John E. Hartley

Stapling procedure for haemorrhoids versus Milligan-Morgan haemorrhoidectomy: randomised controlled trial

Summary Background Surgical haemorrhoidectomy has a reputation for being a painful procedure for a fairly benign disorder. The circular transanal stapled technique for the treatment of haemorrhoids has the potential to offer a less painful rectal procedure in place of ablative perianal surgery. We compared the short-term outcome of the circular stapled procedure for haemorrhoids with current standard surgery in a randomised controlled trial. Methods 40 patients admitted for surgical treatment of prolapsing haemorrhoids were randomly assigned to Milligan-Morgan haemorrhoidectomy (n=20) or the circular stapled procedure. Under general anaesthesia patients underwent standardised diathermy excision haemorrhoidectomy or had a circumferential doughnut of rectal mucosa and submucosa above the dentate line excised and closed with a standard circular end-to-end stapling device. All patients received standardised preoperative and postoperative analgesic and laxative regimens. Patients completed linear analogue pain charts each day and were interviewed at 1, 3, and 6–10 weeks postoperatively. Summary measures of average pain experience were calculated from 10 cm linear analogue pain scores and were used as the primary outcome measure. Findings The stapled group had shorter anaesthesia time (median 18 [range 9–25] vs 22 [15–35] mins). Average pain in the stapled group was significantly lower than it was in the Milligan-Morgan group (2·1 [0·2–7·6] vs 6·5 [3·1–8·5], 95·1% CI difference medians 1·9–4·7, p U test). Average pain relative to what the patient expected was also significantly less in the stapled group (−2·8 [−4·4 to 1·3] vs 0·7 [−1·8 to 3·4]. Hospital stay and time to first bowel motion were not significantly different between groups. Return to normal activity was significantly shorter in the stapled group (17 [3–60] vs 34 [14–90]. Early and late complications, patient-assessed symptom control, and functional outcome appear similar after short-term follow-up Interpretation The circular stapled technique offers a significantly less painful alternative to Milligan-Morgan haemorrhoidectomy and is associated with an earlier return to normal activity. Early symptom control and functional outcome appear similar. However, long-term symptomatic and functional outcome need further study.

Artificial neural networks applied to outcome prediction for colorectal cancer patients in separate institutions

BACKGROUND Artificial neural networks are computer programs that can be used to discover complex relations within data sets. They permit the recognition of patterns in complex biological data sets that cannot be detected with conventional linear statistical analysis. One such complex problem is the prediction of outcome for individual patients treated for colorectal cancer. Predictions of outcome in such patients have traditionally been based on population statistics. However, these predictions have little meaning for the individual patient. We report the training of neural networks to predict outcome for individual patients from one institution and their predictive performance on data from a different institution in another region. METHODS 5-year follow-up data from 334 patients treated for colorectal cancer were used to train and validate six neural networks designed for the prediction of death within 9, 12, 15, 18, 21, and 24 months. The previously trained 12-month neural network was then applied to 2-year follow-up data from patients from a second institution; outcome was concealed. No further training of the neural network was undertaken. The networks predictions were compared with those of two consultant colorectal surgeons supplied with the same data. FINDINGS All six neural networks were able to achieve overall accuracy greater than 80% for the prediction of death for individual patients at institution 1 within 9, 12, 15, 18, 21, and 24 months. The mean sensitivity and specificity were 60% and 88%. When the neural network trained to predict death within 12 months was applied to data from the second institution, overall accuracy of 90% (95% CI 84-96) was achieved, compared with the overall accuracy of the colorectal surgeons of 79% (71-87) and 75% (66-84). INTERPRETATION The neural networks were able to predict outcome for individual patients with colorectal cancer much more accurately than the currently available clinicopathological methods. Once trained on data from one institution, the neural networks were able to predict outcome for patients from an unrelated institution.

Patterns of Recurrence and Survival After Laparoscopic and Conventional Resections for Colorectal Carcinoma

ObjectiveTo determine whether survival and recurrence after laparoscopic-assisted surgery for colorectal cancer is compromised by an initial laparoscopic approach. Summary Background DataLaparoscopic colorectal resection for malignancy remains controversial 8 years after its first description. Fears regarding compromised oncologic principles and early recurrence (particularly the phenomenon of port-site metastases) have tempered enthusiasm for this approach. Long-term follow-up data are at present scarce. MethodsA prospective comparative trial was undertaken between December 1993 and May 1996, during which 114 patients had laparoscopic-assisted resection by a single laparoscopic colorectal surgeon or conventional open surgery by a second specialist colorectal surgeon. Intensive follow-up for at least 2 years is available on 109 patients. Analysis was performed on an intention-to-treat basis. ResultsRecurrent disease has developed in 27 patients (25%), 16 of 57 in the laparoscopic group (28%) and 11 of 52 in the conventional group (21%). Crude death rates are 26/57 (46%) in the laparoscopic group and 24/52 (46%) in the conventional group. No port-site metastases have occurred; however, wound metastases associated with disseminated disease have developed in three patients in the open group and one in the laparoscopic group. Stage-for-stage survival and recurrence figures are comparable. ConclusionOncologic outcome at a minimum of 2 years is not compromised by the laparoscopic approach. Wound recurrences are a feature of laparoscopic and conventional surgery for advanced disease.

Stapled versus excision haemorrhoidectomy: long-term follow up of a randomised controlled trial

Advantages of the stapling procedure for haemorrhoids include reduced postoperative pain and shortened convalescence; however, there are few data with respect to functional and symptomatic outcome. At a dedicated clinic, we reviewed patients between Dec, 2001, and March, 2002, who had taken part in a randomised controlled trial undertaken at the unit in 1999, which compared outcomes after open or stapled haemorrhoidectomy. We noted the presence or absence of haemorrhoid specific symptoms, and assessed overall satisfaction, continence, and quality of life. Rigid sigmoidoscopy and an anorectal examination were also used to examine symptomatic recurrence and disease activity. At minimum follow-up of 33 months since surgery, both techniques seem to be equally effective.

Magnetic resonance imaging accuracy in assessing tumour down‐staging following chemoradiation in rectal cancer

Objective  Magnetic resonance imaging (MRI) is increasingly accepted as the radiological modality of choice staging rectal cancer but is subject to error. Neoadjuvant therapy is increasingly used in rectal cancer and MRI is used to stage response and occasionally plan surgery. We aim to assess the staging accuracy of MRI following chemoradiotherapy in rectal cancer.

Local excision of rectal cancer: review of literature.

In selected patients, local excision of rectal cancer may be an alternative to radical surgery such as abdominoperineal excision of the rectum or anterior resection. Local excision carries lower mortality and morbidity, without the functional disturbance or alteration in body image that can be associated with radical surgery. There are several techniques of local therapy for rectal cancer, with most experience being available in transanal excision. Transanal endoscopic microsurgery is also used but experience with this newer technique is limited. Patient selection is the most important factor in successful local excision, however specific criteria for selecting patients have not been universally accepted. Review of the published literature is difficult because of the variation in adjuvant therapy regimes and follow-up strategies, as well as results reported in terms of local recurrence and survival rates. There is increasing evidence to suggest that local excision should be restricted to patients with T1 stage rectal cancer without high-risk factors. The place for local excision in patients with T2 or high-risk T1 tumours requires prospective, randomised multi-centre trials comparing radical surgery with local excision, with or without adjuvant therapy.

Transanal endoscopic microsurgery in early rectal cancer: time for a trial?

Objective  The optimal aim of oncological surgery is to balance cancer outcomes with preservation of function and quality of life. Radical resection (RR) offers the best curative procedure in colorectal cancer but at significant morbidity. Transanal endoscopic microsurgery (TEM) offers an alternative with less morbidity and better function. Its role remains unclear and needs to be established in the light of new emerging trends in rectal cancer. This review aims to evaluate the use of TEM and its limitations.

Registration rates, adequacy of registration, and a comparison of registered and published primary outcomes in randomized controlled trials published in surgery journals.

Objective:To determine the proportion of registered trials published in the surgical literature, to compare, in registered trials, the primary outcomes registered with those published and to determine whether outcome-reporting bias favored significant primary outcomes. Background:Trial protocol registration before patient enrolment for randomized controlled trials (RCTs) is a perquisite for many journals in attempt to decrease publication and selective reporting bias. Analysis of the medical literature demonstrates poor registration rates with discrepancies between reported and registered primary outcomes. This has not been evaluated in contemporary surgical journals. Methods:RCTs were identified for 2009 and 2010 from 10 high-impact factor surgical journals. One investigator identified all RCTs and extracted primary and secondary outcomes, dates of commencement and completion of study, funding source, and trial registration number. Trial registers were searched using the trial registration number for primary and secondary outcomes, dates of commencement and completion of study, and date of registration. Trial registration rates and registration adequacy were recorded. Register and published primary outcomes were then compared. Results:A total of 246 papers were analyzed, among which 86 (34.9%) were not registered and 52 (21%) were inadequately registered. Of the 108 adequately registered trials, 32 (29%) had a discrepancy between the published primary outcome and that registered in trial register. In the 24 published studies where it was possible to assess, the discrepancy favored a statistically significant primary outcome in 22 (91.7%) whereas in 2 (8.3%) the discrepancy produced a statistically insignificant result. Conclusions:Less than half of all RCTs published in general surgical journals were adequately registered, and approximately 30% had discrepancies in the registered and published primary outcome with 90% of those assessable favoring a statistically positive result.

Percutaneous Radiofrequency Ablation of Colorectal Hepatic Metastases – Initial Experience

Background and Aim: Most patients with hepatic metastases from colorectal carcinoma are unsuitable for resection. Radiofrequency ablation (RFA) has been applied to such lesions at laparotomy. This study aimed to evaluate the less invasive approach of percutaneous RFA. Method: Patients with unresectable liver metastases identified on cross-sectional imaging were considered for percutaneous RFA either alone or in combination with systemic chemotherapy. Subjects with >6 lesions or lesions of maximum size >70 mm were excluded. Percutaneous RFA was applied under sedation and radiological guidance (CT/US). Treatment effect was determined by follow-up imaging. Actuarial survival was calculated by the Kaplan-Meier analysis. Results: Thirty patients (21 males), median age 74.5 years (range 44–85 years), underwent percutaneous RFA to 56 lesions during 54 treatment sessions. The median size of lesion was 30 mm (range 8–70 mm). Fifteen lesions were treated more than once because of recurrence or incomplete ablation. The median ablation time per lesion was 12 min (range 4.5–36 min). Eleven patients had pre-procedural chemotherapy and 15 patients received chemotherapy after treatment. There was minimal associated morbidity (5.6% of treatments). Median hospital stay per treatment was 1 day (range 1–7). Median actuarial survival from the date of first percutaneous RFA was 22 months (95% CI 12.9–31.1 months). Eleven patients were alive at the time of data collection. Conclusion: Percutaneous RFA is a safe, well-tolerated intervention for unresectable hepatic metastases which can be repeated, if required. The technique may be associated with prolonged survival in this selected group of subjects. Future studies should consider the role of percutaneous RFA either in place of or as an adjunct to palliative chemotherapy.

Changes in T cell subsets, interleukin-6 and C-reactive protein after laparoscopic and open colorectal resection for malignancy

Background: Attenuation of the immune response to surgery, as demonstrated with the laparoscopic approach to cholecystectomy, has potential benefits in patients undergoing laparoscopic colonic resection for malignancy. We aimed to study the perioperative immune response in patients undergoing laparoscopically assisted and open surgery for colorectal cancer. Methods: This study involved 23 patients undergoing laparoscopically assisted (n = 13) and open surgery (n = 10). Interleukin-6 (IL-6) C-reactive protein (CRP), the total lymphocyte count, and the CD3, CD4, CD8, CD16, and CD19 lymphocyte subpopulations were assayed preoperatively and at 4, 8, 10, 24, 48, and 168 h postoperatively. Results: Significant rises in IL-6 and CRP were demonstrated within 4 and 24 h, respectively (p < 0.001) in both groups. However, no significant difference between the groups was seen. Significant decreases in total lymphocyte count and all T cell subsets were demonstrated in both groups, beginning at 4 h (p < 0.01). However, no significant difference between the groups was seen. All parameters, excluding CRP, had returned to baseline by 7 days postoperatively in both groups. Conclusions: Patients with malignancy exhibit significant perioperative immune disturbance with laparoscopically assisted and open surgery. The current data do not provide justification for the laparoscopically assisted approach on grounds of immune preservation.