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出境医 / 临床实验 / Early Detection of Lower Extremity Lymphedema After Lymphadenectomy in Gynecological Cancer

Early Detection of Lower Extremity Lymphedema After Lymphadenectomy in Gynecological Cancer

Study Description
Brief Summary:

This study aims to detect and treat early lower limb lymphedema secondary to lymphadenectomy with the aim of increasing the quality of life of patients with this chronic condition.

To this end, a group of patients (treatment group) will be referred to the Rehabilitation service for a previous consultation and after surgery where lymphedema could be detected early. In addition, the usual follow-up will be carried out in Gynecology Oncology consultation (GO). In the second group, also called control, will be performed the usual follow-up in GO.

For this we randomize to one of these two groups. The research project has the favorable report of the Center's Clinical Research Ethics Committee


Condition or disease Intervention/treatment Phase
Lymphedema of Limb Sentinel Lymph Node Other: Early lymphedema detection Other: Usual follow-up Not Applicable

Detailed Description:

METHODOLOGY:

  1. Type of study: A) Randomized clinical trial B) Prospective cohort observational study
  2. Study period: from January 2017 to December 2017.
  3. Scope: health area of the province of Gipuzkoa and the University Hospital of Donostia as a reference center.
  4. Selection of the population:

    4.1. The inclusion criteria will be: A) Diagnostic gynecological cancer patients submitted to bilateral laparoscopic pelvic lymphadenectomy as laparotomics (B: Sentinel Node Biopsy study, SNB) within the usual surgical protocol, with expected survival greater than 12 weeks and adequate liver, renal and medullary functions to accept And sign informed consent 4.2. The exclusion criteria for the study will be: Blood clotting or hematological disorders, previous thromboembolic disease and history of lymphatic system disease (lymphedema or lymphocele), contraindication for physiotherapy or who do not wish to participate and / or do not sign informed consent.

    4.3. Sample size: A) Assuming that according to previous studies the overall incidence of lymphedema after LPL is 21% (Hareyama et al), its estimated that a minimum sample of 44 patients will bi needed in order to be able to demonstrate at least 4-fold detection (Torres et al) of Lymphedemas with early follow-up with alpha = 0.05 and beta = 0.2, estimating that habitual follow-up detects 13% of lymphedema ( Mohler III et al).

    4.4. Recruitment Process: Will be selected consecutively and offered to participate in the study.

  5. 5.1 Intervention: A) After diagnosis and programming for surgery at the GO consultation, circometry is performed by a trained nurse. During the admission, the nurse delivers and explains recommendations sheet and is offered to participate in the clinical trial giving him the Informed Consent (IC) and Information Sheet created for this purpose. In case of accepting and signing the IC, it is randomized (total randomization) according to system of envelopes with code.

Distribution of the intervention;

  • Treatment group: Face-to-face consultation in Rehabilitation for early detection of lymphedema after surgery (1,6,12 months). Lower Limb measurement and care education
  • Control group: The usual follow-up will be carried out in GO consultation (0,1,6,12 months)

The pelvic lymphadenectomy will be performed by the same surgical team using a transperitoneal approach. The limits of lymph node dissection will be: the psoas muscle, laterally, the postero-medially internal iliac artery, the bifurcation of the common iliac artery cranially, where it crosses the ureter, and caudally the origin of the epigastric vessels, to level of the deep circumflex iliac vein.

B) After diagnosis and programming for surgery at the GO consultation, circometry is performed by trained and yearly nurse. During the entrance, it is delivered and explains the recommendations sheet. SNB is performed by detecting sentinel ganglion from the above mentioned areas according to the protocol of the service. The usual follow-up will be carried out in GO consultation (0,1,6,12 months)

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Recruitment Process: patients will be selected consecutively and offered to participate in the study
Masking: Single (Outcomes Assessor)
Masking Description: randomization according to system of envelopes with code
Primary Purpose: Diagnostic
Official Title: Study to Evaluate the Efficacy of Early Detection of Lower Extremity Lymphedema After Lymphadenectomy in Gynecological Cancer and Implantation of the Protocol
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 1, 2018
Arms and Interventions
Arm Intervention/treatment
Experimental: Early lymphedema detection
Face-to-face consultation in Rehabilitation for early detection of lymphedema after surgery. Lower Limb measurement and care education
Other: Early lymphedema detection
Face-to-face consultation in Rehabilitation for early detection of lymphedema after surgery (1,6,12 months). Lower Limb measurement and care education

Active Comparator: Usual follow-up
The usual follow-up will be carried out in GO consultation (0,1,6,12 months)
Other: Usual follow-up
Usual follow-up carried out in GO consultation

Outcome Measures
Primary Outcome Measures :
  1. Efficacy of the implantation of a standardized postoperative follow-up for the early detection of lymphedema secondary to lymphadenectomy in gynecological cancer [ Time Frame: 12 months ]
    Lower Limb measurement secondary to lymphadenectomy in gynecological cancer


Secondary Outcome Measures :
  1. Implementation of educational strategy for patients and professionals [ Time Frame: 12 months ]
    Care education questionnaire results


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A) Diagnostic gynecological cancer patients submitted to bilateral laparoscopic pelvic lymphadenectomy as laparotomics (B: Sentinel Node Biopsy study, SNB) within the usual surgical protocol, with expected survival greater than 12 weeks and adequate liver, renal and medullary functions to accept And sign informed consent

Exclusion Criteria:

  • The exclusion criteria for the study will be: Blood clotting or hematological disorders, previous thromboembolic disease and history of lymphatic system disease (lymphedema or lymphocele), contraindication for physiotherapy or who do not wish to participate and / or do not sign informed consent.
Contacts and Locations

Locations
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Spain
Donostia Hospital
San Sebastián, Gipuzkoa, Spain, 20014
Sponsors and Collaborators
Hospital Donostia
Investigators
Layout table for investigator information
Principal Investigator: IBON JAUNARENA Hospital Donostia
Tracking Information
First Submitted Date  ICMJE August 16, 2018
First Posted Date  ICMJE April 17, 2019
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE April 1, 2017
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2019)
Efficacy of the implantation of a standardized postoperative follow-up for the early detection of lymphedema secondary to lymphadenectomy in gynecological cancer [ Time Frame: 12 months ]
Lower Limb measurement secondary to lymphadenectomy in gynecological cancer
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2019)
Implementation of educational strategy for patients and professionals [ Time Frame: 12 months ]
Care education questionnaire results
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Detection of Lower Extremity Lymphedema After Lymphadenectomy in Gynecological Cancer
Official Title  ICMJE Study to Evaluate the Efficacy of Early Detection of Lower Extremity Lymphedema After Lymphadenectomy in Gynecological Cancer and Implantation of the Protocol
Brief Summary

This study aims to detect and treat early lower limb lymphedema secondary to lymphadenectomy with the aim of increasing the quality of life of patients with this chronic condition.

To this end, a group of patients (treatment group) will be referred to the Rehabilitation service for a previous consultation and after surgery where lymphedema could be detected early. In addition, the usual follow-up will be carried out in Gynecology Oncology consultation (GO). In the second group, also called control, will be performed the usual follow-up in GO.

For this we randomize to one of these two groups. The research project has the favorable report of the Center's Clinical Research Ethics Committee

Detailed Description

METHODOLOGY:

  1. Type of study: A) Randomized clinical trial B) Prospective cohort observational study
  2. Study period: from January 2017 to December 2017.
  3. Scope: health area of the province of Gipuzkoa and the University Hospital of Donostia as a reference center.
  4. Selection of the population:

    4.1. The inclusion criteria will be: A) Diagnostic gynecological cancer patients submitted to bilateral laparoscopic pelvic lymphadenectomy as laparotomics (B: Sentinel Node Biopsy study, SNB) within the usual surgical protocol, with expected survival greater than 12 weeks and adequate liver, renal and medullary functions to accept And sign informed consent 4.2. The exclusion criteria for the study will be: Blood clotting or hematological disorders, previous thromboembolic disease and history of lymphatic system disease (lymphedema or lymphocele), contraindication for physiotherapy or who do not wish to participate and / or do not sign informed consent.

    4.3. Sample size: A) Assuming that according to previous studies the overall incidence of lymphedema after LPL is 21% (Hareyama et al), its estimated that a minimum sample of 44 patients will bi needed in order to be able to demonstrate at least 4-fold detection (Torres et al) of Lymphedemas with early follow-up with alpha = 0.05 and beta = 0.2, estimating that habitual follow-up detects 13% of lymphedema ( Mohler III et al).

    4.4. Recruitment Process: Will be selected consecutively and offered to participate in the study.

  5. 5.1 Intervention: A) After diagnosis and programming for surgery at the GO consultation, circometry is performed by a trained nurse. During the admission, the nurse delivers and explains recommendations sheet and is offered to participate in the clinical trial giving him the Informed Consent (IC) and Information Sheet created for this purpose. In case of accepting and signing the IC, it is randomized (total randomization) according to system of envelopes with code.

Distribution of the intervention;

  • Treatment group: Face-to-face consultation in Rehabilitation for early detection of lymphedema after surgery (1,6,12 months). Lower Limb measurement and care education
  • Control group: The usual follow-up will be carried out in GO consultation (0,1,6,12 months)

The pelvic lymphadenectomy will be performed by the same surgical team using a transperitoneal approach. The limits of lymph node dissection will be: the psoas muscle, laterally, the postero-medially internal iliac artery, the bifurcation of the common iliac artery cranially, where it crosses the ureter, and caudally the origin of the epigastric vessels, to level of the deep circumflex iliac vein.

B) After diagnosis and programming for surgery at the GO consultation, circometry is performed by trained and yearly nurse. During the entrance, it is delivered and explains the recommendations sheet. SNB is performed by detecting sentinel ganglion from the above mentioned areas according to the protocol of the service. The usual follow-up will be carried out in GO consultation (0,1,6,12 months)

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Recruitment Process: patients will be selected consecutively and offered to participate in the study
Masking: Single (Outcomes Assessor)
Masking Description:
randomization according to system of envelopes with code
Primary Purpose: Diagnostic
Condition  ICMJE
  • Lymphedema of Limb
  • Sentinel Lymph Node
Intervention  ICMJE
  • Other: Early lymphedema detection
    Face-to-face consultation in Rehabilitation for early detection of lymphedema after surgery (1,6,12 months). Lower Limb measurement and care education
  • Other: Usual follow-up
    Usual follow-up carried out in GO consultation
Study Arms  ICMJE
  • Experimental: Early lymphedema detection
    Face-to-face consultation in Rehabilitation for early detection of lymphedema after surgery. Lower Limb measurement and care education
    Intervention: Other: Early lymphedema detection
  • Active Comparator: Usual follow-up
    The usual follow-up will be carried out in GO consultation (0,1,6,12 months)
    Intervention: Other: Usual follow-up
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2019)
44
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 1, 2018
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A) Diagnostic gynecological cancer patients submitted to bilateral laparoscopic pelvic lymphadenectomy as laparotomics (B: Sentinel Node Biopsy study, SNB) within the usual surgical protocol, with expected survival greater than 12 weeks and adequate liver, renal and medullary functions to accept And sign informed consent

Exclusion Criteria:

  • The exclusion criteria for the study will be: Blood clotting or hematological disorders, previous thromboembolic disease and history of lymphatic system disease (lymphedema or lymphocele), contraindication for physiotherapy or who do not wish to participate and / or do not sign informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03917771
Other Study ID Numbers  ICMJE IJM-EDL- 2017-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party IBON JAUNARENA, Hospital Donostia
Study Sponsor  ICMJE Hospital Donostia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: IBON JAUNARENA Hospital Donostia
PRS Account Hospital Donostia
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP