comparator: 4
Patients will receive P-I reconstruction after total gastrectomy as intervention.
|
Procedure: P-I reconstruction after total gastrectomy
Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels.To make the jejunal pouch, jejunojejunostomy was done with a linear stapler at the antimesenteric border,The pouch was 20 cm long, with a 10-cm jejunal loop with the P-I.
Other Name: P-I reconstruction
|
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients should be younger than 80 years old with adequate renal, pulmonary, and heart functions.
Exclusion Criteria:
- death or other reason which cause information discontinue
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00677456
Please refer to this study by its ClinicalTrials.gov identifier: NCT00677456
Contacts
| Contact: Xian Li He, doctor | 86-029-8477-7432 | wanghe@fmmu.edu.cn | |
| Contact: Guo Qiang Bao, doctor | 86-029-8477-7731 | guoqiangbao@163.com |
Locations
| China, Shaanxi | |
| Department of general surgery,Tangdu hospital | Recruiting |
| Xi'an, Shaanxi, China, 710038 | |
| Contact: GuoQiang Bao, doctor 86-029-8477-7731 guoqiangbao@163.com | |
| Contact: JiKai Yin, doctor 86-029-8477-7732 yjkfmmuu@hotmail.com | |
| Principal Investigator: XianLi He, doctor | |
| Principal Investigator: GuoQiang Bao, doctor | |
| Principal Investigator: JiKai Yin, doctor | |
Sponsors and Collaborators
Tang-Du Hospital
Fourth Military Medical University
Investigators
| Principal Investigator: | XianLi He, doctor | Department of general surgery, Tangdu hospital of fourth military medical university |
More Information
| Responsible Party: | He XianLi/director of department of Gastrointestinal Surgery, Tang-Du Hospital, Department of Gastrointestinal Surgery, Tang-Du Hospital |
| ClinicalTrials.gov Identifier: | NCT00677456 History of Changes |
| Other Study ID Numbers: | TDH00431 |
| Study First Received: | May 12, 2008 |
| Last Updated: | May 12, 2008 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Tang-Du Hospital:
|
Gastric Cancer total gastrectomy reconstruction life quality |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
ClinicalTrials.gov processed this record on September 30, 2016