Excision and suture in the midline versus Karydakis flap surgery for pilonidal sinus: randomized clinical trial.

BACKGROUND: There are several surgical options for the management of pilonidal disease, including midline and off midline closure, but prospective studies are rare. The study hypothesis was that Karydakis flap surgery would result in shorter wound healing and fewer recurrences than excision of pilonidal sinus and suture in the midline. METHODS: A randomized clinical trial was conducted in two hospitals in Sweden between 2006 and 2015 to compare excision and suture in the midline with Karydakis flap surgery. Adult patients with a chronic pilonidal sinus disease were randomized 1:1 at the outpatient clinic without blinding. Power calculation based on recurrence of 2 per cent for Karydakis flap and 10 per cent for excision and primary closure in the midline required 400 patients with 90 per cent statistical power at 5 per cent significance assuming 10 per cent loss during follow-up. Participants were followed up until complete wound healing; late follow-up after 6-13 years was performed by telephone by two blinded assessors. The two co-primary outcomes were time to complete wound healing and recurrence rate. RESULTS: The study was terminated early at a planned interim analysis due slow recruitment and a significant difference in primary outcome. In total, 125 patients were randomized, of whom 116 were available for the present analysis. Median wound healing time was 49 days (95 per cent confidence interval (c.i.) 32 to 66) for excision with suture in the midline and 14 days (95 per cent c.i. 12 to 20) for Karydakis flap surgery (P < 0.001). There were five recurrences in each group, after a median follow-up of 11 years (P = 0.753). CONCLUSION: Karydakis flap surgery for pilonidal sinus disease led to a shorter wound healing time than excision and suture in the midline but no difference in recurrence rates.Registration number: NCT00412659 (http://www.clinicaltrials.gov).

Oncological Impact of High Vascular Tie After Surgery for Rectal Cancer: A Nationwide Cohort Study.

OBJECTIVE: The purpose of this study was to investigate the impact of tie level on oncological outcomes in rectal cancer surgery. SUMMARY BACKGROUND DATA: Theoretically, a high tie of the inferior mesenteric artery could facilitate removal of apical node metastases and improve tumor staging accuracy. However, no appropriately sized randomized controlled trial exists and results from observational studies are not consistent. METHODS: All stage I-III rectal cancer patients who underwent abdominal surgery with curative intention in 2007 to 2014 were identified and followed, using the Swedish Colorectal Cancer Registry. Primary outcome was cancer-specific survival, whereas overall and relative survival, locoregional and distant recurrence, and lymph node harvest were secondary outcomes, with high tie as exposure. We used propensity score matching to emulate a randomized controlled trial, and then performed Cox regression analyses to estimate hazard ratios (HRs) with confidence intervals (CIs). RESULTS: Some 8287 patients remained for analysis, of which 37% had high tie surgery. After propensity score matching, the 5-year cancer-specific survival rate was overall 86% and we found no association between the level of tie and cancer-specific (HR 0.92, 95% CI 0.79-1.07) or overall (HR 0.98, 95% CI 0.89-1.08) survival, nor to locoregional (HR 0.85, 95% CI 0.59-1.23) or distant (HR 1.01, 95% CI 0.88-1.15) recurrence, nor to relative survival (HR 1.05, 95% CI 0.85-1.28). Stratification and sensitivity analyses were similarly insignificant, after adjustment for confounding. Total lymph node harvest was, however, increased after high tie surgery (P < 0.01), but no differences were seen regarding positive nodes (P = 0.72). CONCLUSION: In this nationwide cohort study, the level of tie did not influence any patient-oriented oncological outcome, neither overall nor in node-positive patients. This would allow the patient's anatomical configuration and the surgeon's preferences to determine the level of tie.

Defunctioning stomas may reduce chances of a stoma-free outcome after anterior resection for rectal cancer.

AIM: To investigate the conflicting consequences of faecal diversion on stoma outcomes and anastomotic leakage in anterior resection for rectal cancer, including interaction effects determined by the extent of mesorectal excision. METHOD: Anterior resections between 2007 and 2016 were identified using the Swedish Colorectal Cancer Registry. National Patient Registry data were added to determine stoma outcome 2 years after surgery. Tumour distance from the anal verge constituted a proxy for extent of mesorectal excision [total mesorectal excision (TME): ≤10 cm; partial mesorectal excision (PME): 13-15 cm]. With confounder-adjusted probit regression, the total effect of defunctioning stoma on permanent stoma, and the interaction effect of extent of mesorectal excision, were estimated together with the indirect effect through anastomotic leakage. Baseline risks, risk differences (RDs) and relative risks (RRs) were reported. RESULTS: The main study cohort included 4529 patients. Defunctioning stomas influenced the absolute permanent stoma risk (TME: RD 0.11 [95% CI 0.09-0.13]; PME: RD 0.15 [95% CI 0.13-0.16]). The baseline risk was higher in TME, with a resulting greater RR in PME (2.23 [95% CI 1.43-3.02] vs 4.36 [95% CI 3.05-5.68]). The indirect reduction in permanent stoma rates, due to the alleviating effect of faecal diversion on anastomotic leakage, was small (TME: 0.89 [95% CI 0.81-0.96]; PME: 0.96 [95% CI 0.91-1.00]). CONCLUSION: In anterior resection for rectal cancer, defunctioning stomas may reduce chances of a stoma-free outcome. Considering leakage reduction benefits, consequences of routine diversion in TME might be fairly balanced, while this seems questionable in PME.

Mucosal blood flow in the remaining rectal stump is more affected by total than partial mesorectal excision in patients undergoing anterior resection: a key to understanding differing rates of anastomotic leakage?

PURPOSE: Anterior resection is the procedure of choice for tumours in the mid and upper rectum. Depending on tumour height, a total mesorectal excision (TME) or partial mesorectal excision (PME) can be performed. Low anastomoses in particular have a high risk of developing anastomotic leakage, which might be explained by blood perfusion compromise. A pilot study indicated a worse blood flow in TME patients in an open setting. The aim of this study was to further evaluate perianastomotic blood perfusion changes in relation to TME and PME in a predominantly laparoscopic context. METHOD: In this prospective cohort study, laser Doppler flowmetry was used to evaluate the perianastomotic colonic and rectal perfusion before and after surgery. The two surgical techniques were compared in terms of mean differences of perfusion units using a repeated measures ANOVA design, which also enabled interaction analyses between type of mesorectal excision and location of measurement. Anastomotic leakage until 90 days after surgery was reported for descriptive purposes. RESULTS: Some 28 patients were available for analysis: 17 TME and 11 PME patients. TME patients had a reduced blood perfusion postoperatively compared to PME patients in the aboral posterior area (mean difference: -57 vs 18 perfusion units; p = 0.010). An interaction between mesorectal excision type and anterior/posterior location was detected at the aboral level (p = 0.007). Two patients developed a minor leakage, diagnosed after discharge. CONCLUSION: Patients operated on using TME have a decreased blood flow in the aboral posterior quadrant of the rectum postoperatively compared to patients operated on using PME. This might explain differing rates of anastomotic leakage. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02401100.

Multicentre, randomised trial comparing acellular porcine collagen implant versus gluteus maximus myocutaneous flap for reconstruction of the pelvic floor after extended abdominoperineal excision of rectum: study protocol for the Nordic Extended Abdominoperineal Excision (NEAPE) study.

INTRODUCTION: Different surgical techniques are used to cover the defect in the floor of the lesser pelvis after an 'extralevator' or 'extended' abdominoperineal excision for advanced rectal cancer. However, these operations are potentially mutilating, and the reconstruction method of the pelvic floor has been studied only sparsely. We aim to study whether a porcine-collagen implant is superior or equally beneficial to a gluteus maximus myocutaneous flap as a reconstruction method. METHODS AND ANALYSIS: This is a multicentre non-blinded randomised controlled trial with the experimental arm using a porcine-collagen implant and the control arm using a gluteus maximus muscle and skin rotation flap. Considered for inclusion are patients with rectal cancer, who are operated on with a wide abdominoperineal rectal excision including most of the levator muscles and where the muscle remnants cannot be closed in the midline with sutures. Patients with a primary or recurrent rectal cancer with an estimated survival of more than a year are eligible. The randomisation is computer generated with a concealed sequence and stratified by participating hospital and preoperative radiotherapy regimen. The main outcome is physical performance 6 months after surgery measured with the timed-stands test. Secondary outcomes are perineal wound healing, surgical complications, quality of life, ability to sit and other outcomes measured at 3, 6 and 12 months after surgery. To be able to state experimental arm non-inferiority with a 10% margin of the primary outcome with 90% statistical power and assuming 10% attrition, we aim to enrol 85 patients from May 2011 onwards. ETHICS AND DISSEMINATION: The study has been approved by the Regional Ethical Review board at Umeå University (protocol no: NEAPE-2010-335-31M). The results will be disseminated through patient associations and conventional scientific channels. TRIAL REGISTRATION NUMBER: NCT01347697; Pre-results.

Anterior resection for rectal cancer in Sweden: validation of a registry-based method to determine long-term stoma outcome.

BACKGROUND: A permanent stoma after anterior resection for rectal cancer is common. Nationwide registries provide sufficient power to evaluate factors influencing this phenomenon, but validation is required to ensure the quality of registry-based stoma outcomes. METHODS: Patients who underwent anterior resection for rectal cancer in the Northern healthcare region of Sweden between 1 January 2007 and 31 December 2013 were reviewed by medical records and followed until 31 December 2014 with regard to stoma outcome. A registry-based method to determine nationwide long-term stoma outcomes, using data from the National Patient Registry and the Swedish Colorectal Cancer Registry, was developed and internally validated using the chart reviewed reference cohort. Accuracy was evaluated with positive and negative predictive values and Kappa values. Following validation, the stoma outcome in all patients treated with an anterior resection for rectal cancer in Sweden during the study period was estimated. Possible regional differences in determined stoma outcomes between the six Swedish healthcare regions were subsequently evaluated with the χ2 test. RESULTS: With 312 chart reviewed patients as reference, stoma outcome was accurately predicted through the registry-based method in 299 cases (95.8%), with a positive predictive value of 85.1% (95% CI 75.8%-91.8%), and a negative predictive value of 100.0% (95% CI 98.4%-100.0%), while the Kappa value was 0.89 (95% CI 0.82-0.95). In Sweden, 4768 patients underwent anterior resection during the study period, of which 942 (19.8%) were determined to have a permanent stoma. The stoma rate varied regionally between 17.8-29.2%, to a statistically significant degree (p = .001). CONCLUSION: Using data from two national registries to determine long-term stoma outcome after anterior resection for rectal cancer proved to be reliable in comparison to chart review. Permanent stoma prevalence after such surgery remains at a significant level, while stoma outcomes vary substantially between different healthcare regions in Sweden.

Costs and quality of life of small-incision open cholecystectomy and laparoscopic cholecystectomy - an expertise-based randomised controlled trial.

BACKGROUND: Health care providers need solid evidence based data on cost differences between alternative surgical procedures for common surgical disorders. We aimed to compare small-incision open cholecystectomy (SIOC) and laparoscopic cholecystectomy (LC) concerning costs and health-related quality of life using data from an expertise-based randomised controlled trial. METHODS: Patients scheduled for cholecystectomy were assigned to undergo LC or SIOC performed by surgeons in two different expert groups. Total costs were calculated in USD. Reusable instruments were assumed for the cost analysis. Quality of life was measured using the EuroQol 5-D 3-L (EQ 5-D-3L), at five postoperative time points and calculated to Area Under Curve (AUC) for 1 year postoperatively. Two hospitals participated in the trial, which included both emergency and elective surgery. RESULTS: Of 477 patients that underwent a cholecystectomy during the study period, 355 (74.9%) were randomised and 323 analysed, 172 LC and 151 SIOC patients. Both direct and total costs were less for SIOC than for LC patients. The total costs were 5429 (4293-6932) USD for LC and 4636 (3905-5746) USD for SIOC, P = 0.001. The quality of life index did not differ between the LC and SIOC groups at any time. Median values (25th and 75th percentiles (p25-p75)) for AUC at 1 year were as follows: 349 (337-351) for LC and 349 (338-350) for SIOC. CONCLUSIONS: In this expertise-based randomised controlled trial LC was a more costly procedure and quality of life did not differ after SIOC and LC. (ClinicalTrials.gov Identifier: NCT00370344, August 30, 2006).

Surgery for acute gallbladder disease in Sweden 1989-2006--a register study.

OBJECTIVE: Since early 1970s, prospective randomized controlled trials have emphasized the advantages of early cholecystectomy in patients with acute cholecystitis, compared to elective delayed cholecystectomy. The aim of this investigation was to study surgery for acute gallbladder disease in Sweden during a 15-year period when open cholecystectomy was replaced by a laparoscopic procedure. MATERIAL AND METHODS: Data from the Swedish National Patient Register and the Cause of Death Register 1988-2006 comprising hospital stays with a primary diagnosis of gallbladder/gallstone disease in Sweden were retrieved. Patients were analyzed with reference to timing of cholecystectomy, length of hospital stay, and mortality. RESULTS: Emergency cholecystectomy at index (first) admission or at readmission within 2 years of index admission was performed in 32.2% and 6.1% of patients, respectively. Elective cholecystectomy within 2 years of index admission was performed in 20.3% patients, whereas 41.3% of all patients did not undergo cholecystectomy within 2 years. Standardized mortality ratio did not significantly change during the audit period. Total hospital stay (days at index stay and subsequent stay(s) for biliary diagnoses within 2 years) was shorter for patients who had emergency cholecystectomy at first admission compared to patients with later or no cholecystectomy within 2 years. CONCLUSIONS: Around 30% of patients with acute gallbladder disease were operated with cholecystectomy during the first admission with no time trend from 1990 through 2004. A total of 40% of patients with acute gallbladder disease were not cholecystectomized within 2 years. Analysis of outcome of long-term conservative treatment is warranted.

Treatment of common bile duct stones in Sweden 1989-2006: an observational nationwide study of a paradigm shift.

BACKGROUND: The preferred strategies for treatment of common bile duct stones have changed from choledochotomy with cholecystectomy to sphincterotomy with or without cholecystectomy. The aim of the present study was to compare the effectiveness of these treatment strategies on a nationwide level in Sweden. METHODS: All patients with hospital care for benign biliary diagnoses 1988-2006 were identified in Swedish registers. Patients with common bile duct stones and a first admission with choledochotomy and or endoscopic sphincterotomy from 1989 through 2006 comprised the study group. These patients were analyzed with respect to readmission for biliary diagnoses and acute pancreatitis. RESULTS: Incidence of open and laparoscopic choledochotomy decreased from 19.4 to 5.2, whereas endoscopic sphincterotomy increased from 5.1 to 26.1 per 100,000 inhabitants per year, respectively. Among patients treated for common bile duct stones (n = 26,815), 60.0 % underwent cholecystectomy during the first hospital admission in 1989-1994, compared to 30.1 % in 2001-2006. The treatment strategy that included endoscopic sphincterotomy was associated with more readmissions for biliary diagnoses and increased risk for acute pancreatitis than the treatment strategy with choledochotomy. However, patients treated with endoscopic sphincterotomy and concurrent cholecystectomy at the index admission had the lowest risk of readmission. CONCLUSIONS: Cholecystectomy has been increasingly separated from treatment of bile duct stones, and endoscopic sphincterotomy has superseded choledochotomy as a first alternative for bile duct clearance in Sweden. In patients fit for surgery, clearance of the common bile duct can be combined with cholecystectomy, as it probably reduces the need for biliary related readmissions.

Physical performance and quality of life after extended abdominoperineal excision of rectum and reconstruction of the pelvic floor with gluteus maximus flap.

PURPOSE: This study aimed to evaluate the physical performance and quality of life after an extended abdominoperineal excision of the rectum and the reconstruction with a right-sided unilateral gluteus myocutaneus rotation flap in patients with rectal and anal cancer. METHOD: Nineteen patients with primary or recurrent rectal or anal cancer were investigated a mean of 26 months (range, 10-39 mo) after the operation. All patients received preoperative radiation therapy. Physical performance, hip movability, balance, and ability to sit were measured according to a prospective protocol, and the patients' perception of pain and quality of life were investigated with questionnaires. Postoperative complications and oncological results were registered retrospectively from patient records of 36 patients who had undergone operations. RESULTS: The timed-stands test showed that 12 of 19 patients performed worse than the upper limit of reference values adjusted for age and gender. The Berg balance scale showed a mean score of 52.8 that is close to the maximum score (56) of the test. The mean calculated EQ-5D (EuroQol Group, Rotterdam, The Netherlands) quality-of-life index was 0.71 based on the 5 questions in the instrument. The ability to sit 10 minutes was reduced in 4 patients, and 8 patients used a cushion or ring. Mean pain score was 20 (visual analog scale from 0 to 100) while sitting, and only 9 of 19 patients were pain free. The hip mobility was normal, but 6 patients had reduced flexion strength on the right side compared with the left side. Twenty-eight of 36 patients (78%) had some kind of early or late complication after surgery. Local recurrence was found in 4 of 36 patients (11%). CONCLUSION: The oncological outcome of the operation was acceptable, but functional drawbacks must be considered preoperatively in counseling the patient. More research is needed to find ways to preserve better function and well-being.

Low-volume bowel preparation is inferior to standard 4 1 polyethylene glycol.

BACKGROUND: Four liters or more of orally taken polyethylene glycol solution (PEG) has proved to be an effective large-bowel cleansing method prior to colonoscopy. The problem has been the large volume of fluid and its taste, which is unacceptable to some examinees. We aimed to investigate the effectiveness of 2 l PEG combined with senna compared with 4 l PEG for bowel preparation. METHODS: The design was a single-center, prospective, randomized, investigator-blinded study with parallel assignment, in the setting of the Endoscopy Unit of Umeå University Hospital. Outpatients (n = 490) scheduled for colonoscopy were enrolled. The standard-volume arm received 4 l PEG, and the low-volume arm received 36 mg senna glycosides in tablets and 2 l PEG. The cleansing result (primary endpoint) was assessed by the endoscopist using the Ottawa score. The patients rated the subjective grade of ease of taking the bowel preparation. Analysis was on an intention-to-treat basis. RESULTS: There were significantly more cases with poor or inadequate bowel cleansing after the low-volume alternative with senna and 2 l PEG (22/203) compared with after 4 l PEG (8/196, p = 0.027). The low-volume alternative was better tolerated by the examinees: 119/231 rated the treatment as easy to take compared with 88/238 in the 4 l PEG arm (p = 0.001). CONCLUSIONS: 4 l PEG treatment is better than 36 mg senna and 2 l PEG as routine colonic cleansing before colonoscopy because of fewer failures.

Cholecystectomy in Sweden 2000-2003: a nationwide study on procedures, patient characteristics, and mortality.

BACKGROUND: Epidemiological data on characteristics of patients undergoing open or laparoscopic cholecystectomy are limited. In this register study we examined characteristics and mortality of patients who underwent cholecystectomy during hospital stay in Sweden 2000 - 2003. METHODS: Hospital discharge and death certificate data were linked for all patients undergoing cholecystectomy in Sweden from January 1st 2000 through December 31st 2003. Mortality risk was calculated as standardised mortality ratio (SMR) i.e. observed over expected deaths considering age and gender of the background population. RESULTS: During the four years of the study 43072 patients underwent cholecystectomy for benign biliary disease, 31144 (72%) using a laparoscopic technique and 11928 patients (28%) an open procedure (including conversion from laparoscopy). Patients with open cholecystectomy were older than patients with laparoscopic cholecystectomy (59 vs 49 years, p < 0.001), they were more likely to have been admitted to hospital during the year preceding cholecystectomy, and they had more frequently been admitted acutely for cholecystectomy (57% Vs 21%, p < 0.001). The proportion of women was lower in the open cholecystectomy group compared to the laparoscopic group (57% vs 73%, p < 0.001). Hospital stay was 7.9 (8.9) days, mean (SD), for patients with open cholecystectomy and 2.6 (3.3) days for patients with laparoscopic cholecystectomy, p < 0.001. SMR within 90 days of index admission was 3.89 (3.41-4.41) (mean and 95% CI), for patients with open cholecystectomy and 0.73 (0.52-1.01) for patients with laparoscopic cholecystectomy. During this period biliary disease accounted for one third of all deaths in both groups. From 91 to 365 days after index admission, SMR for patients in the open group was 1.01 (0.87-1.16) and for patients in the laparoscopic group 0.56 (0.44-0.69). CONCLUSION: Laparoscopic cholecystectomy is performed on patients having a lower mortality risk than the general Swedish population. Patients with open cholecystectomy are more sick than patients with laparoscopic cholecystectomy, and they have a mortality risk within 90 days of admission for cholecystectomy, which is four times that of the general population. Further efforts to reduce surgical trauma in open biliary surgery are motivated.