"Prophylactic" transanal irrigation (TAI) to prevent symptoms of low anterior resection syndrome (LARS) after rectal resection: results at 12-month follow-up of a controlled randomized multicenter trial.

BACKGROUND: Low anterior resection syndrome (LARS) is associated with a severe negative impact on patients' quality of life (QOL). In a recent prospective randomized controlled trial (RCT) by our group, early ("prophylactic") use of transanal irrigation (TAI) following rectal resection for rectal cancer was shown to improve symptoms associated with LARS significantly compared with a group under supportive therapy (ST) within 1 and 3 months following closure of the protective ileostomy. The aim of the present study was to evaluate the outcome after 12 months when patients had the option to choose between the two therapeutic options and/or modify the regimen of TAI (volume and time). METHODS: In the RCT, 18 patients had been allocated to start with TAI following ileostomy closure, while 19 patients remained on ST only. Once the 3-month follow-up had been completed patients could choose between TAI or ST, respectively, and were invited for follow-up after 12 months. The maximum number of bowel movements during the day and the Wexner and LARS score as well as physical (PC) and mental (MC) component of the SF-36 questionnaire were evaluated. Furthermore, in patients who had changed their treatment arm, reasons for this decision were reported. RESULTS: Six patients were lost to follow-up (all in the ST group). One patient from the ST group started with TAI due to problems associated with LARS, bringing the total number of TAI patients to 19. Nine patients from the previous TAI arm changed to ST due to the long duration of the emptying process (n: 8) or pain during TAI (n: 1), respectively. After 12 months, the median volume of water used for irrigation was 600 ml (range 200-1000 ml). The ten patients who continued with TAI patients showed a lower number of defecation episodes per daytime (TAI median 3; 1-6, ST median 5; 2-10, p: 0.018) and per night (TAI median 0; 0-1, ST median 1; 0-5, p: 0.004) compared to the ST group. Although the LARS score was lower in patients who used TAI after 12 months (TAI median 18; 9-32, ST median 30; 3-39), this failed to reach the level of significance (p: 0.063). Evaluation of the Wexner score and the 36-item Short Form Health Survey as well as comparison of patients who remained on TAI (n: 9) versus those who had stopped TAI after 3 months (n: 9) failed to find any statistically significant difference between TAI and ST. CONCLUSIONS: This follow-up study revealed that a considerable number of patients decided to stop TAI within 12 months. However, the number of bowel movements during the day were still lower when TAI was used than when patients had ST only. CATEGORY: Randomized trial. REGISTRATION NUMBER: DRKS00011752, https://apps.who.int/trialsearch/ .

Randomized clinical trial of prophylactic transanal irrigation versus supportive therapy to prevent symptoms of low anterior resection syndrome after rectal resection.

Background: Low anterior resection syndrome (LARS) is a frequent problem after rectal resection. Transanal irrigation (TAI) has been suggested as an effective treatment in patients who have developed LARS. This prospective RCT was undertaken to evaluate the effect of TAI as a prophylactic treatment to prevent symptoms of LARS. Methods: Patients who had undergone ultralow rectal resection were randomized to start TAI on a daily basis, or to serve as a control with supportive therapy only after ileostomy closure. All patients were seen after 1 week, 1 month and 3 months, and the maximum number of defaecation episodes per day and night documented during follow-up. Wexner score, LARS score and Short Form 36 questionnaire responses were evaluated in both groups. Results: Thirty-seven patients could be evaluated according to protocol (TAI 18, control 19). The maximum number of stool episodes per day and per night was significantly lower among patients who underwent TAI at 1 month (median 3 versus 7 episodes/day in TAI versus control group, P = 0·003; 0 versus 3 episodes/night, P = 0·001) and 3 months (3 versus 5 episodes per day, P = 0·006; 0 versus 1 episodes/night, P = 0·002). LARS scores were significantly better in the TAI group after 1 month (median 16 versus 32 in control group; P = 0·044) and 3 months (9 versus 31; P = 0·001). A significantly better result in terms of Wexner score was seen in the TAI group after 3 months (median 2 versus 6 in controls; P = 0·046). Conclusion: Prophylactic TAI led to a significantly better functional outcome compared with supportive therapy for up to 3 months. Registration number: DRKS00011752 ( http://apps.who.int/trialsearch/).

Experience with split-course external beam irradiation +/- chemotherapy and integrated Ir-192 high-dose-rate brachytherapy in the treatment of primary carcinomas of the anal canal.

PURPOSE: The effect of the treatment of anal cancer by performing a high-dose-rate (HDR) brachytherapy boost during a short split between the external beam radiotherapy series (EBR) +/- chemotherapy was investigated. METHODS AND MATERIALS: Thirty-nine patients with anal canal cancers, stages T1-T4 N0-2 M0, were treated with split-course EBR (50-50.4 Gy) and a Iridium 192 ((192)Ir-) HDR boost (6 Gy) performed during the 1-2-week split. Patients who failed to achieve a complete tumor response received additional brachytherapy. Chemotherapy with 5-fluorouracil and mitomycin C was offered to patients with tumors > 3 cm and employed concomitantly on days 1-5 and day 1, respectively, of each EBR series. RESULTS: Follow-up ranged from 3 to 140 months (median 31). Median treatment duration was 56 days. The 3-year (5-year) actuarial rates of locoregional control (LRC) and disease-specific survival (DSS) were 81% (76%) and 80% (76%), respectively. The crude rate of anal preservation was 77% overall, and 97% in patients in whom LRC was achieved. Uncompromised anal function was recorded in 93% of these patients. The actuarial 3-year (5-year) rate of colostomy-free survival (CFS) was 78% (73%). There was a statistically significant difference in LRC and DSS according to stage, tumor size, and nodal status. Complications requiring surgical intervention occurred in 7.6% of patients. CONCLUSION: The integration of the HDR boost in a split-course EBR regimen +/- chemotherapy resulted in excellent sphincter function without an increase of severe complications and with rates of LRC, DSS, and CFS, which compare favorably with those reported in the literature.

Expression of various MHC class II molecules and of intracellular adhesion molecule-1 (ICAM-1) on focal clusters of dendritic cells in iodine deficiency goitres.

Thyroid sections from 18 consecutive euthyroid patients undergoing surgery for iodine deficiency goitre were investigated by means of immunohistochemistry and immunofluorescence, evaluating the expression of MHC class II antigens (HLA-DR, -DP, -DQ, and RFD1) and intercellular adhesion molecule-1 on the formerly described clusters of dendritic cells, as well as on thyrocytes. Eleven of 18 iodine deficiency goitres contained clusters of dendritic cells. These clusters appeared to express only HLA-DR in two cases; in nine of 12 cases they showed a differential expression of class II molecules in the following frequency: HLA-DR > DQ and/or -DP > RFD1. These dendritic cells also were ICAM-1+. In four of 18 iodine deficiency goitres, thyroid epithelial cells showed MHC class II expression in several combinations, but were ICAM-1-. In normal thyroids and in nodular goitres from inhabitants of the endemic area not having an actual iodine deficiency, only sparse clusters of dendritic cells were found; these cells were only HLA-DR+. Follicle lining cells were negative for the MHC class II molecules. In normal thyroids from an area with sufficient iodine supply, no clusters of dendritic cells were seen. The few dendritic cells observed were lying isolated in the interstitium and only positive for HLA-DR and ICAM-1; epithelial cells were negative for the studied markers. These data show clusters of dendritic cells in thyroids of inhabitants of an endemic area. When goitre is accompanied by iodine deficiency at the moment of operation, there appears to be activation of these dendritic cells and of thyroid epithelial cells.

Thyroid infiltrating dendritic cells, epitheloid cells and giant cells in iodine deficiency.

This study describes dendritic cells in thyroid sections of iodine deficient goiters. Cells were characterized by monoclonal markers and detected by immunohistochemistry and double labelling immunofluorescence. We observed dendritic cells located in focal aggregates in the interstitium and epitheloid cells as well as multinucleated giant cells filling thyroid follicles. All these cells showed strong positivity for the MHC class II molecules HLA-DR, -DQ, -DP and RFD1, a monoclonal marker for active antigen presenting cells.

Intrathyroidal dendritic cells, epitheloid cells, and giant cells in iodine deficient goiter.

Immunohistochemistry and immunofluorescence were performed on thyroid sections of 44 consecutive patients undergoing thyroid surgery for goiter due to iodine deficiency. Sections were compared with specimens from ten individuals without goiters from the same endemic area, with specimens from ten sporadic nontoxic goiter patients, and with specimens from an area with sufficient iodine supply from nine healthy subjects. Cells were characterized using monoclonal antibodies to the CR3 receptor (CD11b) and the p150/95 antigen (CD11c) present on macrophages, to HLA-DR, to antigen presenting cells (RFD1), to T helper (CD4) and to T suppressor/cytotoxic cells (CD8), and with a polyclonal antibody to human cytokeratin. In iodine deficient goiters, focal aggregates were found of RFD1-positive dendritic cells. Furthermore, RFD1-positive epitheloid cells were seen. In 27% of cases, these epitheloid cells completely filled the thyroid follicles. Within the epitheloid cell clusters, multinucleated giant cells could be detected that carried the macrophage markers. Dendritic cells, epitheloid cells, and giant cells were strongly HLA-DR positive. In nongoitrous thyroids from the endemic area such aggregates could also be seen but they were more sparse and were RFD1 negative. Giant cells were absent there. In normal thyroids with sufficient iodine supply, only a few isolated dendritic cells were seen. All except RFD1, which was negative, showed the same marker pattern. In sporadic nontoxic goiters from an area with sufficient iodine supply, dendritic cells occurred in much higher numbers than in the normal thyroids from that area, and they were RFD1 positive. They never aggregated as in iodine deficiency, and giant cells were not observed. These observations on iodine deficient goiter strongly suggest involvement of active antigen-presenting cells in this disorder. However, the immunohistologic difference between this disease and sporadic goiter suggests different underlying mechanisms.

A theory of protection: parents as sex educators.

A theory of protection was proposed to organize and explain the dynamic interactions between parents and children as they relate to sex education. Sixteen mothers were interviewed and the data analyzed through the constant comparative method. The optimal goal of sex education was determined to be self-protection, that is, attainment by the child of personal boundary control in order to function positively in society while maintaining his or her own values. The processes of sex education are governed by parents' perceptions of providing protection for the child through the identification and control of boundaries. Major variables moderating the quality of protection are mutuality, knowledge, and values. Using the theory of protection, suggestions are offered for clinical practice, parent teaching, and further investigation.

[Goiter surgery in endemic regions]. / Strumachirurgie im Endemiegebiet.

From 1976 07 01 to 1981 06 30 we performed 882 operations of goiter. It seems to be essential, that the nodular goiter dominates respectively not decreases significantly in spite of iodized salt prophylaxis. An exact preoperative diagnosis and preparation decides about the postoperative success. The postoperative complications are described and analysed. Relating to the recurrence goitre prevention we execute a careful instruction to the GPs and to the patients.