Translation and validation of the Norwegian version of the postoperative quality of recovery score QoR-15.

BACKGROUND: As patient-centered care gains more attention, assessing the patient's perspective on their recovery has become increasingly important. In response to the need for a reliable and valid patient reported outcome measurement tool for major surgical resections in Norway. The Norwegian Registry for Gastrointestinal Surgery (NORGAST) initiated a project to translate and evaluate QoR-15's psychometric properties for patients going through general, gastrointestinal (GI), and hepato-pancreato-biliary (HPB) resectional surgery. METHODS: After a translation and adaption of the original version of QoR-15 into Norwegian, the QoR-15NO was psychometrically evaluated including a confirmatory factor analysis to test for unidimensionality, as well as tests for content validity, internal consistency, measurement error, construct validity, feasibility, and responsiveness. This process included cognitive interviews using a structured interview guide. Further, patients who underwent various types of GI/HPB surgery at five hospitals in different parts of Norway completed the QoR-15NO before surgery and on the first or second day after surgery. The impact of surgery was classified according to Surgical Outcome Risk Tool v2 (SORT), in extra major/complex, major, intermediate, and minor. RESULTS: This study included 324 patients with 83% return rate with both pre- and postoperative forms. There were negative correlations between duration of surgery and postoperative QoR-15 score and the difference between post- and preoperative score (change score). Individuals who had gone through surgery with major impact had a lower postoperative mean QoR-15 score (97) than their counterparts who had experienced either medium (QoR-15: 110) or minor (QoR15: 119) impact surgery. Cronbach's alpha (0.88) and Omega Alpha Total (ωt = 0.90) indicate that the scale has good to very good internal consistency. Test-retest reliability was measured by Intra-class Correlation Coefficient to ICC = 0.70. Confirmatory factor analyses supported that a one-factor model with correlated residuals had a good fit to data. CONCLUSION: This study supports QoR-15NO as a valid, essentially unidimensional, feasible, and responsive instrument among patients undergoing general, GI, and HPB resectional surgery in Norway. The total QoR-15NO score provides important information that can be used in an everyday clinical setting and integrated into NORGAST.

Laparoscopic rectal cancer resection yields comparable clinical and oncological results with shorter hospital stay compared to open access: a 5-year national cohort.

PURPOSE: Although widely applied, the results following laparoscopic rectal resection (LRR) compared to open rectal resection (ORR) are still debated. The aim of this study was to assess clinical short- and long-term results as well as oncological resection quality following LRR or ORR for cancer in a 5-year national cohort. METHODS: Data from the Norwegian Registry for Gastrointestinal Surgery and the Norwegian Colorectal Cancer Registry were retrieved from January 2014 to December 2018 for patients who underwent elective resection for rectal cancer. Primary end point was 5-year overall survival. Secondary end points were local recurrence rates within 5 years, oncological resection quality, and short-term outcome measures. RESULTS: A total of 1796 patients were included, of whom 1284 had undergone LRR and 512 ORR. There was no difference in 5-year survival rates between the groups after adjusting for relevant covariates with Cox regression analyses. Crude 5-year survival was 77.1% following LRR compared to 74.8% following ORR (p = 0.015). The 5-year local recurrence rates were 3.1% following LRR and 4.1% following ORR (p = 0.249). Length of hospital stay was median 8.0 days (quartiles 7.0-13.0) after ORR compared to 6.0 (quartiles 4.0-8.0) days after LRR. After adjusting for relevant covariates, estimated additional length of stay after ORR was 3.1 days (p < 0.001, 95% CI 2.3-3.9). Rates of positive resection margins and number of harvested lymph nodes were similar. There were no other significant differences in short-term outcomes between the groups. CONCLUSION: LRR was performed with clinical and oncological outcomes similar to ORR, but with shorter hospital stay.

Diverting stomas reduce reoperation rates for anastomotic leak but not overall reoperation rates within 30 days after anterior rectal resection: a national cohort study.

PURPOSE: A diverting stoma is commonly formed to reduce the rate of anastomotic leak following anterior resection with anastomosis, although some studies question this strategy. The aim of this study was to assess the leak rates and overall complication burden after anterior resection with and without a diverting stoma. METHODS: A 5-year national cohort with prospectively registered data of patients who underwent elective anterior resection for rectal cancer located < 15 cm from the anal verge. Data were retrieved from the Norwegian Registry for Gastrointestinal Surgery and the Norwegian Colorectal Cancer Registry. Primary end point was relaparotomy or relaparoscopy for anastomotic leak within 30 days from index surgery. Secondary endpoints were postoperative complications including reoperation for any cause. RESULTS: Some 1018 patients were included of whom 567 had a diverting stoma and 451 had not. Rate of reoperation for anastomotic leak was 13 out of 567 (2.3%) for patients with diverting stoma and 35 out of 451 (7.8%) (p > 0.001) for patients without. In multivariable analyses not having a diverting stoma (aOR 3.77, c.i 1.97-7.24, p < 0.001) was associated with increased risk for anastomotic leak. However, there were no differences in overall reoperation rates following anterior resection with or without diverting stoma (9.3% vs 10.9%, p = 0.423), and overall complication rates were similar. Reoperation was associated with increased mortality irrespective of the main intraoperative finding. CONCLUSION: Diverting stoma formation after anterior resection is protective against reoperation for anastomotic leak but does not affect overall rates of reoperation or complications within 30 days.

Lower conversion rate with robotic assisted rectal resections compared with conventional laparoscopy; a national cohort study.

BACKGROUND: Conversion from laparoscopic to open access colorectal surgery is associated with a poorer postoperative outcome. The aim of this study was to assess conversion rates and outcomes after standard laparoscopic rectal resection (LR) and robotic laparoscopic rectal resection (RR). METHODS: A national 5-year cohort study utilizing prospectively recorded data on patients who underwent elective major laparoscopic resection for rectal cancer. Data were retrieved from the Norwegian Registry for Gastrointestinal Surgery and from the Norwegian Colorectal Cancer Registry. Primary end point was conversion rate. Secondary end points were postoperative complications within 30 days and histopathological results. Chi-square test, two-sided T test, and Mann-Whitney U test were used for univariable analyses. Both univariable and multivariable logistic regression analyses were used to analyze the relations between different predictors and outcomes, and propensity score matching was performed to address potential treatment assignment bias. RESULTS: A total of 1284 patients were included, of whom 375 underwent RR and 909 LR. Conversion rate was 8 out of 375 (2.1%) for RR compared with 87 out of 909 (9.6%) for LR (p < 0.001). RR was associated with reduced risk for conversion compared with LR (aOR 0.22, 95% CI 0.10-0.46). There were no other outcome differences between RR and LR. Factors associated with increased risk for conversion were male gender, severe cardiac disease and BMI > 30. Conversion was associated with higher rates of major complications (20 out of 95 (21.2%) vs 135 out of 1189 (11.4%) p = 0.005), reoperations (13 out of 95 (13.7%) vs 93 out of 1189 (7.1%) p = 0.020), and longer hospital stay (median 8 days vs 6 days, p = 0.001). CONCLUSION: Conversion rate was lower with robotic assisted rectal resections compared with conventional laparoscopy. Conversions were associated with higher rates of postoperative complications.

Molecular differences of adipose-derived mesenchymal stem cells between non-responders and responders in treatment of transphincteric perianal fistulas.

BACKGROUND: Injection of autologous adipose tissue (AT) has recently been demonstrated to be an effective and safe treatment for anal fistulas. AT mesenchymal stem cells (AT-MSCs) mediate the healing process, but the relationship between molecular characteristics of AT-MSCs of the injected AT and fistula healing has not been adequately studied. Thus we aimed to characterize the molecular and functional properties of AT-MSCs isolated from autologous AT injected as a treatment of cryptogenic high transsphincteric perianal fistulas and correlate these findings to the healing process. METHODS: 27 patients (age 45 ± 2 years) diagnosed with perianal fistula were enrolled in the study and treated with autologous AT injected around the anal fistula tract. AT-MSCs were isolated for cellular and molecular analyses. The fistula healing was evaluated by MRI scanning after 6 months of treatment. AT-MSC phenotype was compared between responders and non-responders with respect to fistula healing. RESULTS: 52% of all patients exhibited clinical healing of the fistulas as evaluated 6 months after last injection. Cultured AT-MSCs in the responder group had a lower short-term proliferation rate and higher osteoblast differentiation potential compared to non-responder AT-MSCs. On the other hand, adipocyte differentiation potential of AT-MSCs was higher in non-responder group. Interestingly, AT-MSCs of responders exhibited lower expression of inflammatory and senescence associated genes such as IL1B, NFKB, CDKN2A, TPB3,TGFB1. CONCLUSION: Our data suggest that cellular quality of the injected AT-MSCs including cell proliferation, differentiation capacity and secretion of proinflammatory molecules may provide a possible mechanism underlying fistula healing. Furthermore, these biomarkers may be useful to predict a positive fistula healing outcome. TRIAL REGISTRATION: NTC04834609, Registered 6 April 2021. https://clinicaltrials.gov/ct2/show/NCT04834609.

A New Extraperitoneal Method for Entero-atmospheric Fistula Closure Using a Free Muscle Flap.

Treatment of an entero-atmospheric fistula (EAF) is challenging and associated with significant morbidity and mortality. For an EAF with protrusion of mucosa, chances for spontaneous closure are minimal. Standard surgical procedures may be associated with a high risk for complications in patients with a hostile abdomen. This article describes a new method for extraperitoneal closure of an EAF in a patient with a hostile abdomen. A free segmental latissimus dorsi musculocutaneous flap was harvested on its thoracodorsal pedicle, leaving the remaining muscle innervated. The flap was anastomosed to the internal mammary vessels. The muscle was sutured into the fistula opening using a parachute technique and temporarily immobilized with a negative wound pressure device. The skin of the flap was used for monitoring and later replaced by a skin graft. The postoperative course was uneventful. At 24 months follow-up, there were no signs of recurrences. The patient had no pain and had no defecation problems. Extraperitoneal closure of an EAF with a segmental free latissimus dorsi muscle flap sutured into the fistula opening with a parachute technique may be a new promising technique in patients where standard surgical procedures are associated with too high a risk for complications and where a local pedicled muscle flap is not available. The advantages of this method are that no laparotomy is required, the intestinal lumen is not reduced in diameter, and that no bowel resection is performed, which is a particular advantage in cases with a short bowel syndrome.

Anal Sphincter Length as Determined by 3-Dimensional Endoanal Ultrasound and Anal Manometry: A Study in Healthy Nulliparous Women.

OBJECTIVES: The normal female external anal sphincter (EAS) is shorter anteriorly than laterally and posteriorly. Furthermore, the thickness of the very proximal part of the circular EAS is thinner than 50% of the lateral and posterior EAS thickness. The extent of these features is not fully explored. The aim of this prospective study was to assess the normal anal sphincter with 3-dimensional (3D) endoanal ultrasound (EAUS) and to relate 3D EAUS length measurements to sphincter length determined by anal manometry. METHODS: Healthy premenopausal nulliparous women underwent anal manometry and 3D EAUS examinations. Two experienced colorectal surgeons independently assessed all scans, blinded to any patient data. RESULTS: A total of 43 women were included. Four scans were incomplete and excluded from the analysis. Interobserver agreement was fair to very good for the various length measurements. The mean length from the distal border of the puborectal muscle to the very proximal border of the anterior EAS (the anterior gap) was 4.4 (95% confidence interval, 3.9-4.9) mm, whereas the length to the level where the anterior EAS thickness was at least 50% of the lateral and posterior EAS thickness was 7.2 (95% confidence interval, 6.5-7.9) mm. Manometric sphincter length at rest did not correlate with any 3D EAUS length measurements. CONCLUSIONS: In the normal anterior female anal canal, the EAS is not present or appears with less than 50% of the thickness of the lateral and posterior EAS for the first 7.2 mm below the distal border of the puborectal muscle.

Strong agreement between interview-obtained and self-administered Wexner and St. Mark's scores using a single questionnaire.

INTRODUCTION AND HYPOTHESIS: St Mark's incontinence score (SMIS) and the Wexner score have been constructed and validated as interview-based scoring systems. We developed a single questionnaire from which a separate SMIS or Wexner score could be derived. This study aimed to demonstrate the level of agreement between self-administered (sSMIS and sWexner) and interview-based (iSMIS and iWexner) scores using this questionnaire. METHODS: One hundred five consecutive patients (30 male) seen in the incontinence outpatient clinics at the Østfold Hospital Trust, Sarpsborg, and University Hospital of North Norway, Tromsø, completed the self-administered incontinence questionnaire prior to the appointment. Following clinical investigation, the patients were interviewed about their symptoms according to the SMIS and Wexner scores, with the interviewers blinded to the results from self-reported questionnaire. Agreement between total scores and between subscores of the various items were determined using interclass correlation coefficient (ICC) and kappa statistics, respectively. RESULTS: The self-administered questionnaire was incomplete in six cases (5.7%) and the interview-based was incomplete in two cases. Agreement was almost perfect between the iSMIS and sSMIS and between the iWexner score and sWexner score (ICC 0.90 and 0.92, respectively). Agreement was substantial to almost perfect for all items in both scoring systems, with kappa values ranging from 0.64-0.94. Mean iSMIS was 9.48 versus 9.53 for sSMIS (p = 0.90) and 8.26 versus 8.44 for the iWexner and sWexner score, respectively (p = 0.42). CONCLUSION: The SMIS and Wexner scores can be completed by the patients using a single questionnaire, and the derived SMIS and Wexner scores are highly consistent with scores obtained by interview.

Interview-based versus self-reported anal incontinence using St Mark's incontinence score.

INTRODUCTION AND HYPOTHESIS: St Mark's incontinence score (SMIS) was originally designed and validated for use in an interview setting (iSMIS), and there is conflicting evidence for the validity of the self-administered SMIS (sSMIS). Our objective was to compare self-administered and interview-based reports of anal incontinence (AI) symptoms. METHODS: A total of 147 women reported symptoms of AI on a sSMIS before inclusion in a clinical study investigating the effect of conservative treatment for AI 1 year after delivery. After clinical investigations, an iSMIS was completed by one of two consultant surgeons blinded to the sSMIS results. The correlation and agreement among the individual items of the iSMIS and the sSMIS were assessed using Spearman's rho and weighted kappa statistics, respectively. RESULTS: The mean iSMIS and sSMIS reported was 4.0 (SD: 3.6) and 4.3 (SD: 4.0), respectively. Spearman's rho showed a strong relationship between the two total SMIS scores (r = 0.769, n = 147, p < 0.001), and explained variance was 59% (r2=0.591). Except for the individual item about gas incontinence, women reported more frequent AI symptoms on the sSMIS than on the iSMIS. The assessment of consistency among the individual items of the iSMIS and sSMIS showed substantial agreement (κ ≥ 0.60) for all items except for fair agreement for the item about formed stool incontinence (κ = 0.22), and moderate for the item about any change in lifestyle (κ = 0.5). CONCLUSIONS: The level of consistency between the two methods of reporting anal incontinence symptoms suggests that the St Mark's score may be used as both an interview-based and a self-administered incontinence score.

Increased lymph node retrieval decreases adjuvant chemotherapy rate for stage II colon cancer.

OBJECTIVE: Investigation of lymph nodes in colorectal specimens after surgery due to cancer is important for staging the cancer. There has to be an adequate number of lymph nodes to conclude a node-negative status. Our aim was to investigate if change in fixative could give increased lymph node yield, and if this could result in a potential decrease of adjuvant treatment for stage II patients. In addition, we wanted to evaluate if the change in fixative could potentially affect subsequent molecular testing. MATERIAL AND METHODS: All resection specimens from one hospital were from 2011 fixed in GEWF while resection specimens from two other hospitals were fixed in conventional buffered formalin. Number of lymph nodes harvested were compared from two periods; 2009/2010 and 2012/2013. In addition, tumors fixed in GEWF and tumors fixed in formalin were tested separately with immunohistochemical staining and molecular testing. RESULTS: There was a significant increase in lymph node retrieval in specimens fixed in GEWF compared to number of lymph nodes found before the implementation of this fixative (p < 0.001). For hospitals using only formalin, the number of nodes did not increase significantly. Number of positive lymph nodes did not increase. Immunohistochemical staining can be a problem with tumors fixed in GEWF, but DNA quality seems not affected by the changes. CONCLUSIONS: GEWF enhances lymph node detection in colorectal cancer specimens, leading to fewer patients being falsely defined as high-risk stage II. The loss of stability when staining for MMR-proteins can be overcome by molecular analysis when needed.

Primary Aortoduodenal Fistula-A Case Report and a Review of the Literature.

Primary aortoduodenal fistula (PADF) is a direct communication between the abdominal aortic aneurysm (AAA) and duodenum. It is a rare entity and causes life-threatening gastrointestinal hemorrhage. Diagnosis requires a high index of clinical suspicion, and surgery offers the only hope for survival. We present a 73-year-old male who was initially admitted to the hospital with back pain and fever. He was diagnosed with pyelonephritis and treated with antibiotics. Computed tomography of the abdomen showed an AAA, but no aortoduodenal fistula was seen. Twelve days later, he was admitted to the hospital as he was hemodynamically unstable. An emergency laparotomy revealed a PADF which was repaired. The aortic aneurysm was repaired with an in situ silver graft and a bifemoral bypass. However, the patient developed severe graft infection and later succumbed.

Sacral nerve stimulation.

BACKGROUND: Sacral nerve stimulation implies electrical stimulation of a sacral nerve root by an electrode and a pacemaker. Within the past few years, sacral nerve stimulation has become a possible treatment option for selected patients with urinary retention, urinary incontinence, anal incontinence and constipation. The method is furthermore being tested for several other conditions. MATERIAL AND METHODS: The article presents the method and treatment results following various indications based on the authors' own experience and non-systematic PubMed search. RESULTS: During a test period an external pacemaker is used for 3-30 days, with length of test differing according to the indication. A positive test (improvement of symptoms by 50 % or more) is achieved by 70-90 % of patients with anal incontinence, 70 % with urinary non-obstructive retention, 52-77 % with urinary urge incontinence and 43-72 % with constipation. Sacral nerve stimulation may also be effective in patients with chronic pelvic pain. Following implantation of a pacemaker a sustainable effect is seen in 50-90 % of patients with a positive test. Up to 75 % of patients will need repeated follow-up including pacemaker reprogramming or reoperations due to diminished effect. The longevity of the pacemaker is 3-10 years, and it must be replaced operatively when the battery has depleted. INTERPRETATION: Treatment with sacral nerve stimulation may be efficient over time in patients with various pelvic floor dysfunctions, especially anal incontinence and non-obstructive urinary retention. Most of the patients will need close follow-up in order to maintain an optimal result.

Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations.

OBJECTIVES: To describe a consensus review of optimal perioperative care in colorectal surgery and to provide consensus recommendations for each item of an evidence-based protocol for optimal perioperative care. DATA SOURCES: For every item of the perioperative treatment pathway, available English-language literature has been examined. STUDY SELECTION: Particular attention was paid to meta-analyses, randomized controlled trials, and systematic reviews. DATA EXTRACTION: A consensus recommendation for each protocol item was reached after critical appraisal of the literature by the group. DATA SYNTHESIS: For most protocol items, recommendations are based on good-quality trials or meta-analyses of such trials. CONCLUSIONS: The Enhanced Recovery After Surgery (ERAS) Group presents a comprehensive evidence-based consensus review of perioperative care for colorectal surgery. It is based on the evidence available for each element of the multimodal perioperative care pathway.

[Assessment of anal incontinence in adults]. / Utredning av anal inkontinens hos voksne.

BACKGROUND: Anal incontinence is involuntary loss of stool and flatus through the anal canal. The condition can be severely debilitating to those affected. MATERIAL AND METHODS: The article is based on relevant literature and the authors' clinical experience. RESULTS: The first examination should include an anorectoscopy as part of a broader clinical examination, and the aim should be to find the cause and describe the condition. An assessment in hospital should comprise endoanal ultrasound for imaging and grading of the incontinence severity with a score system. CONCLUSION: Simple preliminary investigations and eventually more specialized investigations in a specialist clinic give a good impression of the condition, and is the basis for choosing treatment and later evaluation.

Anal incontinence after obstetric sphincter tears: outcome of anatomic primary repairs.

PURPOSE: Obstetric sphincter tears lead to anal incontinence in 40 to 60 percent of affected women. Primary repair is usually performed without identifying the internal anal sphincter. Since 1999 digestive surgeons have participated in the primary repair of such tears at our hospital. The intention was to perform separate repair of the internal and external anal sphincter in cases of combined tears to achieve a lower incontinence rate than is usually reported after conventional primary repair. The aim of the present study was to evaluate our results after anatomic primary repair. METHOD: A follow-up study was undertaken after all primary repairs performed in 1999 and 2000. It included anal ultrasonography manometry and an assessment of incontinence (Wexner score). RESULTS: A total of 74 women sustained obstetric sphincter tears during the study period, and 71 (96 percent) were assessed after a median of 27 months (range, 14-39 months). Nine women declined investigation with ultrasonography/manometry. Incontinence was present in 22 women (31 percent), of whom 17 had gas incontinence only. The symptoms were mild (Wexner score 1-2) in 11 women (50 percent). None of 17 women with normal ultrasonography results were incontinent versus 20 of 45 with pathologic ultrasonographic results (P = 0.001). The mean sphincter length, squeeze pressure, and resting pressure were significantly higher in women with Wexner scores of 0-2 vs. women with a score of more than 2. Sphincter length was inversely correlated with the degree of incontinence (P < 0.001). CONCLUSIONS: The incontinence rate after anatomic primary repair is low compared with the last decade's reported results after conventional primary repair. A short anal sphincter after repair is associated with a poorer outcome.

Anal incontinence after obstetric sphincter tears: incidence in a Norwegian county.

BACKGROUND: Anal sphincter tears during vaginal delivery are a major cause of anal incontinence. We wanted to assess the incidence in a Norwegian county where primary repairs are performed in four hospitals using similar per- and postoperative protocol for the treatment of such injuries. METHODS: A postal questionnaire was distributed to all women who underwent primary repair of obstetric sphincter tears in the years 1999 and 2000 in the county of Möre and Romsdal. Symptoms of incontinence and fecal urgency were recorded. Incontinence was assessed using the Pescatori score system. RESULTS: Clinically detected sphincter tears occurred in 180 of 5123 vaginal deliveries (3.5%). The questionnaire was returned by 156 women (87%). Six women were excluded. Median follow-up was 25 months (range 4-39). Incontinence was reported by 88 women (59%), restricted to flatus incontinence in 53 cases (35%). Fecal urgency without incontinence was reported by 14 women (9%). Sixty-three women (42%) reported de novo moderate to severe symptoms. There was no difference in outcome whether the sphincter injury was partial or complete. Mean Pescatori score was 3.7 in women who felt disabled compared with 2.9 in women who did not feel disabled by their incontinence (P < 0.001). Of 29 women who felt disabled, only three had sought medical attention. Fifty-eight women (39%) had received no information about the sphincter tear before discharge. CONCLUSION: Anal incontinence is common after both partial and complete obstetric sphincter tears. Information before discharge is deficient, and women avoid seeking medical attention when incontinence develops.