Evaluation of Four Reconstructions After Total Gastrectomy
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ClinicalTrials.gov Identifier: NCT00677456 |
Recruitment Status
: Unknown
Verified January 2008 by Tang-Du Hospital.
Recruitment status was: Recruiting
First Posted
: May 14, 2008
Last Update Posted
: May 14, 2008
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Postoperative Life Quality Evaluation of Four Reconstructions After Total Gastrectomy |
Study Start Date : | January 2008 |
Estimated Primary Completion Date : | February 2010 |
Estimated Study Completion Date : | January 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Patients will receive R-Y reconstruction after total gastrectomy as intervention
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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
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Active Comparator: 2
Patients will receive P-Y reconstruction after total gastrectomy as intervention
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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
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Active Comparator: 3
Patients will receive Pouch reconstruction after total gastrectomy as intervention.
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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
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Active Comparator: 4
Patients will receive P-I reconstruction after total gastrectomy as intervention.
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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
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- Patients should live for 6 months at least, and with acceptable life quality [ Time Frame: 6 months ]
- There are significant differences among life qualities of the four reconstructions [ Time Frame: 1 year ]

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Ages Eligible for Study: | 30 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00677456
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 |
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 |
Principal Investigator: | XianLi He, doctor | Department of general surgery, Tangdu hospital of fourth military medical university |
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 |
First Posted: | May 14, 2008 Key Record Dates |
Last Update Posted: | May 14, 2008 |
Last Verified: | January 2008 |
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 |