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

Primary Purpose

Maxillofacial Abnormalities, Post Procedural Discharge

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Manual Lymphatic drainage
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Maxillofacial Abnormalities focused on measuring Maxillofacial Orthognathic Surgery, Manual lymphatic drainage

Eligibility Criteria

14 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UH Montpellier
  • UH Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Manual Lymphatic Drainage

Control

Arm Description

9 daily sessions of manual lymphatic drainage (except on Saturday/Sunday) starting at Day 1 after surgery. 4 more sessions (one every two days).

No session of manual lymphatic drainage

Outcomes

Primary Outcome Measures

Assessment of edema using a centimeter scale.
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
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.
The mental well-being will be assessed by the General Health Questionnaire in its 28 items french version (GHQ-28)

Full Information

First Posted
October 23, 2013
Last Updated
October 19, 2018
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT01983436
Brief Title
Impact of Manual Lymphatic Drainage on Postoperative Edema of the Face and the Neck After Orthognathic Surgery
Acronym
DLMOF
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillofacial Abnormalities, Post Procedural Discharge
Keywords
Maxillofacial Orthognathic Surgery, Manual lymphatic drainage

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Lymphatic Drainage
Arm Type
Experimental
Arm Description
9 daily sessions of manual lymphatic drainage (except on Saturday/Sunday) starting at Day 1 after surgery. 4 more sessions (one every two days).
Arm Title
Control
Arm Type
No Intervention
Arm Description
No session of manual lymphatic drainage
Intervention Type
Other
Intervention Name(s)
Manual Lymphatic drainage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of edema using a centimeter scale.
Description
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.
Time Frame
day 22 after surgery
Secondary Outcome Measure Information:
Title
Comfort criteria
Description
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).
Time Frame
Day 22
Title
mental well-being.
Description
The mental well-being will be assessed by the General Health Questionnaire in its 28 items french version (GHQ-28)
Time Frame
day 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel DI VITTORIO, Mr
Organizational Affiliation
UH TOURS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julie LEGER, Mrs
Organizational Affiliation
UH Tours
Official's Role
Study Chair
Facility Information:
Facility Name
UH Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
UH Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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