دورية أكاديمية
أعرض في EDS

Effect of different oesophagojejunostomy methods on the quality of life of gastric cancer patients after totally laparoscopic total gastrectomy with self-pulling and latter transected technique: study protocol for a randomised trial.

التفاصيل البيبلوغرافية
العنوان: Effect of different oesophagojejunostomy methods on the quality of life of gastric cancer patients after totally laparoscopic total gastrectomy with self-pulling and latter transected technique: study protocol for a randomised trial.
المؤلفون: Wang J; Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China., Tseng Y; Department of Digestive Diseases, Huashan Hospital, Fudan University, Shanghai, China., Hong J; Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China., Hua LC; Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China., Wang YP; Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China haohankun@163.com ayayapple@hotmail.com., Hao HK; Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China haohankun@163.com ayayapple@hotmail.com.
المصدر: BMJ open [BMJ Open] 2022 Apr 15; Vol. 12 (4), pp. e058844. Date of Electronic Publication: 2022 Apr 15.
نوع المنشور: Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
مواضيع طبية MeSH: Laparoscopy*/methods , Stomach Neoplasms*/pathology , Stomach Neoplasms*/surgery, Anastomosis, Surgical ; Gastrectomy/methods ; Humans ; Prospective Studies ; Quality of Life ; Randomized Controlled Trials as Topic ; Treatment Outcome
مستخلص: Introduction: Gastric cancer is the fifth most common cancer worldwide and the detection rate of proximal gastric cancer has been increasing. Currently, surgical resection using gastrectomy and proper perigastric lymphadenectomy is the only treatment option to enhance the survival rate of patients with gastric cancer. Laparoscopic total gastrectomy (LTG) is increasingly performed for adenocarcinoma of the oesophagogastric junction. However, totally LTG (TLTG) is only performed by a few surgeons due to difficulty associated with oesophagojejunostomy (OJ), in which there is no consensus on a standardised anastomosis technique. We propose a randomised trial to compare functional end-to-end anastomosis (FETE) and side-to-side anastomosis (Overlap) for OJ.
Methods and Analysis: A prospective, randomised, open-label, single-centre, interventional trial has been designed to evaluate the quality of life (QoL) outcomes and safety of FETE and Overlap, with a 1-year follow-up as the primary endpoint. The trial began in 2020 and is scheduled to enrol 96 patients according to a previous sample size calculation. Patients were randomly allocated to the FETE or Overlap groups with a follow-up of 1 year to assess QoL after the procedure. All relevant clinical data including biological markers were collected. The primary indicator is the D-value between the postoperative and preoperative QoL. Student's t-tests will be used to compare continuous variables, while χ 2 tests or Fisher's exact tests will be used to compare categorical variables. Statistical analysis will be performed with SPSS V.23.0 statistical software. A p<0.05 will be considered statistically significant.
Ethics and Dissemination: This study has been approved by the Hospital Institutional Review Board of Huashan Hospital, Fudan University (2020-1055). The results will be submitted for publication in peer-reviewed journals.
Trial Registration Number: ChiCTR2000035583.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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فهرسة مساهمة: Keywords: Clinical trials; Gastrointestinal tumours; SURGERY
سلسلة جزيئية: ChiCTR ChiCTR2000035583
تواريخ الأحداث: Date Created: 20220416 Date Completed: 20220419 Latest Revision: 20220716
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC9014080
DOI: 10.1136/bmjopen-2021-058844
PMID: 35428644
قاعدة البيانات: MEDLINE
الوصف
تدمد:2044-6055
DOI:10.1136/bmjopen-2021-058844