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.
机构:[a]Department of Gastrointestinal Surgery, West China Hospital of Sichuan University,四川大学华西医院[b]Institute of Digestive Surgery, State Key Laboratory of Biotherapy and Cancer Center, West China Hospital of Sichuan University,四川大学华西医院[c]Department of Evidence-Based Medicine and Clinical Epidemiology, West China Hospital of Sichuan University, No. 37 Guoxue Lane, Chengdu,四川大学华西医院[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.
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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外文
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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,
共同第一作者:
通讯作者:
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
推荐引用方式(GB/T 7714):
Wenming Yang,Libin Huang,Peng Chen,et al.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.[J].Medicine.2020,99(22):e20245.doi:10.1097/MD.0000000000020245.
APA:
Wenming Yang,Libin Huang,Peng Chen,Yun Yang,Xueting Liu...&Zongguang Zhou.(2020).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..Medicine,99,(22)
MLA:
Wenming Yang,et al."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.".Medicine 99..22(2020):e20245