Patient experience of health and care when undergoing colorectal surgery within the ERAS program.

BACKGROUND: Several studies show that the enhanced recovery after surgery (ERAS) program reduces complications postoperatively and leads to faster recovery and shorter hospital stays. However, little is known about patients' self-reported health in an enhanced recovery context. The aim of this study was firstly to describe patient experiences of health within the concept of ERAS after colorectal (CR) surgery during a hospital stay and within 2 weeks of discharge. Secondly, to explore whether the ASA classification/co-morbidity, sex, and surgical method affect the patient's experience of health. METHODS: Data were collected through the ERAS-HEALTH questionnaire, including two open-ended questions, and through telephone interviews postoperatively. Qualitative and quantitative analysis was used. Patients undergoing CR surgery (n = 80) were included from October 2016 to June 2018. RESULTS: The patients had mainly positive experiences of their hospital stay as well as most of them felt comfortable coming home. However, experienced state of health is affected by factors like surgical method and co-morbidity. Improvements were desired concerning information, food/food intake, pain management, and environment. At home, the patients experienced a lack of information about food/food intake and ostomy care. Decreased appetite and difficulties with micturition were also described. The most troublesome symptom was postoperative fatigue (POF). Analysis of the ERAS-HEALTH questionnaire showed that patients with higher co-morbidity and those who underwent open surgery have a significantly worse experience of their health compared with patients who underwent laparoscopy. However, it seems that the surgical method affects postoperative health to a greater extent than co-morbidity. CONCLUSIONS: The patients reported many positive aspects and challenges when being cared for within the ERAS program. However, several improvements are needed to satisfy patient wishes regarding their care both in hospital and at home. Laparoscopic surgery affects patient state of health positively in several respects compared with open surgery.

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

BACKGROUND: Hospital costs associated with the treatment of rectal cancer are considerable and the formation of a temporary stoma accounts for additional costs. Results from the EASY trial showed that early closure of a temporary ileostomy was associated with significantly fewer postoperative complications but no difference in health-related quality of life up to 12 months after rectal resection. The aim of the present study was to perform a cost analysis within the framework of the EASY trial. METHODS: Early closure (8-13 days) of a temporary stoma was compared to late closure (> 12 weeks) in the randomized controlled trial EASY (NCT01287637). The study period and follow-up was 12 months after rectal resection. Inclusion of participants was made after index surgery. Exclusion criteria were diabetes mellitus, steroid treatment, signs of postoperative complications or anastomotic leakage. Clinical effectiveness and resource use were derived from the trial and unit costs from Swedish sources. Costs were calculated for the year 2016 and analysed from the perspective of the healthcare sector. RESULTS: Fifty-five patients underwent early closure, and 57 late closure in eight Swedish and Danish hospitals between 2011 and 2014. The difference in mean cost per patient was 4060 US dollar (95% confidence interval 1121; 6999, p value < 0.01) in favour of early closure. A sensitivity analysis, taking protocol-driven examinations into account, resulted in an overall difference in mean cost per patient of $3608, in favour of early closure (95% confidence interval 668; 6549, p value 0.02). The predominant cost factors were reoperations, readmissions and endoscopic examinations. CONCLUSIONS: The significant cost reduction in this study, together with results of safety and efficacy from the randomized controlled trial, supports the routine use of early closure of a temporary ileostomy after rectal resection for cancer in selected patients without signs of anastomotic leakage. CLINICAL TRIAL: Registered at clinicaltrials.gov, clinical trials identifier NCT01287637.

The effect of pre- and post-operative physical activity on recovery after colorectal cancer surgery (PHYSSURG-C): study protocol for a randomised controlled trial.

BACKGROUND: Surgery for colorectal cancer is associated with a high risk of post-operative adverse events, re-operations and a prolonged post-operative recovery. Previously, the effect of prehabilitation (pre-operative physical activity) has been studied for different types of surgery, including colorectal surgery. However, the trials on colorectal surgery have been of limited methodological quality and size. The aim of this trial is to compare the effect of a combined pre- and post-operative intervention of moderate aerobic physical activity and inspiratory muscle training (IMT) with standard care on post-operative recovery after surgery for colorectal cancer. METHODS/DESIGN: We are conducting a randomised, controlled, parallel-group, open-label, multi-centre trial with physical recovery within 4 weeks after cancer surgery as the primary endpoint. Some 640 patients planned for surgery for colorectal cancer will be enrolled. The intervention consists of pre- and post-operative physical activity with increased daily aerobic activity of moderate intensity as well as IMT. In the control group, patients will be advised to continue their normal daily exercise routine. The primary outcome is patient-reported physical recovery 4 weeks post-operatively. Secondary outcomes are length of sick leave, complication rate and severity, length of hospital stay, re-admittances, re-operations, post-operative mental recovery, quality of life and mortality, as well as changes in insulin-like growth factor 1 and insulin-like growth factor-binding protein 3, perception of pain and a health economic analysis. DISCUSSION: An increase in moderate-intensity aerobic physical activity is a safe, cheap and feasible intervention that would be possible to implement in standard care for patients with colorectal cancer. If shown to be effective, this lifestyle intervention could be a clinical parallel to pre-operative smoke cessation that has already been implemented with good clinical results. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02299596 . Registered on 17 November 2014.

Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial.

OBJECTIVE: The objective was to study morbidity and mortality associated with early closure (8-13 days) of a temporary stoma compared with standard procedure (closure after > 12 weeks) after rectal resection for cancer. BACKGROUND: A temporary ileostomy may reduce the risk of pelvic sepsis after anastomotic dehiscence. However, the temporary ileostomy is afflicted with complications and requires a second surgical procedure (closure) with its own complications. Early closure of the temporary ileostomy could reduce complications for rectal cancer patients. METHODS: Early closure (8-13 days after stoma creation) of a temporary ileostomy was compared with late closure (>12 weeks) in a multicenter randomized controlled trial, EASY (www.clinicaltrials.gov, NCT01287637) including patients undergoing rectal resection for cancer. Patients with a temporary ileostomy without signs of postoperative complications were randomized to closure at 8 to 13 days or late closure (>12 weeks after index surgery). Clinical data were collected up to 12 months. Complications were registered according to the Clavien-Dindo Classification of Surgical Complications, and Comprehensive Complication Index was calculated. RESULTS: The trial included 127 patients in eight Danish and Swedish surgical departments, and 112 patients were available for analysis. The mean number of complications after index surgery up to 12 months follow up was significantly lower in the intervention group (1.2) compared with the control group (2.9), P < 0.0001. CONCLUSIONS: It is safe to close a temporary ileostomy 8 to 13 days after rectal resection and anastomosis for rectal cancer in selected patients without clinical or radiological signs of anastomotic leakage.

Laparoscopic Lavage for Perforated Diverticulitis With Purulent Peritonitis: A Randomized Trial.

BACKGROUND: Perforated diverticulitis with purulent peritonitis has traditionally been treated with open colon resection and stoma formation with risk for reoperations, morbidity, and mortality. Laparoscopic lavage alone has been suggested as definitive treatment. OBJECTIVE: To compare laparoscopic lavage with open colon resection and colostomy (Hartmann procedure) for perforated diverticulitis with purulent peritonitis. DESIGN: Randomized, controlled, multicenter, open-label trial. (ISRCTN registry number: ISRCTN82208287). SETTING: 9 hospitals in Sweden and Denmark. PATIENTS: Patients who have confirmed Hinchey grade III perforated diverticulitis with purulent peritonitis at diagnostic laparoscopy. INTERVENTION: Randomization between laparoscopic lavage and the Hartmann procedure. MEASUREMENTS: Primary outcome was the percentage of patients having 1 or more reoperations within 12 months. Key secondary outcomes were number of reoperations, hospital readmissions, total length of hospital stay during 12 months, and adverse events. RESULTS: A total of 43 and 40 patients were randomly assigned to laparoscopic lavage and the Hartmann procedure with a median (first, third quartiles) follow-up of 372 days (336, 394) and 378 days (226, 396), respectively. Fewer patients in the laparoscopic group (12 of 43; 27.9%) than in the Hartmann group (25 of 40; 62.5%) had at least 1 reoperation within 12 months (relative risk reduction, 59%; relative risk, 0.41 [95% CI, 0.23 to 0.72]; P = 0.004). Mortality and severe adverse events did not differ between groups. Total length of hospital stay (days) within 12 months was shorter for the laparoscopic group than the Hartmann group, with a reduction of 35% (relative risk, 0.65 [CI, 0.45 to 0.94]; P = 0.047). After 12 months, 3 patients in the laparoscopic group and 11 in the Hartmann group had a stoma. LIMITATION: Not all patients presenting with suspected diverticulitis were enrolled. CONCLUSION: Laparoscopic lavage reduced the need for reoperations, had a similar safety profile to the Hartmann procedure, and may be an appropriate treatment of choice for acute perforated diverticulitis with purulent peritonitis. PRIMARY FUNDING SOURCE: ALF; Sahlgrenska University Hospital, Gothenburg.

GREM1 and POLE variants in hereditary colorectal cancer syndromes.

Hereditary factors are thought to play a role in at least one third of patients with colorectal cancer (CRC) but only a limited proportion of these have mutations in known high-penetrant genes. In a relatively large part of patients with a few or multiple colorectal polyps the underlying genetic cause of the disease is still unknown. Using exome sequencing in combination with linkage analyses together with detection of copy-number variations (CNV), we have identified a duplication in the regulatory region of the GREM1 gene in a family with an attenuated/atypical polyposis syndrome. In addition, 107 patients with colorectal cancer and/or polyposis were analyzed for mutations in the candidate genes identified. We also performed screening of the exonuclease domain of the POLE gene in a subset of these patients. The duplication of 16 kb in the regulatory region of GREM1 was found to be disease-causing in the family. Functional analyses revealed a higher expression of the GREM1 gene in colorectal tissue in duplication carriers. Screening of the exonuclease domain of POLE in additional CRC patients identified a probable causative novel variant c.1274A>G, p.Lys425Arg. In conclusion a high penetrant duplication in the regulatory region of GREM1, predisposing to CRC, was identified in a family with attenuated/atypical polyposis. A POLE variant was identified in a patient with early onset CRC and a microsatellite stable (MSS) tumor. Mutations leading to increased expression of genes can constitute disease-causing mutations in hereditary CRC syndromes.

Laparoscopic Lavage Is Feasible and Safe for the Treatment of Perforated Diverticulitis With Purulent Peritonitis: The First Results From the Randomized Controlled Trial DILALA.

OBJECTIVE: To evaluate short-term outcomes of a new treatment for perforated diverticulitis with purulent peritonitis in a randomized controlled trial. BACKGROUND: Perforated diverticulitis with purulent peritonitis (Hinchey III) has traditionally been treated with surgery including colon resection and stoma (Hartmann procedure) with considerable postoperative morbidity and mortality. Laparoscopic lavage has been suggested as a less invasive surgical treatment. METHODS: Laparoscopic lavage was compared with colon resection and stoma in a randomized controlled multicenter trial, DILALA (ISRCTN82208287). Initial diagnostic laparoscopy showing Hinchey III was followed by randomization. Clinical data was collected up to 12 weeks postoperatively. RESULTS: Eighty-three patients were randomized, out of whom 39 patients in laparoscopic lavage and 36 patients in the Hartmann procedure groups were available for analysis. Morbidity and mortality after laparoscopic lavage did not differ when compared with the Hartmann procedure. Laparoscopic lavage resulted in shorter operating time, shorter time in the recovery unit, and shorter hospital stay. CONCLUSIONS: In this trial, laparoscopic lavage as treatment for patients with perforated diverticulitis Hinchey III was feasible and safe in the short-term.

Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA): study protocol for a randomised controlled trial.

BACKGROUND: Perforated diverticulitis is a condition associated with substantial morbidity. Recently published reports suggest that laparoscopic lavage has fewer complications and shorter hospital stay. So far no randomised study has published any results. METHODS: DILALA is a Scandinavian, randomised trial, comparing laparoscopic lavage (LL) to the traditional Hartmann's Procedure (HP). Primary endpoint is the number of re-operations within 12 months. Secondary endpoints consist of mortality, quality of life (QoL), re-admission, health economy assessment and permanent stoma. Patients are included when surgery is required. A laparoscopy is performed and if Hinchey grade III is diagnosed the patient is included and randomised 1:1, to either LL or HP. Patients undergoing LL receive > 3L of saline intraperitoneally, placement of pelvic drain and continued antibiotics. Follow-up is scheduled 6-12 weeks, 6 months and 12 months. A QoL-form is filled out on discharge, 6- and 12 months. Inclusion is set to 80 patients (40+40). DISCUSSION: HP is associated with a high rate of complication. Not only does the primary operation entail complications, but also subsequent surgery is associated with a high morbidity. Thus the combined risk of treatment for the patient is high. The aim of the DILALA trial is to evaluate if laparoscopic lavage is a safe, minimally invasive method for patients with perforated diverticulitis Hinchey grade III, resulting in fewer re-operations, decreased morbidity, mortality, costs and increased quality of life. TRIAL REGISTRATION: British registry (ISRCTN) for clinical trials ISRCTN82208287http://www.controlled-trials.com/ISRCTN82208287.

Bowel obstruction after laparoscopic and open colon resection for cancer: results of 5 years of follow-up in a randomized trial.

BACKGROUND: Postoperative bowel obstruction caused by intra-abdominal adhesions occurs after all types of abdominal surgery. It has been suggested that the laparoscopic technique should reduce the risk for adhesion formation and thus for postoperative bowel obstruction. This study was designed to compare the incidence of bowel obstruction in a randomized trial where laparoscopic and open resection for colon cancer was compared. METHODS: A retrospective analysis was performed, collecting data of episodes of bowel obstruction with or without surgery. Only episodes treated in the hospital where the index surgery took place were included. Data for 786 patients were collected for the 5-year period after cancer surgery. RESULTS: Baseline characteristics for the evaluated laparoscopic (n = 383) and open (n = 403) groups were comparable. The cumulative obstruction percentages at 5 years for the open and laparoscopic groups were 6.5 and 5.1% respectively and did not significantly differ from each other. Tumor stage seemed to influence the risk for bowel obstruction: 2.8% in stage I, 6.6% in stage II, and 7% in stage III, but the differences were not significant. CONCLUSIONS: This analysis does not support the hypothesis that laparoscopy leads to fewer episodes of bowel obstruction compared with open surgery.

More recurrences after hernia mesh fixation with short-term absorbable sutures: A registry study of 82 015 Lichtenstein repairs.

OBJECTIVE: To assess the effects of different mesh fixation suture materials on the risk of recurrence after Lichtenstein inguinal hernioplasty. DESIGN: Observational, population-based registry study. SETTING: Data from the nationwide Swedish Hernia Registry. PATIENTS: All 82 015 Lichtenstein inguinal hernioplasties with sutured mesh fixation in adolescents and adults (15 years or older) from January 1, 2002, to December 31, 2009, at surgical units enrolled in the Swedish Hernia Registry. INTERVENTIONS: Mesh fixation with nonabsorbable, long-term absorbable, or short-term absorbable sutures. Main Outcome Measure Relative risk (RR) for reoperation due to recurrence of a hernia in the same groin during the study period, based on cumulative reoperation rates adjusted for time and confounding variables. RESULTS: For each study group, RR was calculated with multiregression analysis. There was no significant difference in risk for reoperation after mesh fixation with standard nonabsorbable sutures (RR, 1) or with long-term absorbable sutures (RR, 1.12; 95% confidence interval, 0.81-1.55; P = .49). Short-term absorbable sutures, however, more than doubled that risk (RR, 2.23; 95% confidence interval, 1.67-2.99; P < .001). CONCLUSIONS: With regard to recurrence risk, long-term absorbable sutures are an excellent alternative to permanent sutures for mesh fixation in Lichtenstein inguinal hernioplasty. Short-term absorbable sutures entail an independent risk factor for recurrence and should therefore be avoided.

Local administration of antibiotics by gentamicin-collagen sponge does not improve wound healing or reduce recurrence rate after pilonidal excision with primary suture: a prospective randomized controlled trial.

BACKGROUND: Excision and primary suture for pilonidal disease is associated with a high rate of wound infection and recurrences. This randomized, controlled study was designed to analyze the effect of local application of a gentamicin-containing collagen sponge (Collatamp(®)) in reducing the wound infection rate and recurrences after excision of pilonidal sinus and wound closure with primary midline suture. METHODS: From March 2003 to November 2005, 161 patients with symptomatic pilonidal disease were operated on at 11 hospitals with traditional wide excision of the sinus and all of its tracts. The patients were randomized to filling of the cavity with a gentamicin-containing collagen sponge (Collatamp(®)) before wound closure or to closure with no additional treatment. Information about the treatment allocation was hidden until the end of the study. Information about wound healing was noted at follow-up at the outpatient department after 2-4 days, 2 weeks, 3 months, and 1 year. RESULTS: No statistically significant differences were observed between the groups during follow-up. Patients who received prophylaxis with Collatamp(®) had slightly fewer wounds with exudate at 2-4 days and 2 weeks of follow-up (2% vs. 10%, p = 0.051 and 57% vs. 65%, p = 0.325, respectively), a slightly larger proportion of healed wounds at 3 months follow-up (77% vs. 66%, p = 0.138) but not at 1 year (85% vs. 90%, p = 0.42, respectively), and slightly more reoperations (10% vs. 4%, p = 0.213). CONCLUSIONS: This randomized, controlled study showed no significant differences in the rates of wound infection, wound healing, and recurrences when a gentamicin-collagen sponge was added to the surgical treatment of pilonidal disease with excision and primary midline suture. This does not support the use of gentamicin-collagen sponge for the surgical treatment of pilonidal disease.

Patient symptoms after colonic surgery in the era of enhanced recovery--a long-term follow-up.

AIMS: The main purpose of this study was to analyse, prospectively, patient symptoms during the first four weeks following elective colon surgery. A secondary aim was to find areas to improve inpatient information and postoperative care. BACKGROUND: Fast-track recovery following colon surgery has been proven beneficial to patients in the early postoperative phase. Less is known about the continuous recovery at home. DESIGN: A prospective follow-up survey. METHODS: Consecutive patients (n = 32) planned for elective colon surgery were evaluated. Both open and laparoscopic operations were included. All followed a fast-track protocol in hospital. Patient symptoms were recorded by validated quality of life questionnaires (EORTC QLQ-C 30, EORTC QLQ-CR 38 and Brief Pain Inventory). An interview was conducted five weeks and one year after surgery. RESULTS: The hospital stay was six days, and 10% of patients were readmitted. The fast-track concept worked well. The main problems after discharge were fatigue, nausea and bowel disturbances. Pain was not a significant issue. Most symptoms had disappeared after four weeks. CONCLUSIONS: The first period at home is troublesome, and better information about common symptoms is needed. A direct telephone line has been set up to answer questions and to lower patient anxiety. RELEVANCE TO CLINICAL PRACTICE: Clinical guidelines for patient's discharge planning can be performed based on the results from this study. Further improvement regarding the epidural anaesthesia is needed to reduce minor side effects.

Analysis of patient selection and external validity in the Swedish contribution to the COLOR trial.

OBJECTIVE: The colon cancer laparoscopic or open resection (COLOR) trial is an international, randomised controlled trial comparing outcomes of open and laparoscopic surgery for colon cancer. The main purpose of this study was to determine representability by comparing included and nonincluded patients in the participating Swedish centres. DESIGN: At eight centres, which included 391 of the 422 Swedish patients, a local database search was performed to identify retrospectively all patients (n = 2,384) who underwent surgery for colon cancer during the inclusion period, and data was retrieved from medical records. RESULTS: Four hundred fifty-six patients were randomised, 65 of whom were excluded post randomisation (group 2), leaving 391 patients in the study (group 1). For 1,566 patients, valid exclusion criteria were found (group 3). Thus, 362 patients were eligible but not included (group 4). Relative to group 1, patients in group 4 had a significantly higher American Society of Anaesthesiologists (ASA) score, more advanced tumour stage and difference regarding the resections performed. Results showed that 1470 patients (62%) could be calculated as feasible for laparoscopic colon resection (LCR) in a clinical, nontrial situation. CONCLUSIONS: The study population in the Swedish part of the COLOR trial was representative of the eligible population with the exception of comorbidity, where those actually included had less severe comorbidity than the nonincluded but eligible patients. In Sweden, 50-60% of colon cancer patients can be operated on by laparoscopy.