| Background:In recent years,with the development of neoadjuvant chemoradiotherapy,and laparoscopic surgery,the technical conditions for anal preservation surgery have become increasingly mature,and the research and application of anal preservation surgery are also increasing.However,postoperative anal dysfunction and impaired quality of life in patients undergoing anal preservation surgery are still the research focus.Based on the fact that internal sphincter and sphincter space nerve damage are the main factors leading to poor anal function in patients after anal preservation surgery,Colorectal Surgery Department of Changhai Hospital innovatively proposed the conformal sphincter preservation operation(CSPO)for low rectal cancer.This procedure designs a conformal resection line based on the shape of the tumor and does not free the sphincter space.It aims to protect the patient’s anal function after surgery by retaining more dental lines and the rectal wall on the opposite side of the tumor,and protecting the autonomic nerves in the sphincter space.The clinical efficacy,anal function,and quality of life of anal preservation surgery are key factors to evaluate its success.Previous studies have preliminarily demonstrated that CSPO is safe and feasible in selecting suitable cases,and can achieve lower position anal preservation compared to low anterior resection(LAR)and abdominal perineal resection(APR).In addition,CSPO related anatomical and pathological studies have further improved the theoretical system of CSPO.However,currently,there is a lack of comparability in research on clinical efficacy after CSPO,and there is also a lack of research on anal function and quality of life after CSPO.Therefore,this study first compares the differences in quality of life before and after CSPO surgery longitudinally,and horizontally compares the differences in clinical efficacy,anal function,and quality of life between CSPO and other anal preservation surgery to clarify the advantages of CSPO in anal sphincter preservation,anal function preservation,and quality of life,and to improve the functional and quality of life system of CSPO.As a new type of anal preservation surgery,after clarifying its advantages,how to promote CSPO is a key issue to be solved in the next step.However,compared to conventional radical resection of rectal cancer,CSPO has many difficulties in surgical procedures such as low level dissociation,conformal resection,and low level anastomosis.In addition,there is currently no clinical experience summary on how beginners can safely and smoothly conduct CSPO learning and training to quickly achieve proficiency.Therefore,this topic aims to establish a foundation for further training and promotion of CSPO and improve the learning and training system of CSPO by analyzing its learning curve and independent risk factors that affect its learning and training.Studies have shown that the quality of life of patients after anal preservation surgery is not only the key to measuring the success of anal preservation surgery,but also an independent risk factor affecting the prognosis of patients.Therefore,the determination of preoperative clinical risk factors that lead to a decline in the quality of life of patients with anal preservation is crucial for preoperative clinical decision-making,intraoperative procedures for high-risk patients,and postoperative disease prevention and treatment for CSPO and other anal preservation operations.However,at present,there are few studies on risk factors for decreased quality of life after anal preservation surgery,and there are currently no relevant clinical prediction models.Therefore,this topic finally analyzes the independent risk factors for the decline in quality of life of patients after anal preservation surgery and constructs a clinical prediction model that can be used for risk prediction to improve the preoperative decision-making system of CSPO.To sum up,this study aims to improve CSPO’s functional and quality of life systems through longitudinal and horizontal comparative studies;Further improve CSPO’s learning and training system through research on its learning curve and risk factors;Finally,through the study of risk factors for the decline in quality of life of patients after anal sphincter preservation surgery and the construction of clinical prediction models,improve their preoperative decision-making system.Part Ⅰ Comparative study of health-related quality of life scores after CSPO and EORTC QLQ-C30 norm and newly derived EORTC QLQ-C30 and CR38 reference values for rectal cancer patientsObjective Firstly,the reference values of EORTC QLQ-C30 and CR38 for rectal cancer patients before surgery were summarized;secondly,data on the quality of life of patients after CSPO were retrospectively collected;finally,the quality of life of CSPO after surgery was compared with the newly derived rectal cancer reference value,healthy population norm,colorectal cancer norm data,and subgroup data to longitudinally demonstrate the advantages of CSPO in preserving quality of life.Methods1.The literature on EORTC QLQ-C30 and CR38 questionnaires for rectal cancer patients published in eight major databases such as Pub Med and CNKI by December 2022 was searched.Gradually screen and evaluate the quality according to the inclusion and excluding criteria,and summarize the preoperative EORTC QLQ-C30 and CR38 reference values for rectal cancer patients.2.Retrospective collection of quality of life data for patients after CSPO.3.Longitudinal comparison of the quality of life of CSPO with reference values,norms,and subgroups.Results1.Gradually screen and evaluate the quality of 3906 EORTC QLQ-C30 related literature and 1301 EORTC QLQ-CR38 related literature retrieved.Finally,the first preoperative EORTC QLQ-C30 and CR38 reference values for rectal cancer patients in the world were successfully summarized.2.The median follow-up time was 35 months.A retrospective follow-up was conducted to collect 105 patients with complete quality of life data after CSPO.3.Compared with the newly derived C30 reference value for rectal cancer,the preoperative C30 norm for colorectal cancer,and the C30 norm for the general population,the postoperative quality of life of CSPO patients can exceed the preoperative level for colorectal cancer,reaching a similar level in the healthy population;Compared with the subgroups of gender,age,and tumor staging of the preoperative C30 norm for colorectal cancer,the quality of life benefits of male patients after CSPO were greater than those of women,while the quality of life benefits of patients in the ≥ 70 year old age group and stage Ⅲ-Ⅳ group were limited compared to other subgroups;Compared with the new preoperative CR38 reference value for rectal cancer,the quality of life related to colorectal cancer after CSPO was comparable to that before surgery,but the scores of sexual function and sexual enjoyment were significantly lower than those before surgery.Conclusions1.After a median follow-up period of 35 months,the quality of life of patients with low rectal cancer undergoing CSPO can be significantly improved compared to preoperative and reach a level comparable to that of the general population.2.For rectal cancer patients aged ≥ 70 years and with tumor stages Ⅲ-Ⅳ,the quality of life benefits of CSPO are limited,and the selection and surgical procedures of anal preservation surgery need to be more cautious.3.Before CSPO,patients should be fully informed of the negative impact of surgery on their sexual function and enjoyment,and actively take measures to promote recovery after surgery.Part Ⅱ Comparative study on clinical efficacy,anal function,and quality of life of CSPO and ISR in the treatment of low rectal cancerObjective A retrospective comparison was made between CSPO and ISR in the treatment of low rectal cancer in terms of clinical efficacy,anal function,and quality of life,to horizontally demonstrate the advantages of CSPO in preserving anus,anal function,and quality of life.Methods1.The clinical data of 117 CSPO patients from Changhai Hospital of Naval Medical University and 66 ISR patients from Huashan Hospital of Fudan University from August 2011 to April 2020 were retrospectively collected.The questionnaire was used to follow up the anal function and quality of life data of these patients with anal preservation surgery.2.A comprehensive comparison was made between the two groups of data to explore the differences in the safety,feasibility,anal preservation,functional preservation,and quality of life preservation of the two types of anal preservation surgery.3.Further,univariate and multivariate analysis was conducted to analyze the influencing factors of patients’ stoma return and postoperative quality of life satisfaction.To explore independent risk factors affecting postoperative stoma return and satisfaction with quality of life in patients with anal preservation surgery.Results1.In terms of baseline data,in the CSPO group,the proportion of male patients is higher,the tumor location is lower,and the proportion of neoadjuvant chemoradiotherapy is higher(P<0.05).There was no significant difference in perioperative data,stoma return,and prognostic data between the two groups,except that the CSPO group had more blood loss,shorter operation time,and shorter postoperative hospital stay(P<0.05).2.There was no statistical difference between the two groups in terms of anal function,C30,and CR38 quality of life(except for social function and male sexual problems),but the CSPO group had higher satisfaction with anal function and quality of life(P<0.05).3.Compared with the ISR group,the CSPO group had a slight decrease in social function dimensions(P=0.028)and a moderate increase in male sexual problems dimensions(P=0.002).However,further univariate and multivariate analyses of social function dimension scores and male sexual problems dimension scores >50 showed that CSPO was not an independent risk factor affecting both.4.CSPO(HR=0.35,P<0.001),age(HR=1.02,P=0.008),p T stage(HR=0.18,P<0.001),and preoperative radiotherapy(HR=0.63,P=0.036)significantly prolonged the time between initial surgery and stomal return.5.CSPO significantly improved patients’ satisfaction with quality of life(B=1.22,P=0.005).Preoperative radiotherapy(B=-1.44,P=0.002)and p T stage(B=-0.56,P=0.024)significantly reduced patients’ satisfaction with quality of life.Conclusions1.The CSPO group has a lower tumor location,a higher proportion of male,and more neoadjuvant chemoradiotherapy,which may lead to more difficult surgery,resulting in more blood loss during surgery.2.Although the surgery in the CSPO group is more difficult,CSPO does not increase the incidence of postoperative complications while ensuring the safety of oncology.In addition,it also shortens the operation time and postoperative rehabilitation time of patients,achieving higher postoperative anal function and quality of life satisfaction than ISR.3.For patients with good physical health and high requirements for anal function and quality of life,CSPO may be a better choice than ISR,which can achieve a balance between anal and functional preservation at a lower position while ensuring the safety of oncology.Part Ⅲ Comparative study on clinical efficacy,anal function,and quality of life of CSPO and modified Bacon in the treatment of low rectal cancerObjective A retrospective comparison was made between CSPO and modified Bacon in the treatment of low rectal cancer in terms of clinical efficacy,anal function,and quality of life,to horizontally demonstrate the advantages of CSPO in preserving anus,anal function,and quality of life.Methods1.The clinical data of 117 CSPO patients from Changhai Hospital of Naval Medical University and 109 patients with modified Bacon surgery from Xiangya Hospital of Central South University from August 2011 to December 2021 were retrospectively collected.The questionnaire was used to follow up the anal function and quality of life data of these patients with anal preservation surgery.2.1:1 propensity score matching(PSM)was performed using the nearest neighbor matching method to eliminate the difference in baseline data between the two groups of patients,with a caliper value of=0.1.The standardized mean difference(SMD)was used to conduct a balance test between the groups before and after PSM,and the SMD <0.2 showed good matching.3.A comprehensive comparison of the data before and after matching between the two groups was conducted to explore the differences in the safety,feasibility,anal preservation,functional preservation,and quality of life preservation of the two types of anal preservation surgery.The duration of anal function recovery is defined as the duration from the time after stoma return of CSPO or modified Bacon II surgery to the time when the patient’s anal function recovers to the point where they can basically control loose stools.4.To further analyze the influencing factors of anal function satisfaction in patients with anal preservation surgery by univariate and multivariate analysis,and explore the independent risk factors that affect anal function satisfaction in patients with anal preservation surgery.Results1.There were 122 and 108 patients in the CSPO and modified Bacon groups,respectively,who were included in the study.There were statistically significant differences in gender,neoadjuvant radiotherapy,tumor distance from the anal verge,CEA,CA199,pT,and pN between the matched two groups(SMD>0.2).After PSM,there were 74 patients in each of the two groups.After PSM,the proportion of neoadjuvant radiotherapy in the CSPO group was still higher(P=0.001,SMD=0.588),while the distance from the tumor to the anal verge in the modified Bacon group was still closer(P=0.003,SMD=0.502),but the SMD was decreased compared to before matching.The remaining baseline data SMD was<0.2,reaching a basic balance between the groups.2.Before and after PSM,the CSPO group had a higher proportion of laparotomy and more surgical bleeding(P<0.05),but the CSPO group had shorter surgical time and shorter postoperative hospital stay(P<0.05).There was basically no statistical difference between the two groups in other clinical and prognostic data.3.There was no statistical difference between the two groups in terms of anal function and quality of life,but patients in the CSPO group had higher satisfaction with anal function and shorter recovery time for anal function(P<0.05).4.Multivariate linear regression analysis showed that preoperative radiotherapy(B=-1.184,P=0.003)and duration of anal function recovery(B=-0.18,P=0.000)were independent risk factors for postoperative anal function satisfaction in patients with anal preservation.Conclusions1.The CSPO group has a higher proportion of laparotomy and more neoadjuvant radiotherapy,which may lead to more difficult surgery,resulting in more blood loss during surgery.2.Although the surgery is more difficult,CSPO can also achieve anal preservation while ensuring the safety of oncology,without increasing the incidence of postoperative complications,and obtain shorter surgical time and postoperative hospital stay.In addition,it can also accelerate the recovery of anal function in patients after surgery,achieving better anal function satisfaction than the modified Bacon.3.CSPO may be a better choice than modified Bacon for patients with good physical health,high requirements for postoperative anal function satisfaction,and rapid recovery of anal function,which can achieve a balance between lower position anal preservation and functional preservation while ensuring oncological safety.Part Ⅳ Study on the learning curve of CSPO application in anus preserving surgery for low rectal cancerObjective Analyze the CSPO learning curve and independent risk factors that affect CSPO learning and training,and establish a foundation for further promotion and training of CSPO.Methods1.Retrospective analysis of 123 CSPO patients undergoing sequential surgery performed by the same surgeon at the Changhai Hospital of Naval Medical University from August 2011 to April 2020 was conducted.The existence of the learning curve was determined using a moving average curve as a measurement index,and the cumulative sum analysis(CUSUM)method was used to draw a cumulative sum curve and calculate the learning and training cutoff value.2.According to the CSPO learning and training cutoff point value,the patients were divided into learning and completion periods,and the clinical and prognostic differences between the two periods were further analyzed and compared.3.CSPO was divided into three groups according to the quartile interval of operation time ranking.Univariate and multivariate analysis were conducted to explore the independent risk factors affecting the operation time of CSPO.Results1.After screening by inclusion and excluding criteria,the data of 108 CSPO patients were included for analysis.It was found that there was a learning curve in CSPO’s learning and training,and the learning curve cutoff value was 45 cases.2.There was no statistically significant difference between the two groups in baseline data compared to the 63 patients in the completion period and the 45 patients in the learning period.However,during the completion period,there was less bleeding,shorter postoperative hospital stay,shorter time to eat fluid,and shorter time to exhaust and defecate(P<0.05).3.Univariate and multivariate analysis of factors influencing the operation time of CSPO showed that the distance from the tumor to the anal verge ≥ 4cm(OR=5.18,P=0.039)and T3 stage(OR=4.38,P=0.022)were independent risk factors affecting the operation time of CSPO.Conclusions1.This study not only proves the existence of the CSPO learning curve through moving average curve and CUSUM,but also further clarifies that surgeons with laparoscopic surgery experience need 45 CSPO operations to complete the learning curve.2.Further univariate and multivariate analysis showed that the distance from the tumor to the anal verge(≥ 4cm)and tumor T3 stage were independent risk factors for prolonged CSPO operation time.3.It is recommended for beginners to choose patients with benign or early malignant tumors(<T3)whose tumors are less than 4 cm from the anal verge for CSPO at the initial stage of learning and training,and further select more complex cases after about 45 CSPO cases.Part Ⅴ Risk factors analysis and prediction model construction of overall quality of life decline after anal preservation surgery for low rectal cancerObjective To explore independent risk factors for the decline in overall quality of life of patients after anal preservation surgery,and construct a clinical prediction model that can be used for risk prediction.Methods1.The quality of life data of patients undergoing three types of anal preservation surgery from August 2011 to December 2021 were retrospectively analyzed.The reference value for new rectal cancer reviewed in the first part of the literature was used as the preoperative baseline level,and the overall quality of life dimension score of the patients after surgery was used as the outcome.To analyze the preoperative independent risk factors for the overall quality of life decline in patients with low rectal cancer undergoing anal preservation surgery.2.To construct a clinical prediction model of overall quality of life decline after surgery using a nomogram,and evaluate the model’s discrimination,calibration,and clinical decision-making ability.Results1.Of the 298 patients with low anal preservation surgery,216 patients with complete quality of life data were included.Univariate and multivariate Logistic regression analysis showed that age ≥ 70 years old(OR=5.69,P=0.001),ASA grade III(OR=6.57,P=0.004),distance of tumor from anal verge ≤ 3cm(OR=3.67,P=0.010),and preoperative neoadjuvant radiotherapy(OR=4.18,P=0.003)were independent risk factors for a decrease in overall quality of life dimension scores after surgery compared to preoperative.2.The nomogram risk prediction model was successfully constructed through R software,with a C-index value of 0.786,which has a good prediction effect.The ROC curve discrimination test and calibration curve calibration test were good,and the bootstrap method resampling internal verification was conducted,with an average absolute error of 0.038.The chi-square value of goodness of fit test was 6.794,P=0.559,indicating a high accuracy of the model.Further evaluation of clinical decision-making ability shows that the model has good net benefits in clinical application.Conclusions1.Age ≥ 70 years,ASA grade Ⅲ,distance of tumor from anal verge ≤ 3 cm,and preoperative neoadjuvant radiotherapy are independent risk factors for overall quality of life decline after anal sparing surgery for low rectal cancer.2.Through multiple verifications of the clinical prediction model for the overall quality of life decline after low anal sphincter surgery using a nomograph,it has been shown that the model has good predictive performance,is helpful for early identification of high-risk populations,and provides guidance and assistance for preoperative decision-making and intraoperative resection procedures,perioperative prevention and treatment,and long-term quality of life management after anal sphincter surgery. |
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