The influence of patient positioning on intraoperative blood loss in orthognathic surgery - a randomised controlled trial
Organizational Data
- DRKS-ID:
- DRKS00013348
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2017-11-23
- Last update in DRKS:
- 2019-01-15
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
In rare cases the operative adjustement of the upper and lower jaw due to a wrong bite results in an increased blood loss. If blood loss is very high, the transfusion of foreign blood is necessary. However, this is required only in the rarest cases. The lower the blood loss in this operation, the better the tolerability of the operation. Therefore, by default, many methods or drugs are used to minimize blood loss. Observations have shown that patient positioning during surgery can also affect blood loss. Studies in the field of ear, nose and throat surgery have shown that tilting a patient during operation with limbs up and leg down (so-called "reverse Trendelenburg" position) may potentially reduce intraoperative blood loss. In order to check whether this patient positioning can also reduce blood loss in the area of the operative jaw adjustement, patients are operated in this position and the intraoperative blood loss is determined. The results are then compared to a control group in which the patients were operated in a flat position. The assignment into one of the two groups (flat vs. 15 degrees reverse Trendelenburg position) happens randomly.
Brief summary in scientific language
In orthognathic surgery, blood loss is a common complication due to the high perfusion of the facial region. Many concepts aim at minimizing blood loss to improve patient outcomes. [1-2] In the field of functional endoscopic sinus surgery (FESS) as well as in the field of rhinoplasty surgery, the reverse Trendelenburg Position has proved to be a, non-invasive, low-risk aid to minimize intraoperative blood loss [3-6]. The aim of the present study is to evaluate whether operating a patient in 15 degrees reverse Trendelenburg position can also reduce intraoperative blood loss in orthognathic surgery and thus improve the clinical outcome. Study design: The study is planned as a randomized, controlled trial. Inclusion Criteria: Patients aged 14 to 90 presented to the Department of Oral and Maxillofacial Surgery at the Kepler University Hospital for whom a bignathe surgical remodeling osteotomy is induced due to malocclusion (bilateral sagittal split osteotomy in combination with a Le-Fort 1 osteotomy). Exclusion criteria: Patients with genetic syndromal anomalies, patients with congenital or acquired haemorrhagic diathesis (abnormally increased tendency to bleed), patients with vascular malformations in the neck / head area, revision surgery and previously operated patients (eg patients with orofacial cleft) Patients will be informed by means of the enclosed information sheet and must give their consent to be included in the study by signature. The consultation is carried out by the on-duty senior physician, who examines the patients on the day of admission. Using the existing literature and a power analysis, a necessary number of cases of 40 vs 40 patients was calculated. Randomization takes place by means of the "sealed-envelope" technique. Shortly before surgery, the surgeon draws an envelope indicating whether the patient is being operated in a flat position or in a 15 degree reverse Trendelenburg position. Thereafter, the corresponding position of the table is adjusted by inclinometer. After the operation, the weighing of the required wipes, the measurement of the rinsing liquid and the liquid in the surgical aspirator aswell as the filling of the corresponding attached protocol are carried out by the surgeon and the assistant nurse. Thus, the intraoperative blood loss can be determined as the main target and statistically checked whether there is a significant difference between the two groups. Literatur: 1) C. Rodrigo (1995), Induced Hypotension during Anesthesia, with Special Reference to Orthognathic Surgery - Anesth Prog 42:41-58 2) G. Song, P. Yang, S. Zhu, E. Luo, G. Feng, J. Hu, J. Li, Y. Li; (2013) Tranexamic Acid reducing blood transfusion in children undergoing craniosynostosis rugery, J Craniofac Surg 24(1):299-303 3) Gan EC1, Habib AR, Rajwani A, Javer AR. Five-degree, 10-degree, and 20-degree reverse Trendelenburg position during functional endoscopic sinus surgery: a double-blind randomized controlled trial. Int Forum Allergy Rhinol. 2014 Jan;4(1):61-8 4) Ozkose M1, Baykan H2, Coşkuner İ3. The Effect of Patient Positioning on Amount of Intraoperative Bleeding in Rhinoplasty: A Randomized Controlled Trial. Aesthetic Plast Surg. 2016 Aug;40(4):453-7. 5) Hathorn IF1, Habib AR, Manji J, Javer AR. Comparing the reverse Trendelenburg and horizontal position for endoscopic sinus surgery: a randomized controlled trial. Otolaryngol Head Neck Surg. 2013 Feb;148(2):308-13. 6) Ko MT1, Chuang KC, Su CY. Multiple analyses of factors related to intraoperative blood loss and the role of reverse Trendelenburg position in endoscopic sinus surgery. Laryngoscope. 2008 Sep;118(9):1687-91
Health condition or problem studied
- ICD10:
- K07 - Dentofacial anomalies [including malocclusion]
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Bilateral sagittal split osteotomy in combination with a Le-Fort 1 osteotomy: surgery in flat position (0 degree)
- Arm 2:
- Bilateral sagittal split osteotomy in combination with a Le-Fort 1 osteotomy: surgery in 15 degree reverse Trendelenburg position
Endpoints
- Primary outcome:
- Intraoperative Blood loss: After the operation, the weighing of the required wipes, the measurement of the rinsing liquid and the liquid in the surgical aspirator aswell as the filling of the corresponding attached protocol are carried out by the surgeon and the assistant nurse. Thus, the intraoperative blood loss can be determined as the main target and statistically checked whether there is a significant difference between the two groups.
- Secondary outcome:
- Duration of surgery, length of hospital stay, preoperative laboratory, anesthesiological parameters, transfused volume of erythrocytes, subjective visualization of the operating area by the surgeon, subjective intraoperative blood loss by surgeon
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Austria
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Klinik für Mund-, Kiefer- und Gesichtschirurgie, Med Campus 3, Kepler Universitätsklinikum Linz
Recruitment period and number of participants
- Planned study start date:
- 2017-11-27
- Actual study start date:
- 2018-01-31
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 80
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 14 Years
- Maximum Age:
- 90 Years
- Additional Inclusion Criteria:
- Patients aged 14 to 90 presented to the Department of Oral and Maxillofacial Surgery at the Kepler University Hospital for whom a bignathe surgical remodeling osteotomy is induced due to malocclusion (bilateral sagittal split osteotomy in combination with a Le-Fort 1 osteotomy).
Exclusion Criteria
Patients with genetic syndromal anomalies, patients with congenital or acquired haemorrhagic diathesis (abnormally increased tendency to bleed), patients with vascular malformations in the neck / head area, revision surgery and previously operated patients (e.g. patients with orofacial cleft)
Addresses
Primary Sponsor
- Address:
- Klinik für Anästhesiologie und IntensivmedizinMed Campus IIIKepler Universitätsklinikum LinzProf. Dr. Jens MeierKrankenhausstraße 94020 LinzAustria
- Telephone:
- 004357680832158
- Fax:
- 004357680832154
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kepleruniklinikum.at
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinik für Anästhesiologie und Intensivmedizin, Med Campus III, Kepler Universitätsklinikum LinzProf. Dr. Jens MeierKrankenhausstraße 94020 LinzAustria
- Telephone:
- 004357680832158
- Fax:
- 004357680832154
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kepleruniklinikum.at
Contact for Public Queries
- Address:
- Klinik für Mund-, Kiefer- und Gesichtschirurgie, Med Campus III, Kepler Universitätsklinikum LinzDr. Raphael StehrerKrankenhausstraße 94020 LinzAustria
- Telephone:
- 004357680832124
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kepleruniklinikum.at
Principal Investigator
- Address:
- Klinik für Anästhesiologie und Intensivmedizin, Med Campus III, Kepler Universitätsklinikum LinzProf. Dr. Jens MeierKrankenhausstraße 94020 LinzAustria
- Telephone:
- 004357680832158
- Fax:
- 004357680832154
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kepleruniklinikum.at
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Klinik für Anästhesiologie und IntensivmedizinMed Campus IIIKepler Universitätsklinikum LinzKrankenhausstraße 94020 LinzAustria
- Telephone:
- 004357680832158
- Fax:
- 004357680832154
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kepleruniklinikum.at
Ethics Committee
Address Ethics Committee
- Address:
- Kepler Universitätsklinikum GmbHEthikkommission des Landes Oberösterreich [Ethikkommission des Landes Oberösterreich]Wagner-Jauregg-Weg 154020 LinzAustria
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.kepleruniklinikum.at/lehre-forschung/ethikkommission-des-landes-ooe/was-wir-tun/
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2017-10-18
- Ethics committee number:
- D-48-17
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2017-11-02
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry