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临床试验/NCT03757273
NCT03757273Unknown不适用

Aesthetic Reconstruction of Onco-surgical Mandibular Defects Using Free Fibular Flap With and Without CAD/CAM Customized Osteotomy Guide (A Randomized Controlled Clinical Trial)

Cairo University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
22
试验地点
1
主要终点
Aesthetic

研究概览

简要总结

The purpose of this study is to compare Aesthetic results and operation time of free fibular flap with and without CAD/CAM customized osteotomy guide for reconstruction of mandibular defects.

详细描述

Oral and maxillofacial tumors posing an important fact as a demanding challenge for surgeons causing face disfigurement which require post-ablation reconstruction. One of the most challenging procedure facing reconstructive surgeons lies in mandibular defects after tumor resection causing facial disharmony affecting aesthetics and function.

Free flaps are considered the gold standard for the reconstruction during oncologic surgery combining a high success rate with low donor site morbidity. Various techniques have been practiced and performed in mandibular defect reconstruction. Hidalgo introduced the fibular graft as an option, offering many Assorted advantages: as it provides a sufficient source for bone and soft tissue harvesting; long reliable vascular pedicle; moreover, only minor donor site morbidity may be involved and flap harvesting require no patient reposition.

Mandibular reconstruction using FFF has become the gold standard. However, flap contouring remain an issue and imprecise with inconvenient or suboptimal final results regrading aesthetic and even more consuming time and efforts owing to poor planning when performed traditionally. Recently, with newly introduced technology and virtual planning, the process has become more uniform and reproducible thus enhancing final outcome improving patient life.

Prefabricated cutting guides may be used may be not, however it still in debate regarding its benefits and worth for patient and surgeon. believing that ability of CAD/CAM technology to achieve Aesthetic and operation time improvement with more detailed evaluation in patients undergoing mandibular reconstruction using free fibular flap with CAD/CAM customized cutting guide.

Our priori-hypothesis is that utilization of CAD/CAM-assisted with customized osteotomy guide is not related to an altered result regarding aesthetic outcome and operation time in patient undergoing mandibular reconstruction using free fibular flap. In order to test this hypothesis, we will compare aesthetic outcome and operation time in group of patients receive FFF by CAD/CAM-assisted with customized osteotomy guide to the results of another group of patients receive FFF but without customized osteotomy guide. only model will be performed as conventional method helping in pre-shaping of reconstruction plate which is another well-established concept of management of mandibular defect.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Because the two interventions used in this trial are easily recognized by the participant and the investigators, neither the investigator nor the participant can be blinded. But, the assessor and the statistician will be blinded.

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients affected by tumor involving Mandibular bone.

排除标准

  • •Patients having poor oncological prognosis
  • •Patients with poor performance status together with other relative or absolute vascular contraindication.
  • •Patients require marginal resection or with bilateral fibular fracture

研究组 & 干预措施

FFF with CAD/CAM customized cutting guide

Experimental

Mandibular reconstruction using free fibular flap with CAD/CAM customized osteotomy guide.

干预措施: FFF with CAD/CAM customized cutting guide (Procedure)

FFF without customized cutting guide

Active Comparator

Mandibular reconstruction using free fibular flap without customized osteotomy guide. CAD/CAM 3D model for mandible will be used.

干预措施: FFF without customized cutting guide (Procedure)

结局指标

主要结局

Aesthetic

时间窗: at least three months post operative

Aesthetic outcome will be measured objectively by computerized digital analysis as differential angle and differential area of reconstructed to the other side of the mandible. subjectively will be evaluated using VAS.

次要结局

  • Operation time(intraoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Esmail Abdullah Al-Sabahi

Principal investigator

Cairo University

研究点 (1)

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