Impact of Manual Lymphatic Drainage on Postoperative Edema of the Face and the Neck After Orthognathic Surgery (DLMOF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University Hospital, Tours
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01983436
First received: October 23, 2013
Last updated: May 15, 2014
Last verified: October 2013
  Purpose

Orthognathic surgery aims to standardize position of the maxilla and the mandible and therefore chewing, breathing, phonation and swallowing functions. In postoperative, several physical and functional consequences are observed in patients: transient edema of the face, maxillo-mandibular blocking (causing difficulties to eat and occasional weight loss), pain and sensory disturbances (labial or/and chin paresthesias).

Achieving sessions of manual lymphatic drainage by physiotherapist may allow faster decrease of postoperative edema, improved postoperative comfort and mental well-being.

The main objective of this study is to evaluate the efficacy of sessions of manual lymphatic drainage to reduce postoperative edema.


Condition Intervention
Maxillofacial Abnormalities
Post Procedural Discharge
Other: Manual Lymphatic drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Impact of Manual Lymphatic Drainage on Postoperative Edema of the Face and the Neck After Orthognathic Surgery.Open-label Multicenter Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • Assessment of edema using a centimeter scale. [ Time Frame: day 22 after surgery ] [ Designated as safety issue: No ]
    Assessment in centimeter of the distance between the ear lobes passing under the bottom of the columella, through the chin and passing under the bottom edge of the chin and assessment in centimeter of the neck circumference at 7.5 cm below the lobes ears.


Secondary Outcome Measures:
  • Comfort criteria [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
    Comfort criteria (pain, aesthetic discomfort, difficulty in breathing and discomfort in swallowing) will be assessed by a self-administered questionnaire consisting of visual analogue scale(0-10).

  • mental well-being. [ Time Frame: day 22 ] [ Designated as safety issue: No ]
    The mental well-being will be assessed by the General Health Questionnaire in its 28 items french version (GHQ-28)


Estimated Enrollment: 120
Study Start Date: November 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Manual Lymphatic Drainage
  • 9 daily sessions of manual lymphatic drainage (except on Saturday/Sunday) starting at Day 1 after surgery.
  • 4 more sessions (one every two days).
Other: Manual Lymphatic drainage
Manual lymphatic drainage of the face and the neck is a massage technique that aims to remove an edema of this anatomical region. The technique consists to stimulate the lymph nodes in order to accelerate the lymph flow and to achieve a specific massage to promote the entry of lymph nodes in the initial lymphatics. Massages follow anatomical pathways of vessels and of lymph nodes of the head and the neck. The technique should be smooth and painless.
No Intervention: Control
No session of manual lymphatic drainage

Detailed Description:

Orthognathic surgery aims to standardize position of the maxilla and the mandible and therefore chewing, breathing, phonation and swallowing functions. In postoperative, several physical and functional consequences are observed in patients: transient edema of the face, maxillo-mandibular blocking (causing difficulties to eat and occasional weight loss), pain and sensory disturbances (labial or/and chin paresthesias).

Achieving sessions of manual lymphatic drainage by physiotherapist may allow faster decrease of postoperative edema, improved postoperative comfort and mental well-being.

The main objective of this study is to evaluate the efficacy of sessions of manual lymphatic drainage to reduce postoperative edema. Secondary objectives of the study are to assess impact of sessions of manual lymphatic drainage on patient comfort (pain, aesthetic discomfort, difficulty in breathing and discomfort in swallowing) and on ental well-being.

Patients allocated to the intervention group will have 13 sessions of manual lymphatic drainage and those allocated in control group will not.

Edema of patients will be measured at day 1, day 8, day 15 and day 22 after surgery by a different physiotherapist than physiotherapist achieving drainage sessions, blind to the randomization group of the patient. At the same time, comfort criteria will be assessed by a visual analogue scale and mental well-being with the General Health Questionnaire (GHQ28).

  Eligibility

Ages Eligible for Study:   14 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Orthognathic surgery (mandibular osteotomy, maxillary osteotomy or both)
  • Providing informed consent.

Exclusion Criteria:

  • Postoperative flexible restraint on the chin region.
  • Inability to understand and/or follow all scheduled visits.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01983436

Contacts
Contact: Axel DI VITTORIO, Mr (33)6.61.96.48.67 axel.divittorio@chu-tours.fr
Contact: Catherine FREMONT, Mrs (33)2.18.37.05.35 fremont@med.univ-tours.fr

Locations
France
UH Montpellier Recruiting
Montpellier, France, 34295
Contact: Isabelle BRETON, Mrs    (33) 4 67 33 82 44    i-breton@chu-montpellier.fr   
Contact: Frederic PINNA, Mr    (33) 6.86.60.10.62    f-pinna@chu-montpellier.fr   
Principal Investigator: Isabelle BRETON, Mrs         
Sub-Investigator: Jacques YACHOUH, MD         
Sub-Investigator: Patrick JAMMET, MD         
Sub-Investigator: Bernard GUERRIER, MD         
Sub-Investigator: Corinne CAZALS, Mrs         
Sub-Investigator: Marta NICOLAU de MENA, Mrs         
Sub-Investigator: C LEMAIRE, Mrs         
Sub-Investigator: Claudine DERISBOURG, Mrs         
Sub-Investigator: Miguel GRANADO PINERO, Mr         
UH Tours Recruiting
Tours, France, 37044
Contact: AXEL DI VITTORIO, Mr    (33) 06.61.96.48.67    axel.divittorio@chu-tours.fr   
Contact: Catherine FREMONT, Mrs    (33) 02 18 37 05 35    catherine.fremont@univ-tours.fr   
Principal Investigator: Axel DI VITTORIO, Mr         
Sub-Investigator: Béatrice ORTEGA, Mrs         
Sub-Investigator: Bernard FOUQUET, MPr         
Sub-Investigator: Dominique GOGA, MPr         
Sub-Investigator: Florent SURY, MD         
Sub-Investigator: Boris LAURE, MD         
Sub-Investigator: Isabelle GATIEN, Mrs         
Sub-Investigator: Sophie Anne BENEJEAN, Mrs         
Sub-Investigator: Claire ROYER, Mrs         
Sub-Investigator: Fréderic MOREAU, Mr         
Sub-Investigator: Nejla MASSOUMI-AZAD, Mrs         
Sub-Investigator: Etienne GRZESIAK, Mr         
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Axel DI VITTORIO, Mr UH TOURS
Study Chair: Julie LEGER, Mrs UH Tours
  More Information

No publications provided

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01983436     History of Changes
Other Study ID Numbers: PHRIP/12/ADV/DLMOF
Study First Received: October 23, 2013
Last Updated: May 15, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Tours:
Maxillofacial Orthognathic Surgery
Manual lymphatic drainage

Additional relevant MeSH terms:
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Stomatognathic System Abnormalities
Stomatognathic Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 18, 2014