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A controlled study on the efficacy and quality of life of laparoscopic intersphincteric resection (ISR) and extralevator abdominoperineal resection (ELAPE) in the treatment of extremely low rectal cancer.

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机构: [a]Department of Gastrointestinal Surgery, West China Hospital of Sichuan University, [b]Institute of Digestive Surgery, State Key Laboratory of Biotherapy and Cancer Center, West China Hospital of Sichuan University, [c]Department of Evidence-Based Medicine and Clinical Epidemiology, West China Hospital of Sichuan University, No. 37 Guoxue Lane, Chengdu, [d]Department of General Surgery, West China-Ziyang Hospital of Sichuan University/The First People’s Hospital of Ziyang, No. 66 Rende West Road, Ziyang, [e]Department of General Surgery, West China-Shangjin Hospital of Sichuan University/Chengdu Shangjin Nanfu Hospital, No. 253 Shangjin Road, Chengdu, China.
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关键词: laparoscopic extralevator abdominoperineal excision laparoscopic intersphincteric resection lower rectal cancer neoadjuvant chemoradiation quality of life survival outcome

摘要:
The aim of this study is to compare the postoperative quality of life (QoL) and survival outcomes in lower rectal cancer (LRC) patients who undergo either laparoscopic- intersphincteric resection or extralevator abdominoperineal excision (L-ELAPE) after long-course neoadjuvant chemoradiation therapy (nCRT). This prospective, single-center, non-randomized, controlled, non-blinded, phase I/II clinical trial is designed to enroll 159 eligible LRC patients who achieved favorable response to long-course nCRT (2 × 25 Gy). After informed consent, the patients will be assigned into the laparoscopic intersphincteric resection group or L-ELAPE group according to their own will. Standard radical laparoscopic surgeries will be performed for every participant. Then every participant will be followed up for 3 years. The primary outcomes are scores of QoL questionnaire-core 30, QoL questionnaire-colorectum 29, Wexner incontinence score, International Prostate Symptom Score (for male), International Index of Erectile Function-5 (for male) and Female Sexual Function Index (for female). The secondary outcomes consist of incomplete circumferential resection margin rate, 3-year local recurrence, 3-year disease-free survival, 3-year overall survival and other surgical outcomes. This is the first prospective clinical controlled trial to assess postoperative QoL and efficacy for LRC patients after favorable long-course nCRT. The result is expected to provide new evidence for a more detailed individualized treatment guideline for LRC. This trial was registered at Chinese Clinical Trial Registry (ChiCTR1800017512; ChiCTR.org) on August 2, 2018.

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出版当年[2020]版:
大类 | 4 区 医学
小类 | 4 区 医学:内科
最新[2023]版:
大类 | 4 区 医学
小类 | 4 区 医学:内科
第一作者:
第一作者机构: [a]Department of Gastrointestinal Surgery, West China Hospital of Sichuan University,
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通讯机构: [a]Department of Gastrointestinal Surgery, West China Hospital of Sichuan University, [b]Institute of Digestive Surgery, State Key Laboratory of Biotherapy and Cancer Center, West China Hospital of Sichuan University, [d]Department of General Surgery, West China-Ziyang Hospital of Sichuan University/The First People’s Hospital of Ziyang, No. 66 Rende West Road, Ziyang, [*1]Department of Gastrointestinal Surgery, West China Hospital of Sichuan University, No. 37 Guoxue Lane, Chengdu 610041, China [*2]Department of General Surgery, West China-Ziyang Hospital of Sichuan University/The First People’s Hospital of Ziyang, No. 66 Rende West Road, Ziyang 641301, China [*3]Department of Gastrointestinal Surgery, West China Hospital of Sichuan University, No. 37 Guoxue Lane, Chengdu 610041, China
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