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NCT00003830 · OUTCOME

The Percentage of Technically Successful Sentinel Node Resections as Measured by the Proportion of Patients for Whom at Least One Sentinel Node is Identified.

Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer · Source last updated 2017-12-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At time of surgery (within 30 days of randomization)

What was measured

Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.

Analysis population: Data missing or unknown for some patients. In Arm I, 19 patients did not accept the protocol and another 42 patients did not have a SLN resection leaving 2746 with a SLN resection. In Arm II, 4 declined the protocol treatment and another 10 patients did not have a SLN resection leaving 2790 with a SLN resection.

Groups in this outcome

Arm I:Sentinel Node Resection+Conventional Axillary Dissection

Sentinel node resection immediately followed by axillary dissection conventional surgery: Sentinel node resection immediately followed by axillary dissection.

Arm II: Sentinel Node Resection Followed by Node Examination

Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm I:Sentinel Node Resection+Conventional Axillary Dissection2746
Arm II: Sentinel Node Resection Followed by Node Examination2790

Reported measurements

Source class 1

Success

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I:Sentinel Node Resection+Conventional Axillary Dissection2672Not reportedNot reportedNot reportedNot reported
Arm II: Sentinel Node Resection Followed by Node Examination2707Not reportedNot reportedNot reportedNot reported

Failure

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I:Sentinel Node Resection+Conventional Axillary Dissection74Not reportedNot reportedNot reportedNot reported
Arm II: Sentinel Node Resection Followed by Node Examination83Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2672
      2. group Id
        OG001
        value
        2707
      title
      Success
    2. measurements
      1. group Id
        OG000
        value
        74
      2. group Id
        OG001
        value
        83
      title
      Failure
denoms
  1. counts
    1. group Id
      OG000
      value
      2746
    2. group Id
      OG001
      value
      2790
    units
    Participants
description
Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.
groups
  1. description
    Sentinel node resection immediately followed by axillary dissection conventional surgery: Sentinel node resection immediately followed by axillary dissection.
    id
    OG000
    title
    Arm I:Sentinel Node Resection+Conventional Axillary Dissection
  2. description
    Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.
    id
    OG001
    title
    Arm II: Sentinel Node Resection Followed by Node Examination
param Type
COUNT_OF_PARTICIPANTS
population Description
Data missing or unknown for some patients. In Arm I, 19 patients did not accept the protocol and another 42 patients did not have a SLN resection leaving 2746 with a SLN resection. In Arm II, 4 declined the protocol treatment and another 10 patients did not have a SLN resection leaving 2790 with a SLN resection.
reporting Status
POSTED
time Frame
At time of surgery (within 30 days of randomization)
title
The Percentage of Technically Successful Sentinel Node Resections as Measured by the Proportion of Patients for Whom at Least One Sentinel Node is Identified.
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice