Christopher M. Byrne

META-ANALYSIS OF NON-RANDOMIZED COMPARATIVE STUDIES OF THE SHORT-TERM OUTCOMES OF LAPAROSCOPIC RESECTION FOR COLORECTAL CANCER

Laparoscopic resection remains to be established as the procedure of first choice for operable colorectal cancer. The aim of the study was to conduct a systematic review of non‐randomized comparative studies of laparoscopic resection for colorectal cancer. Published work in English was searched for relevant articles published by the end of 2003. The MOOSE statement was used to conduct the meta‐analysis. Study quality was assessed by two investigators using the MINORS tool and the analysis was conducted using Comprehensive Meta‐analysis software (Biostat, Englewood, NJ, USA) and Microsoft Excel (Microsoft, Redmond, WA, USA). One thousand two hundred and twenty abstracts were reviewed and 398 articles examined in detail. Out of 108 articles reporting the results of relevant studies, 75 were reports of 64 non‐randomized comparative studies. Fifteen studies were excluded. Analysis of the outcomes of 6438 resections showed that the conversion rate was 13.3% with a statistically significant difference between studies with more than 50 versus those with 50 or less attempted resections (11.7 vs 16.5%; P < 0.001). Laparoscopic resection took 27.6% (41 min) longer to carry out than open resection. There was no significant difference between the two groups in early mortality rates (1.2 vs 1.1%; P = 0.787) or likelihood of re‐operation (2.3 vs 1.5%; P = 0.319). Laparoscopic resection was associated with a lower morbidity rate (24.05 vs 30.80%, odds ratio (95% confidence interval) = 0.77 (0.63–0.95); P = 0.014, n = 4111, random‐effects model). Time until passage of first flatus, passage of a bowel motion, tolerating oral fluids and a solid diet was 1.2–1.6 days (26 to 37%) shorter, measurements of pain and narcotic analgesic requirements were 16–35% lower and hospital stay was 3.5 days (18.8%) shorter following laparoscopic resection compared with open resection. The two approaches were 99% similar in terms of adequacy of oncological clearance. Meta‐analysis of non‐randomized comparative studies favours laparoscopic over open resection for colorectal cancer. The results were remarkably similar to those of a contemporaneous meta‐analysis of randomized controlled trials published by the end of 2002.

Treatment of metastatic melanoma using electroporation therapy with bleomycin (electrochemotherapy).

Electroporation therapy (EPT) is a novel treatment modality that uses brief, high-intensity, pulsed electrical currents to enhance the uptake of chemotherapeutic agents, vaccines and genes into cells. This technique is potentially useful for patients with secondary and, possibly, some primary tumours. Nineteen patients with metastatic melanoma were enrolled in a phase two, randomized, open-label study comparing intralesional bleomycin+EPT with intralesional bleomycin alone. Of 18 study lesions, 13 (72%) showed a complete response, one (5%) showed a partial response, three (18%) showed no change and one (5%) showed disease progression over a period of greater than 12 weeks. This represents a 78% objective response rate, which was significantly greater than the 32% response rate observed in the 19 patients with tumours treated with intralesional bleomycin alone (χ2=7.94, 1 df, P=0.005). An additional 36 lesions, not enrolled in the study, were also treated with bleomycin+EPT. Of the total of 54 lesions treated with bleomycin+EPT, there was a 72% objective response rate. EPT treatment was well tolerated and was performed on an outpatient basis.

Assessment of Quality of Life in the Treatment of Patients With Neuropathic Fecal Incontinence

AbstractINTRODUCTION: Development of quality-of-life measures has been the focus of research in colorectal disorders in recent years. The assessment of quality of life for fecal incontinence should be more important than quantitative measurement of soiling. PURPOSE: This study assesses specific patient quality-of-life objectives, categorizes objectives, and correlates these objectives with continence scores. METHODS: One hundred eighteen patients entered into a randomized, controlled trial of biofeedback were assessed using the Direct Questioning of Objectives quality-of-life measure. All objectives were documented, categorized, and correlated with continence scores and analog scales. RESULTS: In patients with neuropathic fecal incontinence, the most frequent quality-of-life group concerned the ability to get out of home, to socialize outside of home, to go shopping, and not to have to worry about the location of the nearest toilet while out of home (34 percent; 123/364). At least one of these four objectives was stated by 72 percent of patients (85/118). Only 31 percent of patients (37/118) nominated an objective related to the physical act of soiling. The ability to travel (29 percent), exercise including walking (25 percent), perform home duties (19 percent), family and relationships (22 percent), and job (13 percent) were less frequently cited by patients. CONCLUSION: Continence scores focus heavily on the physical aspects of incontinence such as soiling and hygiene, aspects which seem to be less important to the patients themselves. It is important, therefore, that assessments of fecal incontinence should include reference to quality of life, and in particular to its impact on activities relating to “getting out of the house.”

Long-Term Functional Outcomes After Laparoscopic and Open Rectopexy for the Treatment of Rectal Prolapse

PurposeLaparoscopic rectopexy to treat full-thickness rectal prolapse has proven short-term benefits, but there is little long-term follow-up and functional outcome data available.MethodsPatients who had abdominal surgery for prolapse during a ten-year period were identified and interviewed to ascertain details of prolapse recurrence, constipation, incontinence, cosmesis, and satisfaction. Additional details on recurrences that required surgery and mortality were obtained from chart review and the State Death Registry.ResultsOf 321 prolapse operations, laparoscopic rectopexy was performed in 126 patients, open rectopexy in 46, and resection rectopexy in 21 patients. At a median follow-up of five years after laparoscopic rectopexy, there were five (4 percent) confirmed full-thickness recurrences that required surgery. Actuarial recurrence rates of laparoscopic rectopexy were 6.9 percent at five years (95 percent confidence interval, 0.1–13.8 percent) and 10.8 percent at ten years (95 percent confidence interval, 0.9–20.1 percent). Seven patients underwent rubber band ligation for mucosal prolapse and seven required other surgical procedures. There was one recurrence after open rectopexy (2.4 percent) and one after resection rectopexy (4.7 percent), and there was no significant difference between groups. Overall constipation scores were not increased after laparoscopic rectopexy, with no significant difference to open rectopexy or resection rectopexy.ConclusionsThis study has demonstrated that laparoscopic rectopexy has reliable long-term results for treating rectal prolapse, including low recurrence rates and no overall change in functional outcomes.

Role of electrochemotherapy in the treatment of metastatic melanoma and other metastatic and primary skin tumors.

Electroporation is a novel therapeutic modality that uses pulsed electrical currents to enhance the uptake of drugs, vaccines and genes into cells, and has been used for over 20 years. Electroporation therapy using cytotoxic drugs is called electrochemotherapy. Electrochemotherapy has been studied in vitro, in vivo and in clinical trials. It is potentially useful for treating patients with metastatic tumors, such as melanoma, and even select primary tumors, such as head and neck squamous cell carcinomas and basal cell carcinoma. Various chemotherapeutic agents have been tested with electroporation therapy, but bleomycin and cisplatin are the two most widely used. The biological basis of electroporation therapy is outlined in this review and basic science studies and the limited clinical studies that have involved electrochemotherapy are reviewed. Particular focus is placed on trials involving melanoma, head and neck cancers and other primary and metastatic skin cancers.

Multicenter Randomized Trial of Centralized Nurse-Led Telephone-Based Care Coordination to Improve Outcomes After Surgical Resection for Colorectal Cancer: The CONNECT Intervention

PURPOSE To investigate the effectiveness of a centralized, nurse-delivered telephone-based service to improve care coordination and patient-reported outcomes after surgery for colorectal cancer. PATIENTS AND METHODS Patients with a newly diagnosed colorectal cancer were randomly assigned to the CONNECT intervention or usual care. Intervention-group patients received standardized calls from the centrally based nurse 3 and 10 days and 1, 3, and 6 months after discharge from hospital. Unmet supportive care needs, experience of care coordination, unplanned readmissions, emergency department presentations, distress, and quality of life (QOL) were assessed by questionnaire at 1, 3, and 6 months. RESULTS Of 775 patients treated at 23 public and private hospitals in Australia, 387 were randomly assigned to the intervention group and 369 to the control group. There were no significant differences between groups in unmet supportive care needs, but these were consistently low in both groups at both follow-up time points. There were no differences between the groups in emergency department presentations (10.8% v 13.8%; P = .2) or unplanned hospital readmissions (8.6% v 10.5%; P = .4) at 1 month. By 6 months, 25.6% of intervention-group patients had reported an unplanned readmission compared with 27.9% of controls (P = .5). There were no significant differences in experience of care coordination, distress, or QOL between groups at any follow-up time point. CONCLUSION This trial failed to demonstrate substantial benefit of a centralized system to provide standardized, telephone follow-up for postoperative patients with colorectal cancer. Future interventions could investigate a more tailored approach.

Patient Preferences Between Surgical and Medical Treatment in Crohn’s Disease

PurposeCrohn’s disease poses difficult choices in which the most appropriate treatment option is not always obvious. When this state of uncertainty exists, patients’ preferences should have an increasingly important part of clinical decision making. The purpose of this study was to compare patients’ preferences for surgical intervention in Crohn’s disease with the preferences of surgeons and gastroenterologists.MethodsOutpatients with Crohn’s disease were interviewed to quantify their preferences for six scenarios by using the prospective preference measure. An identical questionnaire was mailed to all Australian and New Zealand colorectal surgeons and a random sample of 300 Australian gastroenterologists.ResultsForty-one of 123 patients with Crohn’s disease (33 percent), 92 of 127 colorectal surgeons (72 percent), and 74 of 272 gastroenterologists (27 percent) participated. There were significant differences between patients and gastroenterologists for three of six scenarios and between surgeons and gastroenterologists in four of six scenarios. Seventy-six percent of gastroenterologists were willing to gamble to avoid an ileocolic resection compared with 37 percent of surgeons (chi-squared = 25.44; P < 0.0001) and 39 percent of patients (chi-squared = 15.44; P < 0.001).ConclusionsPatients and clinicians were able to trade and gamble life expectancy as a measure of preference for varying hypothetical surgical treatments, even though these treatment options impacted on quality of life rather than survival. Patients’ preferences did not align with clinicians. For most scenarios, colorectal surgeons’ preferences were significantly different to those of gastroenterologists.

Hyoscine butylbromide administered at the cecum increases polyp detection: a randomized double-blind placebo-controlled trial.

BACKGROUND AND STUDY AIMS Removal of colonic polyps prevents progression of colonic neoplasia. Miss rates of polyps range from 5 % to 32 %. The effect of colonic contractility on polyp detection has not been studied adequately. Hyoscine butylbromide results in colonic spasmolysis and may improve polyp detection. PATIENTS AND METHODS Patients undergoing colonoscopy for standard indications were included and randomized to receive either 20  mg hyoscine butylbromide or placebo at cecal intubation. Operators were blind to the intervention. Data on indication, preparation, sedation, colonoscope type, times of insertion/withdrawal, polyps, and failure were recorded. The primary end point was the number of polyps detected per patient. Secondary endpoints were adenoma detection rate and polyp detection rate. RESULTS A total of 303 patients received hyoscine butylbromide and 298 received placebo. More polyps per patient were identified in the hyoscine group than in the placebo group (0.91 vs. 0.70; P = 0.044). Adenoma detection rate and polyp detection rate were higher in the hyoscine arm but not significantly different (27.1 % vs. 21.8 % [P = 0.13] and 43.6 % vs. 36.6 % [P = 0.08], respectively). After adjusting for confounding variables, the odds of detecting any polyp were 1.56 higher in the hyoscine than the placebo group (95 % confidence interval [CI] 1.09 - 2.21, P = 0.014). The adjusted odds of detecting any adenoma were 1.62 higher in the hyoscine group compared with the placebo group (95 %CI 1.09 - 2.42, P = 0.017). There were no differences in baseline characteristics between the groups. No adverse colonoscopy-related events were recorded. One patient experienced transient tachycardia without sequelae. CONCLUSIONS Hyoscine butylbromide administered at the cecum aids polyp detection. Further studies are required to determine the contribution of colonic spasm to polyp miss rates.

Prospective evaluation of a two-tiered trauma activation protocol in an Australian major trauma referral hospital

OBJECTIVE To evaluate a two-tiered trauma activation protocol in a major trauma referral hospital in Australia. METHODS A prospective study performed over a 12-month period of all consecutive trauma activations in a major trauma referral hospital. The triage tool assigned patients into two tiers of trauma activation. The full trauma activation was initiated where physiological or anatomical criteria were present. These patients were assessed by a multispecialty trauma team. A consult trauma activation was initiated where only mechanism of injury criteria was present. These patients were assessed by the Emergency Department Registrar and Surgical Registrar. The primary endpoint was major trauma outcome defined as either injury severity score (ISS) greater than 15, requirement for High Dependency Unit or Intensive Care Unit (HDU/ICU) admission, need for urgent operative intervention, or in hospital mortality. RESULTS Of 1144 trauma activations, 468 (41%) were full trauma and 676 (59%) were consult trauma activations. The full trauma activation group had a significantly higher proportion of the major trauma outcome (34% vs. 5%, p<0.01) and all 18 patients (2%) who died were in the full trauma activation group. Sensitivity of the triage tool for the major trauma outcome was 83%, specificity was 68%, undertriage was 3% and overtriage was 27%. CONCLUSIONS The two-tiered trauma activation protocol is effective in identifying patients with major trauma from those with minor trauma. There were no deaths in undertriaged patients.

Urological leaks after pelvic exenterations comparing formation of colonic and ileal conduits

BACKGROUND The aim of this study was to assess possible risk factors for urinary leakage of a newly formed urinary conduit after a partial or total pelvic exenteration. METHODS An analysis was conducted from prospectively collected data of patients who underwent a pelvic exenteration with conduit formation for advanced and recurrent pelvic cancer. RESULTS Of 232 patients undergoing a pelvic exenteration, 74 (32%) had a conduit formed. Of these, 47 (64%) had an ileal conduit compared with 27 (36%) a colonic conduit. Twelve (16%) patients developed a leak, of which nine occurred within the first month. Factors associated with a conduit leak included involvement of R2 surgical margins (43%), the magnitude of the exenteration and a current cardiovascular medical history (27%). Leaks were not found to be associated with either radiotherapy or chemotherapy. The 30-day leak rate for ileal conduits was 17% (8/47) and 4% (1/27) for colonic conduits with enterocutaneous fistula only occurring in the ileal conduit group (2/47). Fistula, drained collections and sepsis occurred in 40% of ileal and 19% of colonic conduits (p < 0.01). Patients with a conduit leak had a longer length of stay (59 versus 23 days, p < 0.001). CONCLUSIONS Urine leaks after conduit formation in association with exenterations are relatively common with a prolonged length of hospital stay. Positive surgical margins and exenterations involving all four quadrants of the pelvis were associated with higher leak rates. There was no evidence of a difference between ileal and colonic conduits and number of leaks. However colonic conduits had less total complications including sepsis, leak and pelvic collections with comparatively no complications of a small bowel fistula.