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

R

Regional University Hospital Center (CHRU)

Status

Completed

Conditions

Maxillofacial Abnormalities
Post Procedural Discharge

Treatments

Other: Manual Lymphatic drainage

Study type

Interventional

Funder types

Other

Identifiers

NCT01983436
PHRIP/12/ADV/DLMOF

Details and patient eligibility

About

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.

Full 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).

Enrollment

120 patients

Sex

All

Ages

14 to 50 years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Manual Lymphatic Drainage
Experimental group
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).
Treatment:
Other: Manual Lymphatic drainage
Control
No Intervention group
Description:
No session of manual lymphatic drainage

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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