Complexity of surgery and treatment burden in patients with peritoneal malignancy is not determined by addition of hyperthermic intraperitoneal chemotherapy.

BACKGROUND: This study describes surgical and quality of life outcomes in patients with peritoneal malignancy treated by cytoreductive surgery (CRS) alone compared with a subgroup treated with CRS and hyperthermic intraperitoneal chemotherapy (HIPEC). METHODS: Peritoneal malignancy patients undergoing surgery between 2017 and 2023 were included. The cohort was divided into patients treated by CRS and HIPEC and those treated by CRS without HIPEC (including CRS only or maximal tumour debulking (MTB)). Main outcomes included surgical outcomes, survival, and quality of life. Groups were compared using non-parametric tests and log-rank test was used to compare survival curves. RESULTS: 403 had CRS and HIPEC, 25 CRS only and 15 MTB. CRS and HIPEC patients had a lower peritoneal carcinomatosis index (12.0 vs. 17.0 vs. 35.0; P < 0.001) and longer surgical operative time (9.3 vs. 8.3 vs. 5.2 h; P < 0.001), when compared to CRS only and MTB, respectively. No other significant difference between groups was observed. CONCLUSIONS: The optimal management of selected patients with resectable peritoneal malignancy incorporates a combined strategy of CRS and HIPEC. When HIPEC is not utilized, due to significant residual disease or comorbidity precluding safe delivery, CRS alone is associated with good outcomes. Hospital stay and complications are acceptable but not significantly different to the CRS and HIPEC group. CRS alone is a complex intervention requiring comparable resources with good outcomes. In view of our findings 'intention to treat' with CRS and HIPEC should be the basis for resource allocation and funding.

Training Paradigms in Critical Care Cardiology: A Scoping Review of Current Literature.

Background: Over the past decade there has been increasing interest in critical care medicine (CCM) training for cardiovascular medicine (CV) physicians either in isolation (separate programs in either order [CV/CCM], integrated critical care cardiology [CCC] training) or hybrid training with interventional cardiology (IC)/heart failure/transplant (HF) with targeted CCC training. Objective: To review the contemporary landscape of CV/CCM, CCC, and hybrid training. Methods: We reviewed the literature from 2000-2022 for publications discussing training in any combination of internal medicine CV/CCM, CCC, and hybrid training. Information regarding training paradigms, scope of practice and training, duration, sequence, and milestones was collected. Results: Of the 2,236 unique citations, 20 articles were included. A majority were opinion/editorial articles whereas two were surveys. The training pathways were classified into - (i) specialty training in both CV (3 years) and CCM (1-2 years) leading to dual American Board of Internal Medicine (ABIM) board certification, or (ii) base specialty training in CV with competencies in IC, HF or CCC leading to a non-ABIM certificate. Total fellowship duration varied between 4-7 years after a three-year internal medicine residency. While multiple articles commented on the ability to integrate the fellowship training pathways into a holistic and seamless training curriculum, few have highlighted how this may be achieved to meet competencies and standards. Conclusions: In 20 articles describing CV/CCM, CCC, and hybrid training, there remains significant heterogeneity on the standardized training paradigms to meet training competencies and board certifications, highlighting an unmet need to define CCC competencies.

Outcome Heterogeneity in Prehabilitation Trials-Are We Comparing Apples and Oranges?

INTRODUCTION: Over the last decade, the number of prehabilitation randomised controlled trials (RCTs) has increased significantly. Therefore, this review aimed to describe the outcomes reported in prehabilitation RCTs in patients undergoing cancer surgery. METHODS: A search was conducted in Embase, Allied and Complementary Medicine Database, The Cochrane Library, PsycINFO, MEDLINE, and Cumulated Index to Nursing and Allied Health Literature from inception to July 2021. We included RCTs evaluating the effectiveness of preoperative exercise, nutrition, and psychological interventions on postoperative complications and length of hospital stay in adult oncology patients who underwent thoracic and gastrointestinal cancer surgery. The verbatim outcomes reported in each article were extracted, and each outcome was assessed to determine whether it was defined and measured using a validated tool. Verbatim outcomes were grouped into standardized outcomes and categorized into domains. The quality of outcome reporting in each identified article was assessed using the Harman tool (score range 0-6, where 0 indicated the poorest quality). RESULTS: A total of 74 RCTs were included, from which 601 verbatim outcomes were extracted. Only 110 (18.3%) of the verbatim outcomes were defined and 270 (44.9%) were labeled as either "primary" or "secondary" outcomes. Verbatim outcomes were categorized into 119 standardized outcomes and assigned into one of five domains (patient-reported outcomes, surgical outcomes, physical/functional outcomes, disease activity, and intervention delivery). Surgical outcomes were the most common outcomes reported (n = 71 trials, 95.9%). The overall quality of the reported outcomes was poor across trials (median score: 2.0 [IQR = 0.00-3.75]). CONCLUSIONS: Prehabilitation RCTs display considerable heterogeneity in outcome reporting, and low outcome reporting quality. The development of standardized core outcome sets may help improve article quality and enhance the clinical utility of prehabilitation following cancer surgery.

Healthcare Costs of Laparoscopic versus Open Surgery for Rectal Cancer Patients in the First 12 Months: A Secondary Endpoint Analysis of the Australasian Laparoscopic Cancer of the Rectum Trial (ALaCaRT).

BACKGROUND: Laparoscopic-assisted surgery for rectal cancer is widely used, however the healthcare costs are thought to be higher than for open resection. This secondary endpoint analysis of a randomized controlled trial aimed to evaluate total healthcare costs of laparoscopic-assisted surgery compared with open resection for rectal cancer over a 12-month period. METHODS: Patients in the Australasian Laparoscopic Cancer of the Rectum Trial (ALaCaRT) were included in a prospective costing analysis. All healthcare use for the index surgery and hospital admission, readmissions, and follow-up care over 12 months were included. Unit costs were valued in Australian dollars (AUD$) using scheduled Medicare fees and hospital cost weights. The primary outcome was mean per patient cost. Non-parametric bootstrapping with 10,000 replications was undertaken for robustness checks. RESULTS: Data from 468 patients indicated that the laparoscopic-assisted surgical procedure incurred a mean cost of AUD$4542 (standard deviation [SD] AUD$1050)-AUD$521 higher than the open procedure mean cost of AUD$4021 (SD AUD$804) due to longer operative time and involvement of more costly equipment (95% confidence interval [CI] AUD$354-AUD$692). At 12 months, the average cost for the laparoscopic-assisted and open groups was AUD$43,288 (SD AUD$40,883) and AUD$45,384 (SD AUD$38,659), respectively, due to the shorter subsequent hospital stays. No overall significant cost difference between groups was found (95% CI -AUD$9358 to AUD$5003). One-way sensitivity analyses confirmed the robustness of the results. CONCLUSION: While initially higher, the costs of laparoscopic-assisted surgery for rectal cancer were similar to open resection at 12 months. Clinicians may choose a surgical approach based on clinical need. TRIAL REGISTRATION: The Australasian Gastro-Intestinal Trials Group (AGITG) was the legal sponsor and trial coordination was performed by the NHMRC Clinical Trials Centre. The trial was registered with the Australian and New Zealand Clinical Trial Registry (ACTRN12609000663257).

Pelvic exenteration combined with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for advanced primary or recurrent colorectal cancer with peritoneal metastases.

AIM: The aim was to report early outcomes of six patients who underwent combined pelvic exenteration (PE), cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for advanced or recurrent colorectal cancer with colorectal peritoneal metastases at a single centre. The literature contains limited data on the safety and oncological outcomes of patients who undergo this combined procedure. METHODS: Six patients who underwent combined PE, CRS and HIPEC at Royal Prince Alfred Hospital, Sydney, between January 2017 and February 2020 were identified and included. Data were extracted from prospectively maintained databases. RESULTS: Three patients underwent surgery for advanced primary rectal cancer, while two patients had recurrent sigmoid cancer and one had recurrent rectal cancer. All patients had synchronous peritoneal metastases. Two patients required total PE and two patients had a central (bladder-sparing) PE. The median peritoneal carcinomatosis index was 6 (range 3-12) and all patients underwent a complete cytoreduction. The median operating time was 702 min (range 485-900) and the median blood loss was 1650 ml (range 700-12,000). The median length of intensive care unit and hospital stay was 4.5 and 25 days, respectively. There was no inpatient, 30-day or 90-day mortality. Three patients (50%) experienced a major (Clavien-Dindo III/IV) complication. At a median follow-up of 11.5 months (range 2-18 months), two patients died with recurrent disease, one patient was alive with recurrence, while three patients remain alive and disease-free. Of the three patients who developed recurrent disease, one had isolated pelvic recurrence, one had pelvic and peritoneal recurrences and one had bone metastases. CONCLUSION: Early results from this initial experience with simultaneous PE, CRS and HIPEC suggest that this combined procedure is safe and feasible; however, the long-term oncological and quality of life outcomes require further investigation.

Quality of Life After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy: Early Results from a Prospective Cohort Study of 115 Patients.

BACKGROUND: This study aimed to describe short- and medium-term longitudinal quality-of-life (QoL) outcomes after cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). METHODS: Consecutive patients undergoing CRS and HIPEC were recruited. The primary outcome was QoL, measured using the short-form 36 questionnaire and expressed as a physical component score (PCS) and a mental component score (MCS), with higher scores representing better QoL. Data were collected prospectively at baseline and before discharge, then 3, 6, and 12 months postoperatively. Trajectories of the PCS and MCS were described for the study period and grouped according to a peritoneal carcinomatosis index (PCI) (≤ 12 vs. ≥ 13) and a completeness of cytoreduction (CC) score (CC0 vs. CC1-CC3). RESULTS: Overall, 117 patients underwent CRS and HIPEC and 115 (98.3%) of the 117 patients participated in the study. The main primary pathology was colorectal in 52 (45%) of the 115 patients and appendiceal in 27 (23.5%) of the 115 patients. The median baseline PCS [48.16; interquartile range (IQR), 38.6-54.9] had decreased at pre-discharge (35.34; IQR, 28.7-41.8), then increased slightly at 3 months (42.54; IQR, 37.6-51.6), before returning to baseline within 6 months (48.35; IQR, 39.1-52.5) and remaining unchanged 12 months after surgery (48.55; IQR, 40.8-55.5). The MCS remained unchanged during the study period. The patients with a PCI of 13 or higher had worse PCS and MCS during the postoperative period than the patients with a PCI of 12 or lower. CONCLUSIONS: The CRS and HIPEC procedures impaired PCS, with scores returning to baseline within 6 months after surgery, whereas MCS remained unchanged. The patients with a lower PCI had better postoperative QoL outcomes. For patients with peritoneal malignancy, CRS and HIPEC can be performed with acceptable short- to medium-term QoL outcomes.

The Impact of Preoperative Immunonutrition and Standard Polymeric Supplements on Patient Outcomes After Pelvic Exenteration Surgery, Taking Compliance Into Consideration: A Randomized Controlled Trial.

BACKGROUND: The effect of immunonutrition vs standard polymeric nutrition in the preoperative phase on patient outcomes is still unclear, which could be due to contributing factors such as poorly reported compliance and unequal provision of protein, energy, and volume. The aim of this study was to examine the effects of preoperative immunonutrition compared with standard polymeric supplements matched for energy, protein, volume, length of stay, and postoperative complications in pelvic exenteration surgery, taking into consideration compliance. METHODS: This was a single-blinded, randomized, controlled trial in patients undergoing pelvic exenteration surgery. Fifty-two participants were randomly assigned to consume 3 immunonutrition supplements/d for 5 days preoperatively, and 56 participants were randomly assigned to consume 3 standard polymeric supplements/d for 5 days preoperatively. Primary and secondary outcome measures were assessed. Compliance with each nutrition regime was recorded during the intervention, and subanalysis was conducted. RESULTS: There was no significant difference between immunonutrition and standard polymeric supplements on length of stay (P = 0.988) or postoperative complications (P = 0.179) after pelvic exenteration surgery. Compliance with nutrition supplements was significantly less in malnourished (n = 33) compared with well-nourished participants (n = 74) (P = 0.016). Compliance varied between study groups, although not significant. CONCLUSION: Preoperative immunonutrition did not significantly impact length of stay or postoperative complications compared with standard polymeric supplements after pelvic exenteration surgery, despite controlling for protein, energy, and volume. Compliance, protein, and energy may considerably impact the effect of immunonutrition, particularly in malnourished patients.

Accelerating the learning curve in cytoreductive surgery and hyperthermic intraperitoneal chemotherapy using an external mentor model.

BACKGROUND: Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is an accepted therapeutic approach in selected patients with peritoneal malignancy. The aim of this study was to describe early outcomes in the first 50 patients managed with CRS and HIPEC in a newly established peritoneal malignancy centre in Sydney, Australia, under the guidance of an experienced peritoneal malignancy mentor. METHODS: This is a retrospective review of a prospective maintained database of early outcomes in the first 50 patients who underwent CRS and HIPEC between April 2017 and April 2018 at a newly established peritoneal malignancy centre. Type of primary, surgery time, length of hospital stay, blood loss, peritoneal carcinomatosis index, completeness of surgery, complications, recurrence rate and 30-day mortality were reviewed. RESULTS: A total of 135 patients were referred and reviewed at the multidisciplinary team meeting with 50 (26 male) patients undergoing CRS and HIPEC. Of these 50 patients, 47 (94%) underwent complete cytoreduction while three (6%) had maximal tumour debulking surgery. Tumour pathology was of appendix origin (44%) and colorectal peritoneal metastases (44%). Median surgical time was 7.4 h (interquartile range 5.7-10.0). Median length of hospital stay was 13 days (interquartile range 9.7-19.0). Six (12%) patients experienced a grade III or IV Clavien-Dindo complication. There was no 30-day mortality. CONCLUSION: This study reports the successful establishment of a peritoneal malignancy centre under the guidance of an experienced peritoneal malignancy mentor. The short-term surgical outcomes observed in the first 50 cases are promising and comparable to other more experienced centres.

Exploring reasons behind patient compliance with nutrition supplements before pelvic exenteration surgery.

PURPOSE: Compliance with oral nutrition support (ONS) is poorly reported in the literature. Many factors influence compliance, which could mask the true benefits of preoperative ONS. Surgical oncology patients, including pelvic exenteration patients, are often requested by healthcare workers to consume nutrition supplements before surgery. Exploration of barriers and enablers to compliance with nutrition supplements is needed to improve patient compliance and understand the real impact of preoperative ONS. METHOD: A qualitative study using semi-structured interviews was performed to investigate enablers and barriers to preoperative nutrition supplement compliance. Twenty participants who had been asked to consume 15 nutrition supplements, either immunonutrition or standard polymeric supplements, were interviewed. Inductive thematic analysis was used to determine major themes associated with compliance. RESULTS: Twelve out of 20 participants were not compliant with recommended dosing. Well-nourished participants were more compliant than malnourished participants. Major themes associated with compliance were flavour, volume, texture, impact on dietary intake and motivation to consume supplements. Flavour differed between the two groups, negatively impacting compliance in the immunonutrition group. Volume, texture and impact on dietary intake also negatively impacted compliance whereas motivation positively impacted compliance. CONCLUSION: To overcome barriers and enforce enablers with nutrition supplement compliance, it is essential healthcare workers implement individualised interventions, taking into account nutritional status. A range of flavours, minimal volume and low viscosity supplements should be provided to address individual preference and minimise poor compliance. Better-targeted education and regular motivation are needed to improve compliance.

Acute Adverse Events and Postoperative Complications in a Randomized Trial of Preoperative Short-course Radiotherapy Versus Long-course Chemoradiotherapy for T3 Adenocarcinoma of the Rectum: Trans-Tasman Radiation Oncology Group Trial (TROG 01.04).

OBJECTIVE: To compare acute adverse events (AE) and postoperative complication rates in a randomized trial of short-course (SC) versus long-course (LC) preoperative radiotherapy. BACKGROUND: Evidence demonstrates that adding neoadjuvant radiotherapy to surgery offers better local control in the management of rectal cancer. With both SC and LC therapy there is a potential for acute treatment-related toxicity and increased patient morbidity. METHODS: Eligible patients had clinical-stage T3 rectal adenocarcinoma within 12 cm of the anal verge with no evidence of metastasis. SC consisted of pelvic radiotherapy 5 × 5 Gy in 1 week, early surgery and 6 courses of adjuvant chemotherapy. LC was 50.4 Gy administered in 28 fractions during 5.5 weeks, with infusion 5-fluorouracil, surgery in 4 to 6 weeks, and 4 courses of chemotherapy. RESULTS: All SC patients and 93% of LC patients received preoperative planned radiotherapy. There was no 30-day operative mortality. A statistically significant higher percentage of at least 1 AE occurred in the LC group (SC, 72.3%; LC, 99.4%; P < 0.001). There were significant differences in favor of SC for grade 3 AE: radiation dermatitis (0% vs 5.6%, P = 0.003), proctitis (0% vs 3.7% P = 0.016), nausea (0% vs 3.1%, P = 0.029), fatigue (0% vs 3.7%, P = 0.016) and grade 3/4 diarrhea rates (1.3% vs 14.2% P < 0.001). No statistically significant differences in surgical complication rates were seen (SC 53.2 vs 50.4% LC, p = 0.68), although permanent stoma (38.0% vs 29.8%, P = 0.13) and anastomotic breakdown (7.1% vs 3.5%, P = 0.26) rates favored LC with perineal wound complications (38.3% vs 50.0%, P = 0.26) in favor of SC. CONCLUSIONS: LC had significantly higher AEs compared with SC with no statistically significant differences in postoperative complications. There were clinical trends in permanent stoma rates and anastomotic leaks in favor of LC but with an increased perineal wound breakdown rate.

Hemodialysis Catheter Heat Transfer for Biofilm Prevention and Treatment.

Central line-associated bloodstream infections (CLABSIs) are not easily treated, and many catheters (e.g., hemodialysis catheters) are not easily replaced. Biofilms (the source of infection) on catheter surfaces are notoriously difficult to eradicate. We have recently demonstrated that modest elevations of temperature lead to increased staphylococcal susceptibility to vancomycin and significantly soften the biofilm matrix. In this study, using a combination of microbiological, computational, and experimental studies, we demonstrate the efficacy, feasibility, and safety of using heat as an adjuvant treatment for infected hemodialysis catheters. Specifically, we show that treating with heat in the presence of antibiotics led to additive killing of Staphylococcus epidermidis with similar trends seen for Staphylococcus aureus and Klebsiella pneumoniae. The magnitude of temperature elevation required is relatively modest (45-50°C) and similar to that used as an adjuvant to traditional cancer therapy. Using a custom-designed benchtop model of a hemodialysis catheter, positioned with tip in the human vena cava as well as computational fluid dynamic simulations, we demonstrate that these temperature elevations are likely achievable in situ with minimal increased in overall blood temperature.

Short-term outcomes of local infiltration anaesthetic in total knee arthroplasty: a randomized controlled double-blinded controlled trial.

BACKGROUND: The primary objective of the study was to determine if local infiltration anaesthetic (LIA) reduced total length of hospital stay in total knee arthroplasty (TKA) patients. The study also examined whether LIA improves early pain management, patient satisfaction and range of motion in TKA patients. METHODS: We conducted a randomized controlled double-blinded study. Fifty patients undergoing TKA were randomized to receive either placebo or LIA at the time of surgery and on the first day post-operatively. Pain scores, level of satisfaction and range of motion were recorded preoperatively and post-operatively. RESULTS: There was no statistical difference between the groups for length of stay, post-operative pain scores, satisfaction scores or range of motion 6 weeks post-operatively. CONCLUSION: This randomized double-blinded trial did not demonstrate a decrease in pain or reduction of length of stay due to local infiltration analgesia.

Australian and New Zealand study comparing laparoscopic and open surgeries for colon cancer in adults: organization and conduct.

This article describes the initiation and implementation of the multicentre Australia and New Zealand prospective randomized controlled clinical study comparing laparoscopic and conventional open surgical treatments of right-sided and left-sided potentially curable colon cancer (Australasian Laparoscopic Colon Cancer Study). Six hundred and one adult patients were admitted with a clinical diagnosis of a single adenocarcinoma based on a physical examination and colonoscopy, barium enema or computed tomography scan and randomly allocated to either laparoscopic or open surgery. The primary aim of the study is to compare 5-year mortality and tumour recurrence rates between the two groups. Secondary aims include comparisons of safety (intraoperative and early postoperative complications, wound site recurrence, postoperative recovery and 30-day mortality), quality of life, in-hospital costs and short-term mortality and tumour recurrence. The data for 592 patients have been collected. There are currently 3141 person years of follow up. In all 370 patients have been assessed at 5 years. This study shows that large cooperative Australia-New Zealand surgical trials can and should be carried out to address significant clinical issues. When possible, coherence with similar, concurrent international trial protocols ensures broader analyses and applicability of results. It is important to recognize that special attention to sustained funding, surgeon credentialing, clinical protocol standardization, data management, publication policy and the protection of study credibility is required from the outset. The Australasian Laparoscopic Colon Cancer Study will achieve its aims with 5-year assessments of all entered patients in March 2010.

Biofeedback for fecal incontinence: short-term outcomes of 513 consecutive patients and predictors of successful treatment.

PURPOSE: Biofeedback is well established as a treatment for fecal incontinence but little is known about factors that may be associated with its effectiveness. This study assessed short-term outcomes, predictors of patients who completed treatment, and predictors of treatment success. METHODS: This study was a retrospective review of consecutive patients treated with biofeedback at a tertiary referral colorectal clinic during ten years. Clinical, physiologic, and quality of life measures were collected prospectively at the time of treatment. Regression analysis was performed. RESULTS: Of 513 patients, 385 (75 percent) completed the treatment program. Each outcome was improved for more than 70 percent of patients. Incontinence scores decreased by 32 percent (from 7.5 to 5.2 of 13), patient assessment of continence increased by 40 percent (from 5.3 to 3.2 of 10), quality of life improved by 89 percent (from 0.34 to 0.67 of 1.0), and maximum anal sphincter pressure increased by a mean 12 mmHg (14 percent; from 90 to 102 mmHg). Patients who did not complete treatment were younger, were more likely to be male, and had less severe incontinence. Treatment success was predicted by completion of all treatment sessions (odds ratio, 10.34; 95 percent confidence interval, 4.46-24.19), female gender (odds ratio, 4.11; 95 percent confidence interval, 1.04-7.5), older age (odds ratio, 1.02 per year; 95 percent confidence interval, 1-1.04), and more severe incontinence before treatment (odds ratio, 1.19 per unit increase in St. Mark's score; 95 percent confidence interval, 1.05-1.34). CONCLUSIONS: More than 70 percent of patients in this large series demonstrated improved short-term outcomes. Treatment success was more likely in those who completed six training sessions, were female, older, or had more severe incontinence. Patients were less likely to complete treatment if they were male, younger, or had milder incontinence.

Regional health information organizations: a vehicle for transforming health care delivery?

Information technology (IT) has the potential to be a significant enabler in transforming the health care delivery system. New types of organizations are needed to guide the change. Regional Health Information Organizations (RHIOs) hold promise as agents for transformation. This essay discusses the results from a case study on how RHIOs are advancing IT adoption in the health care community. Results indicate that the RHIO model is early in its evolution. To be a catalyst of change, the RHIO must overcome privacy barriers, actively engage purchasers of care, and create compelling incentives for clinicians to adopt the RHIOs' services.

Telephone vs. face-to-face biofeedback for fecal incontinence: comparison of two techniques in 239 patients.

PURPOSE: Biofeedback is an effective treatment for patients with fecal incontinence, yet little is known about how it works or the minimum regime necessary to provide clinical benefit. This study compares the effectiveness of a novel protocol of telephone-assisted biofeedback treatment for patients living in rural and remote areas with the standard face-to-face protocol for patients with fecal incontinence. METHODS: A new treatment program comprising an initial face-to-face assessment and treatment with transanal manometry and ultrasound biofeedback, followed by three treatments conducted via telephone and a final face-to-face assessment, was developed. Standard treatment involved five face-to-face treatment sessions with manometry and ultrasound. Patients from rural areas were offered the telephone-assisted treatment protocol. Data gathered prospectively included incontinence scores, a quality of life index, anal manometry, and external sphincter isometric and isotonic fatigue times. RESULTS: A total of 239 consecutive patients treated between July 2001 and July 2004 were enrolled. There were no significant differences in demographic details, past history, or pretreatment measures of the two groups. Forty-six of 55 patients (84 percent) treated with the telephone protocol and 129 of 184 (70 percent) treated by the standard technique completed treatment. There were substantial, significant improvements after treatment, including 54 percent mean improvement in patient's own rating of their incontinence in both groups; a mean decrease of 3.1 and 3.2 on the St. Mark's incontinence score (from 7.9 to 4.7 and 7.4 to 4.2 of 13) and relative improvements of 128 and 130 percent in the quality of life index (from 0.29 to 0.65 and 0.3 to 0.69 of 1) for the telephone-assisted and standard groups respectively. Importantly, there were no significant differences between the telephone-assisted or standard groups in any outcome. Of patients who completed treatment, 78 percent were better or much better. CONCLUSIONS: A less intensive regime of biofeedback seems to be equally effective as the standard intensive protocol. This finding adds weight to the evolving concept that the physical aspects of biofeedback treatment, such as manometry or ultrasound, may not be necessary in the treatment of most patients with fecal incontinence. This needs to be further tested in a randomized, controlled trial.