A Study for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection

NCT02476357 | Completed Results

• 1 other identifier: LYMPH-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing groin or axillary Radical lymph node dissection (RLND) or completion lymph node dissection (CLND, after positive sentinel lymph node biopsy (SLNB) for melanoma or breast cancer were randomized in a controlled trial for surgical dissection technique. Harmonic scalpel dissection were compared with classic dissection in term of lymphocoele and oedema.

Conditions

Lymph Node Dissection; Lymphoedema; Lymphocoele

Outcome Measures

Primary Outcomes (1)

• Postoperative Draining Time

  Duration (days) between surgery and removal of postoperative suction drain

  Lymph quantity measured every day. Drained removed when < 50 ml. per day for 2 consecutive days

Secondary Outcomes (1)

• Daily Amount of Drained Lymph

  Lymph quantity measured every day, up to 50 days.

Study Arms (2)

Harmonic

ACTIVE COMPARATOR

Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)

Device: Harmonic scalpel

Control

ACTIVE COMPARATOR

Monopolar scalpel and ligature

Device: Harmonic scalpel

Interventions

Harmonic scalpel DEVICE

Control; Harmonic

Eligibility Criteria

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

You may qualify if:

• All adult patients undergoing groin or axillary Radical lymph node dissection (RLND) or completion lymph node dissection (CLND), after positive sentinel lymph node biopsy (SLNB) for melanoma or breast cancer were included.

You may not qualify if:

• Patient with a past medical history of contralateral lymph node dissection or other cause for lymphedema (trauma, deep venous thrombosis, radiotherapy, etc.) were excluded.

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Department of Visceral Surgery, University Hospital Center

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

• Gie O, Matthey-Gie ML, Marques-Vidal PM, Demartines N, Matter M. Impact of the Ultrasonic scalpel on the amount of drained lymph after axillary or inguinal lymphadenectomy. BMC Surg. 2017 Mar 21;17(1):27. doi: 10.1186/s12893-017-0222-1.

  PMID: 28327108 DERIVED

MeSH Terms

Conditions

Lymphedema; Lymphocele

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Cysts; Neoplasms

Results Point of Contact

• Title: Prof. Dr Med. Maurice MATTER
• Organization: Lausanne University Hospita! and University of Lausanne

maurice.matter@chuv.ch

795561071

Study Officials

• Maurice Matter, Prof

  University of Lausanne Hospitals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: unblinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Monocentric, open, interventional, randomized with two arms 1:1

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: June 19, 2015
• Study Start: January 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 31, 2017
• Last Updated: August 6, 2020
• Results First Posted: April 29, 2020

Record last verified: 2020-07

Locations

CH (1)