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

NCT ID: NCT01983436

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2018-10-31

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).

Conditions

Maxillofacial Abnormalities; Post Procedural Discharge

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Manual Lymphatic Drainage

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

Group Type: EXPERIMENTAL

Manual Lymphatic drainage

Intervention Type: OTHER

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.

Control

No session of manual lymphatic drainage

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Manual Lymphatic drainage

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Axel DI VITTORIO, Mr

Role: PRINCIPAL_INVESTIGATOR

UH TOURS

Julie LEGER, Mrs

Role: STUDY_CHAIR

UH Tours

Locations

UH Montpellier

Montpellier, , France

UH Tours

Tours, , France

Countries

France

Other Identifiers

PHRIP/12/ADV/DLMOF

Identifier Type: -

Identifier Source: org_study_id