Risk of hernia formation after radical prostatectomy: a comparison between open and robot-assisted laparoscopic radical prostatectomy within the prospectively controlled LAPPRO trial.

PURPOSE: In addition to incisional hernia, inguinal hernia is a recognized complication to radical retropubic prostatectomy. To compare the risk of developing inguinal and incisional hernias after open radical prostatectomy compared to robot-assisted laparoscopic prostatectomy. METHOD: Patients planned for prostatectomy were enrolled in the prospective, controlled LAPPRO trial between September 2008 and November 2011 at 14 hospitals in Sweden. Information regarding patient characteristics, operative techniques and occurrence of postoperative inguinal and incisional hernia were retrieved using six clinical record forms and four validated questionnaires. RESULTS: 3447 patients operated with radical prostatectomy were analyzed. Within 24 months, 262 patients developed an inguinal hernia, 189 (7.3%) after robot-assisted laparoscopic prostatectomy and 73 (8.4%) after open radical prostatectomy. The relative risk of having an inguinal hernia after robot-assisted laparoscopic prostatectomy was 18% lower compared to open radical retropubic prostatectomy, a non-significant difference. Risk factors for developing an inguinal hernia after prostatectomy were increased age, low BMI and previous hernia repair. The incidence of incisional hernia was low regardless of surgical technique. Limitations are the non-randomised setting. CONCLUSIONS: We found no difference in incidence of inguinal hernia after open retropubic and robot-assisted laparoscopic radical prostatectomy. The low incidence of incisional hernia after both procedures did not allow for statistical analysis. Risk factors for developing an inguinal hernia after prostatectomy were increased age and BMI.

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.

Recovery after breast cancer surgery following recommended pre and postoperative physical activity: (PhysSURG-B) randomized clinical trial.

BACKGROUND: The effect of preoperative physical activity on recovery and complications after primary breast cancer surgery is unknown. The objective of this trial was to evaluate whether a recommendation of non-supervised physical activity improved recovery after breast cancer surgery. METHODS: This parallel, unblinded, multicentre interventional trial randomized women in whom breast cancer surgery was planned. The intervention consisted of an individual recommendation of added aerobic physical activity (30 min/day), before and 4 weeks after surgery. The control group did not receive any advice regarding physical activity. The primary outcome was patient-reported physical recovery at 4 weeks after surgery. Secondary outcomes included mental recovery, complications, reoperations, and readmissions. RESULTS: Between November 2016 and December 2018, 400 patients were randomized, 200 to each group. Some 370 participants (180 intervention, 190 control) remained at 4 weeks, and 368 at 90 days. There was no significant difference in favour of the intervention for the primary outcome physical recovery (risk ratio (RR) 1.03, 95 per cent c.i. 0.95 to 1.13). There was also no difference for mental recovery (RR 1.05, 0.93 to 1.17) nor in mean Comprehensive Complication Index score (4.2 (range 0-57.5) versus 4.7 (0-58.3)) between the intervention and control groups. CONCLUSION: An intervention with recommended non-supervised physical activity before and after breast cancer surgery did not improve recovery at 4 weeks after surgery. Registration number: NCT02560662 (http://www.clinicaltrials.gov).

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.

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.

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).

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.

No consensus on restrictions on physical activity to prevent incisional hernias after surgery.

PURPOSE: In the postoperative phase after colorectal surgery, restrictions on physical activity are often recommended for patients to prevent incisional hernias. However, evidence does not support that restrictions may prevent such hernias. The purpose of this study was to evaluate the extent of restrictions on physical activity recommended for patients operated for colorectal cancer and to evaluate the agreement among surgical specialists. METHODS: A questionnaire was sent to 60 general surgeons (specialists) in Denmark and Sweden working in academic departments of surgery with a high volume of colorectal cancer resections. The questionnaire was case based and contained questions regarding possible restrictions on physical activity recommended for patients 0-2, 2-6 and >6 weeks after resection for colorectal cancer. Agreement among the surgeon on whether restrictions should be recommended was analyzed. RESULTS: Forty-one surgeons answered the questionnaire (68.3 %). The probability that two randomly chosen specialists agreed on whether restrictions should be given was generally low for the first two time periods (0-2 and 2-6 weeks); however, at >6 weeks there was a high level of agreement. Moreover, the number of restrictions recommended was different between the 41 surgeons (p < 0.0005) and more restrictions were recommended for open compared with laparoscopic surgery (p < 0.0005). CONCLUSIONS: Major disagreements exist on the degree of restrictions on physical activity that should be recommended for patients after colorectal surgery. As there is no evidence to support that specific restrictions prevent hernia formation, these are merely based on personal preferences. Clinical studies in this area are therefore highly warranted.

Fracture risk following bariatric surgery: a population-based study.

UNLABELLED: The effects of bariatric surgery on skeletal health are poorly understood. We found that bariatric surgery patients are more prone to fracture when compared to the general population. While further studies of fracture risk in this population are needed, bone health should be discussed in bariatric surgery clinics. INTRODUCTION: Bariatric surgery is an increasingly common treatment for medically complicated obesity. Adverse skeletal changes after bariatric surgery have been reported, but their clinical importance remains unknown. We hypothesized that bariatric surgery patients are at increased risk of fracture. METHODS: We conducted a historical cohort study of fracture incidence among 258 Olmsted County, Minnesota, residents who underwent a first bariatric surgery in 1985-2004. Relative fracture risk was expressed as standardized incidence ratios (SIRs), while potential risk factors were evaluated by hazard ratios (HR) obtained from a time-to-fracture regression model. RESULTS: The mean (±SD) body mass index at bariatric surgery was 49.0 ± 8.4 kg/m(2), with an average age of 44 ± 10 years and 82% (212) females. Gastric bypass surgery was performed in 94% of cases. Median follow-up was 7.7 years (range, 6 days to 25 years), during which 79 subjects experienced 132 fractures. Relative risk for any fracture was increased 2.3-fold (95% confidence interval (CI), 1.8-2.8) and was elevated for a first fracture at the hip, spine, wrist, or humerus (SIR, 1.9; 95% CI, 1.1-2.9), as well as for a first fracture at any other site (SIR, 2.5; 95% CI, 2.0-3.2). Better preoperative activity status was associated with a lower age-adjusted risk (HR, 0.4; 95% CI, 0.2-0.8) while prior fracture history was not associated with postoperative fracture risk. CONCLUSIONS: Bariatric surgery, which is accompanied by substantial biochemical, hormonal, and mechanical changes, is associated with an increased risk of fracture.

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.