Clinical trial NCT01983436: Impact of Manual Lymphatic Drainage on Postoperative Edema of the Face and the Neck After Orthognathic Surgery
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
Overall status: COMPLETED
Phase: NA
Conditions: Maxillofacial Abnormalities
Post Procedural Discharge
Keywords: Maxillofacial Orthognathic Surgery
Manual lymphatic drainage
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 120
Sex: ALL
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Assessment of edema using a centimeter scale.
timeFrame: day 22 after surgery
Secondary outcomes:
measure: Comfort criteria
timeFrame: Day 22
measure: mental well-being.
timeFrame: day 22
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
city: Tours
country: France
facility: UH Tours
Study officials:
affiliation: UH TOURS
name: Axel DI VITTORIO, Mr
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Tours
name: Julie LEGER, Mrs
role: STUDY_CHAIR
References: