Cargando…
Comparison of the survival outcomes of laparoscopic, abdominal and gasless laparoscopic radical hysterectomy for early-stage cervical cancer: trial protocol of a multicenter randomized controlled trial (LAGCC trial)
BACKGROUND: Radical hysterectomy (RH) is considered a cornerstone in the treatment of early-stage cervical cancer. However, the debate surrounding the optimal surgical approach, whether minimally invasive or open surgery, remains controversial. The objective of this trial is to evaluate the survival...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10679326/ https://www.ncbi.nlm.nih.gov/pubmed/38023150 http://dx.doi.org/10.3389/fonc.2023.1287697 |
_version_ | 1785142119339393024 |
---|---|
author | Tang, Xiaoyan Zhou, Shan Zhang, Xuyin Hua, Keqin He, Yuan Wang, Ping Teng, Yincheng Feng, Weiwei |
author_facet | Tang, Xiaoyan Zhou, Shan Zhang, Xuyin Hua, Keqin He, Yuan Wang, Ping Teng, Yincheng Feng, Weiwei |
author_sort | Tang, Xiaoyan |
collection | PubMed |
description | BACKGROUND: Radical hysterectomy (RH) is considered a cornerstone in the treatment of early-stage cervical cancer. However, the debate surrounding the optimal surgical approach, whether minimally invasive or open surgery, remains controversial. The objective of this trial is to evaluate the survival outcomes of cervical cancer patients who undergo different surgical approaches. METHODS: This study is designed as a prospective, multicenter, open, parallel, and randomized controlled trial. A total of 500 patients diagnosed with stage IA1 with LVSI, IA2, IB1, or IB2 (2018 FIGO) will be recruited. Recruitment of participants started in November 2020. The participants will be randomly assigned to one of three groups: conventional laparoscopic RH, gasless laparoscopic RH, or abdominal RH. The primary endpoint of this trial is the 2-year disease-free survival (DFS) rate. The secondary endpoints will include the 2-year overall survival (OS) rate, 5-year DFS/OS, recurrence rates, operation time, intraoperative blood loss, surgery-related complications, and impact on quality of life (QoL). DISCUSSION: We expect this trial to provide compelling and high-quality evidence to guide the selection of the most appropriate surgical approach for early-stage cervical cancer. CLINICAL TRIAL REGISTRATION: Chinese Clinical Trial Register, identifier ChiCTR2000035515. |
format | Online Article Text |
id | pubmed-10679326 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-106793262023-01-01 Comparison of the survival outcomes of laparoscopic, abdominal and gasless laparoscopic radical hysterectomy for early-stage cervical cancer: trial protocol of a multicenter randomized controlled trial (LAGCC trial) Tang, Xiaoyan Zhou, Shan Zhang, Xuyin Hua, Keqin He, Yuan Wang, Ping Teng, Yincheng Feng, Weiwei Front Oncol Oncology BACKGROUND: Radical hysterectomy (RH) is considered a cornerstone in the treatment of early-stage cervical cancer. However, the debate surrounding the optimal surgical approach, whether minimally invasive or open surgery, remains controversial. The objective of this trial is to evaluate the survival outcomes of cervical cancer patients who undergo different surgical approaches. METHODS: This study is designed as a prospective, multicenter, open, parallel, and randomized controlled trial. A total of 500 patients diagnosed with stage IA1 with LVSI, IA2, IB1, or IB2 (2018 FIGO) will be recruited. Recruitment of participants started in November 2020. The participants will be randomly assigned to one of three groups: conventional laparoscopic RH, gasless laparoscopic RH, or abdominal RH. The primary endpoint of this trial is the 2-year disease-free survival (DFS) rate. The secondary endpoints will include the 2-year overall survival (OS) rate, 5-year DFS/OS, recurrence rates, operation time, intraoperative blood loss, surgery-related complications, and impact on quality of life (QoL). DISCUSSION: We expect this trial to provide compelling and high-quality evidence to guide the selection of the most appropriate surgical approach for early-stage cervical cancer. CLINICAL TRIAL REGISTRATION: Chinese Clinical Trial Register, identifier ChiCTR2000035515. Frontiers Media S.A. 2023-11-13 /pmc/articles/PMC10679326/ /pubmed/38023150 http://dx.doi.org/10.3389/fonc.2023.1287697 Text en Copyright © 2023 Tang, Zhou, Zhang, Hua, He, Wang, Teng and Feng https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Oncology Tang, Xiaoyan Zhou, Shan Zhang, Xuyin Hua, Keqin He, Yuan Wang, Ping Teng, Yincheng Feng, Weiwei Comparison of the survival outcomes of laparoscopic, abdominal and gasless laparoscopic radical hysterectomy for early-stage cervical cancer: trial protocol of a multicenter randomized controlled trial (LAGCC trial) |
title | Comparison of the survival outcomes of laparoscopic, abdominal and gasless laparoscopic radical hysterectomy for early-stage cervical cancer: trial protocol of a multicenter randomized controlled trial (LAGCC trial) |
title_full | Comparison of the survival outcomes of laparoscopic, abdominal and gasless laparoscopic radical hysterectomy for early-stage cervical cancer: trial protocol of a multicenter randomized controlled trial (LAGCC trial) |
title_fullStr | Comparison of the survival outcomes of laparoscopic, abdominal and gasless laparoscopic radical hysterectomy for early-stage cervical cancer: trial protocol of a multicenter randomized controlled trial (LAGCC trial) |
title_full_unstemmed | Comparison of the survival outcomes of laparoscopic, abdominal and gasless laparoscopic radical hysterectomy for early-stage cervical cancer: trial protocol of a multicenter randomized controlled trial (LAGCC trial) |
title_short | Comparison of the survival outcomes of laparoscopic, abdominal and gasless laparoscopic radical hysterectomy for early-stage cervical cancer: trial protocol of a multicenter randomized controlled trial (LAGCC trial) |
title_sort | comparison of the survival outcomes of laparoscopic, abdominal and gasless laparoscopic radical hysterectomy for early-stage cervical cancer: trial protocol of a multicenter randomized controlled trial (lagcc trial) |
topic | Oncology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10679326/ https://www.ncbi.nlm.nih.gov/pubmed/38023150 http://dx.doi.org/10.3389/fonc.2023.1287697 |
work_keys_str_mv | AT tangxiaoyan comparisonofthesurvivaloutcomesoflaparoscopicabdominalandgaslesslaparoscopicradicalhysterectomyforearlystagecervicalcancertrialprotocolofamulticenterrandomizedcontrolledtriallagcctrial AT zhoushan comparisonofthesurvivaloutcomesoflaparoscopicabdominalandgaslesslaparoscopicradicalhysterectomyforearlystagecervicalcancertrialprotocolofamulticenterrandomizedcontrolledtriallagcctrial AT zhangxuyin comparisonofthesurvivaloutcomesoflaparoscopicabdominalandgaslesslaparoscopicradicalhysterectomyforearlystagecervicalcancertrialprotocolofamulticenterrandomizedcontrolledtriallagcctrial AT huakeqin comparisonofthesurvivaloutcomesoflaparoscopicabdominalandgaslesslaparoscopicradicalhysterectomyforearlystagecervicalcancertrialprotocolofamulticenterrandomizedcontrolledtriallagcctrial AT heyuan comparisonofthesurvivaloutcomesoflaparoscopicabdominalandgaslesslaparoscopicradicalhysterectomyforearlystagecervicalcancertrialprotocolofamulticenterrandomizedcontrolledtriallagcctrial AT wangping comparisonofthesurvivaloutcomesoflaparoscopicabdominalandgaslesslaparoscopicradicalhysterectomyforearlystagecervicalcancertrialprotocolofamulticenterrandomizedcontrolledtriallagcctrial AT tengyincheng comparisonofthesurvivaloutcomesoflaparoscopicabdominalandgaslesslaparoscopicradicalhysterectomyforearlystagecervicalcancertrialprotocolofamulticenterrandomizedcontrolledtriallagcctrial AT fengweiwei comparisonofthesurvivaloutcomesoflaparoscopicabdominalandgaslesslaparoscopicradicalhysterectomyforearlystagecervicalcancertrialprotocolofamulticenterrandomizedcontrolledtriallagcctrial |