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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. Jie Shi and Yi-Kan Cheng contributed equally to this work. *Correspondence: Hong-Cheng Lin email@example.com Xin-Juan Fan firstname.lastname@example.org Full list of author information is available at the end of the article © The Author(s) 2023. 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The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Shi et al. BMC Cancer (2023) 23:467 Page 2 of 7 Keywords Anorectal function, Locally advanced rectal cancer, Neoadjuvant chemoradiotherapy, Total mesorectal excision, Sphincter preservation treatments Introduction and Wexner continence score or LARS score after differ - Background and rationale ent treatment regimens would be investigated. Rectal cancer represents an important public health problem that compromises patients’ health-related Methods quality of life. Worldwide in 2020, the incidence of rec- Study design and setting tal cancer was 3.8%, while its mortality rate was 3.4% The study is a prospective, observational, controlled, . Currently, total mesorectal excision (TME) is the multicentre study of patients diagnosed with LARC. gold standard method in sphincter-preserving therapy The eligible patients will be informed about the study in for locally advanced rectal cancer (LARC) [2, 3]. Neo- detail. After providing written informed consent, these adjuvant chemoradiotherapy (NCRT) is being used in patients will undergo sphincter-preserving therapies patients with LARC (T3–T4 or N0–N1), with the pur- including either NCRT with surgery, or NCT with sur- pose of reducing the local recurrence rates and increas- gery or surgery only. All patients will receive anorectal ing the likelihood of sphincter preservation [4, 5]. manometry, Wexner continence score and LARS score However, NCRT, especially neoadjuvant radiotherapy, before and after the treatment and at follow-up visits. and sphincter-saving operations are always criticized The acquired data will be finally analyzed (Fig. 1). to cause a series of functional disorders, including high bowel frequency, urgency, and fecal incontinence (FI) [6– Participants 9]. These functional disorders are associated with wors - Patients diagnosed with LARC at The Sixth Affiliated ening patients’ quality of life (QOL) [10, 11]. Hospital, Sun Yat-sen University and Nanfang Hospital, Indeed, both radiotherapy and surgery may greatly dis- Southern Medical University will be assessed for suitabil- turb anorectal function [12, 13]. However, how and to ity for inclusion. which extent the NCRT and TME on the anorectal dys- function is still unclear. Anorectal manometry is the pre- Inclusion criteria ferred technique to provide objective evaluation about • 18–75 years of age. the function of anorectal since it can identify functional • LARC with pathological diagnosis. sphincter weakness, poor rectal compliance, and rectal • Patient will undergo sphincter-preserving therapies. sensation impairment [14, 15]. In addition, the Wexner • Eastern Cooperative Oncology Group (ECOG) score continence score is usually used to subjectively deter- for performance status is 0–2. mine the degree of FI [16, 17]. Low anterior resection • Written informed consent. syndrome (LARS) score is another tool for the subjective evaluation of anorectal function [18, 19]. Previous studies Exclusion criteria have evaluated short-term or long-term effects of NCRT • Patients who have undergone pelvic surgery, such as and/or surgery on the anorectal function of patients with rectal cancer surgery and gynecological procedures. rectal cancer through anorectal manometry, Wexner • Patients who have received pelvic radiotherapy. continence score and LARS score [20–22]. Particularly, • Patients with other active malignant tumors. prospective studies dynamically evaluating the differ - • Patients with a history of prior peri-anal abscess, ent roles of radiotherapy, chemotherapy and surgery on anorectal trauma, and inflammatory bowel disease anorectal function are lacking. Dynamic evaluation of the (IBD). anorectal function might have implications for alleviating • Recently (less than 4 weeks) received surgery or functional disorders and improving QOL by intervening patients with recent severe trauma. treatments for sphincter-saving patients. • Significant cardiac disease: congestive heart failure of New York Heart Association class ≥ 2; patients with Objectives recent (less than 12 months) active coronary artery This prospective, observational, controlled, multicentre disease (unstable angina or myocardial infarction). study aims to dynamically evaluate the different roles of • Recent (less than 6 months) thrombosis or embolism NCRT with surgery, neoadjuvant chemotherapy (NCT) events, such as cerebrovascular accident (including with surgery and surgery only on the anorectal func- transient ischemic attack), pulmonary embolism and tion of patients with LARC by using anorectal manom- deep vein thrombosis. etry, Wexner continence score and LARS score. In addition, the correlation between manometric findings Shi et al. BMC Cancer (2023) 23:467 Page 3 of 7 Fig. 1 Flow diagram of the study design • Patients with toxicity (Common Terminology Outcomes Criteria for Adverse Events (CTCAE) Grade ≥ 2) Evaluations will take place at baseline (T1), after radio- caused by previous treatment that has not subsided. therapy or chemotherapy (before surgery, T2), after sur- • Women who suffered anal sphincter tear after gery (before closing the temporary stoma, T3), and at vaginal delivery. follow-up visits (every 3 to 6 months, T4, T5……). Fol- • Pregnant or lactating women. low-up for each patient will be at least 2 years. The primary outcome is the average resting pressure Interventions (ARP) of anal sphincter. The secondary outcomes are The eligible patients who voluntarily sign the consent maximum anal sphincter contraction pressure, Wexner form will undergo either NCRT with surgery, or NCT continence score and LARS score. We will use high- with surgery, or surgery only according to treatment resolution anorectal manometry (Solar GI HRM; MMS, guidelines. The protocol for neoadjuvant radiotherapy Enschede, the Netherlands) to assess the average resting with conventional fractionation is as follows: 1.8-2.0 Gy pressure and maximal contraction pressure, which has per day per fraction from Monday to Friday for a total of proven to be adequate for clinical use [23, 24]. This test 25 fractions and a total dose of 45–50 Gy during cycles will be performed by the trained physicians. In addition, 2–4 of neoadjuvant chemotherapy. The neoadjuvant che - we will use Wexner continence score and LARS score to motherapy scheme consisted of oxaliplatin 85 mg/m assess fecal incontinence symptoms of patients following intravenously, leucovorin 400 mg/m intravenously, flu - sphincter-preserving rectal cancer surgery. orouracil 400 mg/m intravenously, and fluorouracil 2.4 g/m for 48 h continuously intravenous infusion, to be High-resolution anorectal manometry examination repeated every 14 days for a total of 5–6 cycles. Surgery procedure will be performed according to the standard total meso- Bowel preparation is routinely used before the examina- rectal excision principles. tion. The patient is placed in the left lateral position with Shi et al. BMC Cancer (2023) 23:467 Page 4 of 7 Table 1 Collected information Baseline (T1) After radiotherapy or chemothera- After surgery (before closing Follow-up py (before surgery, T2) the temporary stoma, T3) (every 3 to 6 months, T4, T5……) Age Sex BMI ECOG Colonoscopy CT/PET-CT scan MRI scan TNM stage Defecography Tumor marker Allocation Table 2 Wexner continence score The study is a prospective, observational, controlled Type of Frequency Incontinence study without randomization. Treatment decisions will Never Rarely Some- Usually Al- times ways be made by multidisciplinary team for eligible patients Solid 0 1 2 3 4 who voluntarily sign the consent form. All patients will Liquid 0 1 2 3 4 receive evaluation of the anorectal function through ano- Gas 0 1 2 3 4 rectal manometry, Wexner continence score and LARS Wears pad 0 1 2 3 4 score before and after therapies and at follow-up visits. Lifestyle alteration 0 1 2 3 4 0 = normal, 1– 8 = minor incontinence, 9–14 = average incontinence, Questionnaire used in the study 15–20 = complete incontinence. The questionnaire we use are Wexner continence score Never = 0 (never). (Table 2) and LARS score (Table 3), which will be writing Rarely = < l/month in Chinese thus patients can use their native language. Sometimes = < l/week ,_>l/month Usually = < l/day, _>l/week Participant timeline Always = _>l/day Recruitment started in January 2023 at The Sixth Affili - knees and hips bent at a 90° angle, and the lubricated ated Hospital, Sun Yat-sen University and Nanfang Hos- probe is gently inserted into the rectum. Once positioned, pital, Southern Medical University. The data collected the probe assembly remains stationary for the duration of from the participants and the follow-up timeline are pre- the study. The procedure included assessment of average sented in Table 1. resting pressure and maximum anal sphincter contrac- tion pressure. Sample size The sample size calculation was performed considering Other information the results of a previous case-control study with rectal Table 1 shows the information that is collected in addi- cancer patients undergoing chemoradiotherapy and/or tion to manometric findings and Wexner continence surgery . In this study, RP was significantly lower in score. The study physicians will record each patient’s the chemoradiotherapy group than in the surgery group baseline and main examination data. (32.7 +/- 17 vs. 45.3 +/- 18 mmHg; P = 0.03) at the time of BMI, Body Mass Index; ECOG, Eastern Cooperative ileostomy closure. These values were introduced at PASS Oncology Group; CT, Computerized Tomography; PET, v11 software (NCSS, LLC. Kaysville, Utah, USA) with a Positron Emission Tomography; MRI, Magnetic Reso- power of 80%, alpha 0.05, and an enrollment ratio of 1/1, nance Imaging; TNM, Tumor, Node and Metastasis. resulting in an estimated sample size of 122 participants in each group. Then, considering the need of lost to fol - Recruitment low-up, which is estimated at around 10.0% of the cases, Patients aged 18–75 years who have been diagnosed with a total of 134 patients in each group will be required in LARC and consider sphincter-preserving therapies are this study. eligible for the study. After obtaining informed consent, the patient will be recruited to the study. Shi et al. BMC Cancer (2023) 23:467 Page 5 of 7 Table 3 Low anterior resection syndrome (LARS) score The aim of this questionnaire is to assess your bowel function. Please tick only one box for each question. It may be difficult to select only one answer, as we know that for some patients symptoms vary from day to day. We would kindly ask you to choose one answer which best describes your daily life. If you have recently had an infection affecting your bowel function, please do not take this into account and focus on answering questions to reflect your usual daily bowel function. Do you ever have occasions when you cannot control your flatus (wind)? □ No, never 0 □ Yes, less than once per week 4 □ Yes, at least once per week 7 Do you ever have any accidental leakage of liquid stool? □ No, never 0 □ Yes, less than once per week 3 □ Yes, at least once per week 3 How often do you open your bowels? □ More than 7 times per day (24 h) 4 □ 4–7 times per day (24 h) 2 □ 1–3 times per day (24 h) 0 □ Less than once per day (24 h) 5 Do you ever have to open your bowels again within one hour of the last bowel opening? □ No, never 0 □ Yes, less than once per week 9 □ Yes, at least once per week 11 Do you ever have such a strong urge to open your bowels that you have to rush to the toilet? □ No, never 0 □ Yes, less than once per week 11 □ Yes, at least once per week 16 Total Score: Interpretation: 0–20 = No LARS, 21–29 = Minor LARS, 30–42 = Major LARS Data management, collection and monitoring Research ethic approval All protocol-required information collected during the The study adheres to the Declaration of Helsinki on study will be entered by the investigator in the electronic medical research protocols and ethics. The protocol was case report forms (CRF). The investigator should com - reviewed and approved by the Human Medical Ethics plete the CRF as soon as possible after information is Committee of the Sixth Affiliated Hospital of Sun Yat-sen collected. An explanation should be given for all missing University (number 2022ZSLYEC-614). data. The completed CRF will be reviewed and signed by the investigator. The main investigator will continuously Confidentiality monitor data. Data will be stored in the secured network Patient confidentiality will be strictly maintained. of Sun Yat-sen University and for security reasons, in an external hard drive which will be used to back up regu- Dissemination policy larly the database. The final study results will be published in peer-reviewed scientific journals. Furthermore, results will be commu - Statistical methods nicated through professional meetings and the media. For statistical analysis of the quantitative variables with normal distribution, the mean, standard deviation (SD), Discussion median and interquartile range will be calculated. Group This paper presents a protocol for a prospective, obser - comparisons will be made using t tests or Mann-Whitney vational, controlled, multicentre study to dynamically U test for continuous variables. Associations between the evaluate the different roles of NCRT with surgery, NCT categorical variables will be tested with the Chi-Square- with surgery and surgery only on the anorectal function test or the Fisher exact test, when appropriate. Paired val- of LARC patients. There are similar studies published, ues (before and after therapies) will be compared for each but their main objective was to clarify the short-term or patient using a paired t test or a Wilcoxon test. The data long-term contribution of neoadjuvant chemoradiother- will be analyzed using IBM SPSS Statistics for Windows, apy and/or surgery on the impairment of anorectal func- version 27.0 (IBM Corporation, Armonk, NY, USA). A tion in patients with rectal cancer [12, 25, 26]. The most significance threshold of p < 0.05 will be adopted for all recent study has reported that the rectal adenocarcinoma tests. patients undergoing neoadjuvant therapy were submitted Shi et al. BMC Cancer (2023) 23:467 Page 6 of 7 TNM Tumor, Node and Metastasis to functional evaluation by anorectal manometry and the CRF Case report forms SD Standard deviation degree of FI using the Wexner continence score, before and eight weeks after NCRT . Besides that, a pro- Acknowledgements spective study has performed anorectal manometry pre- Not applicable. operatively and a median of 384 days postoperatively to Authors’ contributions evaluate the impact of NCRT on anal sphincter function The study was designed by X.J.F, H.C.L, X.B.W and J.S. The principal investigator . of the study is X.J.F. J.S, Y.K.C and F.H were the major contributors in writing the manuscript. J.Z and Y.L.W designed the statistical methods of the study. All Major anorectal dysfunction is common in patients authors participated in writing and revising the manuscript. All authors read with rectal cancer undergoing sphincter-saving treat- and approved the final manuscript. ment. Long-term follow-up of patients and continued Funding symptom assessment is necessary to improve the treat- This work was supported by the National Science Fund for Distinguished ment of major anorectal dysfunction. Unlike most previ- Young Scholars (No. 82225040); the Ministry of Science and Technology of ous studies, our study will dynamically assess the changes the People’s Republic of China (No. 2022YFC2503700, No. 2022YFC2503702); the National Key R&D Program of China (2022YFA1105300); the National of anorectal function in patients with rectal cancer before Science Fund for Excellent Young Scholars (No. 82122057); the Natural Science and after sphincter-saving treatment and at follow-up Foundation of China (No. 82103770, No. 82171163); Guangdong Natural visits and further evaluate the different roles of NCRT, Science Funds for Distinguished Young Scholars (No. 2021B1515020022); Guangdong Science and Technology Project (No. 2019B030316003, NCT and surgery in determining anorectal dysfunctions. No. 2019A1515010901, and No. 2022A1515012363); the program of Focusing on the dynamic effects of different treatments Guangdong Provincial Clinical Research Center for Digestive Diseases for anorectal function will provide more information on (No. 2020B1111170004); and Beijing Bethune Charitable Foundation (No. flzh202102). therapeutical options and strategies to reduce anorectal dysfunction. Availability of data and materials Our study will use high-resolution anorectal manom- The datasets generated or analyzed during the current study are not publicly available due to the laws on privacy protection but are available from the etry to evaluate anorectal function, which is widely used corresponding author on reasonable request. in clinical studies. Although Dulskas A et al. found that anorectal manometry might be insufficient to properly Declarations capture LARS . Kitaguchi D and colleagues reported that high-resolution anorectal manometry was reliable Competing interests The authors declare that they have no competing interests. for the evaluation of anorectal function after intersphinc- teric resection . Hence, anorectal manometry can be Ethics approval and consent to participate used as an appropriate tool for evaluating anorectal dys- The Human Medical Ethics Committee of the Sixth Affiliated Hospital of Sun Yat-sen University has approved the study and its consent to participate functions in patients with rectal cancer. (number 2022ZSLYEC-614). The study will be conducted in accordance There are some limitations in this study. The study with the Declaration of Helsinki. All researchers are trained and certified in design is observational but not randomized and blinded. Good Clinical Practices. A written informed consent will be taken from all participants. At the end of the study, we will stratify the patients according to age, sex, and cancer stage. After completing Consent for publication the recruitment and preliminary evaluation, we will fur- Not applicable. ther determine whether to enlarge the sample size or not. Author details Department of Radiation Oncology, The Sixth Affiliated Hospital, Sun Yat- Trial status sen University, Guangzhou, Guangdong 510655, P.R. China Department of General Surgery, Guangdong Provincial Key Laboratory The trial recruitment started on 1 January 2023, and it is of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun estimated to be complete by the end of December 2026. Yat-sen University, Guangzhou, Guangdong 510655, P.R. China Department of Coloproctology, The Sixth Affiliated Hospital, Sun Yat-sen Abbreviations University, Guangzhou, Guangdong 510655, P.R. China TME Total mesorectal excision Department of Pathology, The Sixth Affiliated Hospital, Sun Yat-sen LARC Locally advanced rectal cancer University, Guangzhou, Guangdong 510655, P.R. China NCRT Neoadjuvant chemoradiotherapy FI Fecal incontinence Received: 13 February 2023 / Accepted: 11 May 2023 QOL Qualit y of life LARS Low anterior resection syndrome NCT Neoadjuvant chemotherapy ECOG Eastern Cooperative Oncology Group IBD I nflammatory bowel disease CTCAE Common Terminology Criteria for Adverse Events ARP Average resting pressure References BMI Body Mass Index 1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray CT Computerized Tomography F. Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and PET Positron Emission Tomography Mortality Worldwide for 36 cancers in 185 countries. CA Cancer J Clin. MRI Magnetic Resonance Imaging 2021;71(3):209–49. Shi et al. BMC Cancer (2023) 23:467 Page 7 of 7 2. Dou R, He S, Deng Y, Wang J. 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Neuro- published maps and institutional affiliations. gastroenterol Motil. 2022;34(3):e14208.
BMC Cancer – Springer Journals
Published: May 22, 2023
Keywords: Anorectal function; Locally advanced rectal cancer; Neoadjuvant chemoradiotherapy; Total mesorectal excision; Sphincter preservation treatments
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