Anal Fissure

Background and Significance Currently there are no consensus guidelines for the best approach to patient with severe hematochezia. One strategy is to perform an urgent colonoscopy (following a colon purge) within 12-15 hours. Although this strategy has been associated with a decreased length of hospitalization and an improved diagnostic and therapeutic yields, it has drawbacks. A major disadvantage of performing an urgent colonoscopy is that the endoscopist can evaluate only the colon and the distal ileum, while more proximal sources of bleeding are not evaluated. Another limitation is that thorough cleansing of the colon is required to facilitate complete evaluation, identification of stigmata of recent hemorrhage and lesion diagnosis. Urgent colonoscopy is labor intense and relies on a dedicated bleeding team with expertise in both diagnosis and hemostasis. Another option for patients with persistent or recurrent hematochezia is to perform either a tagged RBC scan or an angiogram to identify the bleeding location. However, these techniques also have major disadvantages, including low diagnostic yields for severe hematochezia, requiring additional tests for diagnosis, and cannot visually detect non-bleeding stigmata of hemorrhage on lesions that can be seen during colonoscopy or by capsule endoscopy. Research Design and Methods This is a study of patients who being admitted to the hospital for severe hematochezia or inpatients who developed hematochezia after hospitalization for an unrelated non-GI bleeding reason. Those who meet entry criteria and lack exclusions on screening before will being asked to participate in this study. After informed consent, patients will be a colon preparation prior to ingestion of the colon capsule. The capsule recording system will be activated once patients swallow the capsule. Once the capsule has been excreted or if the capsule stops recording images (usually 10 hours after activation), the video recorder will then be taken to a workstation and the video will be downloaded for reading. In addition to having the capsule endoscopy, all consented patients will undergo standard tests for the initial diagnosis and management of severe hematochezia: tagged RBC scan and/or computerized tomographic angiography (CTA), magnetic resonance imaging (MRI) angiogram, or conventional angiography. Because of contra indication, MRI angiography will not be performed until the capsule has been excreted, nor will CT angiography because the capsule may interfere with interpretation. All patients will also have urgent colonoscopy after clearing the colon of blood and stool with the purge. All of these diagnostic procedures will be performed within 48 hours of GI consultation, but ideally as soon as possible. If a bleeding site is not identified by colonoscopy, further diagnostic workup are usually performed as part of the standard of care, including anoscopy, esophagogastroduodenoscopy, push enteroscopy, or deep enteroscopy. If bleeding continues or worsens, surgery may be necessary to control the bleeding. The GI endoscopist, nuclear medicine physician, and radiologist will be blinded to the results of the capsule endoscopy until 24 hours after the other diagnostic tests (i.e. tagged RBC scan, angiography, and endoscopy/colonoscopy) have been performed. Then the results of all tests will be unblinded. This will be done for the purpose of not delaying clinical management, but also to avoid biasing the interpretations of these diagnostic studies. Data Collection and Monitoring Demographic data and medical history including details of co-morbid illnesses, risk factors, and characteristics of the GI bleeding will be recorded. Reasons for exclusion will be documented. Baseline physical examinations, American Society of Anesthesiology (ASA) classification, laboratory results, Blatchford-Glasgow score, units of blood products transfused, and results of the real-time viewer will also be recorded. Results of RBC scanning, angiography, capsule endoscopy, endoscopy, pathology, and surgery will be recorded. The outcomes including rates of re-bleeding or persistent bleeding, treatment of bleeding at endoscopy or radiology, need for surgery, major complications, transfusions after initial resuscitation, hospital and intensive care unit days, and death will be prospectively recorded up to the time of hospital discharge and 30 days following discharge. Subgroup analysis regarding results of urgent colonoscopy/enteroscopy will be performed to assess for differences in diagnostic yield and therapeutic interventions between different endoscopists. The number of patients who experience any difficulties in capsule swallowing will be recorded, including inability to swallow the capsule, incomplete examination of small bowel or colon, and capsule retention. Sample size calculation The initial sample size estimate was made from results of our prior comparative retrospective study of small bowel capsule endoscopy in patients with severe hematochezia. In that study, the diagnostic yield of tagged red blood cell scanning and/or CTA was 47% and the urgent capsule endoscopy was 67%. For 80% power to detect a 20% difference in diagnostic yield at a 0.05 level, a sample size of 46 patients was calculated. Accounting for patients who consented but had incomplete testing, 14 additional patients would be enrolled for a total of 60 patients. Based upon actual May 2022 preliminary results of 11 patients who were hospitalized with severe hematochezia and completed the diagnostic testing with both standard imaging and colon capsule, a revised study sample size was estimated. This was based upon a diagnostic yield of RBC scanning or angiography of 25 % and the diagnostic yield of colon capsule of 75% for patients with severe hematochezia. With this 50% difference in diagnostic yield (for both bleeding site localization and lesion diagnosis), 19 total patients would yield statistically significant results. This is with a very conservative estimate for an alpha of 0.05 and 90% power - a beta of 0.10 with two-tailed testing. Including those patients who consented but have incomplete testing, we propose a total enrollment of 23 patients. This is a new sample size to complete the study. Statistical analysis methods A descriptive analysis will be performed for baseline demographic characteristics. Continuous data will be summarized as means ± standard deviations and categorical data will be summarized as percentages. The primary end point of the study will be the diagnostic yield (defined as the frequency of detection and percentage of positive results) for each technique for the localization of the bleeding site and/or etiologic diagnosis (e.g. definitive if stigmata of recent hemorrhage are found or presumptive if a clean lesion is diagnosed and no other lesions are found by complete evaluation). The diagnostic yield of each technique will be calculated and compared by the McNemar test for paired data using exact methods. The sensitivity, specificity, and accuracy will be determined for lesion localization; absence of lesions in the foregut, small bowel, or colon; and etiologic diagnosis (definitive or presumptive) for capsule endoscopy, tagged red blood cell scan/angiography, and endoscopy. The final diagnosis by endoscopy, angiography, pathology, and surgery will be considered the gold standard. Concordance between each diagnostic strategy will be calculated and reported with the kappa index. A p-value of less than 0.05 will be considered statistically significant. Confidentiality: Study data will be physically and electronically secured. All personal information will be replaced with a code de-identifying subject's information. The researchers will do their best to make sure that all subject's private information is kept confidential as possible. Data Management Records will be labelled with a code number and then only de-identified information will be entered into our encrypted Statistical Analysis System (SAS) electronic database located at the VA West Los Angeles. No identifiable information about them will be kept in the electronic research data files. All personal information will be replaced with a code. A list linking the code and their identifiable information will be kept separate from the research data files in a locked file in the research team's office located at VA West Los Angeles. (VA CURE GI Hemostasis Research Unit). This list will be protected by the Principal Investigator (Dennis Jensen, MD) and the research team. At the end of the study, the investigators will destroy this link and no one - not even the researchers - will be able to connect their identity to the research data. Future Use of Data After the study finishes, the research team will continue to use the patient's de-identified medical data from their medical history, laboratory results, labs, radiological, surgical, and pathology results, and colonoscopy results and information on their medical progress to continue to analyze and to report new GI research results. Data and Safety Monitoring Plan Adverse events The following adverse event information will be prospectively collected: capsule retention rates and those requiring endoscopic removal, perforations, aspiration, myocardial infarctions, strokes, and deaths within 30 days of enrollment. Frequency Safety data will be collected daily while hospitalized and weekly after discharge from the hospital, up to 30 days after enrollment. Data collection will start as soon as the patient enrolls in the study and swallows the capsule. Review Cumulative safety data will be reviewed every 30 days. All serious adverse events (SAE's) will be reported to the IRB as mandated by the VA research service. The safety data will be overseen by the PI and the biostatistician. All results will be reported to the IRB, who will review all SAE's. Based upon widespread utilization and safety of capsule endoscopy for small bowel bleeding since 2001 in the U.S. and many other countries worldwide, the investigators do not expect any clinical condition which would trigger an immediate suspension of this research study.

Historically, pregnancy and childbirth has been erroneously considered to be an innocuous physiological event. However, vaginal delivery may be associated with perineal injury, a common occurrence affecting up to 80% of women. Perineal injury is classified into four categories, as per the Sultan classification: Grade 1: involvement of perineal skin +/- vaginal mucosa Grade 2: involvement of perineal muscles Grade 3a: \<50% External Anal Sphincter (EAS) Grade 3b: \>50% EAS Grade 3c: EAS + Internal Anal Sphincter (IAS) Grade 4: Grade 3c + anorectal mucosa The latter two categories are associated with considerable morbidity and are known as obstetric anal sphincter injuries (OASIS). OASIS encompass grade 3 and 4 perineal tears and effect the integrity of the anorectal sphincter complex, with or without involvement of the anorectal mucosa. Such injuries may be associated with a myriad of devastating and stigmatizing sequelae, including faecal and urinary incontinence, dyspareunia, rectovaginal fistulae, perineal pain and pelvic organ prolapse, which in turn may have a negative impact on a woman's quality of life and day-to-day living. Indeed, sustaining an Obstetric Anal Sphincter Injury (OASI) has been associated with both physical and psychological sequelae. Symptoms of urgency and urge faecal incontinence, are suggestive of damage to the external anal sphincter, while symptoms of passive leakage are indicative of damage to the internal anal sphincter. Not all women with OASIS are symptomatic. Symptomatic OASIS occurs in about 30-50% of women. It is important to note that the real incidence may be higher as it may very well be underreported. The incidence of OASIS in the UK is 2.9%. Although OASIS is uncommon, the rate of OASIS in singleton, cephalic and first vaginal deliveries, has reportedly tripled from 1.8% to 5.9% from 2000 to 2012. This may, however, be secondary to better detection of these injuries following improvements in education, training and the utilization of a standardized classification system for perineal tears. To address the rising OASI rates, the OASI care bundle was introduced which primarily focused on interventions in the antenatal period to reduce the incidence of OASIS. Prevention of OASIS, however, will not always be possible, even with the best efforts of care. Therefore, focus should also be placed on the optimal management of these patients' post-partum. The RCOG (royal college of obstetricians and gynaecologists) guidance states that clinicians should diagnose an OASI at the time of delivery by meticulous inspection of the perineum, which should include a digital rectal examination. Referral to a colorectal specialist should be considered in those who are symptomatic of incontinence. However, in the absence of a standardised national pathway, the provision of healthcare appears to rely heavily on the availability of resources, a clinician's discretion and ultimately a 'postcode lottery'. Indeed, while some trusts may have the necessary provisions in place to support mothers with OASIS, in other areas, women may be left to fend for themselves. Moreover, the stigma and shame associated with sustaining such an injury may perpetuate the difficulty in seeking medical attention, even in the most motivated patients, thereby producing a population of silent sufferers, who are stuck in a pervasive pattern of shame, embarrassment and inevitably, melancholy. There may also be the erroneous belief among healthcare professionals, that these symptoms would settle on their own and this may be communicated to the afflicted individual who may be reassured by this information. Although 60-80% of women are asymptomatic at one year, some remain symptomatic, with devastating consequences on their quality of life. Further, patients with an asymptomatic injury ought to be counselled regarding the risk of incontinence in later life, secondary to advancing age and hormonal influence on pelvic floor function as well as the added impact of future deliveries. When discussing mode of delivery for future pregnancies, it should be highlighted that although an elective caesarean section may protect against an anal sphincter injury, it may not prevent pudendal neuropathy which may also contribute to symptoms of incontinence.

The study was a prospective, multicenter, real-world study with eligible patient data as of May 1, 2024. The prospective study was a continuous, multicenter study.

A chronic anal fissure is a rupture of the mucous membrane of the anal canal, lasting more than 2 months and resistant to non-surgical treatment. This condition is accompanied by a strong pain syndrome during and after defecation (defecation). This condition is most often found in young and ablebodied adults, so the issue of treatment is of particular relevance. The main cause of the development of a chronic anal fissure is a spasm of the internal sphincter. It should be eliminated first of all to ensure effective therapy. All the main treatment methods, such as medicinal relaxation of the internal sphincter with 0.4% nitroglycerin ointment, lateral subcutaneous sphincterotomy, and pneumodivulsion of the anal sphincter are aimed at its removal. However, the optimal method has not yet been developed. Non-surgical treatments are often attended by relapse of disease, while surgical treatment is often complicated by intestinal contents incontinence, usually gas and loose or hard stool in some occasions (grade 3 anal sphincter insufficiency). In particular, lateral subcutaneous sphincterotomy performed in such patients is associated with an increase in the degree of anal incontinence in the early postoperative period. Botulinum Toxin Type A application in treatment of patients with chronic anal fissure (after fissure excision) is intended to improve the therapy results, namely to reduce the frequency and duration of anal sphincter insufficiency after sphincter spasm removal (reduction in the number of patients suffering from post-operative incontinence)

Trial Design: This trial is designed as a 1:1:1 randomized, controlled, parallel design. The primary endpoints are change in pain score and wound healing from baseline to 1 week from the study start date; secondary endpoints are change in pain score and wound healing at 6 and 10 weeks from the study start date, defecation strain score \& the patient's global impression of improvement at 10 weeks. Assessments \& Visits: The patient will be assessed for pain, wound healing, strain during defecation, impression of improvement, \& adverse events at weeks 1, 6 \& 10 after the study start date. Trained resident or research assistant (RA) will administer the questionnaires on pain score, strain during defecation, \& patient's global impression of improvement. During the follow-up visits, the average score for each of the pain \& defecation strain scores will be taken for the 3 most recent days that the patient has defecated. The patient will be given a paper diary to record the pain score \& strain score during defecation 3 days prior to the follow-up clinic visit. Sample Size: The investigators will design this superiority trial as three-arm trials, where one arm is Diltiazem, second is MEBO, \& last is a combination of both. Assuming that the pain score difference between both treatments will be 0.5 points with a 1-point standard deviation on the numeric rating scale (5 for DTZ \& 3 for combination arm DTZ \& MEBO), \& using an alpha of 0.05 \& a power of 80%, a sample size of 47 patients in each arm is needed. After accounting for a 30% loss to follow up, 61 patients will need to be recruited in each arm. The total number of patients to be recruited in the three arms is 183 patients. Recruitment: At the American University of Beirut Medical Center, patients with acute anal fissure are treated at the outpatient center (private \& outpatient clinics) of the hospital by all the general surgeons. The patients will be introduced to the study by their attending physician. If the patient agrees to participate, the RA (part of the research team) will approach \& screen the patient according to the defined inclusion \& exclusion criteria. If the patient is found eligible for the study, the RA will discuss the study \& obtain his/her informed consent. The expected recruitment rate is 4 patients/week. The first 2 visits of the patient to the clinic at weeks 1 \&6 from the start date of the study are part of clinical care \& the patient will not be reimbursed for these visits. The last visit to the clinic that will take place at week 10 will be for follow-up as part of the research, so the patient and physician will be reimbursed for transportation and professional fees, respectively, by the research grant. ASSIGNMENT OF INTERVENTIONS Sequence Generation: Participants will be randomly assigned to their treatment in a 1:1:1 ratio, according to a computer-generated schedule, stratified by type of treatment (MEBO or DTZ), using permuted blocks of variable sizes. Allocation Concealment Mechanism: Random sequence generation will be selected by CRI biostatistician using computer software. The CRI person will hold details of the blocking \& block sizes in a separate document unavailable to those involved in the study so ensure allocation concealment. The CRI person will not share the treatment intervention with study personnel until baseline characteristics are collected, \& the patient is recruited into the trial. The physician will contact the CRI biostatistician \& receive treatment allocation, so he/she can prescribe the ointment to which the patient is randomized to. Implementation: The CRI biostatistician, who is not involved in this study, will generate the randomization sequence \& keep hold of it. The patient will be recruited \& consented without any knowledge about their allocation arm. The allocation will be revealed only to the physician to administer the treatment. Blinding: The physician \& the patient will not be blinded to the allocation, but the rest of the study team will be blinded. It is difficult to blind the physician or patient because of the characteristic smell of MEBO that is easily recognizable. Also blinded to allocation is the physician who will assess for outcomes, the RA who are collecting the data, \& data analyst. DATA COLLECTION, MANAGEMENT, \& ANALYSIS Data Collection Methods: Data on basic demographics of the study subjects, relevant risk factors, confounders, \& indication for the type of treatment will be collected at baseline using protocol-specific standardized case report forms (CRF). The CRF will be completed by the RA directly from patients, following informed consent \& prior to the administration of treatment. The different sections of that data will be collected at the different points in time of the study by questionnaires administered by the study RA to the patient. Evaluators are requested to fill immediately a case report form each time an outcome evaluation on a study subject is performed. These forms will be handed in the same setting to the RA who will take care of storing them. To improve retention \& compliance to the study, the investigators will contact the patient ahead of time, \& help schedule their clinic visits on time to collect the outcomes. When a patient fails to comply with the follow-up exams, the investigators will collect applicable data on the phone (Appendix C). For those who drop from the study, the investigators will analyze their basic demographic \& disease data to determine whether or not those are similar to those who stayed on the study. Data Management: The RA will enter the data from the CRFs on the study data excel sheet within 1 week of its collection. The data will be manually entered twice \& independently by the RA \& another member of the study team. Data will be entered as the actual numeric values or categorical variables, initially. In the end, the statistician will code all the data in preparation for analysis. The principal investigator (PI) will perform spot checks on the data \& will review weekly all the CRF \& assessment collection sheets performed within each week. At AUBMC, data will be stored on the AUB intranet server on the PI's computer. All research members will have access to the data. The Case Report Forms will be stored in a locked cabinet in the PI office 3 years following the publication of study results. The investigators will provide an SOP detailing data management procedure to ensure consistency in case of a change in the study members. Audits will be performed monthly on 20% of the charts. Statistical Methods: the investigators will compare the three arms for the primary, secondary, \& exploratory outcomes. The investigators will use the chi-square or Fischer exact test if the expected count of any of the outcomes is less than 5 per cell for analysis of the incidence of categorical outcomes (like wound healing). The investigators will use the independent t-test for analysis of the continuous outcomes (like pain score, defecation strain score, Patient's Global Impression of Improvement). The investigators will calculate relative risk with corresponding 95% confidence intervals to compare the incidence of the categorical outcomes while reporting a difference in means for the continuous outcomes. SPSS version 20 will be used to conduct the analysis. A 2 sided p-value will be set at 5%. The univariate analysis will be performed separately for the two primary outcomes \& the three secondary outcomes at weeks 1, 6 \& 10. Multivariate analysis for change in pain score \& wound healing will be performed using linear regression and logistic regression respectively, controlling for age, gender, duration of the anal fissure since presentation, analgesic medications intake (only with pain score), defecation strain score. The investigators will perform both ITT \& PP analysis for all outcome measures. The ITT analysis will include all patients randomized per arm. In case of failure of treatment in one of the arms, those who will switch to another arm will be still analyzed as part of the arm initially randomized to. Multiple imputation methods will be used to handle missing data. To assess the effect of missing data on the analysis, sensitivity analyses will be performed. The study biostatistician will perform the best case scenario, worst-case scenario, \& group averages. The investigators will assess the baseline characteristics of those who will be lost to follow up, which would help understand what were the potential outcomes. DATA MONITORING Data Monitoring Committee: The DMC will be independent of the PI \& funders of the trial \& composed of a surgeon, an internist, a nurse, a biostatistician, \& a representative from the patient advocacy office at AUBMC. The internist will have a clinical research background. The nurse is chosen from the inpatient floors, to make sure that there is no interaction with study subjects. All members should not have any conflict of interest related to the study. The DMC will be chaired by the internist, who has to keep a record of the meetings \& recommendations for future reference. Since this is an investigator-initiated trial, the PI will appoint the DMC members. The DMC will meet every other month, at times of scheduled interim analysis, \& upon conclusion of the study. The primary role of the DMC is to review accumulating data \& alert the steering committee if there are alarming rates of side effects (SE) in any arm of the trial. This committee doesn't have executive power to stop the trial or modify treatment. The committee will report results to the PI. In addition, the DMC will keep track of the accrual rate. Interim Analysis: The interim analysis will be done 3 times throughout the study; upon recruiting quarter, two-quarters, \& three-quarters of the study population. The study biostatistician who is blind to the treatment allocations will conduct the interim analysis \& will use the O'Brien Fleming stopping rules. The study biostatistician will report the results of the interim analysis to the DMC confidentially. At each interim-analysis interpretation, the DMC will alert the PI if one arm is found to be beyond doubt either more beneficial or more harmful than the other arm. The PI will take into consideration the results of the interim analysis, opinion of the DMC, \& various important factors to decide upon the fate of the trial. The chairperson of the DMC will monitor the ClinicalTrials.gov website for registration of new trials \& for newly reported results from trials addressing the similar questions as this trial. Harms: The adverse effects can be part of the outcome measures detailed earlier in the protocol or other not specified SEs. Either way, any SE will be reported \& the subject will be managed according to the standard of care or the preference of the treating physician. In case any adverse effects arise outside scheduled follow-up time, the patient will be seen by the treating physician in an extra add-on visit. Those who fail (meaning those who do not report any pain improvement after two weeks of treatment) from either the MEBO or the Diltiazem arm will be switched to the combination arm. If these patients also fail to improve after 2 weeks on the combination arm, then the patient will be offered surgery. If the patient refuses to switch to the combination arm \& wishes to proceed to surgery immediately, then the patient will be directed to surgery. In case of failure of the treatment, which is after 6 weeks of treatment, the patient will undergo surgery. The patient may also undergo surgery in case he/she decides to stop medical therapy during the treatment period \& proceed to surgery. There is no standard for the risk of failure of topical therapy to necessitate surgery. Hence, the risk of failure cannot be evaluated with the use of MEBO. The primary physician who is treating the patient will be responsible for the management of the SEs.

Chronic anal fissure is a rupture of anal canal mucosa lasting for more than 2 months and resistant to non-surgical treatment. This condition is attended by severe pain syndrome during and after bowel movement (defecation). This condition is most frequent in younger and working-age adults; therefore, the treatment issue is of particular relevance. The main cause of chronic anal fissure development is spasm of the internal sphincter. It should be eliminated in the first instance, in order to provide the effective therapy. All the main treatment methods, such as medicinal relaxation of the internal sphincter with 0.4% nitroglycerin ointment, lateral subcutaneous sphincterotomy, and pneumodivulsion of the anal sphincter are aimed at its removal. However, the optimal method has not yet been developed. Non-surgical treatments are often attended by relapse of disease, while surgical treatment is often complicated by intestinal contents incontinence, usually gas and loose or hard stool in some occasions (grade 3 anal sphincter insufficiency). In particular, lateral subcutaneous sphincterotomy performed in such patients is associated with an increase in the degree of anal incontinence in the early post-operative period. Botulinum Toxin Type A application in complex treatment of patients with chronic anal fissure (after fissure excision) is intended to improve the therapy results, namely to reduce the frequency and duration of anal sphincter insufficiency after sphincter spasm removal (reduction in the number of patients suffering from post-operative incontinence).

This Phase 1b trial is conducted to evaluate the initial safety and efficacy of local (percutaneous) injections of E-CEL UVEC cells, genetically-engineered (pro-survival gene, E4ORF1+), human umbilical vein endothelial cells, as an experimental treatment of patients with chronic anal fissure (CAF) who have failed medical therapy (i.e., topical vasodilators ± botulinum injection). The study is a non-randomized, open-label, single arm study, meaning every study participant will receive some dose of the experimental study drug (no placebo). Consented, eligible participants will receive percutaneous injections of E-CEL UVEC cell product along the sides of the fissure; the treatments are spaced 3 to 4 weeks apart. Initial safety and efficacy parameters will be observed over a 6-month period, followed by a long-term follow-up consisting of annual questionnaire provided by electronic means. This research study is being done because, in animal studies, E-CEL UVEC cells have been shown to aid in restoring or accelerating the normal healing in various tissues. This study will test if it is safe to use E-CEL UVEC cell therapy and if they it would aid in restoring or improve healing of CAF that was not responding to medical therapy. Improvement of CAF would be assessed in a standard, clinical manner (using brief digital palpation by the doctor), a method acceptable to the FDA, versus the original method (detailed quantitative photo-documentation). This study is being led by Dr. Kelly Garrett, Associate Professor of Surgery, and conducted by surgeons in the Colon and Rectal Surgery Division of Weill Cornell Medical College.

This study aims to assess the role of Enhanced recovery after surgery(ERAS) protocol in reducing postoperative urine retention (POUR) after surgery for benign anorectal conditions. Patients of both sexes aged between 18 and 90 years old presented; with benign anorectal conditions including chronic anal fissure, hemorrhoids, and fistula-in-ano will be eligible for the study. Eligible patients will be randomized in equal proportions to RRAS or ROUTINE pathways. The ERAS pathway was developed based on the available guidelines and protocols it includes 14 items. Patients allocated to ERAS pathway must fulfill all the 14 items. The ROUTINE pathway will represent the routine practice which may include certain ERAS items or those who will not fulfill the 14 items. For the end points of the study, all patients will be followed-up by a phone call 72 hours postoperatively then in the outpatients' department for a period of a total of 30 days postoperatively. However, patients will be advised to visit the outpatients' department at any other time during the trial if they developed any unfavorable event. The primary outcome will be the 72-hours postoperative urinary retention after anorectal surgery.

The study, "Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery," aims to evaluate the impact of preoperative listening to standardized music sequences on postoperative pain in patients undergoing proctologic surgery (for hemorrhoids, fistulas, or anal fissures). This research will assess the influence of preoperative music on postoperative pain management, the use of analgesics after surgery and during the following month, and its effect on the quality of life post-surgery. MUSICO-PROCTO is an interventional, randomized study involving two groups (patients will be randomly assigned to either the music intervention or control group). The study is monocentric, conducted at Clinique Saint Vincent in France, and includes 550 participants. Participants will be followed for 28 days, while the overall study duration will span 28 months. To participate, individuals must: Be aged 18 or older. Be affiliated with a social security system. Provide signed informed consent. Undergo proctologic surgery for hemorrhoids, fistulas, or anal fissures. This study seeks to explore the potential of music as a complementary method to improve postoperative outcomes.

A primary diverting stoma is widely used by surgeons in order to bypass the low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Today a stoma is created for all high-risk patients even though the expected anastomotic leak rate is less than 20%. This means that 80% of patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit. CG-100, a removable, temporary intraluminal bypass device, developed by Colospan, is designed to address this need by safely postponing the creation of a protective stoma until 10 days after surgery only for patients who need it (i.e. have a defect in the anastomosis); thereby allowing patients with an intact anastomosis a quicker and safer return to normal activity.