Randomized controlled trial of stroke volume optimization during elective major abdominal surgery in patients stratified by aerobic fitness.

BACKGROUND: The benefits of stroke volume optimization during surgery are unclear, with recent data not replicating the positive effects of earlier studies. METHODS: This was a randomized controlled trial of standard fluid therapy with or without supplementary blinded intraoperative stroke volume optimization in 220 patients having major elective rectal resection or cystectomy with ileal conduit. All patients were treated using a contemporary enhanced recovery pathway. Interventional fluid challenges used Gelofusine (B Braun, Germany), guided by stoke volume variability measured by LiDCOrapid (LiDCO, UK). Participants were stratified by aerobic fitness (characterized by preoperative cardiopulmonary exercise test), surgical specialty, and intended surgical approach (open or laparoscopic). The primary outcome was the prevalence of moderate or severe complications on day 5 after surgery, defined using the postoperative morbidity survey (POMS) criteria. RESULTS: Patients received ∼13 ml kg(-1) h(-1) of i.v. fluids during surgery. The intervention group received an additional mean (sd) 956 (896) ml Gelofusine. There were no statistically significant differences between groups in any primary or secondary end point. A positive POMS on postoperative day 5 was noted in 54 of 111 control subjects (48.6%) and 55 of 109 participants in the intervention group [50.5%; adjusted odds ratio 0.90 (95% confidence interval 0.52-1.57), P=0.717]. Mean (sd) hospital length of stay was 9.6 (6.8) days in the control group and 11.8 (11.5) days in the intervention group (adjusted difference -2.1 (-4.6 to 0.3) days, P=0.091). There was no statistical interaction between stroke volume optimization and aerobic fitness in terms of rate of complications or length of stay. CONCLUSIONS: Algorithm-driven stroke volume optimization is of no benefit when superimposed on a liberal baseline fluid regimen in patients having elective major abdominal surgery, when stratified to minimize differences in fitness and surgical approach between groups. CLINICAL TRIAL REGISTRATION: ISRCTN21597243.

Patients' inability to perform a preoperative cardiopulmonary exercise test or demonstrate an anaerobic threshold is associated with inferior outcomes after major colorectal surgery.

BACKGROUND: Surgical patients with poor functional capacity, determined by oxygen consumption at anaerobic threshold (AT) during cardiopulmonary exercise testing (CPET), experience longer hospital stays and worse short- and medium-term survival. However, previous studies excluded patients who were unable to perform a CPET or who failed to demonstrate an AT. We hypothesized that such patients are at risk of inferior outcomes after elective surgery. METHODS: All patients undergoing major colorectal surgery attempted CPET to assist in the planning of care. Patients were stratified by their test results into Fit (AT ≥ 11.0 ml O2 kg(-1) min(-1)), Unfit (AT < 11.0 ml O2 kg(-1) min(-1)), or Unable to CPET groups (failed to pedal or demonstrate an AT). For each group, we determined hospital stay and mortality. RESULTS: Between March 2009 and April 2010, 269 consecutive patients were screened, and proceeded to bowel resection. Median hospital stay was 8 days (IQR 5.1-13.4) and there were 44 deaths (16%) at 2 yr; 26 (9.7%) patients were categorized as Unable to CPET, 69 (25.7%) Unfit and 174 (64.7%) Fit. There were statistically significant differences between the three groups in hospital stay [median (IQR) 14.0 (10.5-23.8) vs 9.9 (5.5-15) vs 7.1 (4.9-10.8) days, P < 0.01] and mortality at 2 yr [11/26 (42%) vs 14/69 (20%) vs 19/174 (11%), respectively (P < 0.01)] although the differences between Unable and Unfit were not statistically different. CONCLUSIONS: Patients' inability to perform CPET is associated with inferior outcomes after major colorectal surgery. Future studies evaluating CPET in risk assessment for major surgery should report outcomes for this subgroup.

Does every patient need to be discussed at a multidisciplinary team meeting?

AIM: To evaluate the clinical impact and cost-effectiveness of a multidisciplinary team (MDT) meeting in a large hospital in the UK. MATERIALS AND METHODS: A management plan for colorectal cancer patients was recorded by the supervising surgical consultant prior to the MDT meeting using the available clinical information and the available reports for imaging and histopathology. The recorded outcomes were then compared with the outcomes documented at the subsequent MDT meeting. The cost of the MDT meeting was calculated based on the salaries of individuals involved plus relevant overheads. A range of opportunity costs were considered, the most significant of which was the expenditure required to re-provide direct clinical care displaced by the MDT. RESULTS: Over a 3 month period a sample of 47 random cases were reviewed from the colorectal MDT. In three patients, there were significant differences between the preliminary consultant decision and the MDT recommendation: in one case management was changed based on further information about patient co-morbidity and performance status. In only one case was there a material alteration to a CT report, which altered management. The annual costs of running this colorectal local MDT alone were estimated at £162,734+ per annum with opportunity costs of at least twice that. CONCLUSION: The costs of MDT meetings are very high producing a small clinical impact. At a time of increasing financial and capacity pressure in healthcare systems, the use of scarce resources may be better deployed elsewhere.

Attendance at iron deficiency anaemia clinic: audit of outcomes 5 years on.

AIM: To determine the long-term outcomes of patients in whom no initial cause for their anaemia is established. METHOD: Six hundred and thirty-nine patients presenting to an iron deficiency anaemia pathway were prospectively entered onto a database. Initial assessment included haematological review, coeliac screen, oesophagogastroduodenoscopy and colonic imaging as per British Society of Gastroenterology guidelines. A 5-year audit of outcomes was undertaken using patient medical records and hospital laboratory databases. RESULTS: A diagnosis was found initially in 266 (42%) patients, with 124 (19%) having a gastrointestinal (GI) luminal neoplasm, 54 (8%) of which were malignant. Twelve patients had a nonluminal or non-GI malignancy. Eighty-eight (14%) had benign upper GI bleeding and 23 (4%) had coeliac disease. One hundred and forty-three (22%) did not have confirmed iron deficiency anaemia on review of haematinics. Complete records were available for 595 (93%) patients at 5 years. Of the 373 patients in whom a cause was not initially diagnosed, 6 (2%) were ultimately diagnosed with a GI luminal malignancy and 18 (5%) with a nonluminal or non-GI malignancy. There was no difference in the incidence of malignancies between those with or without confirmed iron deficiency. CONCLUSIONS: Most patients in whom no cause was found at initial investigation resolve on oral iron supplements. Patients with normal ferritin values had as high an incidence of GI malignancies as those with low values and should be investigated. In the over 50s if the anaemia remains after a course of iron further investigation is recommended as there is a significant incidence of both GI and non-GI pathology.

Randomized controlled trial of intraoperative goal-directed fluid therapy in aerobically fit and unfit patients having major colorectal surgery.

BACKGROUND: Intraoperative fluid therapy regimens using oesophageal Doppler monitoring (ODM) to optimize stroke volume (SV) (goal-directed fluid therapy, GDT) have been associated with a reduction in length of stay (LOS) and complication rates after major surgery. We hypothesized that intraoperative GDT would reduce the time to surgical readiness for discharge (RfD) of patients having major elective colorectal surgery but that this effect might be less marked in aerobically fit patients. METHODS: In this double-blinded controlled trial, 179 patients undergoing major open or laparoscopic colorectal surgery were characterized as aerobically 'fit' (n=123) or 'unfit' (n=56) on the basis of their performance during a cardiopulmonary exercise test. Within these fitness strata, patients were randomized to receive a standard fluid regimen with or without ODM-guided intraoperative GDT. RESULTS: GDT patients received an average of 1360 ml of additional intraoperative colloid. The mean cardiac index and SV at skin closure were significantly higher in the GDT group than in controls. Times to RfD and LOS were longer in GDT than control patients but did not reach statistical significance (median 6.8 vs 4.9 days, P=0.09, and median 8.8 vs 6.7 days, P=0.09, respectively). Fit GDT patients had an increased RfD (median 7.0 vs 4.7 days; P=0.01) and LOS (median 8.8 vs 6.0 days; P=0.01) compared with controls. CONCLUSIONS: Intraoperative SV optimization conferred no additional benefit over standard fluid therapy. In an aerobically fit subgroup of patients, GDT was associated with detrimental effects on the primary outcome. TRIAL REGISTRY: UK NIHR CRN 7285, ISRCTN 14680495. http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=7285.

Experimental comparison of mesenteric vessel sealing and thermal damage between one bipolar and two ultrasonic shears devices.

BACKGROUND: Several instruments are available for open and laparoscopic dissection, including electrothermal bipolar vessel sealers and ultrasonically coagulating shears. The vessel sealing ability of three devices in colorectal specimens was compared in an experimental study. METHODS: Surgical specimens from patients scheduled for elective open or laparoscopic colorectal resection were allocated to one of the three devices. After removal of the surgical specimen, up to eight mesenteric vessels were dissected ex vivo and sealed using the allocated instrument. The vessel seal was tested for the maximum pressure at which it leaked and then assessed by a pathologist for depth of thermal tissue damage. RESULTS: A total of 93 vessels from 18 patients were assessed ex vivo (LOTUS™ n = 33; Harmonic Ace® n = 30; LigaSure™ n = 30), a median of 6 (range 1-8) vessels per surgical specimen with a mean(s.d.) diameter of 1·06(0·70) mm and wall thickness of 0·29(0·19) mm. Mean(s.d.) bursting pressures were 1170(440), 1470(670) and 1510(740) mmHg with LOTUS(™) , Harmonic Ace® and LigaSure™ respectively. ANCOVA showed no difference in bursting pressure between the instruments (P = 0·058). The depth of thermal damage was significantly greater with LigaSure™ (3·37(1·44) mm) than with LOTUS(™) (2·18(0·99) mm; P < 0·001) or Harmonic Ace® (1·95(0·92) mm; P < 0·001). CONCLUSION: All three instruments were equally good at sealing blood vessels, with bursting pressures well above physiological blood pressure levels. REGISTRATION NUMBER: NCT01121614 (http://www.clinicaltrials.gov).

How do you measure performance as a colonoscopist?

AIM: The aim of this study was to describe an easy and reproducible method of measuring clinical performance in colonoscopy. METHOD: Data from all endoscopy procedures performed within the main endoscopy unit at Derriford Hospital between January and December 2007 were analysed. Points were allocated for given procedures. A local health economic analysis revealed that at least 8 points (or four colonoscopies) must be performed to meet list costs. The clinical performance was described as a capability index of crude Caecal Intubation Rate (CIR) vs the mean Points Performed/Endoscopy List (points/list). RESULTS: Overall, 3884 colonoscopies were performed, with a mean crude CIR of 89.6% and 8.3 points/List. Only 7/23 endoscopists consistently met the Joint Advisory Group on Gastrointestinal Endoscopy (JAG) standard in a cost-effective way. An annual colonoscopy rate of ≥ 150 cases was associated with higher points per list (points/list) (P = 0.003). Endoscopists offering ≥ 15% of cases as training cases had significantly higher crude CIRs and points/list (P = 0.051; P = 0.017). CONCLUSIONS: Clinical performance is a function of quality provided in a cost-effective way. Our capability index is an effective and reproducible way of measuring clinical performance. Training was not associated with reduced volume.

Randomized clinical trial of preoperative intravenous iron sucrose to reduce blood transfusion in anaemic patients after colorectal cancer surgery.

BACKGROUND: The transfusion rate following colorectal cancer resection is between 10 and 30 per cent. Receipt of allogeneic blood is not without risk or cost. A preoperative adjunct that reduced the need for transfusion would mitigate these risks. This study was designed to determine whether iron sucrose reduces the likelihood of postoperative blood transfusion in patients undergoing elective colorectal cancer resection. METHODS: In this randomized prospective blinded placebo-controlled trial of patients undergoing resectional surgery with a preoperative diagnosis of colorectal cancer, 600 mg iron sucrose or placebo was given intravenously in two divided doses, at least 24 h apart, 14 days before surgery. The primary outcome measures were serum haemoglobin concentration, recorded at recruitment, immediately before surgery and at discharge, and perioperative blood transfusions. RESULTS: No difference was demonstrated between treatment groups (iron sucrose, 34 patients; placebo, 26) for any of the primary outcome measures, for either the whole study population or a subgroup of anaemic patients. CONCLUSION: This pilot study provided no support for the use of intravenous iron sucrose as a preoperative adjunct to increase preoperative haemoglobin levels and thereby reduce the likelihood of allogeneic blood transfusion for patients undergoing resectional surgery for colorectal cancer. REGISTRATION NUMBER: 2005-003608-13UK (Medicines and Healthcare products Regulatory Agency).

Is patient outcome affected by the administration of intravenous fluid during bowel preparation for colonic surgery?

INTRODUCTION: We have previously shown that Picolax bowel preparation causes a significant dehydrating effect, which can be minimised by administering a calculated volume of intravenous fluid. The aim of this prospective study was to assess whether peri-operative outcome is affected by administering a calculated volume of intravenous fluid during bowel preparation. PATIENTS AND METHODS: Patients having bowel preparation (Picolax: Ferring Pharmaceuticals Ltd, Middlesex, UK) prior to colonic surgery were prospectively randomised to receive no intravenous fluid (group 1) or calculated intravenous crystalloid based on their body weight (group 2), during preparation. In both groups, transfusion was protocol-driven. Outcome variables measured included intra-operative and postoperative intravenous fluid requirement, hourly recorded urine output for 24 h, number of patients transfused, number of units of blood transfused, time to the passage of flatus, time to having their bowels open, time until tolerating a full diet, complications and length of stay in hospital. RESULTS: Thirty-three patients were recruited - group 1 (n = 18) and group 2 (n = 15). There were 24 men and 9 women, median age 69 years (range, 29-86 years). There was no significant difference between the groups with respect to age, sex, weight, ASA grade, pre-operative haemoglobin concentration, duration or type of operation. The total number of patients receiving a transfusion (P = 0.026) and the number of units of blood transfused (P = 0.017) was significantly greater in group 1. The number of units of blood transfused intra-operatively was significantly greater in group 1 (P = 0.029). Significantly fewer patients had a urine output < 30 ml/h in the first 24-h after operation (P = 0.046) in group 2. There was no difference between groups in other outcomes measures. CONCLUSIONS: This study indicates that a calculated volume of intravenous fluid administered during bowel preparation improves patient outcomes with respect to blood transfusion and postoperative oliguria. We advocate calculated intravenous fluid administration in all patients undergoing bowel preparation prior to colonic surgery.

Pre-operative oral iron supplementation reduces blood transfusion in colorectal surgery - a prospective, randomised, controlled trial.

INTRODUCTION: Allogeneic blood transfusion confers a risk to the recipient. Recent trials in colorectal surgery have shown that the most significant factors predicting blood transfusion are pre-operative haemoglobin, operative blood loss and presence of a transfusion protocol. We report a randomised, controlled trial of oral ferrous sulphate 200 mg TDS for 2 weeks' pre-operatively versus no iron therapy. PATIENTS AND METHODS: Patients diagnosed with colorectal cancer were recruited from out-patient clinic and haematological parameters assessed. Randomisation was co-ordinated via a telephone randomisation centre. RESULTS: Of the 49 patients recruited, 45 underwent colorectal resection. There were no differences between those patients not receiving iron (n = 23) and the iron-supplemented group (n = 22) for haemoglobin at recruitment, operative blood loss, operation duration or length of hospital stay. At admission to hospital, the iron-supplemented group had a higher haemoglobin than the non-iron treated group (mean haemoglobin concentration 13.1 g/dl [range, 9.6-17 g/dl] versus 11.8 g/dl [range, 7.8-14.7 g/dl]; P = 0.040; 95% CI 0.26-0.97) and were less likely to require operative blood transfusion (mean 0 U [range, 0-4 U] versus 2 U [range, 0-11 U] transfused; P = 0.031; 95% CI 0.13-2.59). This represented a cost reduction of 66% (47 U of blood = pound4700 versus oral FeSO(4) at pound30 + 15 U blood at pound1500). At admission, ferritin in the iron-treated group had risen significantly from 40 microg/l (range, 15-222 microg/l) to 73 microg/l (range, 27-386 microg/l; P = 0.0036; 95% CI 46.53-10.57). CONCLUSIONS: Oral ferrous sulphate given pre-operatively in patients undergoing colorectal surgery offers a simple, inexpensive method of reducing blood transfusions.

Management of colorectal cancer: variations in practice in one hospital.

AIMS: The Royal College of Surgeons of England and the Association of Coloproctology of Great Britain and Ireland guidelines for the management of colorectal cancer were published in 1996. We audited our practice against these guidelines. METHODS: Data from 211 consecutive patients undergoing colorectal cancer surgery, between September 1999 and September 2000, have been prospectively collected. Preoperative large bowel and liver imaging, assessment by colorectal specialist nurses and median number of lymph nodes resected have been compared between specialist colorectal and non-colorectal surgeons for rectal and colonic cancers. The adequacy of resection and rates of abdomino-perineal resection have been compared for rectal cancers. Following presentation of our findings, we re-audited practice between January and June 2002. RESULTS: There was marked variation in practice within our hospital. Colorectal specialists were more likely to conform to best practice guidelines, performed fewer abdomino-perineal resections and tended to perform more extensive lymphadenectomy. Following presentation of these data, compliance with guidelines was markedly improved and the number of rectal procedures performed by non-colorectal surgeons decreased. CONCLUSIONS: The ability of audit to change practice has been demonstrated. We feel that completion of this audit cycle has improved the quality of service we provide for colorectal cancer patients in our hospital.

A pilot study of adjuvant intraperitoneal 5-fluorouracil using 4% icodextrin as a novel carrier solution.

AIM: This pilot study utilised the sustained intraperitoneal (i.p.) dwell properties of an iso-osmotic solution of 4% icodextrin to investigate the tolerability, toxicity and feasibility of home-based i.p. 5FU adjuvant chemotherapy following resective surgery for colorectal cancer. METHODS: Twenty eligible patients (Dukes' stage B and C with potentially curative resection) underwent perioperative Tenckhoff catheter placement. Ten (6 male, 4 female, aged 46-85; mean 67.5 years) received 5FU chemotherapy. After initial flushing and gradual increase in volumes of 4% icodextrin alone, patients received home-based i.p. 5FU (150-300 mg/m(2)/day given as equal doses at 12-hourly intervals) for 14 days, with a 14-day recovery period, for a maximum of 6 courses. Two incurable patients, treated on compassionate grounds, provided further safety data. RESULTS: Nine of the 10 patients became proficient in self-treatment with 5FU and two completed 6 courses. Frequent abdominal pain was the main dose-limiting toxicity of 5FU, causing withdrawal of three patients after a high (300 mg/m(2)/day) first course and one following a third course at lower doses. I.p. 5FU concentrations (mean>30000 ngml(-1)) were 1000 fold higher than systemic venous levels. Bacterial peritonitis led to two withdrawals but was not a frequent event (microbiologically confirmed incidence of 1 per 27 catheter-months). CONCLUSIONS: Home-based i.p. adjuvant chemotherapy is a feasible treatment option in patients with surgically resected colorectal carcinoma.

Perianal Hodgkin's lymphoma complicating Crohn's disease.

BACKGROUND: The perianal region is a very rare location for Hodgkin's lymphoma, and clinicians may often neglect the diagnosis in patients with inflammatory bowel disease. PATIENT PRESENTATION: We present a case of perianal Hodgkin's lymphoma in patient with Crohn's disease who was on long-term immunosuppression and whose symptoms would normally be attributed to Crohn's disease. Diagnosis was based on the morphological appearance of atypical cells in the lamina propria and the immunohistochemical profile of Reed Sternberg and Hodgkin's cells, showing co-expression of CD15 and CD30. CONCLUSION: Perianal complaints in patients with inflammatory bowel disease may be a manifestation of other pathology. Hodgkin's lymphoma could be a progression in the chronically inflamed tissue in this unusual location.

Acute normovolaemic haemodilution in colorectal surgery.

AIMS: Blood transfusions are often given to surgical patients. This study was designed to assess whether acute normovolaemic haemodilution (ANH) reduces exposure to allogeneic blood, affects clinical outcome and hospital stay, and is feasible in colorectal surgery. METHODS: All ASA 1 and 11 patients undergoing colectomies performed between 1997 and 1999 were identified retrospectively from our colorectal cancer database to ascertain our current peri and postoperative transfusion practice. Twenty-six selected patients subsequently underwent ANH during colectomy surgery. The number of patients and units transfused were identified. RESULTS: One hundred and twenty-three of 317 (39%) patients identified from our colorectal cancer database were transfused a total of 328 units (median 2, range 1-7). Of the 26 patients undergoing ANH, 4 (15%) were transfused a total of 13 units (median 3, range 2-5). The reduction in number of patients transfused was statistically significant (P=0.017). ANH increased anaesthetic time by a median of 19 min. There were no complications associated with ANH and the median hospital stay was 9 days (range 6-13). CONCLUSIONS: In this pilot study of selected patients, ANH is a feasible and effective method of reducing allogeneic blood exposure in major colorectal surgery. A prospective randomised controlled trial is now urgently required.

Randomized clinical trial of intravenous fluid replacement during bowel preparation for surgery.

BACKGROUND: Bowel preparation using purgatives has previously been shown significantly to increase haemoglobin concentration and decrease weight. This prospective randomized study assessed the effects of administering intravenous fluid during bowel preparation. METHODS: Patients having bowel preparation with Picolax for colonic procedures were randomized prospectively to receive no intravenous fluid (group 1) or calculated intravenous crystalloid based on body-weight (group 2) during preparation. Physiological, haematological and biochemical variables were measured before and after bowel preparation. RESULTS: Forty-one patients were recruited with a median age of 69 (range 29-86) years, 22 in group 1 and 19 in group 2. There was no difference between groups in any of the variables measured before bowel preparation. On completion, there was a significant difference between groups in mean weight loss (P = 0.01), postural change in systolic pressure (P = 0.015) and serum creatinine concentration (P = 0.008). In addition there was a significant fall in erect blood pressure after bowel preparation in group 1 (P = 0.02). The mean urine output in group 1 was 982 ml and in group 2 was 1808 ml (P = 0.004). The faeces weight between groups was not significantly different. CONCLUSION: Picolax bowel preparation has a significant dehydrating effect, which can be minimized by administering a simultaneous volume of intravenous fluid (mean 2 litres in this study).

Histopathological detection of lymph node metastases from colorectal carcinoma.

AIM: To evaluate whether the assessment of multiple sections from retrieved nodes yields an increased number of metastases compared with the number that would be detected by the commonly applied method of microscopy of a single section of lymph node only. METHODS: A prospective study of 72 colorectal carcinoma resection specimens. Lymph node sampling was based on the current guidelines for the detection of breast cancer metastases in axillary nodes. Lymph nodes up to approximately 5 mm in maximum extent were processed in entirety, without prior sectioning, and assessed histologically at three levels; larger lymph nodes were processed in entirety as multiple sections and histologically assessed at one level. RESULTS: From a total of 72 carcinomas, eight were Dukes's A, 26 were Dukes's B, and 38 were Dukes's C. The mean and median numbers of nodes identified were 13 and 12, respectively (range, three to 44). Of the Dukes's C cases, four contained lymph node metastases identified by our method that might have gone undetected by the current, generally applied method. In one case, this led to the detection of the only nodal metastasis present and therefore "upstaged" the tumour from Dukes's B to C. On average, six extra tissue blocks were processed for each case in applying this method. CONCLUSION: The assessment of multiple sections of lymph nodes from colorectal specimens leads to the detection of only a small number of additional nodal metastases. The method involves increased workload for pathologists and laboratory staff.

Prospective audit following the introduction of short-course preoperative radiotherapy for rectal cancer.

BACKGROUND: The value of introducing a short course of preoperative radiotherapy before operation for rectal cancer is still subject to debate. METHODS: One hundred consecutive patients, of mean age 68 (range 29-87) years undergoing pre- operative radiotherapy for rectal cancer between January 1997 and December 1998 at two radiotherapy centres were audited prospectively. RESULTS: The time from referral to radiotherapy was 33 (11-74) days and from radiotherapy to operation 5 (1-42) days. There was a higher than expected anastomotic leak rate (15 per cent) and perineal wound infection rate (18 per cent). Patients waiting more than 7 days were more likely to suffer perineal wound breakdown: 15 per cent (n = 39) versus 30 per cent (n = 10). CONCLUSION: The high anastomotic leak and perineal wound infection rates suggest that the introduction of preoperative radiotherapy combined with total mesorectal excision should be audited carefully or performed as part of the CRO7 trial. Presented to the Association of Coloproctology of Great Britain and Ireland in St Helier, Jersey, June 1998