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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 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. 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).


Sponsor: University Hospital, Tours

Current Primary Outcome: Assessment of edema using a centimeter scale. [ Time Frame: day 22 after surgery ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Comfort criteria [ Time Frame: Day 22 ]
    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 ]
    The mental well-being will be assessed by the General Health Questionnaire in its 28 items french version (GHQ-28)


Original Secondary Outcome: Same as current

Information By: University Hospital, Tours

Dates:
Date Received: October 23, 2013
Date Started: November 2013
Date Completion: January 2018
Last Updated: May 3, 2017
Last Verified: May 2017