Feasibility RCT of definitive chemoradiotherapy or chemotherapy and surgery for oesophageal squamous cell cancer.

BACKGROUND: The optimal treatment for localised oesophageal squamous cell carcinoma (SCC) is uncertain. We assessed the feasibility of an RCT comparing neoadjuvant treatment and surgery with definitive chemoradiotherapy. METHODS: A feasibility RCT in three centres examined incident patients and reasons for ineligibility using multi-disciplinary team meeting records. Eligible patients were offered participation in the RCT with integrated qualitative research involving audio-recorded recruitment appointments and interviews with patients to inform recruitment training for staff. RESULTS: Of 375 patients with oesophageal SCC, 42 (11.2%) were eligible. Reasons for eligibility varied between centres, with significantly differing proportions of patients excluded because of total tumour length (P=0.002). Analyses of audio-recordings and patient interviews showed that recruiters had challenges articulating the trial design in simple terms, balancing treatment arms and explaining the need for randomisation. Before analyses of the qualitative data and recruiter training no patients were randomised. Following training in one centre 5 of 16 eligible patients were randomised. CONCLUSIONS: An RCT of surgical vs non-surgical treatment for SCC of the oesophagus is not feasible in the UK alone because of the low number of incident eligible patients. A trial comparing diverse treatment approaches may be possible with investment to support the recruitment process.

Assessment and comparison of recovery after open and minimally invasive esophagectomy for cancer: an exploratory study in two centers.

BACKGROUND: Minimally invasive esophagectomy (MIE) may lead to early restoration of health-related quality of life, but few prospective comparative studies have been performed. This exploratory study compared recovery between totally minimally invasive esophagectomy (MIE), laparoscopically assisted esophagectomy (LAE) and open surgery (OE). METHODS: A prospective study in 2 specialist centers recruited consecutive patients undergoing OE, LAE, or MIE for high-grade dysplasia or cancer. Patients completed validated questionnaires, the Multi-Dimensional Fatigue Inventory (MFI-20), modified Katz Scale, and modified Lawton and Brody Scale (assessing activities of daily living) before and 6 weeks and 3 and 6 months after surgery. RESULTS: A total of 97 patients (26 women; median age 64 years) were scheduled for surgery that was abandoned in 11 due to occult low-volume metastatic disease. In the remaining 86 (OE = 19, LAE = 31, and MIE = 36), there were 4 in-hospital deaths (4 %), and 54 postoperative complications (OE = 12, LAE = 19, and MIE = 23). Overall questionnaire compliance was high (77 %) and baseline scores similar in all groups, although clinical differences between groups were observed with earlier tumors and more squamous cell cancers selected for MIE. Following surgery fatigue levels increased dramatically and activity levels reduced in all groups. These gradually recovered to baseline following MIE and LAE within 6 months, but the ability to perform activities of daily living and most parameters of fatigue had not returned to baseline levels in the OE group. CONCLUSIONS: This exploratory prospective nonrandomized study of recovery after different types of surgery for esophageal cancer showed possible small benefits to MIE. A much larger study is needed to confirm these findings.

Aorto-conduit fistula developing four years after esophagectomy.

A 71 year old lady was treated for a squamous cell carcinoma of the oesophagus with neo-adjuvant chemotherapy followed by a two phase Ivor-Lewis oesophagectomy with two field lymphadenectomy. She presented four years later with life threatening bleeding from a fistula between the thoracic aorta and the gastric conduit, which was treated successfully with a thoracic aortic stent.

Demonstration of the IDEAL recommendations for evaluating and reporting surgical innovation in minimally invasive oesophagectomy.

BACKGROUND: The Idea, Development, Evaluation, Assessment and Long term study (IDEAL) framework makes recommendations for evaluating and reporting surgical innovation and adoption, but remains untested. METHODS: A prospective database was created for the introduction of minimally invasive techniques for oesophagectomy. IDEAL stages of development and evaluation were examined retrospectively in a series of patients undergoing laparoscopically assisted oesophagectomy (LAO), two- or three-phase minimally invasive oesophagectomy (MIO) and open oesophagectomy. RESULTS: A total of 192 patients were involved. In IDEAL stages 1 and 2a, LAO in 16 patients was uneventful, but two-phase MIO in six patients was abandoned following consecutive technical complications. Two-phase MIO was modified to a three-phase MIO procedure, and the results of LAO (67 patients), three-phase MIO (35) and open techniques (68) were studied in IDEAL stage 2b. Major complications (Clavien-Dindo grades III and IV) occurred in 12 (18 per cent), nine (26 per cent) and 14 (21 per cent) LAO, three-phase MIO and open procedures respectively. There were four in-hospital deaths (2 LAO and 2 open). CONCLUSION: The IDEAL framework is a feasible method for documenting the development and implementation of a procedure. MIO should now be compared with open surgery in a randomized controlled trial (IDEAL stage 3).

Evaluation of a radiographer-provided barium enema service.

AIM: Radiographers performed and reported 5516 double contrast barium enemas (RDCBEs) over 4 years to October 2001. This study was undertaken to assess the accuracy of RDCBE and the sensitivity for diagnosing colorectal cancer (CRC). METHOD: A total of 224 consecutive outpatient RDCBEs were reported; normal (C1), diverticulosis (C2), diverticulosis with filling defect (C3), diverticulosis & other pathology (C4) and abnormal (C5). RDCBEs were then reported by a radiologist (AL, NS) and the two reports compared. Of 450 CRCs, 153 had undergone DCBE; 152 RDCBEs. Reports were analysed to establish concurrence between radiographer and radiologist and final CRC diagnosis. RESULTS: By category: C1 - 37%, C2 - 31%, C3 - 21%, C4 - 11%, C5 - 0%. C4s included polyps (50%), cancer (12.5%), disrupted anastomosis (8%) and colitis (4%). There was no discrepancy between RDCBE and radiologist reports. Radiology and CRC diagnosis agreed in 145 of 152 DCBEs. There were three exclusions: DCBEs occurred outside the study period (2), one only with raised possibility of malignancy. Of eight remaining RDCBEs, seven were false negatives and one false positive. Sensitivity score for RDCBE was 94.5%. Double reporting by a radiologist did not improve sensitivity. CONCLUSION: RDCBEs are as accurate as those performed by radiologists and have a very high sensitivity for CRC. In a time of ever increasing demands for complex staging investigations for CRC and interventional radiology, the ACPGBI needs to reconsider its guidelines on radiographers not only performing but also reporting DCBE.

Bacterial contamination of surgical gloves by water droplets spilt after scrubbing.

Wound infection and deep sepsis can have disastrous consequences, particularly in orthopaedic surgery. Strict protocols, ultra-clean air, prophylactic antibiotics, and impervious gowns and drapes, have all been shown to diminish wound infection. However it remains a common and significant problem. The water droplets spilt from the surgeons hands after meticulous scrubbing with povidone iodine were cultured. The permeability of the surgical glove packaging to Gram-positive bacteria was also investigated. The water droplets from the surgeon's arms contained environmental and potentially pathogenic bacteria including a micrococcus, a coliform and coagulase-negative staphylococci. The paper packaging for the range of sterile surgical gloves tested was discovered to be permeable to Gram-positive bacteria. In conclusion accidental water droplet contamination of surgical gloves is a potential source of infection. Alternative recommendations are made.