Bowel function and quality of life after local excision or total mesorectal excision following chemoradiotherapy for rectal cancer.

BACKGROUND: Local excision for rectal cancer is expected to offer a better functional outcome than conventional surgery. The aim of the present study was to compare quality of life and bowel function in patients with rectal cancer who underwent either local excision or conventional surgery after chemoradiotherapy. METHODS: This was a retrospective multicentre study. Patients who underwent local excision were compared with those who had mesorectal excision. Quality of life and bowel function were investigated using validated questionnaires (European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, EORTC QLQ-CR29 and Memorial Sloan-Kettering Cancer Center Bowel Function Instrument) at a median follow-up of 49 (range 13-95) months. Further analysis was undertaken of data from patients who underwent local excision alone compared with those requiring subsequent radical surgery. Statistical significance was set at P < 0·010. RESULTS: The mean constipation score was significantly better in the local excision group than in the mesorectal excision group (3·8 (95 per cent c.i. 0·3 to 7·2) versus 19·8 (12·1 to 27·4); P < 0·001). Compared with patients who underwent mesorectal excision, those who had local excision had less sensation of incomplete emptying (mean score 3·7 (3·4 to 4·0) versus 2·8 (2·5 to 3·1); P < 0·001) and second bowel movements within 15 min (mean score 3·6 (3·3 to 3·9) versus 3·0 (2·7 to 3·3); P = 0·006). Patients who underwent local excision alone scored better than those who had mesorectal excision, particularly for bowel function, who, in turn, scored better than patients requiring subsequent radical surgery following local excision. CONCLUSION: Patients who underwent local excision had a better quality of life and bowel function than those who underwent mesorectal excision.

A phase II study on the efficacy and safety of procedural analgesia with fentanyl buccal tablet in cancer patients for the placement of indwelling central venous access systems.

BACKGROUND: Pain in cancer patients is often related to oncologic therapies and diagnostic procedures. The placement of fully implantable venous access systems is a very common procedure in oncology patients. Local anaesthesia is the method most commonly used to overcome pain related to this surgical procedure, but the local anaesthetic may be unable to completely eradicate all pain. This study investigates the effectiveness and safety of fentanyl buccal tablet (FBT), administered by OraVescent® technology, in reducing procedural pain related to the placement of indwelling central venous access systems (Ports) in opioid-naïve cancer patients. METHODS: Inpatients who required an indwelling vascular access (Port) were preoperatively assessed with a self-assessment questionnaire on anxiety and pain. A 100 µg FBT was administered 10 min before preparation of the operating field. A self-assessment scale for pain experienced during the procedure was administered at the end of the procedure. Vital signs and the presence of any side effects or bothersome symptoms were monitored during the procedure, at the end, and 4 h later. RESULTS: From October 2012 to June 2014, 65 patients were enrolled in the study. A total of 61 (93.9 %) patients perceived no or a little pain during the procedure. Four patients (6.2 %) reported a lot of pain. No patient reported very severe pain. This data is significant in terms of the lower than expected presence of pain (Fisher test p = 0.0018) as assessed in our previous experience without procedural analgesia. The most common side effects of FBT was drowsiness, experienced by 28 patients at the end of the procedure (43.1 %), significantly reduced (p < 0.01) to 8 patients after 4 h (12.5 %). Nausea was present in 6 cases at the end of the procedure (9.2 %) and in 7 cases 4 h later (10.9 %). Vomiting was present in 3 cases at the end (4.7 %) and in 2 other patients after 4 h (7.8 %). No significant change of vital parameters was observed between the baseline and the subsequent measurements in all patients studied. CONCLUSIONS: The significant improvement in the number of patients experiencing little or no pain, accompanied by a lower number of non-severe side effects, suggests that FBT is a valid, practical and safe method of procedural analgesia. It will be necessary to perform further studies, taking into account the need for standard antiemetic pre-medication to minimise the incidence of nausea and vomiting.

Validity and reliability of the MSKCC Bowel Function instrument in a sample of Italian rectal cancer patients.

AIMS: The purpose of this study was to translate the Memorial Sloan Kettering Cancer Centre (MSKCC) Bowel Function Instrument into Italian and to test its psychometric validity and reliability in a sample of Italian rectal cancer patients. METHODS: The MSKCC questionnaire was translated into Italian using a standard procedure of double-back translation. Construct validity was tested using a factor analysis and internal reliability was estimated using the Cronbach's alpha coefficient. Concurrent validity was determined by correlations with European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-CR38 quality of life scales. A non-parametric analysis of variance was used to establish the discriminant validity of the questionnaire. Test-retest reliability was assessed using the intra-class correlation coefficient. RESULTS: 124 rectal cancer patients participated in the validation study. The number of missing items was 2.2%. The factorial structure was found to be quite similar to the original one and the internal reliability was 0.7 for urgency, 0.6 for frequency, and 0.7 for dietary subscale. The test-retest reliability was acceptable with one exception: the dietary subscale showed a low reproducibility (ICC = 0.4). All three subscales showed a significant correlation with the QLQ-C30 and QLQ-CR38 domains and were able to discriminate several groups of clinical relevance. CONCLUSIONS: The Italian version of the MSKCC Bowel Function Instrument shows acceptable psychometric properties and can be considered a valuable and specific instrument to assess bowel functions in rectal cancer patients, both for research purposes and in clinical practise.

Quality of life in patients with epidermolysis bullosa.

BACKGROUND: Epidermolysis bullosa (EB) is a rare, inherited group of disorders characterized by blistering of the skin following friction or mechanical trauma. EB has a clinical and socioeconomic impact on patients and their families. OBJECTIVES: To assess the quality of life (QoL) in patients with EB and to determine disease burden. METHODS: The study was an observational, cross-sectional postal survey. One hundred and eighty-five patients were invited to participate. Different sets of questionnaires [Short Form-36 (SF-36), Skindex-29, General Health Questionnaire-12 (GHQ-12), EuroQol 5 dimensions] were sent to patients according to age. The perceived severity of the disease was evaluated by patients or by the mothers of the younger children with EB, using the Patient Global Assessment five-point scale. Carers received the Family Strain Questionnaire. RESULTS: One hundred and twenty-five respondents were analysed. Patients with EB showed lower values in physical components of the SF-36, while the mental components were not significantly impaired. Among EB types, patients with junctional EB and severe generalized recessive dystrophic EB reported lower values and their GHQ-12 scores were significantly different from those of patients with EB simplex. There were no significant differences among EB types/subtypes for Skindex-29 values. Women had a worse QoL compared with men in all Skindex-29 and SF-36 scales (P < 0.05). GHQ-positive cases were more frequent among women (48%) compared with men (16%) (P = 0.003); GHQ-positive cases had a worse QoL compared with GHQ-negative patients. The patient QoL decreased and the family burden increased with increasing patient perceived disease severity and with increasing patient body surface involved. No differences were seen among EB types for the family burden. CONCLUSIONS: In patients with EB mental components of SF-36 scores are similar to the normal population. The perceived disease severity and skin area involved are relevant for QoL in all EB types/subtypes. EB imposes a heavy burden on the caregiver and the family. Psychological support and close monitoring of QoL may help patients with EB and their carers.

The EORTC quality of life questionnaire-head and neck 35 in Italian laryngectomized patients. European organization for research and treatment of cancer.

The aim of this study was to test the validity and reliability of the European organization for research and treatment of cancer (EORTC) quality of life questionnaire (QLQ)-head and neck (H&N) 35 in Italian laryngeal cancer patients. The original questionnaire was developed by the EORTC quality of life (QoL) study group and tested in H&N cancer patients from Norway, Sweden, and the Netherlands. The Italian translation of the questionnaire used in this study was made by a team of the CRO, National Cancer Institute, using a double-back translation method between independent translators. The translated EORTC QLQ-H&N35 was given to 99 patients with H&N cancer who had undergone total laryngectomy 1-26 years before and had been then treated with radiotherapy and, in some cases, chemotherapy. The questionnaire was re-administrated to 33 patients after 1 month to test its stability over time. It was structurally made up of seven scales (pain, swallowing, sense, speech, social eating, social contact, and sexuality) and 11 single items that considered the most important clinical aspects characterizing the QoL in H&N cancer patients. The statistical analysis of the indexes of validity and reliability confirmed the results obtained with other linguistic versions of the questionnaire. Our Italian version of the EORTC QLQ-H&N35 proved to be a statistically valid instrument to assess QoL in laryngectomized patients.

Psychological and symptom distress in terminal cancer patients with met and unmet needs.

This study identified the needs of terminal cancer patients, investigated the factors associated with unmet needs, and assessed psychological and symptom distress associated with unsolved needs. Ninety-four patients were randomly selected from 324 patients admitted for palliative care in 13 Italian centers. Two self-administered questionnaires (the Symptom Distress Scale and the Psychological Distress Inventory) were administered to all the patients. Patients needs were identified using a semi-structured interview, aimed at exploring five areas: physiological needs, safety needs, love and belonging needs, self-esteem needs, self-fulfillment needs. A content analysis of the answers defined 11 needs, and identified patients with unmet needs. The most frequent unmet needs were symptom control (62.8%), occupational functioning (62.1%), and emotional support (51.7%). The less frequently reported needs were those related to personal care (14.6%), financial support (14.1%), and emotional closeness (13.8%). Low functional state was significantly associated with a high proportion of patients with unmet needs of personal care, information, communication, occupational functioning, and emotional closeness. Patients with unmet needs showed significantly higher psychological and symptom distress for most needs. This study provides some suggestions about the concerns that should be carefully considered during the late stage of cancer.

Experimental vesicoureteral reflux in the fetus depends on bladder function and causes renal fibrosis.

PURPOSE: Prenatal diagnosis allows the early detection of vesicoureteral reflux in an increasing number of newborns, some of whom are born with impaired kidney function. This situation challenges our current understanding of the pathophysiology, natural history and, therefore, treatment of reflux. We created a fetal sheep model of vesicoureteral reflux to study the mechanisms of fetal reflux nephropathy. MATERIALS AND METHODS: Vesicoureteral reflux was induced in fetal sheep at 95 days of gestation (term 140 days) by open bladder incision of the intravesical ureteral tunnel. All animals underwent urachal ligation and in female subjects mild bladder outlet obstruction was created with a gold ring. RESULTS: At term reflux was detected in 18 of 28 renal units by filling cystography. Refluxing kidneys were hydronephrotic and larger than normal. At term mean kidney weight was 21.1 gm. (range 12.2 to 35.0) in male subjects with reflux compared to 8.5 gm. (range 6.5 to 11.3) in normal male subjects (p <0.001) and 11.5 gm. (range 8.5 to 15.8) in male subjects with urachal ligation only (p = 0.035). In female subjects there was no change in renal weight. Renal histology revealed a thin, structurally normal cortex with small subcortical cysts and a hypoplastic medulla with mesenchymal tissue replacing normal ducts. Total mean renal collagen content was significantly increased to 51.7 mg. (range 35 to 81) in the refluxing kidneys of male animals, while it was 23.8 mg. (range 12.1 to 38.4) in normal male animals (p = 0.03). The fractional excretion of sodium was elevated in refluxing kidneys based on sodium-to-creatinine ratios in bladder urine. CONCLUSIONS: In a novel model of fetal vesicoureteral reflux we showed that prenatal reflux nephropathy is characterized by altered renal growth regulation, structural maldevelopment without overt dysplasia, excess matrix deposition and impaired excretory function.

[Results of radiotherapy in patients with bladder carcinoma]. / Risultati del trattamento radioterapico nei pazienti con carcinoma vescicale.

The authors analyse the results of treatment with radiotherapy with therapeutic doses and traditional fractionation scheme 60 patients affected by bladder cancer, from 1980 through 1991, at the Institute of Radiology of the University "La Sapienza" in Rome. We evaluated the association of radiotherapy (RT) with trans-urethral resection and biopsy (TURB) and the association of RT with cystectomy (total or partial), both in T1-T2 and T3-T4 bladder stages. The mean follow-up was 85 months (from 24 months to 11 years). The survival at 5 years after completing the treatment was 33.3%; the survival of stages T1-T2 was of 40% at 5 years while that of stages T3-T4 was of 28.5%. Our study shows that the association of radiotherapy and TURB for T1 or T2 bladder cancer is an alternative to mutilating surgery like total or partial cystectomy; in this group, indeed, we showed a survival of 54.5% at 5 years as compared to the 28.5% of the group treated with cystectomy + RT. For T3 and T4 bladder cancer we had better results with surgery (total or partial cystectomy) and RT: in these patients the survival at 5 years was of 31%, while the group treated with TURB + RT showed a survival of 19%.