NCT04819542

Brief Summary

Lymphocele secondary to a mastectomy whether or not associated with a lymph node procedure (sentinel lymph node or axillary dissection) is an almost systematic consequence observed in the postoperative situation in this type of surgery. This can be the source of pain, skin complications, and infection with a significant impact on the length of hospitalization for patients treated for breast cancer. There is no consensus regarding the management of lymphocele. The placement of a compression bandage after mastectomy and / or axillary dissection would allow a more efficient and rapid reduction of the lymphocele and a reduction in recurrences. This would make it possible to reduce the duration of the wearing of the drain, which determines the length of hospitalization and reduce the recurrence of lymphoceles, the punctures of which can be one of the risk factors for secondary lymphedema.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

August 16, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

4.2 years

First QC Date

March 17, 2021

Last Update Submit

October 21, 2024

Conditions

Lymphocele

Keywords

mastectomy

Outcome Measures

Primary Outcomes (1)

  • Proportion in percentage of patients treated successfully

    Provide an estimate of the proportion of patients treated successfully (success rate defined by the absence of lymphocele on D4 post mastectomy) in two groups of patients (drain + compression bandage vs drain without compression bandage).

    6 months

Secondary Outcomes (8)

  • Lymphocele volume in milliliter

    6 months

  • Number of lymphocele punctures

    6 months

  • Clinical signs associated with lymphocele

    8 days

  • Frequency of adverse events

    6 months

  • Clinical signs associated with lymphocele

    8 days

  • +3 more secondary outcomes

Study Arms (2)

drain + compression bandage

EXPERIMENTAL
Device: Bandage

drain without compression bandage

ACTIVE COMPARATOR
Device: No bandage

Interventions

BandageDEVICE

Bandage

drain + compression bandage
No bandageDEVICE

No bandage

drain without compression bandage

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years old,
  • Undergoing mastectomy-type surgery with or without axillary dissection for breast cancer
  • Affiliated with a health insurance plan

You may not qualify if:

  • Recurrence of breast cancer,
  • Mastectomy with RMI (immediate breast reconstruction) at the same time of operation
  • Anticoagulant treatment at curative dose
  • Arteritis obliterans of the upper limbs,
  • Other cancer during treatment,
  • Decompensated heart failure,
  • Acute infectious episode (cellulitis, erysipelas, lymphangitis)
  • Acute deep vein thrombosis upper limb ipsilateral to mastectomy,
  • Cutaneous atrophy of the upper limb,
  • Bullous dermatoses,
  • Hyperalgesia of the shoulder
  • Inability to submit to the constraints of the protocol,
  • Impossibility for the patient to achieve self-restraint at the thoracic level
  • Pregnancy,
  • Feeding with milk
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Lymphocele

Interventions

Bandages

Condition Hierarchy (Ancestors)

CystsNeoplasmsLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Julie MALLOIZEL DELAUNAY, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie MALLOIZEL DELAUNAY, MD

CONTACT

5 61 32 30 33malloizel-delaunay.j@chu-toulouse.fr

Charlotte VAYSSE

CONTACT

5 31 15 53 84vaysse.c@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 29, 2021

Study Start

August 16, 2021

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

October 23, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)