Video-assisted anal fistula treatment versus fistulectomy and sphincter repair in the treatment of high cryptoglandular anal fistula: a randomized clinical study

Background Video-assisted anal fistula treatment (VAAFT) may have a recurrence rate comparable to that of fistulectomy and sphincter repair (FSR) in the treatment of high anal fistula and with potential advantages in wound healing, functional outcome and quality of life. The aim and objectives of the study are to compare the outcome of VAAFT with that of FSR for high cryptoglandular anal fistula. Methods This was a single-centre randomized controlled trial of adults with high anal fistula comparing FSR with VAAFT. Primary outcome was fistula recurrence. Secondary outcomes were results of anal manometry, quality of life and faecal continence. A power calculation of 33 patients in each arm (1 : 1) was based on recurrence in the FSR and VAAFT groups of 5 per cent and 30 per cent respectively. Follow-up at 6 months after surgery included physical examination, MRI, anal manometry, quality-of-life assessment (RAND SF 36 questionnaire) and faecal-continence assessment (Wexner score). Results The study was terminated early due to high recurrence rates in both groups. A total of 45 patients were included. Recurrence rates were 65 per cent for VAAFT and 27 per cent for FSR, with hazard ratio 4.18 (P = 0.016). Length of the fistula was a risk factor with an association with recurrence (hazard ratio 1.8, P = 0.020). There were significant differences in quality of life in favour of FSR and in anal manometry in favour of VAAFT with a significant improvement in Wexner score in both groups. Conclusion FSR was associated with a lower recurrence rate than VAAFT in the management of complex anal fistulae in this single-centre study but the study was terminated early due to higher than predicted recurrence rate in both groups. Registration number NCT02585167 (http://www.clinicaltrials.org).

Insufficiency of the anal sphinter in women

Aim. To analyze and assess the clinical course and changes under instrumental-functional examination (MRI) in the muscles of the obturator apparatus of the rectum in women with anal sphincter insufficiency (ASI).Material and methods. Clinical and instrumental research methods, as well as modern scales for assessing ASI (Wexner score scale), were used in the current study.Results and discussion. The study showed that 110 out of 228 patients with anal sphincter deficiency showed only an organic form of ASI, and 118 (51.8%) had a mixed form (organic and functional). This study shows that the degree of postpartum perineal rupture depends on the factors producing the damage to the pelvic floor muscles.Conclusion. Analysis of the clinical course of ASI in women showed that gender-related factors in 51.8% of cases contributed to the development of a mixed form of the disease. Functional research methods showed that along with the external and internal sphincters of the rectum, the pubo-rectal muscle is damaged in patients with ASI, which should be taken into account when choosing a treatment strategy for the mixed form of ASI.

Αξιολόγηση της λήψης απόφασης και της ποιότητας ζωής του ασθενή στην επιλογή χειρουργικής θεραπείας καρκίνου ορθού με διορθική ενδοσκοπική μικροχειρουργική TEMS

H διορθική ενδοσκοπική μικροχειρουργική (TEMS) είναι μια ελάχιστα επεμβατική διαδικασία, η οποία αφαιρεί με τοπική εκτομή τον όγκο του ορθού διατηρώντας τους σφιγκτήρες και τη λειτουργία του ορθού και εφαρμόζεται σε καρκίνο ορθού πρώιμου σταδίου. H επέμβαση επιτρέπει γρήγορη ανάρρωση και βραχεία νοσηλεία με πολύ χαμηλότερα ποσοστά νοσηρότητας και θνητότητας από τη ριζική χειρουργική επέμβαση (χαμηλή εκτομή ορθού ή κοιλιοπερινεική εκτομή) που είναι η κύρια θεραπεία (Gold standard). Αρκετές μελέτες δείχνουν ότι η θεραπεία των όγκων ορθού πρώιμου σταδίου με TEMS είναι ασφαλής, με χαμηλά ποσοστά στην τοπική υποτροπή και υψηλά ποσοστά επιβίωσης. Επιπλέον, έχουν δείξει ότι η TEMS έχει ανάλογα ογκολογικά αποτελέσματα με τη ριζική χειρουργική εκτομή ταυτόχρονα με πολύ χαμηλότερη νοσηρότητα και θνητότητα. Συνεπώς, η απόφαση ως προς την επιλογή ανάμεσα σε θεραπείες με παρόμοια κλινικά και παθολογοανατομικά αποτελέσματα βασίζεται στην εμπειρία του ασθενή και την ποιότητα ζωής (ΠΖ) που ακολουθεί τη θεραπεία. Η ποιότητα ζωής στους ασθενείς αυτούς δεν έχει διερευνηθεί επαρκώς και δεν είναι γνωστό κατά πόσο δικαιώνει την απόφασή τους υπέρ της TEMS. Η συμμετοχή του ασθενή στην απόφαση για την θεραπεία του αναγνωρίζεται ως θεμελιώδης παράμετρος στην σύγχρονη περίθαλψη και είναι γνωστό ότι έχει ευνοϊκή συνέπεια στην εμπειρία του ασθενή. Έως σήμερα δεν είναι γνωστό ποιοι είναι οι παράγοντες που επηρεάζουν την απόφαση του ασθενή στην επιλογή της θεραπείας TEMS έναντι της ριζικής χειρουργικής θεραπείας. Σκοπός: Σκοπός της παρούσας έρευνας είναι να διερευνηθούν οι παράμετροι που επηρεάζουν τη λήψη απόφασης του ασθενή στην επιλογή της χειρουργικής θεραπείας καρκίνου του ορθού και να αξιολογηθεί η ποιότητα ζωής μετά από διορθική ενδοσκοπική μικροεπέμβαση (Transanal endoscopic microsurgery, TEMS). Σχεδιασμός: Η μελέτη διαθέτει διασταυρούμενο συγχρονικό σχεδιασμό (cross sectional survey).Πλαίσιο: Χειρουργική μονάδα εντέρου-ορθού, King’s College Hospital, κέντρο περιφερειακής αναφοράς θεραπείας TEMS.Πληθυσμός και μέθοδοι: Στη μελέτη συμπεριελήφθησαν ασθενείς διαγνωσμένοι με καρκίνο ορθού: Τ1-Τ2 – N0-M0 σταδίου, οι οποίοι είχαν υποβληθεί σε θεραπεία ΤΕΜS. Στο ερευνητικό ερωτηματολόγιο συμπεριλήφθηκαν τρία έγκυρα ερωτηματολόγια: για τη μέτρηση της γενικής ποιότητας ζωής χρησιμοποιήθηκε το Short Form SF12v2, η εντερική εγκράτεια αξιολογήθηκε με την κλίμακα Wexner Score (CCF-FIS), η σεξουαλική λειτουργικότητα μετρήθηκε με το Sexual Function Questionnaire (SFQ) ερωτηματολόγιο. Οι απόψεις των ασθενών για τη λήψη απόφασης και την εμπειρία τους στη θεραπεία συλλέχθηκαν με ειδικά σχεδιασμένο ερωτηματολόγιο των ερευνητών. Το ελάχιστο διάστημα διερεύνησης ορίστηκε στα τρία χρόνια μετά-TEMS. Έκβαση: Ποιότητα ζωής, εμπειρία ασθενών στην TEMS θεραπεία και οι απόψεις των ασθενών για τη λήψη απόφασης στην επιλογή της θεραπείας TEMS. Αποτελέσματα: Το 86,2% των ασθενών θα έμμενε στην αρχική τους απόφαση και θα επέλεγε πάλι την TEMS θεραπεία με μέση τιμή τα 6,9 (SD=2.0) έτη μετά-TEMS. Τη δήλωση αυτή επηρέασαν η ικανοποίηση από την εμπειρία (p=0,003), η ικανοποιητική μετεγχειρητική λειτουργία του εντέρου (p<0,001), η καλύτερη εγκράτεια Wexner Score (p=0,020) και η υψηλή συνέπεια μεταξύ εμπειρίας και προεγχειρητικής πληροφόρησης (p=0.049). Ο βαθμός ικανοποίησης της εμπειρίας TEMS συσχετίστηκε με την υποστήριξη από την οικογένεια (p=0,034) και τον βαθμό συμφωνίας μεταξύ εμπειρίας και προεγχειρητικής πληροφόρησης (p=0,047), όπως επίσης, έδειξε συσχέτιση με την λειτουργικότητα του εντέρου (p=0,026) και την ψυχική ποιότητα ζωής (p=0,003). Οι δύο διαστάσεις της γενικής ποιότητας ζωής, φυσική και ψυχική, ήταν συγκρίσιμες ως προς τον γενικό πληθυσμό κυμαινόμενες σε παρόμοια επίπεδα και είχαν αρνητική συσχέτιση με το βαθμό εντερικής εγκράτειας (Wexner Score) (r=-0,40 p=0,019) και (r=-0,-38 p=0,025), αντίστοιχα. Το μέσο σκορ στην κλίμακα Wexner ήταν 3,97 (SD=3,86). Η συνολική σεξουαλική λειτουργικότητα είχε σημαντική θετική συσχέτιση με τη φυσική ποιότητα ζωής (p=0,014) και αρνητική με την ηλικία (p=0,006), ενώ λιγότερα προβλήματα έδειξαν όσοι είχαν βελτιωμένη ψυχική ποιότητα ζωής (p=0,030). Οι ασθενείς δήλωσαν χαμηλό μετεγχειρητικό πόνο με μέσο όρο 3,1 (3,3) στη κλίμακα 0-10 που σχετίστηκε θετικά με την στήριξη της οικογένειας (p=0,009). Συμπεράσματα: Οι σημαντικοί παράγοντες για τους ασθενείς στην εμπειρία της TEMS θεραπείας είναι η επαρκής και αξιόπιστη προεγχειρητική πληροφόρηση, η καλή ποιότητα ζωής και η στήριξη της οικογένειας. Οι επαγγελματίες υγείας θα πρέπει να γνωρίζουν αυτές τις παραμέτρους και να τις συμπεριλαμβάνουν στην πρακτική τους όταν παραστέκονται στους ασθενείς τους στη λήψη απόφασης για τη χειρουργική θεραπεία στον καρκίνο του ορθού και παρέχουν πληροφορίες για συναίνεση στην επέμβαση TEMS. Τα αποτελέσματα της έρευνας δείχνουν πως η TEMS συσχετίζεται με καλή μακροπρόθεσμη μετεγχειρητική ΠΖ ενώ είναι η πρώτη μελέτη που αναδεικνύει τη μετά-TEMS ΠΖ ως τον κύριο παράγοντα που δικαιώνει τους ασθενείς για την απόφαση της θεραπευτικής τους επιλογής.

Influence of Locomotion Therapy With the Wearable Cyborg HAL on Bladder and Bowel Function in Acute and Chronic SCI Patients

Study Design: Retrospective survey. Objectives: Purpose of this study was to explore whether bowel and bladder management can be influenced by locomotion therapy with HAL Robot Suit. Methods: 35 subjects with acute (< one year since injury, n = 13) or chronic (> one year since injury, n = 22) incomplete paraplegia (American Spinal Injury Association Impairment Scale (AIS) B, n = 1 / AIS C, n = 22 / AIS D, n = 7) or complete paraplegia (AIS A, n = 5) with zones of partial preservation (ZPP) participated. A retrospective survey was carried out asking for bowel incontinence (Wexner Score), constipation (Cleveland Clinic Constipation Scoring System (CCCS)) and bladder function (self-developed questionnaire) before and after completing a training period of 12 weeks with HAL. Results: Wexner Score over all patients and for group of chronic patients decreased significantly. For group of acute patients Wexner Score decreased insignificantly. Patients from both groups with higher baseline scores could decrease significantly. CCCS was insignificantly reduced for all patients, group of acute and group of chronic patients. For subgroup of chronic patients with higher baseline scores, CCCS decreased at end of training period missing out significance. The self-developed questionnaire showed an improvement in bladder function in 28.24% of all patients, 31.43% of chronic patients, and 23.08% of acute patients. Conclusions: Our findings show trends of enhanced bladder and bowel function following exoskeleton training. Patients with higher baseline scores in Wexner Score and CCCS seem to benefit more than those with mild to moderate scores.

Sacral Nerve Stimulation Lead Migration through the Sciatic Foramen, Successfully Repositioned

Introduction: SNS (Sacral Nerve Stimulation) has become an established minimally invasive procedure for urinary and faecal incontinence. Minor complications related to the procedure are common; include pain, infection or migration. We present a case of a tined lead migration through the sciatic foramen. Case Report: A 72-year-old woman with faecal incontinence, who did not respond to dietary of medical treatment, underwent a sacral nerve stimulation test. Under fluoroscopic vision a tined lead was placed in S3 foramen, with an adequate motor and sensory response. In the 7th postoperative day, she reported no improvement and she referred sensory response in the thigh and leg. Radiography showed migration of the electrode through the sciatic foramen. The repositioning of the same electrode was possible with a gentle traction of the lead. Correct placement of the lead was confirmed radiologically, and the patient showed motor and sensory response in the anal area. The patient improved Wexner score from 18/20 to 4/20. Conclusion: Migration of the tined lead should be considered if loss of response in found. Repositioning of the same lead is possible in selected patients, without the need of removal of the device.

Adynamic Graciloplasty for Faecal Incontinence in an Adult after Anal Atresia Correction in Infancy – a Case Report

Background. Here we present a case of female patient suffering from bowel incontinence. Case report. The patient underwent unstimulated graciloplasty. Postoperative period was uneventful. After 4 weeks, a course of low frequency electric external stimulation in the area around the neurovascular bundle in the thigh was performed. Patient was evaluated 3 months postoperatively. On inspection, her anus was closed at rest. She stated moderate improvement in her continence and quality of life, her Wexner score was 10 and FISI score was 32 (prior surgery 19 and 44 accordingly). Conclusion. Adynamic graciloplasty seems to be a reasonable method of choice for faecal incontinence.

Autologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: a prospective case-control study

Background Complex cryptoglandular perianal fistula (CPAF) is a kind of anal fistula that may cause anal incontinence after surgery. Minimally invasive surgery of anal fistula is constantly emerging. Over the past 20 years, there are several sphincter-sparing surgeries, one of which is autologous adipose-derived stem cell (ADSC) transplantation. However, to date, there is no study regarding the treatment of complex CPAF with ADSC in China. This is the first study in China on the treatment of complex CPAF with ADSC to evaluate its safety and efficacy. Methods Totally, 24 patients with complex CPAF were enrolled in this prospective case-control study from January 2018 to December 2019 in the National Colorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine. Patients were divided into ADSC group and endorectal advancement flap (ERAF) group according to their desire. The healing of fistulas (healing of all treated fistulas at baseline, confirmed by doctor’s clinical assessment and magnetic resonance imaging or transrectal ultrasonography) was evaluated at week 12 after treatment. In addition to their safety evaluation based on adverse events monitored at each follow-up, the patients were also asked to complete some scoring scales at each follow-up including pain score with visual analog score (VAS) and anal incontinence score with Wexner score. Results The closure rates within ADSC group and ERAF group at week 12 were 54.55% (6/11) and 53.85% (7/13), respectively, without significant difference between them. VAS score in ADSC group was significantly lower than that in ERAF group at the 5th day postoperatively [1(0,2) VS 2(2,4), p = 0.011], but no differences were observed at the other time. Wexner score of all patients was not increased with no significant differences between the two groups. Adverse events were observed fewer in ADSC group (27.27%) than that in ERAF group (53.85%), but there was no significant difference between them. Conclusion This study indicated safety and efficiency of ADSC for the treatment of complex CPAF in the short term, which is not inferior to that of ERAF. ADSC may provide a promised and potential treatment for complex CPAF conforming to the future of the treatment, which is reconstruction and regeneration. Trail registration ChiCTR, ChiCTR1800014599. Registered 23 January 2018—retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=24548

Randomized clinical trial on the use of a colon-occlusion device to assist rectal washout

Background Transrectal Natural Orifice Transluminal Endoscopic Surgery is currently limited by the inherent risk of surgical site infection due to peritoneal contamination after rectotomy. Coloshield has been developed as a temporary colon occlusion device to facilitate rectal washout. However, effectiveness and safety has not been evaluated in humans. Methods Twenty-two patients have been randomly assigned to undergo proctological intervention with a rectal washout with and without the use of Coloshield. Patients and assessors were blinded. Boston Bowel Preparation Scale (BBPS) has been determined 30 min as well as immediately after rectal washout. Feasibility, pain, intra- and postoperative morbidity as well as bowel function and continence 6 weeks after surgery were assessed. Results BBPS 30 min after rectal washout with and without Coloshield was in mean 2.42 ± 1.02 and 2.12 ± 0.89 (p = 0.042). Mean BBPS immediately after rectal washout was 2.39 ± 1.02 and 2.24 ± 0.66 (p = 0.269). Mean BBPS immediately after rectal washout and 30 min thereafter did not differ (p = 0.711). Coloshield application was feasible without any complications. The median (interquartile range) numeric rating scale for pain 4 h after surgery was 1 (0–1) and 3 (0–4) (p = 0.212). Six weeks after surgery 0/11 and 1/11 patients suffered from evacuation difficulties (p = 1.0) and the median Vaizey–Wexner score was 1 (0–3) and 1 (0–2) (p = 0.360). Conclusions Coloshield application in humans is feasible and safe. Slight benefits in rectal preparation by washout are found when Coloshield is used. Colon occlusion by Coloshield for transrectal NOTES should be evaluated within clinical studies. Trial registration Clinicaltrials.gov NCT02579330

The observation on curative effect of Shouhuitongbian capsule in the treatment of functional constipation: A real world study

Background: Chronic constipation is a common disease caused by a variety of reasons. This study was to observe the improvements on symptoms, quality of life and satisfaction of patients with functional constipation by Shouhuitongbian capsule, and evaluate its safety.Methods: The study was divided into four groups according to the duration of disease. The primary observational indicators were efficacy and safety of Shouhuitongbian capsule after 14 days of treatment, and changes of Wexner score of intestinal function. Effect of Shouhuitongbian capsule on quality of life of patients, and the long-term efficacy and safety of taking capsule after 1 month, 2 months and 3 months were used as secondary observational indicators .Results: The results showed that the improvement effect of capsules on 14th day was better that on the 7th day (P＜0.001). Besides, compared with patients with longer duration of disease, the improvement effect of patients with shorter duration of disease was better (P＜0.001). The long-term improvement effect of patients taking capsules was greater than the short-term improvement effect (P＜0.001). The long-term improvement of patients with shorter duration of disease after taking capsules was more effective than that of patients with longer duration of disease (P＜0.001).Conclusion: The experimental results provide a strong/powerful/ convincing evidence for the re-evaluation of efficacy and safety of Shouhuitongbian capsule after its marketing.