Prospective Evaluation of the Functional Status of Jejunoplasty and Coloplasty in Patients Undergoing Complex Esophageal Reconstruction and Its Impact on Quality of Life (CEREC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number (percentage) of patients who present tolerance to the oral intake and need (volume in milliliters) of enteral nutrition depending on the type of conduit.
研究概览
简要总结
The goal of this prospective population-based cohort study is to assess:
- The evolution of the functional status of patients undergoing complex esophageal reconstruction
- Its impact on quality of life, depending on the type of conduit performed.
Participants
- Will be asked to complete different quality of life questionnaires during every follow-up visit
- Will undergo additional tests to assess functionality
详细描述
-General Justification: In recent years, esophageal reconstruction has been a great surgical challenge for the multidisciplinary teams in charge of carrying out this complex technique, associated with high morbidity and a high impact on the quality of life and functional status of patients.
One of the most important aspects of this surgery is the type of conduit used to restore digestive transit. Classically, gastroplasty has been the technique of choice due to its lower morbidity and mortality and less surgical complexity. On the other hand, in those patients in whom the stomach is not available, a coloplasty or a jejunoplasty is chosen, both of which can be associated with supercharged techniques to improve and ensure good vascular flow.
Currently, there is controversy about which type of conduit to use in the absence of a viable stomach. Since the introduction of microvascular or supercharged techniques, the postoperative results of jejunal grafts are comparable to coloplasty and even gastroplasty according to some authors.
The present study is an initiative of the Complex Esophageal Reconstruction Unit (UREC) of Bellvitge University Hospital (HUB), which aims to compare the different types of conduit used in complex esophageal reconstruction, assessing, in the short and long term, the postoperative functional status and its impact on quality of life through validated test-type tools, as well as carrying out complementary tests that allow evaluating aspects such as swallowing and dysphagia, among others.
- Hypothesis Considering the results of quality of life and functionality in the short and long term, jejunoplasty (free, pedunculated ± supercharged) could be the second technique of choice to perform in the absence of gastric conduit in complex esophageal reconstruction.
- Primary objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 18 years of age) and of both gender.
- •Candidates for complete esophageal reconstruction with cervical anastomosis, regardless of the etiology of the esophagectomy.
- •Decision to indicate a coloplasty (+/- supercharged) or jejunoplasty (free, pedunculated +/- supercharged) as surgical technique after evaluation by the UREC Committee.
- •Acceptance to participate in the study and comply with the program of procedures (schedule of visits).
- •Signing of the informed consent.
排除标准
- •Patients who withdraw their informed consent at any time during the course of the study.
结局指标
主要结局
Number (percentage) of patients who present tolerance to the oral intake and need (volume in milliliters) of enteral nutrition depending on the type of conduit.
时间窗: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
This study aims to describe the functional evolution of complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged).
Quality of life related to the swallowing function assessed using the EORTC QLQ OG25, EORTC QLQ C30, GIQLI and SWAL QoL questionnaire.
时间窗: The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.
This study aims to determine the differences in the quality of life of patients undergoing complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged) using the following questionnaires: * European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ C30): All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. * European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Oesophago Gastric module 25 (EORTC QLQ OG25): All of the scales and single-item measures range in score from 0 to 100. A high score for all the scales and single-items represents a high level of symptomatology or problems. * Gastrointestinal quality of life index (GIQLI): scale range from 0-144 * Swallowing quality of life questionnaire (SWAL QoL): scale range from 0-100
次要结局
- Number (percentage) of dilatations of the conduit(The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.)
- Number (percentage) of patients with chronic diarrhea(The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.)
- Serum albumin value(The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.)
- Volume of enteral nutrition required(The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.)
- Incidence of stenosis of the conduit(The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.)
- Number (percentage) of patients with esophagitis(The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.)
- Body Mass Index(The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.)
- Number of hospitalizations(The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.)
- Incidence of dysphagia(The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.)
- Mean 'time of need for enteral nutrition and oral nutrition supplements'(The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.)
- Number (percentage) of specific complications of the surgery during admission according to the Esophageal Complication Consensus Group (ECCG)(The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.)
- Muscle strength measured by Handgrip strength (HGS) dynamometer(The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.)
- Mortality(The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out.)
研究者
Mònica Miró Martín
Associate surgeon and specialist in Upper Gastrointestinal surgery. PhD, MD.
Hospital Universitari de Bellvitge