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Standardization of the extent of resection in nonradical neck dissections

Phase 2
Conditions
Head and neck cancer
Registration Number
JPRN-UMIN000003213
Lead Sponsor
The Japan Neck Dissection Study Group (JNDSG)
Brief Summary

1. A total of 235 patients were enrolled between Feb. 18, 2004 and Nov. 22, 2006. 2. The follow-up of this study was completed on July 27, 2009. The percentage of patients with a follow-up less than 2 years was 2.3%. 3. Of the 79 questions of the observation form, difference among participating hospitals was confirmed in 13 details and strongly suspected in 7 details. 4. To standardize these 20 details, JNDSG established a manual, "Standard Surgical Maneuvers for Each Detail of Neck Dissection," based on the discussion about the optimal procedures concerning each detail. 5. As the study proceeded from the first to the second stage, the intensity of difference among the hospitals decreased in 11 details and increased in 6 details. Because there were more details showing decreased intensity, this study was concluded to have contributed to some extent to the standardization of nonradical neck dissections in Japan. 6. Although standardization of a surgical procedure in a multi-institutional setting is a very rare undertaking, this study achieved noteworthy success.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
235
Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with recurrent cancer 2) Patients with cancer of unknown primary site 3) Patients considered as inappropriate by their doctors

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
2-year neck control rate
Secondary Outcome Measures
NameTimeMethod
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