Management of idiopathic anal fistula using cross-linked collagen: a prospective phase 1 study.

AIM: Fibrin glue and porcine intestinal submucosa are used in novel sphincter-preserving techniques to heal anal fistulae. However, their success is highly variable and decreases with the length of follow up. The aim of this study was to assess the safety, feasibility and potential efficacy of another novel agent, cross-linked collagen, in two different physical formats, to heal anal fistulae. METHOD: Prospectively recruited patients underwent symptom, continence and anal physiology assessments and magnetic resonance imaging. Patients with secondary tracts or acute sepsis were excluded. At operation, participants were randomized to receiving a solid collagen implant or collagen fibres suspended in fibrin glue. Follow up included repeat symptom, continence and physiological assessments at 3 months, and regular clinical review thereafter. RESULTS: Twenty-nine of 43 entrants were eligible for inclusion. Thirteen patients received the collagen implant, and 16 collagen-fibrin glue. Three months postoperation, no patient experienced acute sepsis or continence disturbance, and sphincter function and integrity were unchanged. At 29 months, 12 of 15 (one lost to follow up) patients treated with collagen-fibrin glue were healed, compared with seven of 13 who received the implant. CONCLUSION: In the short-to-medium term, both techniques are safe and equally effective. The results justify continued research into the use of biomaterials to heal anal fistulae.

Complications of intestinal stomas.

BACKGROUND: Stomal complications are prevalent and associated with considerable morbidity. This study examined the incidence and potential risk factors for their development. METHODS: The time of onset and presence of ten specific complications were recorded for patients with an intestinal stoma over 10 years at two urban hospitals. A database was established with 20 explanatory variables (such as common medical co-morbidities) derived from the stomatherapy and medical records. Univariable and multivariable analyses were performed to identify potential risk factors for the development of complications. RESULTS: Some 1216 patients (mean age 64 years) with a minimum of 2 years' follow-up were included, of whom 544 (44·7 per cent) underwent surgery for malignancy and 647 (53·2 per cent) had a colostomy formed. There were 1219 complications in total; 807 major complications (excluding excoriation and slough) occurred in 564 patients (46·4 per cent), of which the commonest was parastomal hernia (171, 14·1 per cent). On multivariable analysis, musculoskeletal co-morbidity (odds ratio (OR) 1·79, 95 per cent confidence interval 1·05 to 3·07; P = 0·032), cancer (OR 1·48, 1·13 to 1·93; P = 0·004) and high American Association of Anesthesiologists score (OR = 3·80, 2·14 to 6·75; P < 0·001) were associated with an increased risk of complications. Preoperative siting was associated with a reduced risk (OR 0·59, 0·39 to 0·90; P = 0·014). CONCLUSION: Intestinal stomal complications are common, occurring in almost half of patients. There are certain irremediable risk factors, allowing appropriate preoperative counselling.

The 'straight to test' initiative reduces both diagnostic and treatment waiting times for colorectal cancer: outcomes after 2 years.

AIM: This study aimed to determine whether a 'straight to test'(STT) strategy for 2-week wait (2 wk) referrals for suspected colorectal cancer (CRC) reduced the time to diagnosis and treatment for patients with CRC. METHOD: Consecutive 2-week referrals for suspected CRC over a period of 2 years from February 2007 were analysed. The times to the first diagnostic test and treatment and the cancers identified were analysed for those going to STT or the outpatient clinic. RESULTS: Of 662 patients having a 2 wk referral, 519 (78.4%) were suitable for the hospital colorectal telephone triage service, 121 (18.3%) patients went to STT and 502 (75.8%) were seen in the clinic. Of these 401 (79.8%) underwent diagnostic tests and 25 (6.2%) had CRC and in 12 (2.9%) patients other cancers were detected. In the STT group, 7 (5.8%) patients were diagnosed with CRC. The median time to first diagnostic test was 12 days (IQR 9-13) in the STT pathway, compared with 23 days (17-31) in those seen in the clinic (P < 0.0001). The median time to first treatment was 40 (32-48) days for those via STT, compared to 46 (28-55) days for those seen in the clinic (P = 0.004). A total of 162 CRC were diagnosed during the study period of whom 34 (20.9%) were 2 wk referrals (5.1% of all suspected CRC 2 wk referrals), and 14 (2.1%) other cancers were detected via this pathway. CONCLUSION: STT speeds up the patient pathway by reducing the time to diagnosis and treatment for patients with CRC.

Conservative and behavioural management of constipation.

This article deals with psychological contributions, such as stool withholding or responses to abuse experiences, to the aetiology of evacuation disorders (with a focus on dyssynergic defecation), and with education and behavioural approaches to treatment.

Straight to test. Results of a pilot study in a hospital serving an inner city population.

OBJECTIVE: The main aims of the study were to determine the frequency with which two-week wait (2ww) referrals for colorectal cancer (CRC) could proceed directly to straight to test (STT), and the potential improvement in time to diagnosis. METHOD: A telephone interview was attempted in all 2ww referrals not requiring an advocate and under 80 years. Data were assessed according to a test protocol, and where indicated a potential slot for the appropriate investigation was recorded (virtual test). All patients proceeded to clinic, following which differences in time from GP referral to virtual compared with actual requested test, and any discrepancies between virtual and requested tests were analysed. RESULTS: Between 8th January and 16th February 2007, there were 42 2ww referrals. Twenty-one patients were contacted, of whom 14 were suitable for STT: 13 virtual colonoscopies and one CT scan were booked. Following out-patient consultation, eight colonoscopies; three flexible sigmoidoscopies, one barium enema, and two CT scans were actually booked. There was a difference of 15.5 days between the median times of the virtual and actual test. During this 6-week period a total of nine patients were diagnosed with CRC, of whom three were referred via the 2ww pathway, but none were suitable for STT. CONCLUSIONS: This 'straight to test' pilot study suggests a potential strategy for reducing the time to diagnosis and therefore first treatment of those identified with CRC, and offers a methodology for individual hospitals to assess their suitability to employ such a strategy.

The Snug Seton: short and medium term results of slow fistulotomy for idiopathic anal fistulae.

OBJECTIVE: To assess the short and intermediate outcomes of a modification of the traditional cutting seton technique, using a 'snug' silastic seton, to treat idiopathic anal fistulae. PATIENTS AND METHODS: Between August 1997 and December 2002, 35 patients with idiopathic fistulae (4 female; age 26-76 years) underwent insertion of a 'snugly' tied 1 mm silastic seton (silicone nerve vessel retractor, Medasil), as definitive treatment. Short-term assessment was performed by case note review. Patients were subsequently invited to participate in a medium-term review. RESULTS: Twenty-nine patients' notes (3 female) were available for short-term analysis. Fistulae were classified as intersphincteric (9) and transsphincteric (20). The seton spontaneously cut out in 15/29 (52%) after a median of 24 weeks. In 14 patients the seton enclosed residual tissue (< 5 mm) required division as a day case procedure, at a median of 35 weeks. All fistulae healed but 10/29 (34%) patients (1 female; 8 transsphincteric) experienced minor incontinence. Sixteen patients participated in a medium-term review at a median of 42 months; 7 had experienced early continence disturbance. No patient suffered recurrence, but minor incontinence persisted in 4/16 (25%) patients (0 females; 3 transsphincteric). All patients were at least 'satisfied' with the outcome. CONCLUSION: In the short and medium term, the 'snug' seton is a safe and effective addition to the fistula surgeon's armamentarium.

'Paper Clinics'- a model for improving delivery of outpatient colorectal services.

OBJECTIVES: The overburdening of colorectal out-patient clinics necessarily leads to delays in time from referral to consultation and subsequent clinic attendance. This study aimed to ascertain the feasibility of 'paper clinic' follow-up rather than all patients receiving a routine follow-up appointment following investigation. A more efficient outpatient follow-up process should reduce unnecessary follow-up, thereby facilitating the speedy investigation and diagnosis of patients through changes in clinic profiles. METHODS: From August 2001 all patients seen in the outpatient clinic of one (part time) Consultant colorectal surgeon, who required investigation, were prospectively recorded on a 'paper clinic' form. These patients were given the necessary test request forms but were not given a further outpatient appointment. The results of the investigations were reviewed, together with the patients' medical records at a formal fortnightly 'paper clinic' session carried out by the Consultant and Nurse Consultant, and a treatment plan derived. Patients then followed one of 5 follow-up pathways and were notified in writing with a copy to their GP. RESULTS: During a 24-month period a total of 897 patients were reviewed using the 'paper clinic' follow-up system. Of these, 285 (31.8%) patients were discharged without further follow-up. In a given 3-month period when the clinic was well established, 152 patients were reviewed, of whom 27% were discharged from follow-up, 17% received SOS appointments, 13% required further investigation (and consequently were returned to 'paper clinic' follow-up), and 7% received Nurse led follow-up. In this 3-month period 64% of patients reviewed by 'paper clinic' follow-up did not return to Surgical Outpatient's and 12% received a Surgical Outpatient appointment for review. CONCLUSION: 'Paper clinic' follow-up is an effective and feasible follow-up alternative, resulting in a major decrease in outpatient follow-up burden. This has allowed the redesign of the outpatient clinic profile allowing for an increase in new urgent slots, and more rapid clinic follow up review of those patients who need it. Re-design and rationalization of existing services can result in considerable service improvement. Expanding clinics should not be considered the only option when faced with capacity and demand issues.

Creation of a treatment protocol for nurse-led management of anal fissure.

OBJECTIVE: To create a protocol for colorectal nurse-led management of patients with idiopathic anal fissure. PATIENTS AND METHODS: The outcome of 135 patients with anal fissure presenting over a 3-year period to one (half time equivalent) Colorectal Surgeon in a District General Hospital, in whom initial management was centred on the use of 0.2% glyceryl trinitrate (GTN) was audited. Patients unavailable for complete follow-up, those with fissures of a specific aetiology and those in whom GTN was contra-indicated were excluded. 44% of patients were initially seen by a suitably trained and supported Nurse Practitioner (NP). RESULTS: Success rates for fissure healing with 0.2% GTN were similar to those reported in other studies. There were no differences in outcome between those patients managed by the NP and those managed by the Consultant/Specialist Registrar. As a result of the audit, a treatment protocol for use by Nurse Practitioners (as well as surgical staff), a patient information leaflet, and policy documents relating to NP management of anal fissures have been developed. CONCLUSION: It has been possible to construct a treatment protocol allowing rational management of patients with anal fissure by suitably trained and supported nurse specialists within their own clinic. This may be adapted to encompass future treatment developments.

A prospective randomized trial of consultant-led injection sclerotherapy compared with nurse practitioner-led noninvasive interventions in the management of patients with first and second degree haemorrhoids.

OBJECTIVE: To determine whether nurse practitioner (NP)-led advice in relation to bowel and defecatory habits in hemorrhoidal disease is as effective as local invasive treatment (sclerotherapy) in the management of patients with symptomatic 1st and 2nd degree haemorrhoids, with respect to both alleviation of presenting symptoms and relapse rate, and patients' understanding of their condition. PATIENTS AND METHODS: In a prospective randomized trial, 25 patients with bleeding haemorrhoids were allocated to receive either standard medical injection sclerotherapy (Group 1, n=13) or NP-led advice, information and bowel habit retraining (Group 2, n=12). Bulking agents were offered, when deemed appropriate, to patients in both groups. Treatment was administered by two clinicians only. Patients were assessed at 8 weeks, 4 months and finally at 6 months post treatment and any symptoms present were graded. RESULTS: At 6 months, symptomatic improvement was similar in both groups (mean range 3 points) with a patient expected to get better with a good degree of confidence (C.I: 2-4 points). However those patients in Group 2 would be expected to have a slightly better minimum level of improvement (GP 1 P=0.004 GP 2 P=0.0005). At six months, there was no statistical difference between the two groups with regard to the patient's perception of the amount of information given, the clarity of the explanation, and the ability of the patient to understand and discuss their problem. In relation to understanding the cause of their problem patients in Group 2 felt they had a higher level of understanding of the cause of their problem (U=13, NA=7, NB=10, P=0.05) and felt more able to prevent their problem returning (U=12, NA=7, NB=10, P=0.05). CONCLUSION: A bulking agent and Nurse led education, advice and bowel habit retraining is as effective in reducing the incidence of bleeding from 1st and 2nd degree haemorrhoids as injection sclerotherapy. Patients who consult a NP with symptomatic 1st and 2nd degree haemorrhoids feel more empowered in the long term. Non-invasive bowel retraining methods should be offered as an alternative to more traditional, invasive treatments for patients with symptomatic early hemorrhoidal disease.

Extending the role of the stoma care nurse.

Recently, there has been a great deal of interest, argument and debate regarding the extension of nursing roles and the development of nurse practitioner roles in particular. Much of this argument has centred around whether nurses are seeking to gain professional standing by taking on doctors' tasks, but little is heard about the potential benefits to patients and the possibility of developing new patient support services. In this article, the author looks specifically at the area of stoma care and outlines potential advantages and disadvantages to role extension.