Early Detection of Lower Extremity Lymphedema After Lymphadenectomy in Gynecological Cancer

NCT03917771 | Completed

• 1 other identifier: IJM-EDL- 2017-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Lymphedema of Limb; Sentinel Lymph Node

Keywords

physiotherapy

Outcome Measures

Primary Outcomes (1)

• Efficacy of the implantation of a standardized postoperative follow-up for the early detection of lymphedema secondary to lymphadenectomy in gynecological cancer

  Lower Limb measurement secondary to lymphadenectomy in gynecological cancer

  12 months

Secondary Outcomes (1)

• Implementation of educational strategy for patients and professionals

  12 months

Study Arms (2)

Early lymphedema detection

EXPERIMENTAL

Face-to-face consultation in Rehabilitation for early detection of lymphedema after surgery. Lower Limb measurement and care education

Other: Early lymphedema detection

Usual follow-up

ACTIVE COMPARATOR

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

Other: Usual follow-up

Interventions

Early lymphedema detection OTHER

Face-to-face consultation in Rehabilitation for early detection of lymphedema after surgery (1,6,12 months). Lower Limb measurement and care education

Early lymphedema detection

Usual follow-up OTHER

Usual follow-up carried out in GO consultation

Usual follow-up

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Hospital Donostia: lead

Study Sites (1)

Donostia Hospital

San Sebastián, Gipuzkoa, 20014, Spain

Location

Study Officials

• IBON JAUNARENA

  Hospital Donostia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: randomization according to system of envelopes with code
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oncology Gynecologist

Model Details: Recruitment Process: patients will be selected consecutively and offered to participate in the study

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: April 17, 2019
• Study Start: April 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

ES (1)