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

Not Applicable

Completed

• Conditions: Maxillofacial Abnormalities; Post Procedural Discharge

• Registration Number: NCT01983436
• Lead Sponsor: University Hospital, Tours

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).

Study Timeline

• Study First Submitted: 2013-10-23
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-06
• Study First Posted: 2013-11-14
• Status Verified: 2018-10
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of edema using a centimeter scale.	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.

Secondary Outcome Measures

Name	Time	Method
mental well-being.	day 22	The mental well-being will be assessed by the General Health Questionnaire in its 28 items french version (GHQ-28)
Comfort criteria	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).

Trial Locations

Locations (2)

UH Montpellier; 🇫🇷 Montpellier, France

UH Tours; 🇫🇷 Tours, France