Stepped-wedge randomized controlled trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation.

BACKGROUND: The effectiveness of laparoscopic ventral mesh rectopexy (LVMR) in patients with defecatory disorders secondary to internal rectal prolapse is poorly evidenced. A UK-based multicenter randomized controlled trial was designed to determine the clinical efficacy of LVMR compared to controls at medium-term follow-up. METHODS: The randomized controlled trial was conducted from March 1, 2015 TO January 31, 2019. A stepped-wedge RCT design permitted observer-masked data comparisons between patients awaiting LVMR (controls) with those who had undergone surgery. Adult participants with radiologically confirmed IRP refractory to conservative treatment were randomized to three arms with different delays before surgery. Efficacy outcome data were collected at equally stepped time points (12, 24, 36, 48, 60, and 72 weeks). Clinical efficacy of LVMR compared to controls was defined as ≥ 1.0-point reduction in Patient Assessment of Constipation-Quality of Life and/or Symptoms (PAC-QOL and/or PAC-SYM) scores at 24 weeks. Secondary outcome measures included 14-day diary data, the Generalized Anxiety Disorder scale (GAD-7), the Patient Health Questionnaire-9 (PHQ-9), St Marks incontinence score, the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), the chronic constipation Behavioral Response to Illness Questionnaire (CC-BRQ), and the Brief Illness Perception Questionnaire (BIPQ). RESULTS: Of a calculated sample size of 114, only 28 patients (100% female) were randomized from 6 institutions (due mainly to national pause on mesh-related surgery). Nine were assigned to the T0 arm, 10 to T12, and 9 to T24. There were no substantial differences in baseline characteristics between the three arms. Compared to baseline, significant reduction (improvement) in PAC-QOL and PAC-SYM scores were observed at 24 weeks post-surgery (- 1.09 [95% CI - 1.76, - 0.41], p = 0.0019, and - 0.92 [- 1.52, - 0.32], p = 0.0029, respectively) in the 19 patients available for analysis (9 were excluded for dropout [n = 2] or missing primary outcome [n = 7]). There was a clinically significant long-term reduction in PAC-QOL scores (- 1.38 [- 2.94, 0.19], p = 0.0840 at 72 weeks). Statistically significant improvements in PAC-SYM scores persisted to 72 weeks (- 1.51 [- 2.87, - 0.16], p = 0.0289). Compared to baseline, no differences were found in secondary outcomes, except for significant improvements at 24 and 48 weeks on CC-BRQ avoidance behavior (- 14.3 [95% CI - 23.3, - 5.4], and - 0.92 [- 1.52, - 0.32], respectively), CC-BRQ safety behavior (- 13.7 [95% CI - 20.5, - 7.0], and - 13.0 [- 19.8, - 6.1], respectively), and BIPQ negative perceptions (- 16.3 [95% CI - 23.5, - 9.0], and - 10.5 [- 17.9, - 3.2], respectively). CONCLUSIONS: With the caveat of under-powering due to poor recruitment, the study presents the first randomized trial evidence of short-term benefit of LVMR for internal rectal prolapse. TRIAL REGISTRATION: ISRCTN Registry (ISRCTN11747152).

Initial experience with SphinKeeper™ intersphincteric implants for faecal incontinence in the UK: a two-centre retrospective clinical audit.

AIM: The SphinKeeper™ artificial bowel sphincter implant is a relatively new surgical technique for the treatment of refractory faecal incontinence. This study presents the first experience in two UK tertiary centres. METHOD: This is a retrospective audit of prospectively collected clinical data in relation to technique, safety, feasibility and short-term effectiveness from patients undergoing surgery from January 2016 to April 2019. Baseline data, intra-operative and postoperative complications, symptoms [using St Mark's incontinence score (SMIS)] and radiological outcomes were analysed. RESULTS: Twenty-seven patients [18 women, median age 57 years (range 27-87)] underwent SphinKeeper. In 30% of the patients, the firing device jammed and not all prostheses were delivered. There were no intra-operative complications and all patients were discharged the same or the following day. SMIS significantly improved from baseline [median -6 points (range -12 to +3); P < 0.00016] with 14/27 (51.9%) patients achieving a 50% reduction in the SMIS score. On postoperative imaging, a median of seven prostheses (range 0-10) were identified with a median of five (range 0-10) optimally placed. There was no relationship between number of well-sited prostheses on postoperative imaging and categorical success based on 50% reduction in SMIS (χ2 test, P = 0.79). CONCLUSION: SphinKeeper appears to be a safe procedure for faecal incontinence. Overall, about 50% patients achieved a meaningful improvement in symptoms. However, clinical benefit was unrelated to the rate of misplaced/migrated implants. This has implications for confidence in proof of mechanism and also the need for technical refinement.

Altered defaecatory behaviour and faecal incontinence in a video-tracked animal model of pudendal neuropathy.

AIM: The aim was to develop a behavioural animal model of faecal continence and assess the effect of retro-uterine balloon inflation (RBI) injury. RBI in the rat causes pudendal neuropathy, a risk factor for obstetric related faecal incontinence in humans. METHOD: Video-tracking of healthy rats (n = 12) in a cage containing a latrine box was used to monitor their defaecatory behaviour index (DBI) over 2 weeks. The DBI (range 0-1) was devised by dividing the defaecation rate (pellets per hour) outside the latrine by that of the whole cage. A score of 0 indicates all pellets were deposited in the latrine. Subsequently, the effects of RBI (n = 19), sham surgery (n = 4) and colostomy (n = 2) were determined by monitoring the DBI for 2 weeks preoperatively and 3 weeks postoperatively. RESULTS: The DBI for healthy rats was 0.1 ± 0.03 with no significant change over 2 weeks (P = 0.71). In the RBI group, 13 of 19 rats (68%) showed no significant change in DBI postoperatively (0.08 ±  -0.05 vs 0.11 ±  -0.07) while in six rats the DBI increased from 0.16 ±  -0.09 to 0.46 ± 0.23. The negative control, sham surgery, did not significantly affect the DBI (0.09 ± 0.06 vs 0.08 ± 0.04, P = 0.14). The positive control, colostomy, increased the DBI from 0.26 ± 0.03 to 0.86 ± 0.08. CONCLUSIONS: This is the first study showing a quantifiable change in defaecatory behaviour following injury in an animal model. This model of pudendal neuropathy affects continence in 32% of rats and provides a basis for research on interventions for incontinence.

Pathophysiology of fecal incontinence differs between men and women: a case-matched study in 200 patients.

BACKGROUND: Fecal incontinence (FI) is a common and socially disabling condition with obstetric trauma considered the principal etiological factor. This study aimed to systematically evaluate symptom presentation and anorectal function in both females and males with FI. METHODS: One hundred males (M) and 100 age-matched females (F) with FI presenting between 2012 and 2014 were identified from a prospectively collected database. Comparison of clinical (history, symptom profile, and severity using validated questionnaires) and anorectal physiological (manometry, rectal sensory testing, endoanal ultrasonography, and evacuation proctography) data between M and F was performed. KEY RESULTS: Incidence of prior anal surgery (M: 28% vs F: 18%, p = 0.13) and abdominal surgery (M: 25% vs F: 26%, p = 0.90) was similar between sexes, but females had a higher incidence of previous pelvic surgery (M: 4% vs F: 47%, p < 0.001). Eighty-five females were parous and 75% reported history of traumatic vaginal delivery. There was a trend toward higher St Mark's incontinence scores in females (mean ± SD; M: 13 ± 4 vs F: 14 ± 5, p = 0.06). In men, structural sphincter abnormalities were uncommon (M: 37% vs F: 77%, p < 0.001), while impaired rectal sensation (M: 24% vs F: 7%, p = 0.001) and functional disturbances of evacuation (M: 36% vs F: 13%, p = 0.001) were more common than in women. No abnormality on all tests performed was observed in twice as many males (M: 18% vs F: 9%, p = 0.10). CONCLUSIONS & INFERENCES: Pathophysiological mechanisms of FI differ between sexes. Anal sphincter dysfunction was an uncommon finding in males, with impaired rectal sensation and functional disturbances of evacuation much more prominent than in the female cohort. These findings are likely to impact options for symptom management.

Reversal of sensory deficit through sacral neuromodulation in an animal model of fecal incontinence.

BACKGROUND: Sacral neuromodulation (SNM) is a treatment option for intractable fecal incontinence. The mechanism of action is unclear, however, increasing evidence for afferent somatosensory effects exists. This study's aim was to elucidate effects of acute SNM on the cerebral cortex in a rodent model of pudendal nerve injury. METHODS: The effects of 14 Hz and 2 Hz SNM on sensory cortical activation were studied. In 32 anesthetized rats, anal canal evoked potentials (EPs) were recorded over the primary somatosensory cortex. Pudendal nerve injury was produced by 1-hour inflation of two intra-pelvic balloons. Four groups were studied: balloon injury, balloon injury plus either 14 Hz or 2 Hz SNM, sham operation. Immunohistochemistry for the neural plasticity marker polysialylated neural cell adhesion molecule (PSA-NCAM) positive cells (numerical density and location) in the somatosensory cortex was performed. KEY RESULTS: Anal EP amplitudes diminished during balloon inflation; 14 Hz SNM restored diminished anal EPs to initial levels and 2 Hz SNM to above initial levels. Evoked potential latencies were prolonged during balloon inflation. The numerical density of PSA-NCAM positive cells increased in the SNM groups, but not in sham or balloon injury without SNM. Stimulated cortices showed clusters of PSA-NCAM positive cells in layers II, IV, and V. Post SNM changes were similar in both SNM groups. CONCLUSIONS & INFERENCES: Sacral neuromodulation augments anal representation in the sensory cortex and restores afferent pathways following injury. PSA-NCAM positive cell density is increased in stimulated cortices and positive cells are clustered in layers II, IV, and V.

Effects of stimulation frequency and intensity in sacral neuromodulation on anorectal inputs to the somatosensory cortex in an experimental model.

INTRODUCTION: Although sacral neuromodulation (SNM) is an established treatment for faecal incontinence, stimulation parameters have been derived empirically and only one frequency (14 Hz) is employed clinically. The aim of this study was to test a range of stimulation frequencies to establish an optimal frequency of SNM for maximum augmentation of anal canal cortical evoked potentials (EPs) in an animal model. METHODS: In female Wistar rats, anal canal EPs were recorded over the primary somatosensory cortex using a flexible multielectrode array, and the effect of SNM was studied. SNM was applied at 0·1-100 Hz and a frequency response curve plotted. The data were fitted to a quadratic equation. RESULTS: The magnitude of potentiation of anal canal EPs caused by SNM depended significantly on stimulation frequency (P < 0·001). The frequency-potentiation relationship was parabolic in form, with a clear optimum at 2 Hz. The SNM must be applied for at least 3 min. The theoretical maximal potentiation predicted by the model was not found to be statistically different to actual data recorded (P = 0·514-0·814). The response depended on stimulation amplitude in an 'all-or-nothing' fashion. EPs were augmented when the SNM intensity was 0·5 times the motor threshold to tail twitch or greater, but values below this intensity failed to affect the EPs. CONCLUSION: The effect of SNM in this animal model is governed principally by frequency, with an optimum of 2 Hz. If animal data can be translated to humans, optimization of SNM frequency may offer a clinically relevant improvement in the efficacy of SNM. Surgical relevance Sacral neuromodulation (SNM) for faecal incontinence currently employs stimulation parameters that have been derived empirically and may not be optimal. This study used an animal model of SNM and focused on its acute effect on anal canal cortical evoked potentials (EPs). It was found that SNM potentiated EPs, with a clear optimum at a frequency of 2 Hz. If this finding is applicable to the mechanism of action of human SNM, this suggests that there may be a clinically relevant improvement by reducing stimulus frequency from its typical value of 14 Hz to 2 Hz.

Clinical and psychosocial functioning in adolescents and young adults with anorectal malformations and chronic idiopathic constipation.

BACKGROUND: Faecal incontinence (FI) and constipation occur following corrective surgery for anorectal malformations (ARMs) and in children or adults with chronic constipation without a structural birth anomaly (chronic idiopathic constipation, CIC). Such symptoms may have profound effects on quality of life (QoL). This study systematically determined the burden of FI and constipation in these patients in adolescence and early adulthood, and their effect on QoL and psychosocial functioning in comparison with controls. METHODS: Patients with ARMs or CIC were compared with age- and sex-matched controls who had undergone appendicectomy more than 1 year previously and had no ongoing gastrointestinal symptoms. Constipation and FI were evaluated using validated Knowles-Eccersley-Scott Symptom (KESS) and Vaizey scores respectively. Standardized QoL and psychometric tests were performed in all groups. RESULTS: The study included 49 patients with ARMs (30 male, aged 11-28 years), 45 with CIC (32 male, aged 11-30 years) and 39 controls (21 male, aged 11-30 years). The frequency of severe constipation among patients with ARMs was approximately half that seen in the CIC group (19 of 49 versus 31 of 45); however, frequencies of incontinence were similar (22 of 49 versus 21 of 45) (P < 0·001 versus controls for both symptoms). Physical and mental well-being were significantly reduced in both ARM and CIC groups compared with controls (P = 0·001 and P = 0·015 respectively), with generally worse scores among patients with CIC. Both were predicted by gastrointestinal symptom burden (P < 0·001). There were no statistically significant differences in state or trait psychiatric morbidity between groups. CONCLUSION: FI and constipation are major determinants of poor QoL in adolescents and young adults with ARMs and in those with CIC.

Attitudes of patients with metastatic breast cancer toward research biopsies.

BACKGROUND: Research studies involving human tissue are increasingly common. However, patients' attitudes toward research biopsies are not well characterized, particularly when the biopsies are carried out outside the context of therapeutic trials. PATIENTS AND METHODS: One hundred sixty patients with metastatic breast cancer (MBC) from two academic (n = 80) and two community (n = 80) hospitals completed a 29-item self-administered survey to evaluate their willingness to consider providing research purposes only biopsies (RPOBs) (as a stand-alone procedure) and additional biopsies (ABs) (additional needle passes at the time of a clinically indicated biopsy). RESULTS: Eighty-two (51%) of 160 patients would consider having RPOBs, of which 42 (53%) and 40 (50%) patients were from academic and community hospitals, respectively. Patients who had more prior biopsies were less likely to consider RPOBs (RR = 0.6, 95% CI: 0.4-1.0, P = 0.03). Of 160 patients, 115 (72%) patients would consider having ABs. Of these, 64 (80%) and 51 (64%) patients from academic and community hospitals, respectively, would consider ABs (RR = 1.2, 95% CI: 1.0-1.5, P = 0.03). CONCLUSIONS: Many patients with MBC in both academic and community settings report willingness to consider undergoing biopsies for research. Further research is needed to understand ethical, logistical and provider-based barriers to broader participation in such studies.

Anatomical registration and three-dimensional visualization of low and high-resolution pan-colonic manometry recordings.

BACKGROUND: Colonic propagating sequences (PS) are important for the movement of colonic content and defecation, and aberrant PS patterning has been associated with slow transit constipation. However, because these motor patterns are typically recorded over long periods (24 h +), the visualization of PS spatiotemporal patterning is difficult. Here, we develop a novel method for displaying pan-colonic motility patterns. METHODS: A 3D mesh representing the geometry of the human colon was created as follows: (i) Human colon images from the Visible Human Dataset were digitized to create a 3D data cloud, and (ii) A surface mesh was fitted to the cloud using a least-squares minimization technique. Colonic manometry catheters were placed in the ascending colon of healthy controls and patients with slow transit constipation (STC), with the aid of a colonoscope. The colonic manometry data were interpolated and mapped to the model according to the following anatomical landmarks: cecum, hepatic flexure, splenic flexure, sigmoid-descending junction, and anus. KEY RESULTS: These 3D images clearly and intuitively communicate characteristics of normal and abnormal colonic motility. Specifically we have shown the reduced amplitude of the antegrade propagating pressure waves (PPW) throughout the colon and reduced frequency of PPWs at the mid-colon in patients with STC. CONCLUSIONS AND INFERENCES: A novel method for the 3D visualization of PS is presented, providing an intuitive method for representing a large volume of physiological data. These techniques can be used to display frequency, amplitude or velocity data, and will help to convey regions of abnormally in patient populations.

Combined vertical reduction rectoplasty and sacral nerve stimulation for rectal evacuatory dysfunction and faecal incontinence associated with previous anorectal malformation.

Functional outcomes following surgery for anorectal malformation are variable, with many children experiencing persisting anorectal dysfunction. We describe a 34-year-old female with previous vestibular fistula who experienced lifelong rectal evacuatory dysfunction and faecal incontinence; she was treated in a two stage process producing efficient defecation and almost total continence.

Bowel preparation affects the amplitude and spatiotemporal organization of colonic propagating sequences.

BACKGROUND: Colonic manometry is performed using either colonoscopically assisted catheter placement, after bowel preparation, or nasocolonic intubation of the unprepared bowel. There has been little systematic evaluation of the effects of bowel cleansing upon colonic propagating pressure wave sequences. METHODS: Eight healthy volunteers underwent nasocolonic placement of a water-perfused silicone catheter which recorded pressures at 16 recording sites each spaced 7.5 cm apart in the unprepared colon for 24 h. These measures were compared with those obtained in another eight healthy volunteers in whom the catheter was placed to the caecum at colonoscopy in the prepared colon. KEY RESULTS: The colonic motor responses to meals and morning waking, and the normal nocturnal suppression did not differ between the two groups, nor were the overall frequency, regional dependence nor extent of propagating sequences (PS) influenced by bowel preparation. Bowel preparation did result in a significant increase in the frequency of high amplitude PS (22 +/- 7 vs 8 +/- 4 HAPS/24 h; P = 0.003). Additionally, a number of the measures of spatiotemporal organization among consecutive PS (linkage among sequences and predefecatory stereotypical patterning) were significantly altered by bowel preparation. CONCLUSIONS & INFERENCES: The overall frequency of PSs, the colonic responses to physiological stimuli such a meal and morning waking and nocturnal suppression, are not influenced by prior bowel preparation. However, investigators wishing to study HAPS frequency, or the more complex spatiotemporal relationships among consecutive PSs, should control for bowel preparation when making comparisons among study groups.

Importance of extrasphincteric mechanisms in the pathophysiology of faecal incontinence in adults with a history of anorectal anomaly.

BACKGROUND: Although surgery for congenital anorectal anomalies (ARAs) aims to preserve anorectal function, faecal incontinence and constipation often result. Apart from the anal sphincters, continence is dependent on multiple anatomical and physiological factors. The aim of this study was to evaluate adults with a history of ARA to determine the role of such factors in functional outcome. METHODS: The study included 20 consecutive adult patients with faecal incontinence who had undergone anorectal surgery as infants. Comprehensive testing included anal manometry, endoanal ultrasonography, tests of pudendal nerve function and rectal sensory function, evacuation proctography and colonic transit studies. RESULTS: Anal resting tone and squeeze increments were both attenuated in 15 of 19 patients. Integrity of the internal and external anal sphincters was compromised in 16 and 15 of 18 patients respectively. Eleven of 13 had evidence of pudendal neuropathy. Rectal sensation was abnormal in 14 of 18 patients, of whom ten were hypersensitive and four hyposensitive. Rectal evacuation was abnormal in nine of 14. Colonic transit was delayed in five of eight patients with constipation. CONCLUSION: Faecal incontinence in adult patients with ARA is related to various pathophysiologies. Structural integrity of the anal sphincters is a major factor, but extrasphincteric mechanisms, notably rectal sensory function, may be as important.

Normalization of substance P levels in rectal mucosa of patients with faecal incontinence treated successfully by sacral nerve stimulation.

BACKGROUND: Sacral nerve stimulation (SNS) may improve faecal incontinence by modulating rectal sensation. This study measured changes in the peripheral expression of various neural epitopes in response to SNS. METHODS: Rectal mucosal biopsies were taken from 12 patients before and after temporary SNS, and from ten responders at 90 days after permanent stimulation. Sections were immunostained for substance P, transient receptor potential vanilloid (TRPV) 1, vasoactive intestinal peptide (VIP) and calcitonin gene-related peptide (CGRP). Levels were compared with those in nine continent controls. RESULTS: Baseline levels of percentage area immunoreactivities of substance P (median 0.51 (95 per cent confidence interval 0.31 to 0.73) versus 0.13 (0.07 to 0.27) per cent; P < 0.001) and TRPV1 (0.76 (0.41 to 1.11) versus 0.09 (0.04 to 0.14) per cent; P < 0.001), but not of VIP (1.26 (0.37 to 2.15) versus 1.28 (0.39 to 2.17); P = 0.943), were significantly greater than in controls. Successful SNS resulted in a significant decrease in substance P immunostaining after temporary (0.15 (0.06 to 0.51) per cent; P = 0.051) and permanent (0.17 (0 to 0.46) per cent; P = 0.051) stimulation. Immunoreactivity of TRPV1, VIP, CGRP and neural markers showed no qualitative change. CONCLUSION: Patients with faecal incontinence demonstrate normalization of raised rectal mucosal substance P levels following successful SNS.

Rectal intussusception in symptomatic patients is different from that in asymptomatic volunteers.

BACKGROUND: Rectal intussusception is a common finding at evacuation proctography in both symptomatic and asymptomatic individuals. Little information exists, however, as to whether intussusception morphology differs between patients with evacuatory dysfunction and healthy volunteers. METHODS: Thirty patients (19 women; median age 44 (range 21-76) years) with disordered rectal evacuation, in whom an isolated intussusception was seen on proctography, were studied. Various morphological parameters were measured, and compared with those from 11 asymptomatic controls (six women; median age 30 (range 24-38) years) found, from 31 volunteers, to have rectal intussusception. Intussusceptum thickness greater than 3 mm was designated as full thickness. Intussuscepta impeding evacuation were deemed to be occluding. RESULTS: Twenty-two patients had full-thickness intussusception, compared with two controls (P = 0.003). Intussusceptum thickness was significantly greater in the symptomatic group (anterior component: P = 0.004; posterior: P = 0.011). Twenty patients in the symptomatic group, but only three subjects in the control group, had a mechanically occluding intussusception (P = 0.043), although only three patients demonstrated evacuatory dynamics outside the normal range. CONCLUSION: Rectal intussusception in patients with evacuatory dysfunction is more advanced morphologically than that seen in asymptomatic controls; it is predominantly full thickness in patients and mucosal in controls. However, caution is required when selecting patients for intervention based solely on radiological findings.

Contribution of the pudendal nerve to sensation of the distal rectum.

BACKGROUND: Anal and rectal sensory mechanisms and pudendal nerve function are important in the control of faecal continence. The contribution of the pudendal nerve to sensation of the distal rectum was investigated. METHODS: Heat thresholds in the anal canal, distal and mid rectum were measured using a specially designed thermoprobe. Rectal sensory threshold volumes were measured using the balloon distension method. Needle electrodes were inserted into the external anal sphincter. Pudendal nerve block was performed through a perineal approach, and completeness assessed by loss of electromyographic activity. Heat and rectal volume thresholds were measured again following unilateral and bilateral pudendal nerve block. RESULTS: The technique was successful in four of six volunteers. Bilateral pudendal nerve block produced complete anaesthesia to heat in the anal canal (P = 0.029), but had no effect on heat thresholds in the distal or mid rectum. Rectal sensory threshold volumes were also unaffected by pudendal nerve anaesthesia. CONCLUSION: Anal canal sensation is subserved by the pudendal nerve, but this nerve is not essential to nociceptive sensory mechanisms in the distal or mid rectum. The transition between visceral control mechanisms in the lower rectum and somatic mechanisms in the anal canal may have functional importance in the initiation of defaecation and the maintenance of continence.

Medium-term results of vertical reduction rectoplasty and sigmoid colectomy for idiopathic megarectum.

BACKGROUND: Vertical reduction rectoplasty (VRR) was devised specifically to address the physiological abnormalities present in the rectum of patients with idiopathic megarectum (IMR). This study evaluated the medium-term clinical and physiological results of VRR. METHODS: VRR and sigmoid colectomy was performed in ten patients with IMR and constipation (six women). Patients were evaluated before and a median of 60 (range 28-74) months after surgery by assessment of symptoms using scoring systems and anorectal physiological measurements. Independent, detailed postoperative evaluation of rectal diameter, compliance, and sensory and evacuatory function was performed. RESULTS: There were no deaths or late complications. Symptoms recurred necessitating permanent ileostomy formation in two patients. Median (range) constipation scores improved from 22 (18-27) before to 10 (0-24) after surgery (P = 0.016). Median (range) bowel frequency increased from 1.5 (0.2-7) to 7 (0.5-21) per week (P = 0.016). Rectal diameter, compliance and sensory function were normal in seven of eight patients after surgery. Evacuatory function and colonic transit were each normalized in two of eight patients after VRR. CONCLUSION: VRR corrected rectal diameter, compliance and sensory function in most patients, and clinical benefit was sustained in the medium term. The procedure was associated with a low morbidity, and no mortality and should be considered in the surgical management of IMR.

EXternal Pelvic REctal SuSpension (Express procedure) for rectal intussusception, with and without rectocele repair.

BACKGROUND: The results of conventional treatment for rectal intussusception and rectocele are unpredictable. The aim was to develop a less invasive surgical approach and to evaluate outcome in selected patients. METHODS: Seventeen patients (13 women; median age 47 (range 20-67) years) with rectal evacuatory dysfunction and rectal intussusception, 13 of whom had a rectocele, were selected. The intussusception was corrected by external pelvic suspension of the rectum, using collagen strips attached to the rectal wall and pubis. The rectocele was repaired with a collagen patch. Patients were assessed before and 6 months after surgery by symptom and quality of life questionnaires, anorectal physiological investigation and proctography, and were followed up for a median of 12 months. RESULTS: Sepsis requiring exploration occurred in two patients but there was no extrusion or need to remove the collagen. Of the 15 patients assessed after surgery, total symptom scores were significantly decreased (P < 0.001) and quality of life scores improved (P < 0.001). Proctographically, the degree of intussusception was improved in ten patients; six patients had normal postoperative proctograms. The rectocele was reduced in size in all patients, and was not demonstrable in eight. CONCLUSION: An effective procedure for rectal intussusception and rectocele has been developed in a selected group of patients with marked evacuatory symptoms.

External pelvic rectal suspension (the Express procedure) for full-thickness rectal prolapse: evolution of a new technique.

OBJECTIVE: The Délorme's operation for rectal prolapse is a safe procedure but has a high recurrence rate. We aimed to develop an operation akin to it, but designed to reduce this deficit. PATIENTS AND METHODS: Thirty-one consecutive patients with rectal prolapse were included in the study. Initially, a conventional Délorme's procedure was performed and sutures or strips of Gore-Tex were attached circumferentially to the apex of the prolapse, tunneled subcutaneously, and anchored to the external surface of the pelvis. Subsequently, the procedure was modified. Acellular porcine collagen strips were used and buried within the apex without plication of the denuded rectal musculature. Patients were formally assessed preoperatively and four months postoperatively by symptom and quality of life questionnaires and subsequently by regular clinical review. RESULTS: In the Gore-Tex group (N = 11; males:females = 10:1; mean age, 61 years) three patients underwent suture repair and eight had strip fixation. All suture repairs developed sepsis and one patient had a recurrence. Seven of the strip fixations (88 percent) developed sepsis that resulted in implant extrusion. There was one full-thickness and one mucosal recurrence after a median follow-up of 25 months. In the collagen group (N = 20; males:females = 2:18; mean age, 63 years), sepsis occurred in four patients, requiring surgical intervention in one patient (5 percent) (cf Gore-Tex group, P = 0.002). There was one mucosal and three full-thickness (15 percent) recurrences after a median follow-up of 14 months (cf Gore-Tex group, P = not significant). Significant improvements in symptom and quality of life scores were recorded in both groups at four months. CONCLUSION: A new, minimally invasive perineal procedure for rectal prolapse has been developed and initial data testify to its relative safety provided collagen is used. It remains to be seen whether long-term recurrence rates will be lower than those of conventional perineal procedures.

Relationship between symptom response and oesophageal acid exposure after medical and surgical treatment for gastro-oesophageal reflux disease.

BACKGROUND: The relationship between symptom severity and objective evidence of gastro-oesophageal reflux disease (GORD) after medical and surgical treatment has recently been questioned. This study aimed to compare the symptomatic and physiological response (as measured by pHmetry) to the treatment of GORD by proton pump inhibitors (PPIs) and by laparoscopic antireflux surgery, and to examine the relationship between the patient's subjective and objective response to treatment of GORD. METHODS: Seventy patients underwent 24-h oesophageal pH measurement and DeMeester symptom assessment (for heartburn and regurgitation, grade 0-3) while off medical treatment, while taking PPIs and after laparoscopic fundoplication. RESULTS: The median percentage total time with oesophageal pH < 4 off treatment, during medical treatment and after fundoplication was 9.5, 4.3 and 0.5 per cent respectively. After medical treatment 30 patients became asymptomatic although 18 of these still had pathological reflux on pH testing. Of the 19 patients who remained symptomatic after surgery only two had pathological acid reflux. CONCLUSION: The symptomatic response of patients to either PPIs or antireflux surgery is a poor indicator of successful treatment in terms of reduced lower oesophageal acid exposure. A high proportion of patients whose symptoms are improved by PPIs still have pathological levels of acid reflux. Conversely, most patients who complain of reflux symptoms after antireflux surgery have no evidence of residual reflux on pHmetry.