Laparoscopic lavage for perforated diverticulitis in the LapLav study: population-based registry study.

BACKGROUND: The standard treatment for Hinchey III perforated diverticulitis with peritonitis was resection with or without a stoma, but recent trials have shown that laparoscopic lavage is a reasonable alternative. This registry-based Swedish study investigated results at a national level to assess safety in real-world scenarios. METHODS: Patients in Sweden who underwent emergency surgery for perforated diverticulitis between 2016 and 2018 were studied. Inverse probability weighting by propensity score was used to adjust for confounding factors. RESULTS: A total of 499 patients were included in this study. Laparoscopic lavage was associated with a significantly lower 90-day Comprehensive Complication Index (20.9 versus 32.0; odds ratio 0.77, 95 per cent compatibility interval (c.i.) 0.61 to 0.97) and overall duration of hospital stay (9 versus 15 days; ratio of means 0.84, 95 per cent c.i. 0.74 to 0.96) compared with resection. Patients had 82 (95 per cent c.i. 39 to 140) per cent more readmissions following lavage than resection (27.2 versus 21.0 per cent), but similar reoperation rates. More co-morbidity was noted among patients who underwent resection than those who had laparoscopic lavage. CONCLUSION: Laparoscopic lavage is safe in routine care beyond trial evaluations.

Diverticulitis comprises inflammation in pouches (diverticula) of the large intestine. In the most severe instances, this inflammation can cause perforation of the bowel with purulent or faecal peritonitis. If this happens, surgery is needed. The traditional method has been resection of the inflamed bowel with a stoma. A new technique has been proposed whereby the abdomen is rinsed with saline laparoscopically and a drain is placed (laparoscopic lavage). This study aimed to compare these two methods in terms of clinical short-term outcomes, with a focus on complications. It was found that laparoscopic lavage had fewer complications than resectional surgery and a shorter hospital stay. The new method was safe when used in Swedish routine care.

Urinary dysfunction in patients with rectal cancer: a prospective cohort study.

AIM: Urinary dysfunction is one of many complications after treatment for rectal cancer. The aim of this study was to evaluate the prevalence of patient-reported urinary dysfunction at the time of diagnosis and at 1-year follow-up and to assess the risk factors linked to urinary incontinence. METHOD: Patients with newly diagnosed rectal cancer were included in the QoLiRECT study between 2012 and 2015. Questionnaires from the time of diagnosis and 1-year follow-up were analysed, with 1085 and 916 patients, respectively, eligible for analysis. Regression analyses were made to investigate possible risk factors for incontinence. The patient cohort was also compared with a cohort from the Swedish general population. RESULTS: At baseline, the prevalence of urinary dysfunction (14% of women, 8% of men) was similar to that in the general population. At 1-year follow-up, 20% of patients experienced urinary incontinence (29% of women, 14% of men). Emptying difficulties were experienced by 46% (41% of women, 49% of men) and urgency by 58% across both sexes. Abdominoperineal excision and urinary dysfunction at baseline were found to be independent risk factors for incontinence at 1-year follow-up. Among patients who were continent at baseline, risk factors were female sex, physical inactivity at baseline, comorbidity and abdominoperineal excision. CONCLUSION: Urinary dysfunction is frequent among patients with rectal cancer, with up to a two-fold increase in symptoms 1 year after diagnosis. Unfortunately, few factors are modifiable and these results stress the importance of informing patients of possible outcomes related to urinary dysfunction after treatment for rectal cancer.

Quality of life in patients with resectable rectal cancer during the first 24 months following diagnosis.

AIM: An increasing number of patients survive rectal cancer, resulting in more patients living with the side-effects of the treatment. Exploring quality of life before and after treatment enables follow-up and additional treatment to be adjusted to the patient's needs. The aim of the study was to describe the quality of life during the 24 months following diagnosis and to identify risk factors for poor quality of life. METHOD: This is a prospective cohort study of patients with rectal cancer followed up by extensive questionnaires. Patients from 16 surgical departments in Denmark and Sweden from 2012 to 2015 were included. The self-assessed quality of life was measured with a seven-point Likert scale. RESULTS: A total of 1110 patients treated with curative intent were included, and the response rate at the 24-month follow-up was 71%. Patients with rectal cancer assessed their quality of life before start of treatment as poorer than that of a reference population. At the 12- and 24-month follow-up, the quality of life on group level had recovered to the same level as for the reference population. Risk factors for poor quality of life included bother with urinary, bowel and stoma function. A reference population was used for comparison. CONCLUSION: The quality of life of patients with resectable rectal cancer recovered to levels comparable to a reference population 12 and 24 months after diagnosis. Our results indicate that the urinary, bowel and stoma function has an impact on quality of life.

Self-reported sexual dysfunction in patients with rectal cancer.

AIM: Patients with rectal cancer often experience sexual dysfunction after treatment. The aim of this study was to evaluate sexual function in a prospective cohort of patients regardless of treatment and tumour stage and explore what factors might affect sexual activity 1 year after diagnosis. METHOD: The QoLiRECT study (Quality of Life in RECTal cancer) is a prospective study on the health-related quality of life in patients with rectal cancer in Denmark and Sweden. Questionnaires were completed at diagnosis and 1 year. Clinical data were retrieved from national quality registries. RESULTS: Questionnaire data were available from 1085 patients at diagnosis and 920 patients at 1 year. Median age was 69 years (range 25-100). At diagnosis, 29% of the women and 41% of the men were sexually active, which was lower than an age-matched reference population. This was further reduced to 25% and 34% at 1 year. Risk factors for sexual inactivity were absence of sexual activity prior to the diagnosis and the presence of a stoma. Women experienced reduced lubrication and more dyspareunia at 1 year compared with the time of diagnosis. In men, erectile dysfunction increased from 46% to 55% at 1 year. CONCLUSION: Sexual activity in patients with rectal cancer is lower at diagnosis compared with the population norm and is further reduced at 1 year. The presence of a stoma contributed to reduced sexual activity after operation. Sexual dysfunction was difficult to evaluate due to low sexual activity in the cohort. In men, erectile dysfunction is common.

Low anterior resection syndrome in a Scandinavian population of patients with rectal cancer: a longitudinal follow-up within the QoLiRECT study.

AIM: Low anterior resection syndrome (LARS) is common after low anterior resection. Our aim was to evaluate the prevalence and 'bother' (subjective, symptom-associated distress) of major LARS after 1 and 2 years, identify possible risk factors and relate the bowel function to a reference population. METHOD: The QoLiRECT (Quality of Life in RECTal cancer) study is a Scandinavian prospective multicentre study including 1248 patients with rectal cancer, of whom 552 had an anterior resection. Patient questionnaires were distributed at diagnosis and after 1, 2 and 5 years. Data from the baseline and at 1- and 2-year follow-up were included in this study. RESULTS: The LARS score was calculated for 309 patients at 1 year and 334 patients at 2 years. Prevalence was assessed by a generalized linear mixed effects model. Major LARS was found in 63% at 1 year and 56% at 2 years. Bother was evident in 55% at 1 year, decreasing to 46% at 2 years. Major LARS was most common among younger women (69%). Among younger patients, only marginal improvement was seen over time (63-59%), for older patients there was more improvement (62-52%). In the reference population, the highest prevalence of major LARS-like symptoms was noted in older women (12%). Preoperative radiotherapy, defunctioning stoma and tumour height were found to be associated with major LARS. CONCLUSION: Major LARS is common and possibly persistent over time. Younger patients, especially women, are more affected, and perhaps these patients should be prioritized for early stoma closure to improve the chance of a more normal bowel function.

European Society of Coloproctology: guidelines for the management of diverticular disease of the colon.

AIM: The goal of this European Society of Coloproctology (ESCP) guideline project is to give an overview of the existing evidence on the management of diverticular disease, primarily as a guidance to surgeons. METHODS: The guideline was developed during several working phases including three voting rounds and one consensus meeting. The two project leads (JKS and EA) appointed by the ESCP guideline committee together with one member of the guideline committee (WB) agreed on the methodology, decided on six themes for working groups (WGs) and drafted a list of research questions. Senior WG members, mostly colorectal surgeons within the ESCP, were invited based on publication records and geographical aspects. Other specialties were included in the WGs where relevant. In addition, one trainee or PhD fellow was invited in each WG. All six WGs revised the research questions if necessary, did a literature search, created evidence tables where feasible, and drafted supporting text to each research question and statement. The text and statement proposals from each WG were arranged as one document by the first and last authors before online voting by all authors in two rounds. For the second voting ESCP national representatives were also invited. More than 90% agreement was considered a consensus. The final phrasing of the statements with < 90% agreement was discussed in a consensus meeting at the ESCP annual meeting in Vienna in September 2019. Thereafter, the first and the last author drafted the final text of the guideline and circulated it for final approval and for a third and final online voting of rephrased statements. RESULTS: This guideline contains 38 evidence based consensus statements on the management of diverticular disease. CONCLUSION: This international, multidisciplinary guideline provides an up to date summary of the current knowledge of the management of diverticular disease as a guidance for clinicians and patients.

Functional outcomes from a randomized trial of early closure of temporary ileostomy after rectal excision for cancer.

BACKGROUND: Low anterior resection syndrome (LARS) has a significant impact on postoperative quality of life. Although early closure of an ileostomy is safe in selected patients, functional outcomes have not been investigated. The aim was to compare bowel function and the prevalence of LARS in patients who underwent early or late closure of an ileostomy after rectal resection for cancer. METHODS: Early closure (8-13 days) was compared with late closure (after 12 weeks) of the ileostomy following rectal cancer surgery in a multicentre RCT. Exclusion criteria were: signs of anastomotic leakage, diabetes mellitus, steroid treatment and postoperative complications. Bowel function was evaluated using the LARS score and the Memorial Sloan Kettering Cancer Center Bowel Function Instrument (BFI). RESULTS: Following index surgery, 112 participants were randomized (55 early closure, 57 late closure). Bowel function was evaluated at a median of 49 months after stoma closure. Eighty-two of 93 eligible participants responded (12 had died and 7 had a permanent stoma). Rates of bowel dysfunction were higher in the late closure group, but this did not reach statistical significance (major LARS in 29 of 40 participants in late group and 25 of 42 in early group, P = 0·250; median BFI score 63 versus 71 respectively, P = 0·207). Participants in the late closure group had worse scores on the urgency/soiling subscale of the BFI (14 versus 17; P = 0·017). One participant in the early group and six in the late group had a permanent stoma (P = 0·054). CONCLUSION: Patients undergoing early stoma closure had fewer problems with soiling and fewer had a permanent stoma, although reduced LARS was not demonstrated in this cohort. Dedicated prospective studies are required to evaluate definitively the association between temporary ileostomy, LARS and timing of closure.

Two-year results of the randomized clinical trial DILALA comparing laparoscopic lavage with resection as treatment for perforated diverticulitis.

BACKGROUND: Traditionally, perforated diverticulitis with purulent peritonitis was treated with resection and colostomy (Hartmann's procedure), with inherent complications and risk of a permanent stoma. The DILALA (DIverticulitis - LAparoscopic LAvage versus resection (Hartmann's procedure) for acute diverticulitis with peritonitis) and other randomized trials found laparoscopic lavage to be a feasible and safe alternative. The medium-term follow-up results of DILALA are reported here. METHODS: Patients were randomized during surgery after being diagnosed with Hinchey grade III perforated diverticulitis at diagnostic laparoscopy. The primary outcome was the proportion of patients with one or more secondary operations from 0 to 24 months after the index procedure in the laparoscopic lavage versus Hartmann's procedure groups. The trial was registered as ISRCTN82208287. RESULTS: Forty-three patients were randomized to laparoscopic lavage and 40 to Hartmann's procedure. Patients in the lavage group had a 45 per cent reduced risk of undergoing one or more operations within 24 months (relative risk 0·55, 95 per cent c.i. 0·36 to 0·84; P = 0·012) and had fewer operations (ratio 0·51, 95 per cent c.i. 0·31 to 0·87; P = 0·024) compared with those in the Hartmann's group. No difference was found in mean number of readmissions (1·37 versus 1·50; P = 0·221) or mortality between patients randomized to laparoscopic lavage or Hartmann's procedure. Three patients in the lavage group and nine in the Hartmann's group had a colostomy at 24 months. CONCLUSION: Laparoscopic lavage is a better option for perforated diverticulitis with purulent peritonitis than open resection and colostomy.

Quality of life in a randomized trial of early closure of temporary ileostomy after rectal resection for cancer (EASY trial).

BACKGROUND: A temporary ileostomy may reduce symptoms from anastomotic leakage after rectal cancer resection. Earlier results of the EASY trial showed that early closure of the temporary ileostomy was associated with significantly fewer postoperative complications. The aim of the present study was to compare health-related quality of life (HRQOL) following early versus late closure of a temporary ileostomy. METHODS: Early closure of a temporary ileostomy (at 8-13 days) was compared with late closure (at more than 12 weeks) in a multicentre RCT (EASY) that included patients who underwent rectal resection for cancer. Inclusion of participants was made after index surgery. Exclusion criteria were signs of anastomotic leakage, diabetes mellitus, steroid treatment, and signs of postoperative complications at clinical evaluation 1-4 days after rectal resection. HRQOL was evaluated at 3, 6 and 12 months after resection using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 and QLQ-CR29 and Short Form 36 (SF-36®). RESULTS: There were 112 patients available for analysis. Response rates of the questionnaires were 82-95 per cent, except for EORTC QLQ-C30 at 12 months, to which only 54-55 per cent of the patients responded owing to an error in questionnaire distribution. There were no clinically significant differences in any questionnaire scores between the groups at 3, 6 or 12 months. CONCLUSION: Although the randomized study found that early closure of the temporary ileostomy was associated with significantly fewer complications, this clinical advantage had no effect on the patients' HRQOL. Registration number: NCT01287637 (https://www.clinicaltrials.gov).

Risk of recurrence of sigmoid volvulus: a single-centre cohort study.

AIM: Sigmoid volvulus is a condition with a tendency to recur if treated conservatively. Little is known about the best type of treatment or when to perform definitive surgery. The aim of this study was to review treatment, and assess the outcome, of sigmoid volvulus in adult patients treated at a Swedish university hospital. METHOD: The medical records of patients treated for sigmoid volvulus at Sahlgrenska University Hospital, Sweden from January 2000 to September 2016 were reviewed retrospectively. Median follow-up time was 8.3 years. RESULTS: One hundred and sixty-eight patients were included with a total of 453 admissions for sigmoid volvulus. Nonoperative decompression was attempted as the initial treatment in 438/453 (97%), with a success rate of 92% (403/438), which was not influenced by whether it was the first episode or a recurrence. Without planned surgery, recurrence occurred after 84% of successful nonoperative decompressions with a median of two recurrences (1-16). Recurrence was less common after the first episode compared with subsequent episodes. Median time until recurrence was 58 days. Mortality after planned surgery following successful decompression was 3.3% (2/61) compared with 13% (6/46) following emergency surgery. CONCLUSION: In our cohort, the recurrence rate of sigmoid volvulus following successful nonoperative decompression was high. Still, more than 20% of patients did not experience a recurrence after their first episode. Nonoperative decompression could thus be suggested as the sole treatment for the first episode of volvulus. However, after the second episode it is probable that early planned surgery would improve outcome and reduce health-care consumption.

Urogenital function 3 years after abdominoperineal excision for rectal cancer.

AIM: The aim of this study was to explore urogenital dysfunction and associated risk factors after treatment of rectal cancer, in a large national cohort of patients 3 years after abdominoperineal excision, and to compare outcomes with a reference population and a cohort of patients operated for prostate cancer. METHOD: Patients treated with abdominoperineal excision in 2007-2009 were identified using the Swedish Colorectal Cancer Registry. All consenting patients received a questionnaire. A sample of the Swedish population was contacted and completed a questionnaire. Patients undergoing radical prostatectomy in a prospective multicentre trial received questionnaires 24 months after surgery. RESULTS: In the abdominoperineal excision, reference and radical prostatectomy populations 72%, 51% and 91% of the questionnaires were returned. Within the abdominoperineal excision group 36% of the men and 57% of the women were incontinent postoperatively. Fifteen per cent and 37% of men and women in the reference group were incontinent. Two years after radical prostatectomy 49% were incontinent. Seventy-four per cent of the men had erectile dysfunction after abdominoperineal excision. Nineteen per cent of the women experienced reduced ability to reach orgasm. Fewer men and women experienced their present sex life as satisfying after abdominoperineal excision for rectal cancer compared with the reference population. CONCLUSION: A large proportion of patients endure persistent urogenital dysfunction after abdominoperineal excision for rectal cancer as do men after radical prostatectomy. Effects on sexual and urinary function should be part of preoperative information and after surgery patients should be asked about function in order to identify those in need of further assistance.

Timely access to care in the treatment of rectal cancer and the effect on quality of life.

AIM: The aim of this study was to investigate if a delay in a patient's first contact with a healthcare professional, and any subsequent delay in diagnosis, affected self-assessed quality of life prior to start of treatment for rectal cancer. METHOD: Questionnaires were administered when patients had been informed of the diagnosis and planned treatment. The primary end-point was self-assessed quality of life according to a seven-point Likert scale. The response variables were dichotomized and analysed by unadjusted and adjusted binary logistic regression. RESULTS: A reported duration of symptoms longer than 4 months was found to be associated with a lower quality of life than a reported duration of symptoms of less than 3 months. Furthermore, a reported period of longer than 2 months from first contact with a healthcare professional to a diagnosis was found to correlate with lower quality of life compared with a period shorter than 2 months. However, when adjusting for possible confounding variables the duration of symptoms and time to diagnosis were not found to affect self-assessed quality of life. Several variables were found to have significant influence in the statistical model, including sense of coherence, the presence of negative intrusive thoughts, comorbidity, depressed mood, male sex and comorbidity. CONCLUSION: One conclusion of our study is that further efforts to shorten delay in rectal cancer care with the aim of improving quality of life may be futile. To improve the patient's quality of life at diagnosis other interventions should be considered, such as screening for depression and/or negative intrusive thoughts.

Health economic analysis of laparoscopic lavage versus Hartmann's procedure for diverticulitis in the randomized DILALA trial.

BACKGROUND: Open surgery with resection and colostomy (Hartmann's procedure) has been the standard treatment for perforated diverticulitis with purulent peritonitis. In recent years laparoscopic lavage has emerged as an alternative, with potential benefits for patients with purulent peritonitis, Hinchey grade III. The aim of this study was to compare laparoscopic lavage and Hartmann's procedure with health economic evaluation within the framework of the DILALA (DIverticulitis - LAparoscopic LAvage versus resection (Hartmann's procedure) for acute diverticulitis with peritonitis) trial. METHODS: Clinical effectiveness and resource use were derived from the DILALA trial and unit costs from Swedish sources. Costs were analysed from the perspective of the healthcare sector. The study period was divided into short-term analysis (base-case A), within 12 months, and long-term analysis (base-case B), from inclusion in the trial throughout the patient's expected life. RESULTS: The study included 43 patients who underwent laparoscopic lavage and 40 who had Hartmann's procedure in Denmark and Sweden during 2010-2014. In base-case A, the difference in mean cost per patient between laparoscopic lavage and Hartmann's procedure was €-8983 (95 per cent c.i. -16 232 to -1735). The mean(s.d.) costs per patient in base-case B were €25 703(27 544) and €45 498(38 928) for laparoscopic lavage and Hartmann's procedure respectively, resulting in a difference of €-19 794 (95 per cent c.i. -34 657 to -4931). The results were robust as demonstrated in sensitivity analyses. CONCLUSION: The significant cost reduction in this study, together with results of safety and efficacy from RCTs, support the routine use of laparoscopic lavage as treatment for complicated diverticulitis with purulent peritonitis.

Physical activity before radical prostatectomy reduces sick leave after surgery - results from a prospective, non-randomized controlled clinical trial (LAPPRO).

BACKGROUND: Studies have reported that early physical rehabilitation after surgical procedures is associated with improved outcome measured as shorter hospital stay and enhanced recovery. The aim of this study was to explore the relationship between the preoperative physical activity level and subsequent postoperative complications, sick-leave and hospital stay after radical prostatectomy for prostate cancer in the setting of the LAPPRO trial (LAParoscopic Prostatectomy Robot Open). METHODS: LAPPRO is a prospective controlled trial, comparing robot-assisted laparoscopic and open surgery for localized prostate cancer between 2008 and 2011. 1569 patients aged 64 or less with an occupation were included in this sub-study. The Gleason score was <7 in 52 % of the patients. Demographics and the level of self-assessed preoperative physical activity, length of hospital stay, complications, quality of life, recovery and sick-leave were extracted from clinical record forms and questionnaires. Multivariable logistic regression, with log-link and logit-link functions, was used to adjust for potential confounding variables. RESULTS: The patients were divided into four groups based on their level of activity. As the group with lowest engagement of physical activity was found to be significantly different in base line characteristics from the other groups they were excluded from further analysis. Among patients that were physically active preoperativelly (n = 1467) there was no significant difference between the physical activity-groups regarding hospital stay, recovery or complications. However, in the group with the highest self-assessed level of physical activity, 5-7 times per week, 13 % required no sick leave, compared to 6.3 % in the group with a physical activity level of 1-2 times per week only (p < 0.0001). CONCLUSIONS: In our study of med operated with radical prostatectomy, a high level of physical activity preoperatively was associated with reduced need for sick leave after radical prostatectomy compared to men with lower physical activity. TRIAL REGISTRATION: The trial is registered at the ISCRTN register. ISRCTN06393679 .

Patient-reported genitourinary dysfunction after laparoscopic and open rectal cancer surgery in a randomized trial (COLOR II).

BACKGROUND: This article reports on patient-reported sexual dysfunction and micturition symptoms following a randomized trial of laparoscopic and open surgery for rectal cancer. METHODS: Patients in the COLOR II randomized trial, comparing laparoscopic and open surgery for rectal cancer, completed the European Organization for Research and Treatment of Cancer (EORTC) QLQ-CR38 questionnaire before surgery, and after 4 weeks, 6, 12 and 24 months. Adjusted mean differences on a 100-point scale were calculated using changes from baseline value at the various time points in the domains of sexual functioning, sexual enjoyment, male and female sexual problems, and micturition symptoms. RESULTS: Of 617 randomized patients, 385 completed this phase of the trial. Their mean age was 67·1 years. Surgery caused an anticipated reduction in genitourinary function after 4 weeks, with no significant differences between laparoscopic and open approaches. An improvement in sexual dysfunction was seen in the first year, but some male sexual problems persisted. Before operation 64·5 per cent of men in the laparoscopic group and 55·6 per cent in the open group reported some degree of erectile dysfunction. This increased to 81·1 and 80·5 per cent respectively 4 weeks after surgery, and 76·3 versus 75·5 per cent at 12 months, with no significant differences between groups. Micturition symptoms were less affected than sexual function and gradually improved to preoperative levels by 6 months. Adjusting for confounders, including radiotherapy, did not change these results. CONCLUSION: Sexual dysfunction is common in patients with rectal cancer, and treatment (including surgery) increases the proportion of patients affected. A laparoscopic approach does not change this. REGISTRATION NUMBER: NCT00297791 (http://www.clinicaltrials.gov).

Preoperative risk factors for anastomotic leakage after resection for colorectal cancer: a systematic review and meta-analysis.

AIM: Colorectal anastomotic leakage is a serious complication. Despite extensive research, no consensus on the most important preoperative risk factors exists. The aim of this systematic review and meta-analysis was to evaluate risk factors for anastomotic leakage in patients operated with colorectal resection. METHOD: The databases MEDLINE, Embase and CINAHL were searched for prospective observational studies on preoperative risk factors for anastomotic leakage. Meta-analyses were performed on outcomes based on odds ratios (OR) from multivariate regression analyses. The Newcastle-Ottawa scale was used for bias assessment within studies, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used for quality assessment of evidence on outcome levels. RESULTS: This review included 23 studies evaluating 110,272 patients undergoing colorectal resection for cancer. The meta-analyses found that a low rectal anastomosis [OR = 3.26 (95% CI: 2.31-4.62)], male gender [OR = 1.48 (95% CI: 1.37-1.60)] and preoperative radiotherapy [OR = 1.65 (95% CI: 1.06-2.56)] may be risk factors for anastomotic leakage. Primarily as a result of observational design, the quality of evidence was regarded as moderate or low for these risk factors according to the GRADE approach. CONCLUSION: Based on the best available evidence, important preoperative risk factors for colorectal anastomotic leakage have been identified. Knowledge on risk factors may influence treatment and procedure-related decisions, and possibly reduce the leakage rate.

Health-related quality of life after laparoscopic and open surgery for rectal cancer in a randomized trial.

BACKGROUND: Previous studies comparing laparoscopic and open surgical techniques have reported improved health-related quality of life (HRQL). This analysis compared HRQL 12 months after laparoscopic versus open surgery for rectal cancer in a subset of a randomized trial. METHODS: The setting was a multicentre randomized trial (COLOR II) comparing laparoscopic and open surgery for rectal cancer. Involvement in the HRQL study of COLOR II was optional. Patients completed the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-CR38, and EuroQol - 5D (EQ-5D™) before surgery, and 4 weeks, 6, 12 and 24 months after operation. Analysis was done according to the manual for each instrument. RESULTS: Of 617 patients in hospitals participating in the HRQL study of COLOR II, 385 were included. The HRQL deteriorated to moderate/severe degrees after surgery, gradually returning to preoperative values over time. Changes in EORTC QLQ-C30 and QLQ-CR38, and EQ-5D™ were not significantly different between the groups regarding global health score or any of the dimensions or symptoms at 4 weeks, 6 or 12 months after surgery. CONCLUSION: In contrast to previous studies in patients with colonic cancer, HRQL after rectal cancer surgery was not affected by surgical approach. REGISTRATION NUMBER: NCT00297791 (http://www.clinicaltrials.gov).

Ostomy function after abdominoperineal resection--a clinical and patient evaluation.

PURPOSE: Abdominoperineal resection (APR) for rectal cancer results in a permanent colostomy. As a consequence of a recent change in operative technique from standard (S-APR) to extralevator resection (E-APR), the perineal part of the procedure is now performed with the patient in a prone jackknife position. The impact of this change on stoma function is unknown. The aim was to determine stoma-related complications and the individual patient experience of a stoma. METHODS: Consecutive patients with rectal cancer operated on with APR in one institution in 2004 to 2009 were included. Recurrent cancer, palliative procedures, pre-existing stoma and patients not alive at the start of the study were excluded. Data were collected from hospital records and the national colorectal cancer registry. A questionnaire was sent out to patients. The median follow-up was 44 months (13-84) after primary surgery. RESULTS: Ninety-six patients were alive in February 2011. Seventy seven agreed to participate. Sixty-nine patients (90 %) returned the questionnaire. Stoma necrosis was more common for E-APR, 34 % vs. 10 %, but bandaging problems and low stoma height were more common for S-APR. There were no differences in the patients' experience of stoma function. In all, 35 % of the patients felt dirty and unclean, but 90 % felt that they had a full life and could engage in leisure activities of their choice. CONCLUSIONS: This exploratory study indicates no difference in stoma function after 1 year between S-APR and E-APR. Over 90 % of the patients accept their stoma, but our study indicates that more information and support for patients are warranted.