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 |
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Lymphedema of Limb Sentinel Lymph Node | Other: Early lymphedema detection Other: Usual follow-up | Not Applicable |
METHODOLOGY:
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.
Distribution of the intervention;
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 : | 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 |
Arm | Intervention/treatment |
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Experimental: Early lymphedema detection
Face-to-face consultation in Rehabilitation for early detection of lymphedema after surgery. Lower Limb measurement and care education
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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
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Active Comparator: Usual follow-up
The usual follow-up will be carried out in GO consultation (0,1,6,12 months)
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Other: Usual follow-up
Usual follow-up carried out in GO consultation
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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 |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Donostia Hospital | |
San Sebastián, Gipuzkoa, Spain, 20014 |
Principal Investigator: | IBON JAUNARENA | Hospital Donostia |
Tracking Information | |||||
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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 |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
Implementation of educational strategy for patients and professionals [ Time Frame: 12 months ] Care education questionnaire results
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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 |
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Detailed Description |
METHODOLOGY:
Distribution of the intervention;
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) |
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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
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | IBON JAUNARENA, Hospital Donostia | ||||
Study Sponsor ICMJE | Hospital Donostia | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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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 |