Light-modulated neural control of sphincter regulation in the evolution of through-gut.

The development of a continuous digestive tract, or through-gut, represents a key milestone in bilaterian evolution. However, the regulatory mechanisms in ancient bilaterians (urbilaterians) are not well understood. Our study, using larval sea urchins as a model, reveals a sophisticated system that prevents the simultaneous opening of the pylorus and anus, entry and exit points of the gut. This regulation is influenced by external light, with blue light affecting the pylorus via serotonergic neurons and both blue and longer wavelengths controlling the anus through cholinergic and dopaminergic neurons. These findings provide new insights into the neural orchestration of sphincter control in a simplified through-gut, which includes the esophagus, stomach, and intestine. Here, we propose that the emergence of the earliest urbilaterian through-gut was accompanied by the evolution of neural systems regulating sphincters in response to light, shedding light on the functional regulation of primordial digestive systems.

3D spheroids versus 2D-cultured human adipose stem cells to generate smooth muscle cells in an internal anal sphincter-targeting cryoinjured mouse model.

BACKGROUND: The efficacy of cell implantation via 3D-spheroids to treat basal tone in fecal incontinence remains unclear. To address this, in this study, we aimed to identify cell differentiation and assess the development of a contractile phenotype corresponding to smooth muscle cells (SMCs) following implantation of 3D-spheroid and 2D-cultured human adipose stem cells (hASCs) in an in vivo internal anal sphincter (IAS)-targeted mouse model. METHODS: We developed an IAS-targeted in vivo model via rapid freezing (at - 196 °C) of the dorsal layers of the region of interest (ROI) of the IAS ring posterior quarter, between the submucosal and muscular layers, following submucosal dissection (n = 60 rats). After implantation of tetramethylindocarbocyanine perchlorate (Dil)-stained 3D and 2D-cells into randomly allocated cryoinjured rats, the entire sphincter ring or only the cryoinjured ROI was harvested. Expression of SMC markers, RhoA/ROCKII and its downstream molecules, and fibrosis markers was analyzed. Dil, α-smooth muscle actin (α-SMA), and RhoA signals were used for cell tracking. RESULTS: In vitro, 3D-spheroids exhibited higher levels of SMC markers and RhoA/ROCKII-downstream molecules than 2D-hASCs. The IAS-targeted cryoinjured model exhibited substantial loss of SMC layers of the squamous epithelium lining of the anal canal, as well as reduced expression of SMC markers and RhoA-related downstream molecules. In vivo, 3D-spheroid implantation induced SMC markers and contractile molecules weakly at 1 week. At 2 weeks, the mRNA expression of aSma, Sm22a, Smoothelin, RhoA, Mypt1, Mlc20, Cpi17, and Pp1cd increased, whereas that of fibrosis markers reduced significantly in the 3D-spheroid implanted group compared to those in the sham, non-implanted, and 2D-hASC implanted groups. Protein levels of RhoA, p-MYPT1, and p-MLC20 were higher in the 3D-spheroid-implanted group than in the other groups. At 2 weeks, in the implanted groups, the cryoinjured tissues (which exhibited Dil, α-SMA, and RhoA signals) were restored, while they remained defective in the sham and non-implanted groups. CONCLUSIONS: These findings demonstrate that, compared to 2D-cultured hASCs, 3D-spheroids more effectively induce a contractile phenotype that is initially weak but subsequently improves, inducing expression of RhoA/ROCKII-downstream molecules and SMC differentiation associated with IAS basal tone.

Clinical practices in the management and follow-up of obstetric anal sphincter injuries: a comprehensive review.

OBJECTIVES: To review and compare existing guidelines on the intrapartum management and postpartum follow-up of obstetric anal sphincter injuries (OASIS) METHODS: We conducted a systematic review of clinical guidelines related to OASIS management, focusing on intrapartum care and postpartum follow-up. Searches were performed in July 2024 across multiple databases, including PubMed, Embase, and the Cochrane Library. Guidelines published after 2010 in English were included. RESULTS: Nine national guidelines were included. There was a consensus on OASIS classification and immediate management, particularly regarding suture techniques, materials, and the necessity of adequate analgesia. However, notable variations were identified in the timing of repair, specialist involvement, use of prophylactic antibiotics, and post-operative care protocols. Postpartum follow-up practices also varied, especially regarding the role of physiotherapy and the timing of specialist consultations, reflecting inconsistencies in long-term care recommendations. CONCLUSION: Significant variability existed in the guidelines for the management and follow-up of OASIS, particularly in postpartum care. This study underscored the need for standardized, evidence-based guidelines to ensure consistent and optimal care for women affected by OASIS.

Viral whole genome sequencing reveals high variations in APOBEC3 editing between HPV risk categories.

High-risk human papillomavirus (HPV) infections are responsible for cervical cancer. However, little is known about the differences between HPV types and risk categories regarding their genetic diversity and particularly APOBEC3-induced mutations - which contribute to the innate immune response to HPV. Using a capture-based next-generation sequencing, 156 HPV whole genome sequences covering 43 HPV types were generated from paired cervical and anal swabs of 30 Togolese female sex workers (FSWs) sampled in 2017. Genetic diversity and APOBEC3-induced mutations were assessed at the viral whole genome and gene levels. Thirty-four pairwise sequence comparisons covering 24 HPV types in cervical and anal swabs revealed identical infections in the two anatomical sites. Differences in genetic diversity among HPV types was observed between patients. The E6 gene was significantly less conserved in low-risk HPVs (lrHPVs) compared to high-risk HPVs (hrHPVs) (p = 0.009). APOBEC3-induced mutations were found to be more common in lrHPVs than in hrHPVs (p = 0.005), supported by our data and by using large HPV sequence collections from the GenBank database. Focusing on the most common lrHPVs 6 and 11 and hrHPVs 16 and 18, APOBEC3-induced mutations were predominantly found in the E4 and E6 genes in lrHPVs, but were almost absent in these genes in hrHPVs. The variable APOBEC3 mutational signatures could contribute to the different oncogenic potentials between HPVs. Further studies are needed to conclusively determine whether APOBEC3 editing levels are associated to the carcinogenic potential of HPVs at the type and sublineage scales.

A study of intersphincteric resection rate following robotic-assisted total mesorectal excision versus laparoscopic-assisted total mesorectal excision for patients with middle and low rectal cancer: study protocol for a multicenter randomized clinical trial.

INTRODUCTION: Robotic-assisted complete mesorectal excision (RATME) is increasingly being used by colorectal surgeons. Most surgeons consider RATME a safe method, and believe it can facilitate total mesorectal excision (TME) in rectal cancer, and may potentially have advantages over intersphincteric resection (ISR) and anus preservation. Therefore, this trial was designed to investigate whether RATME has technical advantages and can increase the ISR rate compared with laparoscopic-assisted TME (LATME) in patients with middle and low rectal cancer. METHODS AND ANALYSIS: This is a multicenter, superiority, randomized controlled trial designed to compare RATME and LATME in middle and low rectal cancer. The primary endpoint is the ISR rate. The secondary endpoints are coloanal anastomosis (CAA) rate, conversion to open surgery, conversion to transanal TME (TaTME), abdominoperineal resection (APR) rate, postoperative morbidity and mortality within 30 days, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life. In addition, certain measurements will be conducted to ensure quality and safety, including centralized photography review and semiannual assessment. DISCUSSION: This trial will clarify if RATME improves ISR and promotes anus preservation in patients with mid- and low-rectal cancer. Furthermore, this trial will provide evidence on the optimal treatment strategies for RATME and LATME in patients with mid- and low-rectal cancer regarding improved operational safety. TRIAL REGISTRATION: ClinicalTrials.gov NCT06105203. Registered on October 27, 2023.

One stage anterior sagittal sphincter saving anorectoplasty (ASSSARP) for the repair or rectovestibular fistula: mid and long-term outcome in two tertiary centers.

PURPOSE: This is a retrospective study of one-stage anterior sagittal sphincter saving anorectoplasty (ASSSARP) for repairing rectovestibular fistula (RVF) including operative details and postoperative complications, functional and cosmetic outcome. PATIENTS AND METHODS: Records of 41 cases of RVF, managed between April 2010 and September 2019 by one-stage ASSSARP, were reviewed. Preoperative preparation, both early and late postoperative care & complications, hospital stay, and functional & cosmetic outcomes were reported. RESULTS: The mean age was 6.6 months. Vaginal tear occurred in 5/41 cases, and distal rectal tears in 4/41 cases. Thirteen patients suffered mild superficial wound inflammation; while Skin dehiscence; occurred in five patients. No colostomy or redo was needed. The mean hospital stay was 6.1 days. Mean follow-up was 43.13 months; (Range; 24-100 months). Subclinical anal stricture was detected in six patients. Constipation occurred in 14 cases. Soiling grade I occurred in five patients. Thirty-two patients reached past the age of three years; two of whom showed cough/diarrhea incontinence. CONCLUSION: One-stage ASSSARP is safe and gives functional and cosmetic results comparable to other techniques. It provides better access during RVF repair. The avoidance of muscle incision protects against muscle breakdown, if infection sets in, and thus against incontinence. It avoids the morbidity, cost and psychological burden of performing a three-stage repair.

[Comparative analysis of the characteristics of high-resolution anorectal manometry in children with outlet obstructive constipation of different age groups].

Objective: To compare the characteristics of high-resolution anorectal manometry (HR-ARM) in children with outlet obstructive constipation (OOC) in different age groups. Methods: Retrospective inclusion of clinical data of functional constipation (FC) patients who underwent HR-ARM examination in the Department of Gastroenterology of Children's Hospital Affiliated of Zhengzhou University from January 2019 to September 2023 was conducted. The patients were divided into low age group (4 years old≤age<6 years) and high age group (6 years old≤age≤15 years old) according to age. They were divided into OOC group (the pediatric patients with uncoordinated pelvic floor muscle contractions, insufficient rectal thrust during defecation, or insufficient relaxation of anal sphincter muscles during contraction) and non-OOC group based on HR-ARM results. The rectal motility [rectal resting pressure, maximum squeeze pressure (MSP), rectal pressure during force delivery, residual anal pressure, rectal anal pressure gradient], rectal sensory function (initial rectal sensory capacity threshold, initial fecal sensory capacity threshold, defecation distress capacity threshold, and maximum tolerance capacity threshold) and other indicators were compared between OOC group and non-OOC group in 2 age groups, respectively. Results: A total of 228 children with FC were included, including 146 males and 82 females, with an age [M (Q1, Q3)] of 7.5 (6.0, 9.7) years, including 54 in the low age group and 174 in the high age group. There were 131 cases in the OOC group and 97 cases in the non-OOC group. Compared with non OOC children (24 cases), there were no statistically significant differences in rectal resting pressure, anal sphincter resting pressure, MSP, rectal pressure during force delivery, initial rectal sensory capacity threshold, initial fecal sensory capacity threshold, defecation distress capacity threshold, and maximum tolerance capacity threshold among OOC children (30 cases) in the low age group (all P>0.05). In the high age group, the residual anal pressure of the OOC children (101 cases) was higher than that of the non-OOC children (73 cases) [102 (70, 113) vs 41 (24, 58) mmHg (1 mmHg=0.133 kPa), P<0.001], and the rectal anal pressure gradient was lower than that of the non-OOC children [-43 (-55, -23) vs 16 (9, 29) mmHg, P<0.001];The initial fecal sensory capacity threshold of the OOC children was higher than that of the non-OOC children [90 (54, 110) vs 60 (50, 91) ml, P=0.024]. Conclusions: Compared with non-OOC children in the same age group, OOC children aged 6 years and above have higher residual anal pressure and initial fecal sensory capacity threshold, and lower rectal anal pressure gradient. There is no statistically significant differences in the rectal sensory function in children under 6 years old with OOC.

[Treatment of chronic sinus tract leakage at rectal anastomosis with anal fistula endoscopy].

Objective: To introduce the method of using anal fistula endoscope to treat chronic sinus tract leakage at rectal anastomosis site. Methods: We used anal fistula endoscopy to treat a patient with chronic sinus tract leakage after radical resection of rectal cancer, mainly including the following 5 steps: (1) establishing a water injection circulation system through the anus; (2) scraping off purulent coating and mucosa on the surface of the sinus tract with the brush; (3) hemostasis and removal of necrotic tissue with electrocoagulation rods; (4) filling the sinus tract with bioprotein gel; (5) compressing the sinus tract with transanal drainage tube. Results: The patient is a 70 year old male with rectal cancer. After undergoing 3D laparoscopic assisted radical resection of rectal cancer via abdominal anterior resection (Dixon's procedure) and diverting ileostomy surgery for more than 3 months, leakage of the rectal anastomosis was found through colonoscopy and anal iodine water contrast imaging .The patient started eating and flowing juice 6 hours after surgery, got out of bed 24 hours after surgery, and was discharged 48 hours after the removal of the anal canal. Three months after surgery, colonoscopy and transanal iodine hydrography showed that the sinus repair was intact. The diverting ileostomy was reduced 4 months after surgery. Conclusion: Anal fistula endoscope is safe and feasible for the treatment of chronic sinus tract anastomotic leakage in selected patients.

Temporal trends and treatment patterns in anal fissure management: insights from a multicenter study in Italy.

INTRODUCTION: Anal fissure (AF) poses a common challenge in clinical practice, prompting various treatment approaches. This multicenter study, conducted by the Italian Society of Colorectal Surgery, aimed to assess treatment trends in AF over a 10 year period. METHODS: A survey of proctologists and retrospective analysis of patient records were conducted to evaluate treatment modalities and outcomes across six different clinical scenarios based on AF presentation (acute/chronic) stratified by sphincter function (normal/hypertonic/hypotonic). RESULTS: Analysis of data from 17 principal investigators and 22,016 patients revealed significant variability in treatment approaches, influenced by factors such as symptom duration, anal tone, and surgeon preference. Conservative treatments were commonly utilized, while surgical interventions were reserved for refractory cases. Specifically, pharmaceutical treatment was administered to 66-75% of patients in cases of acute AF and 63-67% for chronic AF, while 10-15% underwent anal dilation, and < 2% received botulinum toxin injection. Among medical treatments, nifedipine with lidocaine and glycerin film-forming ointments were the most utilized. The most performed surgical techniques were fissurectomy and anoplasty, except for patients with chronic AF and hypertonic sphincter where sphincterotomy prevailed. Trends in treatment utilization varied depending on the clinical scenario, with notable shifts observed over time. CONCLUSIONS: This study provides insights into the evolving landscape of AF management, highlighting the need for further research to elucidate optimal treatment strategies and improve patient outcomes.

Analysis of the correlation between defunctioning stoma and postoperative low anterior resection syndrome in rectal cancer: a prospective cohort study.

BACKGROUND: To evaluate the effect of stoma-related factors (stoma or no stoma, stoma type, and stoma reversal time) on the occurrence of low anterior resection syndrome (LARS), a highly prevalent condition that can develop after anal sphincter-sparing surgery for rectal cancer and impair quality of life, which includes fecal incontinence, fecal urgency and frequent defecation. METHODS: Patients who underwent radical rectal cancer surgery from July 2018 to July 2022 in a tertiary hospital were included. Baseline data, tumor condition, operation condition and postoperative recovery were obtained by clinical observation. Follow-up data were collected by telephone follow-up. The chi-square and Fisher exact tests were used to analyse differences, coefficient of contingency was used to determine correlations, and independent risk factors for the occurrence of LARS (Patients with a score of 21 or more points were defined as having LARS using the LARS score) were further determined by binary logistic regression. RESULTS: A total of 480 patients met the inclusion criteria, of which 267 used a defunctioning stoma and 213 did not use a defunctioning stoma. There was a positive correlation between defunctioning stoma (P < 0.001, P < 0.001, P < 0.05) and the occurrence of LARS at 3, 6, and 12 months postoperatively, and there was no significant correlation between the stoma type or stoma reversal time and the occurrence of LARS at 3, 6 and 12 months postoperatively (P > 0.05). In binary logistic regression analysis, high BMI (Exp(B) = 1.072, P = 0.039), tumor closer to dentate line (Exp(B) = 0.910, P = 0.016), and ultra-low anterior resection (Exp(B) = 2.264, P = 0.011) increased the possibility of LARS at 3 months postoperatively; high BMI, proximity of the tumor to the dentate line, and ultra-low anterior resection were not independent risk factors for LARS at 6 months postoperatively (P > 0.05). However, proximity of the tumor to the dentate line (Exp(B) = 0.880, P = 0.035) increased the likelihood of LARS at 12 months postoperatively, while high BMI and ultra-low anterior resection remained non-significant as independent risk factors for LARS at 12 months postoperatively (P > 0.05). CONCLUSIONS: Defunctioning stoma was not an independent risk factor for the occurrence of LARS, whereas high BMI, tumor closer to dentate line, and ultra-low anterior resection were independent risk factors for the occurrence of LARS. TRIAL REGISTRATION: Not applicable.

Enhanced transanal surgery training through a 4K 3D surgical exoscope: a novel approach for transanal surgery.

PURPOSE: Recently, exoscope was introduced as a more ergonomic alternative to microscope, mainly in nerve and spinal surgery. Exoscope use in general surgery is still experimental and just few reports are present in literature. Here, we describe for the first time its application in transanal surgery, specifically during the transanal transection and single-stapled anastomosis in ileal-pouch anal anastomosis. METHODS: After completing the proctectomy and pouch formation laparoscopically, two surgeons performed the transanal transection and single-stapled anastomosis using the vision provided by the ORBEYE™ exoscope system with a 3D 4K orbital camera and a 55-inches 3D screen. The transanal procedure was carried out with the surgeons looking at the 3D screen rather than at the operating field. RESULTS: The system subjectively provided excellent operative view thanks to the magnification capacity and the high resolution. The ergonomics was improved compared to classical transanal surgery, allowing the operators and observers to have the same view in a comfortable position. In particular, the exoscope magnified vision allowed for clearer demonstration of techniques to trainees. CONCLUSIONS: This is the first report on the intraoperative application of the ORBEYE™ surgical exoscope in transanal surgery. The magnified vision allowed precise movements and the system appeared potentially a ground-breaking tool for surgical training. The ability to project high-quality images to observers make it ideal for teaching complex transanal procedures. Further studies are encouraged to validate this approach into standard colorectal practice.

Feasibility of IAPWG protocol in performing high-definition three-dimensional anorectal manometry: A prospective, multicentric italian study.

BACKGROUND: The International Anorectal Physiology Working Group (IAPWG) suggests a standardized protocol to perform high-resolution anorectal manometry. The applicability and possible limitations of the IAPWG protocol in performing three-dimensional high-definition anorectal manometry (3D-ARM) have still to be extensively evaluated. METHODS: The IAPWG protocol was applied in performing 3D-ARM. Anorectal manometry (ARM) and a balloon expulsion test (BET) were performed according to IAPGW protocol in 290 patients. KEY RESULTS: A total of 84 males and 206 females (mean age 57.1 ± 15.7 years) were enrolled in six Italian centers. The reasons for which the patients were sent to perform 3D-ARM were: constipation (53.1%), fecal incontinence (26.9%), anal pain (3.1%), postsurgical (3.8%) and presurgical evaluation (4.8%), prolapse (3.4%), anal fissure (2.8%), and other (2.1%). Due to organic and functional conditions (low rectal anterior resections, rectal prolapses, and J-pouch after colectomy), we were unable to perform a complete 3D-ARM on six patients. Overall, a complete 3D-ARM and BET following IAPWG protocol was carried out in 284 patients (97.9%). The following were recorded: rest pressure (81.9 ± 32.0 mmHg) and length of the anal sphincter (37.0 ± 6.2 cm), maximum anal squeeze pressure (201.6 ± 81.3 mmHg), squeeze duration (22.0 ± 8.8 s), maximum rectal (48.7 ± 41.0 mmHg) and minimum anal pressure (73.3 ± 36.5 mmHg) during push, presence/absence of a dyssynergic pattern, cough reflex and rectal sensations (first constant sensation 48.4 ± 29.5 mL, desire to defecate 83.7 ± 52.1 mL, and maximum tolerated volume 149.5 ± 72.6 mL), and presence/absence of rectoanal inhibitory reflex. Mean 3D-ARM registration time was 14 min 7 s ± 3 min 12 s. CONCLUSIONS: This is the first multicentric study that evaluates the applicability of the IAPWG protocol in 3D-ARM performed in different manometric laboratories (both gastroenterological and surgical). The IAPWG protocol was easy to perform and was not time consuming. A diagnosis according to the London Classification was easily obtained in most patients in which 3D-ARM was carried out. No clear limitations to the applicability of the IAPWG protocol were detected.

The association of obstetric anal sphincter injury and mediolateral episiotomy with increasing birth weight and duration of second stage of labour in spontaneous vaginal delivery.

OBJECTIVES: Analysis of the association of mediolateral episiotomy (MLE) with obstetric anal sphincter injury (OASI) in women with spontaneous vaginal delivery. DESIGN: Population-based cohort study with data from the Netherlands Perinatal Registry, describing 541 055 women who delivered a singleton live born infant in cephalic presentation spontaneously at term. Risk indicators for OASI were tested using univariate and multivariate analysis. Additional analysis for the interaction of MLE with other risk indicators was performed. RESULTS: The rate of OASI was 4.2 % in 215 241 nulliparous and 1.4 % in 325 814 multiparous women. In nulliparous and multiparous women MLE was associated with a reduction of OASI (adjusted OR (aOR) 0.3, 95 % CI 0.30-0.34 and aOR 0.32, 95 % CI 0.30-0.34). The association of MLE with a reduced rate of OASI was stronger in high birthweight and in prolonged 2nd stage groups. In nulliparous women, the number needed to treat (NNT) for the use of MLE to prevent one OASI is 31 in general. With MLE, the OASI rate reduced from 11.5 % to 2.9 with a NNT of 12 in the group with a birth weight ≥ 4000 g and a duration of the second stage of labour of 60-120 min. The NNT is 9 In the group with a birth weight ≥ 4000 g and a duration of the second stage of labour ≥ 120 min (reduction rate of OASI from 14.2 % to 3.5 %). CONCLUSIONS: Use of MLE is associated with a reduction of OASI in spontaneous vaginal delivery. In nulliparous women, an episiotomy with an anticipated birth weight > 4000 g and a duration of the 2nd stage of more than 60 min should be considered.

Efficacy of radial incision combined with tunnel floating line drainage in the treatment of high posterior horseshoe anal fistula and perianal flora: Randomized control trial.

BACKGROUND: Due to the high prevalence of posterior horseshoe anal fistula and causing numerous complications, this study aimed to investigate the clinical effect of radial incision combined with tunnel floating line drainage (RCTD) and arc incision internal drainage in the treatment of the disease and the influence on perianal flora. METHODS: Ninety-six subjects treated with high posterior horseshoe anal fistula were stochastically assigned to a joint group (RCTD), and control group (arc incision internal drainage). The operation-related conditions, complication rate, anal function, and recurrence rate of 6 months after operation were compared, and perianal secretions were collected before operation and 1 day after operation to detect the changes of microbial flora. RESULTS: After operation, it was corroborated notable difference between joint group and control group in operation time, intraoperative blood loss, wound healing time, visual analogue scale score 6 hours after operation and phase I cure rate. Chi square test analysis showed notable difference between control group (27.08%) and joint group (10.40%) in incidence of complications, in terms of number of pathogens detected around anus, significantly smaller of the incremental change for the joint subgroup versus the control subgroup 1 day after operation. CONCLUSION: RCTD can be the best choice for patients with high posterior horseshoe anal fistula. This operation method has the advantages of short operation time, less trauma, fewer complications, fast recovery of anal function, and can also reduce perianal pathogenic bacteria infection.

Analysis of Monkeypox Virus Exposures and Lesions by Anatomic Site.

We used cross-sectional data from 226 patients with monkeypox virus to investigate the association between anatomic exposure site and lesion development. Penile, anorectal, and oral exposures predicted lesion presence at correlating anatomic sites. Exposure site also predicted the first lesion site of the penis and anus.

Evaluating the efficacy of multi-incision and tube-dragging therapy combined with laser closure for high horseshoe-shaped anal fistula: Protocol of a prospective, randomized, controlled trial.

INTRODUCTION: High horseshoe-shaped anal fistula (HHAF) is a complicated and challenging condition that presents considerable obstacles in treatment. We are presently investigating a novel surgical technique involving a combination of multi-incision and tube-dragging therapy, and laser closure (MITD-LaC) for the management of HHAF. Due to the current scarcity of rigorous evidence evaluating this approach, it is essential to perform a well-designed randomized controlled trial to compare the effectiveness of this new method with incision and thread-drawing therapy. METHODS AND ANALYSIS: This trial is a prospective, randomized, controlled and interventional study. After preliminary screening of qualified outpatients, a total of 64 adult patients will be enrolled in the trial and randomly allocated to either the MITD-LaC group or the control group (n = 32 per group). These patients will receive either MITD-LaC or incision and thread-drawing therapy. The design aims to allow for a robust comparison between the two treatment modalities. The primary endpoint is the wound healing time, while secondary endpoints include postoperative anal pain at 1, 3, and 5 days (measured with visual analogue scale), fecal incontinence score within 30 days after operation (measured with Cleveland Clinic Florida incontinence score), and the occurrence of postoperative complications within 1 month after surgery, and quality of life up to six months postoperatively (evaluated by The Quality of Life in patients with Anal Fistula Questionnaire Score). DISCUSSION: This study represents the first randomized controlled trial evaluating the short-term outcomes of MITD-LaC, thereby aiming to contribute high-quality evidence to guide clinical practice. Moreover, this trial incorporates comprehensive outcome measures assessing both subjective and objective dimensions. Because of this multidimensional assessment, MITD-LaC offers a promising potential for broader application in the treatment of HHAF. Consequently, obtaining more definitive and authoritative evidence through scientifically rigorous clinical trials is of utmost importance in further validating this treatment approach. ETHICS AND DISSEMINATION: We have submitted the clinical study protocol to the Ethics Committee, and it has been approved under ethical approval number 2021-1036-111-01. The results of the trial will be disseminated through peer-reviewed academic journals and presentations at professional conferences. REGISTRATION NUMBER: ChiCTR2100053556.

Randomized controlled trial of an Internet-of-Medical-Things device for patient-guided anorectal biofeedback therapy.

Biofeedback therapy is useful for treatment of functional defecation disorders but is not widely available and is labor intensive. We developed an Internet-of-Medical-Things (IoMT) device, enabling self-guided biofeedback therapy. This study assesses the safety and efficacy of self-guided biofeedback therapy using the IoMT device in comparison to standard operator-led therapy. Patients experiencing urge or seepage fecal incontinence (≥1 episode/week) were randomly assigned to either our IoMT system or to the conventional anorectal manometry-based therapy. Both interventions comprised six weekly sessions, focusing on enhancing anal strength, endurance, and coordination. The novel device facilitated self-guided therapy via visual instructions on a companion app. Primary outcomes included safety/tolerability, changes in Vaizey severity scores, and alterations in anorectal pressure profiles. Twenty-five patients (22 females, 3 males) participated, with 13 in the novel device group and 12 in the standard therapy group. Both groups showed significant reductions in symptom severity scores: IoMT device group -4.2 (95% CI: -4.06, -4.34, p = 0.018), and the standard therapy group -4.8 (95% CI: -4.31, -5.29, p = 0.028). Anal sphincter resting pressure and sustained squeeze time improved significantly in both groups, and the novel device group demonstrated an increase in maximum sphincter squeeze pressure. There were no significant differences between the therapy groups. Importantly, the experimental device was well-tolerated compared with standard therapy, with no serious adverse events observed. This study demonstrates the comparable efficacy of self-administered biofeedback using the IoMT device with traditional biofeedback therapy. The results demonstrates the potential of the IoMT device as a safe, self-guided method for FI therapy, offering convenience and effectiveness in fecal incontinence management.

The long-term post-surgical outcome of intermediate anorectal malformation in our department.

BACKGROUND: Posterior sagittal anorectoplasty and laparoscopic-assisted anorectal pull-through are preferred for anorectal malformation (ARM) today, while careful pull-through procedures with sacroperineal approach yield excellent outcomes. This study focuses on a pull-through procedure emphasizing continence mechanism preservation and compares outcomes with historical studies with various procedures. METHODS: Bowel function of patients with intermediate ARM followed up for over 10 years post-surgically was assessed. Data collected included ARM type with the Krickenbeck classification, comorbidities, complications, post-surgical examinations, follow-up, and bowel function at the latest clinic visit. The literature review collected original articles including more than 10 post-anorectoplasty cases which were followed for over 10 years. RESULTS: Eleven cases were identified, with a median age at anorectoplasty and follow-up length of 6.9 months and 14.4 years. Two fistula recurrences required surgical treatment. Long-term incontinence and constipation were observed in 9% and 45% of the cohort, respectively. Good rectal angulation and a positive rectoanal inhibitory reflex were confirmed in most cases examined. A literature review identified eight studies with various outcome-measuring instruments. CONCLUSION: Outcomes of the introduced pull-through procedure were favorable, while the literature review highlights the variation in outcomes of various anorectoplasty. EVIDENCE LEVEL: Level IV.