Effects of neoadjuvant radiochemotherapy for anorectal function in locally advanced rectal cancer patients: a study protocol for a prospective, observational, controlled, multicentre study
Abstract Background Neoadjuvant chemoradiotherapy (NCRT) and total mesorectal excision are standard treatment regimen for patients with locally advanced rectal cancer (LARC). This sphincter-saving treatment strategy may be accompanied by a series of anorectal functional disorders. Yet, prospective s...
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| Format: | Article |
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BMC
2023-05-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-023-10951-x |
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| author | Jie Shi Yi-Kan Cheng Fang He Jian Zheng Yun-Long Wang Xiang-Bo Wan Hong-Cheng Lin Xin-Juan Fan |
| author_facet | Jie Shi Yi-Kan Cheng Fang He Jian Zheng Yun-Long Wang Xiang-Bo Wan Hong-Cheng Lin Xin-Juan Fan |
| author_sort | Jie Shi |
| collection | DOAJ |
| description | Abstract Background Neoadjuvant chemoradiotherapy (NCRT) and total mesorectal excision are standard treatment regimen for patients with locally advanced rectal cancer (LARC). This sphincter-saving treatment strategy may be accompanied by a series of anorectal functional disorders. Yet, prospective studies that dynamically evaluating the respective roles of radiotherapy, chemotherapy and surgery on anorectal function are lacking. Patients/design The study is a prospective, observational, controlled, multicentre study. After screening for eligibility and obtaining informed consent, a total of 402 LARC patients undergoing NCRT followed by surgery, or neoadjuvant chemotherapy followed by surgery, or surgery only would be included in the trial. The primary outcome measure is the average resting pressure of anal sphincter. The secondary outcome measures are maximum anal sphincter contraction pressure, Wexner continence score and low anterior resection syndrome (LARS) score. Evaluations will be carried out at the following stages: baseline (T1), after radiotherapy or chemotherapy (before surgery, T2), after surgery (before closing the temporary stoma, T3), and at follow-up visits (every 3 to 6 months, T4, T5……). Follow-up for each patient will be at least 2 years. Discussion We expect the program to provide more information of neoadjuvant radiotherapy and/or chemotherapy on anorectal function, and to optimize the treatment strategy to reduce anorectal dysfunction for LARC patients. Trial registration ClinicalTrials.gov (NCT05671809). Registered on 26 December 2022. |
| first_indexed | 2024-03-13T09:01:40Z |
| format | Article |
| id | doaj.art-7b4c858db413410ab17621da85345ea7 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-03-13T09:01:40Z |
| publishDate | 2023-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-7b4c858db413410ab17621da85345ea72023-05-28T11:19:30ZengBMCBMC Cancer1471-24072023-05-012311710.1186/s12885-023-10951-xEffects of neoadjuvant radiochemotherapy for anorectal function in locally advanced rectal cancer patients: a study protocol for a prospective, observational, controlled, multicentre studyJie Shi0Yi-Kan Cheng1Fang He2Jian Zheng3Yun-Long Wang4Xiang-Bo Wan5Hong-Cheng Lin6Xin-Juan Fan7Department of Radiation Oncology, The Sixth Affiliated Hospital, Sun Yat-sen UniversityDepartment of Radiation Oncology, The Sixth Affiliated Hospital, Sun Yat-sen UniversityDepartment of Radiation Oncology, The Sixth Affiliated Hospital, Sun Yat-sen UniversityDepartment of Radiation Oncology, The Sixth Affiliated Hospital, Sun Yat-sen UniversityDepartment of Radiation Oncology, The Sixth Affiliated Hospital, Sun Yat-sen UniversityDepartment of Radiation Oncology, The Sixth Affiliated Hospital, Sun Yat-sen UniversityDepartment of General Surgery, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen UniversityDepartment of General Surgery, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen UniversityAbstract Background Neoadjuvant chemoradiotherapy (NCRT) and total mesorectal excision are standard treatment regimen for patients with locally advanced rectal cancer (LARC). This sphincter-saving treatment strategy may be accompanied by a series of anorectal functional disorders. Yet, prospective studies that dynamically evaluating the respective roles of radiotherapy, chemotherapy and surgery on anorectal function are lacking. Patients/design The study is a prospective, observational, controlled, multicentre study. After screening for eligibility and obtaining informed consent, a total of 402 LARC patients undergoing NCRT followed by surgery, or neoadjuvant chemotherapy followed by surgery, or surgery only would be included in the trial. The primary outcome measure is the average resting pressure of anal sphincter. The secondary outcome measures are maximum anal sphincter contraction pressure, Wexner continence score and low anterior resection syndrome (LARS) score. Evaluations will be carried out at the following stages: baseline (T1), after radiotherapy or chemotherapy (before surgery, T2), after surgery (before closing the temporary stoma, T3), and at follow-up visits (every 3 to 6 months, T4, T5……). Follow-up for each patient will be at least 2 years. Discussion We expect the program to provide more information of neoadjuvant radiotherapy and/or chemotherapy on anorectal function, and to optimize the treatment strategy to reduce anorectal dysfunction for LARC patients. Trial registration ClinicalTrials.gov (NCT05671809). Registered on 26 December 2022.https://doi.org/10.1186/s12885-023-10951-xAnorectal functionLocally advanced rectal cancerNeoadjuvant chemoradiotherapyTotal mesorectal excisionSphincter preservation treatments |
| spellingShingle | Jie Shi Yi-Kan Cheng Fang He Jian Zheng Yun-Long Wang Xiang-Bo Wan Hong-Cheng Lin Xin-Juan Fan Effects of neoadjuvant radiochemotherapy for anorectal function in locally advanced rectal cancer patients: a study protocol for a prospective, observational, controlled, multicentre study BMC Cancer Anorectal function Locally advanced rectal cancer Neoadjuvant chemoradiotherapy Total mesorectal excision Sphincter preservation treatments |
| title | Effects of neoadjuvant radiochemotherapy for anorectal function in locally advanced rectal cancer patients: a study protocol for a prospective, observational, controlled, multicentre study |
| title_full | Effects of neoadjuvant radiochemotherapy for anorectal function in locally advanced rectal cancer patients: a study protocol for a prospective, observational, controlled, multicentre study |
| title_fullStr | Effects of neoadjuvant radiochemotherapy for anorectal function in locally advanced rectal cancer patients: a study protocol for a prospective, observational, controlled, multicentre study |
| title_full_unstemmed | Effects of neoadjuvant radiochemotherapy for anorectal function in locally advanced rectal cancer patients: a study protocol for a prospective, observational, controlled, multicentre study |
| title_short | Effects of neoadjuvant radiochemotherapy for anorectal function in locally advanced rectal cancer patients: a study protocol for a prospective, observational, controlled, multicentre study |
| title_sort | effects of neoadjuvant radiochemotherapy for anorectal function in locally advanced rectal cancer patients a study protocol for a prospective observational controlled multicentre study |
| topic | Anorectal function Locally advanced rectal cancer Neoadjuvant chemoradiotherapy Total mesorectal excision Sphincter preservation treatments |
| url | https://doi.org/10.1186/s12885-023-10951-x |
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