Effect of Redon-type Drains on Postoperative Edema Following Mandibular Orthognathic Surgery: a Randomized, Controlled Superiority Trial With Two Parallel Arms (DPO - OM)
Orthognathic surgery involves the maxillary and/or mandibular skeletal bases; it entails maxillary and/or mandibular osteotomies (such as sagittal split osteotomies of the mandibular rami) aimed at restoring normal maxillomandibular skeletal and dento-occlusal relationships in patients with maxillomandibular dysmorphosis. These deformities give rise to morphological, aesthetic, and functional abnormalities that can be severe (e.g., respiratory issues, temporomandibular joint pain). Postoperative edema is inevitable following orthognathic surgery; it can be significant, causing pain and discomfort while delaying patient recovery and hospital discharge. The use of Redon-type drains for mandibular osteotomies is not a standard practice across surgical teams due to a lack of consensus. The only available data come from studies with methodologies that do not allow for a definitive conclusion regarding the superiority of using-or not using-postoperative Redon drains (Lee et al. 2020), and no clinical trials have investigated this issue. This project aims to evaluate the impact of Redon-type drainage in mandibular osteotomies (sagittal split osteotomies of the mandibular rami), whether or not combined with genioplasty (osteotomy of the mental symphysis). We hypothesize that drainage using Redon-type drains for 6 hours in the immediate postoperative period following mandibular osteotomies significantly reduces postoperative edema.
The primary objective of this clinical trial is to demonstrate the superiority-in terms of reducing postoperative edema at day 2-of placing Redon-type drains for 6 hours immediately following sagittal split osteotomy of the mandibular rami (in addition to standard postoperative care) compared to standard postoperative care alone, without a drainage device.
Hypothesis: Demonstrating that the use of Redon-type drains following orthognathic surgery osteotomies reduces postoperative edema, pain, and discomfort would provide a rational basis for this practice and support its routine implementation. The expected benefits are twofold, impacting both patients and public health. For patients, the anticipated benefits include reduced postoperative discomfort and pain, faster recovery, and shorter hospital stays, with the future prospect of outpatient care.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Anne MORICE, DR
- 電話番号：0247476680
- メール：a.morice@chu-tours.fr
研究場所
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-
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Angers、フランス
- Chu Angers
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Nantes、フランス
- Chu Nantes
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion criteria:
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Patients aged 15 years or older
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Undergoing mandibular osteotomies, with or without genioplasty, with or without wisdom tooth extraction (maxillary and/or mandibular)
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Informed consent obtained from the adult patient, or from the holder(s) of parental authority if the patient is a minor*
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Enrolled in a French social security program
- When both holders of parental authority cannot give joint consent, the consent of a single legal representative may be obtained in situations provided for by regulations or duly justified and documented in the source file.
Exclusion Criteria:
- History of maxillomandibular bone surgery
- Coagulation disorder
- Thrombophilia
- Patients on anticoagulants or antiplatelet agents
- Patients with a constitutional bone disorder
- Patients with a syndromic craniofacial malformation
- Absolute or relative contraindications to treatment with corticosteroids
- Pregnant (urine test) or breastfeeding women
- Patients under legal guardianship, conservatorship, or judicial protection
- Contraindications to the procedure
- Patients who have taken corticosteroids or NSAIDs on the day before the procedure (D-1).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：experimental arm
with drains placed at the end of the procedure, in addition to standard postoperative care. These will be Redon drains with an outlet that is either intraoral or transcutaneous in the cervical region, depending on the participating center's practices (intraoral transmucosal in the Tours and Angers centers or transcutaneous in the Nantes center); these drains will be removed 6 hours after placement Translated with DeepL.com (free version) |
in which drains are placed at the end of the procedure, in addition to standard postoperative care. |
|
アクティブコンパレータ：control arm
which consists of not placing any drainage device immediately after surgery, with standard postoperative care identical to that of the experimental group. |
not placing any drainage device immediately after surgery, with standard postoperative care identical |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative swelling
時間枠：Cervicofacial linear measurement will be collected 48 hours after the randomization (day 2) and at month 3. As the facial skeletal anatomy will be modified by the surgical procedure, month 3 will be considered as the baseline measurement.
|
The primary outcome will be the post operative facial swelling 48 hours after the end of the surgical procedure (randomization will be at this timepoint) measured with cervicofacial linear measurements |
Cervicofacial linear measurement will be collected 48 hours after the randomization (day 2) and at month 3. As the facial skeletal anatomy will be modified by the surgical procedure, month 3 will be considered as the baseline measurement.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postoperative swelling
時間枠：Cervicofacial linear measurement will be collected at 6 hours after randomization, 24 hours after randomization (day 1) and at day 7
|
Postoperative swelling at other time points than for the primary outcome, measured with cervico facial linear measurements |
Cervicofacial linear measurement will be collected at 6 hours after randomization, 24 hours after randomization (day 1) and at day 7
|
|
Postoperative swelling
時間枠：It will be collected 24 hours after randomization (day 1) , at day 2, at day 7 and at month 3
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Postoperative swelling using 3D photogrammetry instead of cervicofacial linear measurements |
It will be collected 24 hours after randomization (day 1) , at day 2, at day 7 and at month 3
|
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Pain intensity
時間枠：Pain will be collected 6 hours after randomization, at day 1 (24 hours after randomization), at day 2 and at day 7
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Pain will be measured using a visual analog scale where 0 corresponds to no pain and 10 to unbearable pain |
Pain will be collected 6 hours after randomization, at day 1 (24 hours after randomization), at day 2 and at day 7
|
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Aesthetic discomfort
時間枠：It will be collected 6 hours after randomization, at day 1 (24 hours after randomization), at day 2 and at day 7
|
Aesthetic discomfort will be measured using a visual analog scale with 0 indicating no discomfort and 10 corresponding to an extremely uncomfortable feeling |
It will be collected 6 hours after randomization, at day 1 (24 hours after randomization), at day 2 and at day 7
|
|
Breathing discomfort
時間枠：It will be collected 6 hours after randomization, at day 1 (24 hours after randomization), at day 2 and at day 7
|
Breathing discomfort will be measured using a visual analog scale where 0 corresponds to no discomfort and 10 to extremely bothersome |
It will be collected 6 hours after randomization, at day 1 (24 hours after randomization), at day 2 and at day 7
|
|
Swallowing discomfort
時間枠：It will be collected 6 hours after randomization, at day 1 (24 hours after randomization), at day 2 and at day 7
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Swallowing discomfort will be measured using a visual analog scale where 0 corresponds to no discomfort and 10 to extremely bothersome |
It will be collected 6 hours after randomization, at day 1 (24 hours after randomization), at day 2 and at day 7
|
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Pain during redon drain removal
時間枠：It will be collected 6 hours after randomization, at time to redon removal.
|
Pain during redon drain removal will be collected for participants of the experimental group after redon drain removal |
It will be collected 6 hours after randomization, at time to redon removal.
|
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The daily bed rest in hours
時間枠：It will be collected at day 1 and at day 2 (how long the participant stay in his bed in the last 24 hours) as well as at day 7 (how long the participants stay in his bed each day of the last 4 days).
|
It corresponds to how long, in hours, the participant stays in his bed each day. |
It will be collected at day 1 and at day 2 (how long the participant stay in his bed in the last 24 hours) as well as at day 7 (how long the participants stay in his bed each day of the last 4 days).
|
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The general well-being
時間枠：It will be collected at day 7 and at month 3
|
General well-being will be assessed using the GHQ-28 self-assessment questionnaire. The GHQ-28 is a questionnaire with 28 items and with scores ranging from 0 - indicating no deterioration in well-being - to 84 - indicating a significant deterioration in well-being. |
It will be collected at day 7 and at month 3
|
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The length of hospital stay
時間枠：a maximum of 90 days
|
It corresponds to the lenght of the hospital stay, in days (a maximum of 90 days) |
a maximum of 90 days
|
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Postoperative adverse events
時間枠：Throughout the three-month follow-up period, whenever an adverse event occurs
|
Postoperative adverse events correspond to hematoma, pre-thoracic hematoma spread, and infection |
Throughout the three-month follow-up period, whenever an adverse event occurs
|
協力者と研究者
捜査官
- スタディディレクター：Anne MORICE, Dr、University Hospital, Tours
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- DR260063 - DPO OM
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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