The affect of personality traits and decision-making style on postoperative quality of life and distress in patients undergoing pelvic exenteration.

AIM: Our aim was to identify whether personality traits and decision-making styles affect quality of life (QoL) outcomes and levels of psychological distress following pelvic exenteration (PE). METHOD: Patients undergoing PE between 2008 and 2015 were identified from a prospectively maintained database at a single quaternary referral centre. Patients were invited to complete two validated questionnaires, with the Big Five inventory being used to assess personality traits and the Melbourne Decision Making Questionnaire to determine decision-making style. Data on QoL outcomes and distress from the prospectively established database were utilized. QoL with respect to both physical and mental health components was measured using Short Form 36 version 2 (SF-36v2) and the Functional Assessment of Cancer Therapy - Colorectal (FACT-C). Distress was measured using the Distress Thermometer. Postoperative pain scores were also measured using SF-36v2. RESULTS: Of the 93 patients eligible for participation, 42 returned the study questionnaire. On multivariate analysis, neuroticism was the most significant predictor of poorer QoL and increased levels of distress, consistent across all of the measures utilized and at the different time points used. Other personality traits showed an isolated statistically significant impact upon QoL. There were no significant findings with respect to decision-making style. Apart from neuroticism, the most significant predictor of QoL was the number of major complications for the patient. CONCLUSION: Patients demonstrating neurotic personality traits show poorer QoL outcomes and higher levels of distress following PE. Identification of these patients would allow targeted pre- and postoperative intervention to improve outcomes following PE.

Quality of life and functional outcomes following pelvic exenteration and sacrectomy.

AIM: The aim was to compare postoperative quality of life (QOL) between patients undergoing pelvic exenteration (PE) and pelvic exenteration with sacrectomy (PES), and to investigate the influence of high (L5-S2) vs low (≤ S3) sacrectomy on QOL and functional outcomes. METHOD: Patients undergoing en bloc sacrectomy as part of a PE and PE alone from 2008 to 2015 were identified from a prospectively maintained database. QOL and functional outcomes were assessed using the 36-Item Short Form Survey, the European Organization for Research and Treatment of Cancer Colorectal Cancer questionnaire and Quality of Life questionnaire, the Revised Musculoskeletal Tumour Scale, the Lower Extremity Functional Scale, the Sexual Health Inventory for Men and the Female Sexual Function Index. RESULTS: Of the 344 patients identified, data were available for 116 patients who underwent PE alone and 140 patients who underwent PES. PES patients had significantly poorer physical component scores (P < 0.001) but not mental component scores (P = 0.17). Of the 140 PES patients, 55 were eligible and were invited to participate in a second functional survey, with 30 patients returning the study questionnaire. High sacrectomy patients, compared with low sacrectomy, had significantly worse lower limb motor function (P = 0.03) and poorer physical (P = 0.001) and mental health component scores (P = 0.02). No differences were found in sexual, bladder and bowel function between high and low sacrectomy patients. CONCLUSIONS: Patients undergoing PES had worse physical component scores compared with PE alone, whereas high sacrectomy patients had significantly worse lower limb motor function and physical and mental component scores but comparable bowel, bladder and sexual functional outcomes compared with low sacrectomy patients.

Prognostic factors and patterns of failure after surgery for T4 rectal cancer in the beyond total mesorectal excision era.

BACKGROUND: Despite advances in the rates of total mesorectal excision (TME) for rectal cancer surgery, decreased local recurrence rates and increased 5-year survival, there still exists large variation in the quality of treatment received. Up to 30 per cent of rectal cancers are locally advanced at presentation and approximately 5-10 per cent still breach the mesorectal plane and invade adjacent structures despite neoadjuvant therapy. With the evolution of extended resections for rectal cancers beyond the TME plane, proponents advocate that these resections should be performed only in specialist centres. The aim was to assess the prognostic factors and patterns of failure after beyond TME surgery for T4 rectal cancers. METHODS: Data were collected from prospective databases at three high-volume institutions specializing in beyond TME surgery for T4 rectal cancers between 1990 and 2013. The primary outcome measures were overall survival, local recurrence and patterns of first failure. RESULTS: Three hundred and sixty patients were identified. The negative resection margin (R0) rate was 82·8 per cent (298 patients) and the local recurrence rate was 12·5 per cent (45 patients). The type of surgical procedure (Hartmann's: hazard ratio (HR) 4·49, 95 per cent c.i. 1·99 to 10·14; P = 0·002) and lymphovascular invasion (HR 2·02, 1·08 to 3·77; P = 0·032) were independent predictors of local recurrence. The 5-year overall survival rate for all patients was 61 (95 per cent c.i. 55 to 67) per cent. The 5-year cumulative incidence of first failure was 8 per cent for local recurrence, 6 per cent for local and distant disease, and 18 per cent for distant disease. CONCLUSION: This study has demonstrated that a coordinated approach in specialist centres for beyond TME surgery can offer good oncological and long-term survival in patients with T4 rectal cancers.

ANTECEDENTES: A pesar de las mejoras en los porcentajes de extirpación total del mesorrecto (total mesorectal excision, TME) en la cirugía de cáncer de recto, la disminución de los porcentajes de recidiva local y el aumento de la supervivencia a 5 años, todavía existe una gran variabilidad en la calidad del tratamiento recibido. Hasta el 30% de los cánceres de recto están localmente avanzados en el momento del diagnóstico y aproximadamente el 5-10% sobrepasarán el plano mesorrectal e invadirán las estructuras adyacentes a pesar del tratamiento neoadyuvante. Con la evolución de las resecciones ampliadas para los cánceres de recto que sobrepasan el plano de la TME, los defensores recomiendan que estas resecciones solo se realicen en centros especializados. El objetivo fue evaluar los factores pronósticos y los patrones de recidiva después de la cirugía ampliada más allá de la TME para los cánceres de recto T4. MÉTODOS: Los datos se recogieron a partir de bases de datos prospectivas de tres instituciones de alto volumen especializadas en resecciones ampliadas más allá de la TME para el cáncer de recto T4 entre 1990 y 2013. Los criterios de valoración principal fueron la supervivencia global, la recidiva local y los patrones de la primera recidiva. RESULTADOS: Se identificaron 360 pacientes. El margen de resección fue negativo (R0) en el 82,8% (n = 298) y el porcentaje de recidiva local fue de 12,5% (n = 45). El tipo de cirugía realizada (Hartmann: cociente de riesgos instantáneos, hazard ratio, HR 4,49; i.c. del 95%: 1,99-10,14; P = 0,002) y la invasión linfovascular (HR 2,02; i.c. del 95%: 1,08-3,77; P = 0,032) fueron factores predictivos independientes de recidiva local. La supervivencia global a 5 años para todos los pacientes fue del 61% (i.c. del 95%: 55-67). La incidencia acumulada a los 5 años de la primera recidiva fue de 8% para la recidiva local, 6% para la recidiva local y a distancia, y 18% para la recidiva a distancia. CONCLUSIÓN: Este estudio demuestra que un abordaje coordinado en centros especializados para cirugía más allá de la TME puede ofrecer una buena supervivencia oncológica y a largo plazo en pacientes con cáncer de recto T4.

Pushing the boundaries of pelvic exenteration by maintaining survival at the cost of morbidity.

BACKGROUND: Pelvic exenteration (PE) provides a potentially curative option for advanced or recurrent malignancy confined to the pelvis. A clear (R0) resection margin is the strongest prognostic factor predicting long-term survival, driving most technical advances in PE surgery. The aim of this cohort study was to describe changing trends in extent of resection, postoperative complications, mortality and overall survival after PE surgery. METHODS: Consecutive patients who underwent PE for advanced or recurrent pelvic malignancy at a single institution in Sydney, Australia, were identified. The cohort was divided into three groups based on time periods reflecting annual surgical volume: 1994-2006 (20 or fewer procedures per year), 2007-2013 (21-50 procedures per year) and 2014-2017 (over 50 procedures per year). Primary outcomes were extent of resection, postoperative complications, 60-day mortality and 3-year overall survival. Secondary outcomes were patient characteristics, receipt of neoadjuvant therapy and duration of hospital stay. RESULTS: There were increases over time in rates of lateral and posterior compartment resections (P < 0·001), and bony pelvis (P = 0·002) and neurovascular (P < 0·001) excision. For patients undergoing reconstruction, the proportion receiving vertical rectus abdominus myocutaneous flaps increased significantly (P = 0·005). Rates of wound infection, dehiscence, and abdominal and pelvic collections increased over the study interval. Short-term mortality decreased, and 1- and 3-year survival rates improved. CONCLUSION: Technical and surgical advancements have led to more complex PE resections, with R0 and mortality rates improving with higher annual volume. There were associated increases in intraoperative blood loss and postoperative morbidity.

ANTECEDENTES: La exenteración pélvica (pelvic exenteration, PE) ofrece una opción potencialmente curativa para el cáncer localmente avanzado o la recidiva de la neoplasia limitada a la pelvis. Un margen de resección libre (R0) es el factor pronóstico más importante que predice la supervivencia a largo plazo, lo que ha impulsado la mayoría de los avances técnicos en la cirugía de la PE. El objetivo de este estudio de cohortes fue describir el cambio en la tendencia relativa a la extensión de la resección, las complicaciones postoperatorias, la mortalidad y la supervivencia global después de la cirugía de la PE. MÉTODOS: Se identificaron pacientes intervenidos de forma consecutiva a los que se practicó una PE por neoplasia pélvica avanzada o recidivante en una sola institución en Sydney, Australia. La cohorte se dividió en tres grupos según períodos de tiempo que reflejan el volumen quirúrgico anual: 1994-2006 (≤ 20 casos por año), 2007-2013 (21-50 casos por año) y 2014-2017 (> 50 casos por año). Los criterios de valoración principal fueron la extensión de la resección, las complicaciones postoperatorias, la mortalidad a los 60 días y la supervivencia a los tres años. Los criterios de valoración secundarios fueron las características del paciente, la administración de tratamiento neoadyuvante y la duración de la estancia hospitalaria. Las tendencias se evaluaron mediante pruebas de χ2 o ANOVA de una vía. RESULTADOS: Los porcentajes de resección de los compartimentos lateral y posterior, pelvis ósea así como de escisión neurovascular aumentaron con el tiempo (P < 0,01). Entre los pacientes en los que se hizo una reconstrucción, el porcentaje de colgajos miocutáneos verticales del recto del abdomen aumentó significativamente (P = 0,005). Las tasas de infección de herida, dehiscencia y colecciones abdominales y pélvicas aumentaron durante el período de estudio. La mortalidad a corto plazo disminuyó y la supervivencia a 1 y 3 años mejoró durante el período de estudio. CONCLUSIÓN: Los avances técnicos y quirúrgicos han permitido realizar resecciones de PE más complejas, mejorando las tasas de resección R0 y de mortalidad al aumentar el volumen anual de intervenciones. Al mismo tiempo se han observado incrementos en las pérdidas intraoperatorias de sangre, en las reconstrucciones y en la morbilidad postoperatoria.

Sacral nerve stimulation for bowel dysfunction following low anterior resection: a systematic review and meta-analysis.

AIM: Low anterior resection syndrome (LARS) can affect up to 70% of all patients with rectal cancer. In the last two decades, sacral nerve stimulation (SNS) has emerged as an effective treatment for faecal incontinence. There is some encouraging literature on the use of SNS in patients with LARS. The purpose of this review is to provide an up to date review on the utility of SNS on LARS. METHOD: A literature search was conducted using the MEDLINE, Embase and PubMed databases (January 1981-March 2019). Studies identified were appraised with standard selection criteria. Data points were extracted, and meta-analysis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. RESULTS: Ten studies met the inclusion criteria and were included in this study. All studies used the Cleveland Clinic Incontinence Score (CCIS), whereas the low anterior resection syndrome score (LARS score) was used in three studies. Overall median improvement in the scoring system was 67.0% (range 35.5%-88.2%) after SNS implantation. There was a significant reduction in CCIS after SNS implantation (mean difference 11.23, 95% confidence interval 9.38-13.07, Z = 11.90, P < 0.00001). The LARS score was also significantly reduced after using SNS in patients with LARS (mean difference 17.87, 95% confidence interval 10.15-25.59, Z = 4.54, P < 0.00001). CONCLUSION: Use of SNS may provide symptomatic benefits for patients with LARS refractory to medical therapy. However, the current level of evidence remains limited. A large multicentre study of SNS for LARS using the validated LARS score is warranted. In addition, the cost-effectiveness of SNS for patients with LARS needs further exploration.

A randomized controlled trial of four different regimes of biofeedback programme in the treatment of faecal incontinence.

AIM: Biofeedback is an established, effective and non-invasive treatment for faecal incontinence (FI). The aim was to compare the effectiveness of four different biofeedback treatment regimes. METHOD: This was a randomized control trial of patients with FI, stratified into two groups (metropolitan and rural) and then randomized into two subgroups (groups 1 and 2 within metropolitan, groups 3 and 4 within rural) with varying face-to-face and telephone biofeedback components. All patients received standardized counselling and education, dietary modification and the use of anti-diarrhoeal medications. Group 1 received four monthly face-to-face biofeedback treatments, groups 2 and 3 received one face-to-face biofeedback followed by telephone biofeedback and group 4 received a one-off face-to-face biofeedback treatment. Primary outcomes were patient-assessed severity of FI and quality of life as assessed by the 36-item Short Form Health Survey and direct questioning of objectives. Secondary outcomes included St Mark's incontinence score, anxiety, depression and anorectal physiology measures (resting, squeeze pressures; isotonic, isometric fatigue times). RESULTS: Between 2006 and 2012, 351 patients were recruited. One patient died leaving 350 for analysis. 332 (95%) were women. Mean age was 60 (SD = 14). All groups had significant improvements in FI, quality of life, incontinence score and mental status (P < 0.001 each). There were no differences in improvements in FI between groups although patient satisfaction was less with reduced face-to-face contact. There were modest improvements in isotonic and isometric fatigue times suggesting improved sphincter endurance (both P < 0.001). CONCLUSION: Biofeedback is effective for FI. Although face-to-face and telephone biofeedback is not necessary to improve FI, it is important for patient satisfaction.

Systematic review of the feasibility of laparoscopic reoperation for early postoperative complications following colorectal surgery.

BACKGROUND: Returning to the operating theatre for management of early postoperative complications after colorectal surgery is an important key performance indicator. Laparoscopic surgery has benefits that may be useful in surgical emergencies. This study explored the evidence for the advantages of laparoscopic reoperation. METHODS: A systematic review was performed to identify publications reporting the outcomes of laparoscopy as a mode of reoperation for the management of early postoperative complications of colorectal surgery. The main outcomes examined were 30-day mortality, 30-day morbidity, length of hospital stay, second reoperation rate, ICU admission and stoma formation at reoperation. RESULTS: After screening 3657 citations, ten non-randomized cohort studies were identified (1137 reoperations). Laparoscopic reoperation was equivalent to or better than open reoperation, with lower rates of 30-day mortality (0-4·4 versus 0-13·6 per cent), 30-day morbidity (6-40 versus 30-80 per cent), length of stay (mean(s.d.) 15·8(2·8) versus 29·1(14·5) days), ICU admission and duration of stay in the ICU. Anastomotic leak was the most common indication, after which more patients received a defunctioning loop stoma instead of an end stoma at laparoscopic than open reoperation. CONCLUSION: Laparoscopic reoperation is feasible in selected patients, with the advantages of improved short-term outcomes.

Cost-effectiveness of pelvic exenteration for locally advanced malignancy.

BACKGROUND: The rising cost of healthcare is well documented. The purpose of this study was to determine the cost-effectiveness of pelvic exenteration (PE). METHODS: Consecutive patients referred for consideration of PE between 2008 and 2011 were recruited into a prospective non-randomized study that compared quality of life (QoL) between patients who did or did not undergo PE. Information on QoL and cost (in Australian dollars, AUD) was collected at baseline, during admission and up to 24 months after discharge. QoL data were converted into a utility-based measure. Quality-adjusted life-years (QALYs) were calculated. Bottom-up costing was performed. The incremental cost-effectiveness ratio (ICER) was calculated per life-year saved and per QALY. RESULTS: There were 174 patients with sufficient data for analysis. Of these, 139 underwent PE. R0 was achieved in 78·4 per cent of patients. The survival rate at 24 months after PE was 74·8 per cent compared with 43 per cent in those without exenteration (P = 0·001). Treatment costs were significantly higher for patients who had PE compared with those who did not (mean AUD 137 407 versus 79 174; P < 0·001). The ICER was AUD 124 147 (95 per cent c.i. 71 585 to 261 876) per life-year saved and AUD 227 330 (109 974 to 1 100 449) per QALY. Curative PE (R0) was found to be more cost-effective than non-curative PE (R1/R2), with an ICER of AUD 101 518 (60 105 to 200 428) versus 390 712 (74 368 to 82 256 739) per life-year saved. CONCLUSION: Treatment of advanced pelvic cancers is expensive regardless of the treatment intent. For a cost difference of only AUD 58 000 (€38 264), PE offers a chance of cure, and improves survival and QoL.

Review article: acute severe ulcerative colitis - evidence-based consensus statements.

BACKGROUND: Acute severe ulcerative colitis (ASUC) is a potentially life-threatening complication of ulcerative colitis. AIM: To develop consensus statements based on a systematic review of the literature of the management of ASUC to improve patient outcome. METHODS: Following a literature review, the Delphi method was used to develop the consensus statements. A steering committee, based in Australia, generated the statements of interest. Three rounds of anonymous voting were carried out to achieve the final results. Acceptance of statements was pre-determined by ≥80% votes in 'complete agreement' or 'agreement with minor reservation'. RESULTS: Key recommendations include that patients with ASUC should be: hospitalised, undergo unprepared flexible sigmoidoscopy to assess severity and to exclude cytomegalovirus colitis, and be provided with venous thromboembolism prophylaxis and intravenous hydrocortisone 100 mg three or four times daily with close monitoring by a multidisciplinary team. Rescue therapy such as infliximab or ciclosporin should be started if insufficient response by day 3, and colectomy considered if no response to 7 days of rescue therapy or earlier if deterioration. With such an approach, it is expected that colectomy rate during admission will be below 30% and mortality less than 1% in specialist centres. CONCLUSION: These evidenced-based consensus statements on acute severe ulcerative colitis, developed by a multidisciplinary group, provide up-to-date best practice recommendations that improve and harmonise management as well as provide auditable quality assessments.

Lateral pelvic compartment excision during pelvic exenteration.

BACKGROUND: Involvement of the lateral compartment remains a relative or absolute contraindication to pelvic exenteration in most units. Initial experience with exenteration in the authors' unit produced a 21 per cent clear margin rate (R0), which improved to 53 per cent by adopting a novel technique for en bloc resection of the iliac vessels and other side-wall structures. The objective of this study was to report morbidity and oncological outcomes in consecutive exenterations involving the lateral compartment. METHODS: Patients undergoing pelvic exenteration between 1994 and 2014 were eligible for review. RESULTS: Two hundred consecutive patients who had en bloc resection of the lateral compartment were included. R0 resection was achieved in 66·5 per cent of 197 patients undergoing surgery for cancer and 68·9 per cent of planned curative resections. For patients with colorectal cancer, a clear resection margin was associated with a significant overall survival benefit (P = 0·030). Median overall and disease-free survival in this group was 41 and 27 months respectively. Overall 1-, 3- and 5-year survival rates were 86, 46 and 35 per cent respectively. No predictors of survival were identified on univariable analysis other than margin status and operative intent. Excision of the common or external iliac vessels or sciatic nerve did not confer a survival disadvantage. CONCLUSION: The continuing evolution of radical pelvic exenteration techniques has seen an improvement in R0 margin status from 21 to 66·5 per cent over a 20-year interval by routine adoption of a more lateral anatomical plane. Five-year overall survival rates are comparable with those for more centrally based tumours.

Myenteric plexitis at the proximal resection margin is a predictive marker for surgical recurrence of ileocaecal Crohn's disease.

AIM: Identifying predictors for the recurrence of Crohn's disease (CD) after surgery to improve disease surveillance or targeted therapy is rational. The purpose of this study was to examine the relationship between myenteric plexitis (MP) and clinical or surgical recurrence. METHOD: Between 2000 and 2010, patients who underwent primary ileocaecal resection for CD at a single tertiary referral centre were identified. The histopathology was retrospectively reviewed for MP at the resection margins. The severity of MP was graded from 0 to 3 using a previously described classification. Information on demographics, surgical details and evidence of clinical or surgical recurrence was obtained from medical records. RESULTS: There were 86 patients (49 women) of median age 31.5 (interquartile ratio 23.5-41.0) years. Seventy-six and 77 specimens were assessable for proximal and distal MP. Proximal MP was present in 53 (69.7%) patients and was classified as mild, moderate or severe in 30 (39.5%), 14 (18.4) and nine (11.8%). MP at the distal resection margin was present in 40 (51.9%). Forty (46.5%) patients developed clinical recurrence of whom 16 (18.6%) required surgery. Clinical factors that predicted recurrence included age > 40 (P = 0.001) and the presence of an anastomosis (P = 0.023). On univariate analysis severe plexitis (Grade 3 MP) was also associated with surgical recurrence (P = 0.035). CONCLUSION: This retrospective study supports the association between MP at the proximal resection margin and surgical recurrence.

Healing under pressure: hyperbaric oxygen and myocutaneous flap repair for extreme persistent perineal sinus after proctectomy for inflammatory bowel disease.

AIM: Persistent perineal sinus (PPS) following proctectomy for inflammatory bowel disease affects about 50% of patients. Up to 33% of cases of PPS remain unhealed at 12 months and the most refractory cases are unhealed at 24 months despite optimal conventional therapy. Reports of hyperbaric oxygen therapy (HBOT) for chronic wounds and Crohn's perianal disease led us to explore perioperative HBOT with rectus abdominis myocutaneous (RAM) flap repair in a highly selected group of patients with extreme PPS who had failed all other interventions. METHOD: Patients with extreme PPS received preoperative HBOT (a 90-min session at 2.2-2.4 atmospheres, five times per week for 5-6 weeks, for a total of up to 30 sessions), before abdominoperineal PPS excision and perineal reconstruction with vertical or transverse RAM flap repair within 2-4 weeks of completing HBOT. Postoperative HBOT (10 further 90-min sessions) was administered within 2 weeks where practicable. RESULTS: Between 2007 and 2011, four patients with extreme PPS underwent RAM flap repair with preoperative HBOT; two also received postoperative HBOT. The median (range) duration of PPS before HBOT was 88.5 (23-156) months. All patients had previously failed multiple (5 to > 35) surgical procedures. Complete healing occurred in all patients at a median (range) follow-up of 2.5 (2-3) months. There were no further hospital admissions for PPS at a median (range) follow-up of 35 (8-64) months. CONCLUSION: Hyperbaric oxygen therapy combined with PPS excision and perineal reconstruction with a RAM flap led to complete perineal healing in four patients with extreme PPS and appears a safe and effective extension to the therapeutic pathway for exceptionally treatment-refractory PPS.

Clinical algorithms for the diagnosis and management of urological leaks following pelvic exenteration.

BACKGROUND: Urine leak following pelvic exenteration for locally advanced pelvic malignancy is a major complication leading to increased mortality, morbidity and length of stay. We reviewed our experience and developed a diagnostic and management algorithm for urine leaks in this patient population. METHODS: Consecutive patients who underwent en bloc cystectomy and conduit formation as part of pelvic exenteration at a single quaternary referral centre from 1995 to 2012 were reviewed. Patients with urine leak were identified. Medical records were reviewed to extract data on diagnosis and management and a suggested clinical algorithm was developed. RESULTS: Of 325 exenterations, there were 102 conduits, of which 15 patients (15%) developed a conduit related urine leak. Most (14/15) patients were symptomatic. Diagnosis was made by drain creatinine studies (12/15) and/or imaging (15/15). Management comprised of conservative management, radiologic urinary diversion, early surgical revision and late surgical revision in 3, 11, 2 and 1 patients respectively. Important lessons from our 17 year experience include a high index of suspicion in a patient who is persistently septic despite appropriate treatment, the importance of regular drain creatinine studies, CT (computer tomography) with delayed images (CT intravenous pyelogram) when performing a CT for investigation of sepsis and early aggressive management with radiologic urinary diversion to facilitate early healing. CONCLUSION: Urine leak after pelvic exenteration is a complex problem. Conservative management usually fails and early diagnosis and intervention is the key. It is hoped that our algorithms will facilitate diagnosis and subsequent management of this group of patients.

Systematic review of randomized controlled trials of the effectiveness of biofeedback for pelvic floor dysfunction.

BACKGROUND: Pelvic floor dysfunction (PFD) is a type of functional constipation. The effectiveness of biofeedback as a treatment remains unclear. METHODS: A systematic review of all randomized controlled trials evaluating the effectiveness of biofeedback in adults with PFD was carried out. All online databases from 1950 to 2007 were searched. This was supplemented by hand searching references of retrieved articles. RESULTS: Seven trials fulfilled the inclusion criteria. Three compared biofeedback with non-biofeedback treatments and four compared different biofeedback modalities. Electromyography feedback was most widely utilized. The trials were heterogeneous with varied inclusion criteria, treatment protocols and definitions of success. Most had methodological limitations. Quality of life and psychological morbidity were assessed rarely. Meta-analysis of the studies involving any form of biofeedback compared with any other treatment suggested that biofeedback conferred a sixfold increase in the odds of treatment success (odds ratio 5.861 (95 per cent confidence interval 2.175 to 15.794); random-effects model). CONCLUSION: Although biofeedback is the recommended treatment for PFD, high-quality evidence of effectiveness is lacking. Meta-analysis of the available evidence suggests that biofeedback is the best option, but well designed trials that take into account quality of life and psychological morbidity are needed.