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Introduction and hypothesisOur primary objective was to prospectively evaluate anorectal symptoms, anal manometry and endoanal ultrasound (EAUS) in women who followed the recommended mode of subsequent delivery following index obstetric anal sphincter injuries (OASIs) using our unit’s standardised protocol. Our secondary objectives were to evaluate the role of internal anal sphincter defects and also to compare outcomes in a subgroup of symptomatic women with normal anorectal physiology.MethodsThis is a prospective follow-up study of pregnant women with previous OASIs who were counselled regarding subsequent mode of delivery between January 2003 and December 2014. Assessment involved the St Mark’s Incontinence Score (SMIS), anal manometry and EAUS at both antepartum and 3-month postpartum visits. Data were analysed using Wilcoxon and Mann–Whitney U tests.ResultsThree hundred and fifty women attended the perineal clinic over the study period, of whom 122 met the inclusion criteria (99 vaginal delivery [VD], 23 caesarean section). No significant worsening of anorectal symptoms was observed following subsequent delivery in the VD group (p = 0.896), although a reduced squeeze pressure was observed at 3 months postpartum (p < 0.001). There were no new defects on EAUS in either group.ConclusionsThis study showed no significant worsening of bowel symptoms and sphincter integrity apart from lower squeeze pressures at 3 months postpartum in the VD group when our standardised protocol was used to recommend subsequent mode of delivery. In the absence of a randomised study, use of this protocol can aid clinicians in their decision-making.

Anal cancer is common in human immunodeficiency virus-infected adults. This randomized trial did not find a benefit from human papillomavirus (HPV) vaccination to prevent anal HPV infection or anal high-grade squamous intraepithelial lesions. There may be a benefit for prevention of oral HPV infections. Abstract Background Adults living with human immunodeficiency virus (HIV) are at increased risk for anal and oropharyngeal cancer caused by human papillomavirus (HPV). The efficacy of HPV vaccines in this population is unknown. Methods In this phase 3, double-blind, randomized, controlled trial, we assigned HIV-infected adults aged ≥27 years to the quadrivalent HPV (types 6, 11, 16, 18) vaccine or placebo (1:1) stratified by sex and presence of anal high-grade squamous intraepithelial lesions on biopsy (bHSIL). The primary endpoint was vaccine efficacy against incident persistent anal infection with quadrivalent vaccine types or single detection at the final visit that were not present at baseline. Secondary endpoints included vaccine efficacy for anal bHSIL after week 52, persistent oral HPV infection. Results A total of 575 participants were randomized. The Data and Safety Monitoring Board stopped the study early due to futility. Vaccine efficacy was 22% (95.1% confidence interval [CI], −31%, 53%) for prevention of persistent anal infection or single detection at the final visit, 0% (95% CI −44%, 31%) for improving bHSIL outcomes and 88% (95.1% CI 2%, 98%) for preventing persistent oral HPV infection, but was 32% (95.1% CI −80%, 74%) for 6-month persistent oral HPV infection or single detection at the final visit. Conclusions These results do not support HPV vaccination of HIV-infected adults aged ≥27 years to prevent new anal HPV infections or to improve anal HSIL outcomes. However, our data suggest a role for prevention of oral HPV infections, but this finding should be confirmed in future studies. Clinical Trials Registration NCT01461096.

Treatments for fecal incontinence (FI) remain unsatisfactory because they do not remedy the underlying multifactorial dysfunction(s) including anorectal neuropathy. The aim of this study was to investigate the optimal dose frequency, clinical effects, and safety of a novel treatment, translumbosacral neuromodulation therapy (TNT), aimed at improving neuropathy. Patients with FI were randomized to receive 6 sessions of weekly TNT treatments consisting of 600 repetitive magnetic stimulations over each of 2 lumbar and 2 sacral sites with either 1, 5, or 15 Hz frequency. Stool diaries, FI severity indices, anorectal neurophysiology and sensorimotor function, and quality of life were compared. Primary outcome measure was the change in FI episodes/week. Responders were patients with ≥50% decrease in weekly FI episodes. Thirty-three patients with FI participated. FI episodes decreased significantly (∆ ±95% confidence interval, 4.2 ± 2.8 (1 Hz); 2 ± 1.7 (5 Hz); 3.4 ± 2.5 (15 Hz); P < 0.02) in all 3 groups when compared with baseline. The 1 Hz group showed a significantly higher (P = 0.04) responder rate (91 ± 9.1%) when compared with the 5 Hz group (36 ± 18.2%) or 15 Hz (55 ± 18.2%); no difference was found between the 5 and 15 Hz groups (P = 0.667). Anal neuropathy, squeeze pressure, and rectal capacity improved significantly only in the 1 Hz (P < 0.05) group compared with baseline, but not in other groups. Quality of life domains improved significantly (P < 0.05) with 1 and 5 Hz groups. No device-related serious adverse events were noted. TNT significantly improves FI symptoms in the short term, and the 1 Hz frequency was overall better than 5 and 15 Hz. Both anorectal neuropathy and physiology significantly improved, demonstrating mechanistic improvement. TNT is a promising, novel, safe, efficacious, and noninvasive treatment for FI (see Visual Abstract, Supplementary Digital Content 3, http://links.lww.com/AJG/B598).

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. 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). 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. 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. ChiCTR2100053556.

In a trial comparing preoperative chemoradiotherapy and FOLFOX in patients with rectal cancer undergoing sphincter-sparing surgery, 5-year disease-free survival was 80.8% with FOLFOX and 78.6% with chemoradiotherapy.

Background Anal sphincter defects are a major cause of fecal incontinence causing negative effects on daily life, social interactions, and mental health. Because human adipose-derived stromal/stem cells (hADSCs) are easier and safer to access, secrete high levels of growth factor, and have the potential to differentiate into muscle cells, we investigated the ability of hADSCs to improve anal sphincter incontinence. Methods The present randomized double-blind clinical trial was performed on patients with sphincter defects. They were categorized into a cell group ( n  = 9) and a control group ( n  = 9). Either 6 × 10 6 hADSCs per 3 ml suspended in phosphate buffer saline (treatment) or 3 ml phosphate buffer saline (placebo) was injected. Two months after surgery, the Wexner score, endorectal sonography, and electromyography (EMG) results were recorded. Results Comparing Wexner scores in the cell group and the control group showed no significant difference. In our EMG and endorectal sonography analysis using ImageJ/Fiji 1.46 software, the ratio of the area occupied by the muscle to total area of the lesion showed a 7.91% increase in the cell group compared with the control group. Conclusion The results of the current study show that injection of hADSCs during repair surgery for fecal incontinence may cause replacement of fibrous tissue, which acts as a mechanical support to muscle tissue with contractile function. This is a key point in treatment of fecal incontinence especially in the long term and may be a major step forward. Trial registration Iranian Registry of Clinical Trials IRCT2016022826316N2 . Retrospectively registered 7 May 2016.

BACKGROUNDThe quadrivalent human papillomavirus (HPV) vaccine (qHPV; types 6, 11, 16, 18) is indicated for men and women aged 9 to 26 years to prevent HPV associated anogenital high-grade squamous intraepithelial lesions (HSIL) and cancer. ACTG 5298 was a randomized placebo controlled Phase 3 study in human immunodeficiency virus (HIV)-infected men who have sex with men, and women of qHPV to prevent persistent anal HPV infection. Baseline data are presented here. METHODSHuman immunodeficiency virus–infected men who have sex with men, and women 27 years or older without previous anogenital or oral cancer were enrolled. Baseline anal cytology, high-resolution anoscopy and collection of anal, oral, and vaginal specimens for HPV genotyping were performed and acceptability assessed. RESULTSFive hundred seventy-five (575) participants were enrolled (82% men and 18% women). Median age was 47 years. Race/ethnicity was 46% white, 31% black, and 20% Hispanic. Plasma HIV-1 RNA was less than 50 copies/mL in 83% and median CD4 T count was 602 cells/μL. Abnormal anal cytology was detected in 62%, with corresponding HSIL on biopsy (bHSIL) in 33%. Anal HPV 6, 11, 16, and 18 were detected in 25%, 13%, 32%, and 18% of the participants, respectively. Prevalence of 0, 1, 2, 3, and 4 qHPV types was 40%, 38%, 17%, 4%, and 1%, respectively. Oral infection with 1 or more qHPV type was detected in 10% of the participants. Study procedures were generally acceptable. CONCLUSIONSAt study baseline, there was a high prevalence of abnormal anal cytology, bHSIL, and HPV infection. Sixty percent of the participants had anal infection with preventable qHPV types.

Background Colorectal cancer remains a significant global health burden, with low rectal tumors posing unique surgical challenges due to their proximity to the anal verge. Traditional abdominoperineal resection (APR) compromises quality of life with permanent colostomy, while sphincter-preserving techniques like laparoscopic intersphincteric resection (L-ISR) face technical limitations. This study evaluates the safety and efficacy of a novel technique — ISR combined with rectal eversion and total extra-abdominal resection (ISRER) — aimed at reducing anastomotic complications, and enhancing anal preservation in anatomically challenging patients. Methods This was a prospective randomized controlled, unmasked, parallel group trial in Henan Provincial People’s Hospital. Intraoperative peritoneal lavage cytology and bacterial culture were performed to assess tumor cell shedding and contamination. Outcomes included distal margin positivity, anal preservation rate, postoperative complications, hospital costs,30-day readmission rates and postoperative stay. Results All 74 patients with low rectal cancer (3–5 cm from the anal verge) between March 2024 and March 2025. Patients were randomly stratified into ISRER ( n  = 35) and laparoscopic ISR (L-ISR) ( n  = 39) groups. No tumor cells or bacterial contamination were detected in peritoneal lavage cytology or cultures. Both groups achieved 100% R0 resection (distal margin negativity). The ISRER group demonstrated a significantly higher anal preservation rate (94.3 vs. 71.8%, P  = 0.011) with comparable postoperative complications (2.9 vs. 2.6%, P  = 0.735), 30-day readmission rates (2.9 vs. 2.6%, P  = 0.938), and hospitalization costs (62,540 vs. 64,937 CNY, P  = 0.915). Median postoperative stay was marginally longer in the ISRER group (10 vs. 9 days, P  = 0.135), while gastrointestinal recovery and inflammatory markers showed no intergroup differences. Conclusion ISRER is a safe and technically feasible sphincter-preserving approach for low rectal cancer, offering superior anal retention without compromising oncological safety or increasing complications.

Apocrine gland anal sac adenocarcinoma is an aggressive neoplasm, and surgery remains the treatment of choice, although it is controversial in advanced cases. The prognostic factors are not well established. Human Epidermal Growth Factor Receptor 2 (HER2) is a membrane protein related to tumorigenesis, whereas Ki67 is a nuclear protein related to cell proliferation. Both are potential prognostic markers and therapeutic targets. This study aimed to evaluate the expression of HER2 and Ki67 markers in canine apocrine gland anal sac adenocarcinoma. The tumor samples were divided into four groups: largest tumor diameter less than 2.5 cm, largest tumor diameter greater than 2.5 cm, metastatic lymph nodes, and control group of non-neoplastic anal sacs. Each contained 10 samples. Immunohistochemistry was performed to verify the expression of HER2 and Ki67 markers. Positive HER2 staining was observed in 45% of the neoplastic cases and negative HER2 staining in 100% of the control group. The Ki67 expression had a median of 25% in all groups, except for the control group, which had a median of 8%. The HER2 and Ki67 expression was present in apocrine gland anal sac adenocarcinoma, making them potential therapeutic targets. However, it was not possible to determine the clinical value of either marker.