摘要:

INTRODUCTION:Evidence‐based medicine relies on reproducible, high‐quality reporting in the literature. Previous evaluations, which have assessed 11 basic elements of design and analysis in top impact clinical journals (both nonsurgical and surgical), have demonstrated that the reporting quality is less than perfect, although improving. The current study evaluates the quality of reporting inDiseases of the Colon and Rectumand other clinically related journals to identify specific areas where future improvements may be made.METHODS:Two independent evaluators assessed all randomized, controlled trials published inDiseases of the Colon and Rectumin the years 1990, 1995, and 2000. Additional assessments for 2000 were performed on all randomized, controlled trials published inAnnals of Surgery, Archives of Surgery, and Gastroenterology. The frequency of reporting of 11 explicitly defined, traditionally important, basic elements of design and analysis were determined. These elements included reporting of eligibility criteria, admission before allocation, randomization (and method), blinded assessment (patient and observer), complications, loss to follow‐up, statistical approach and tests, and power calculation.RESULTS:Interobserver reliability was strong (kappa, 0.76). The number of randomized, controlled trials published inDiseases of the Colon and Rectumincreased from 5 (in 1990) to 13 (in 1995) to 17 (in 2000). Of the 1990 randomized, controlled trials, an average of 60 percent of the 11 basic elements were reported. Of the 1995 randomized, controlled trials, 72 percent of the items were reported (P= 0.05), whereas of the 2000 randomized, controlled trials, 77 percent of the 11 items were reported (P< 0.002vs.1990). The best‐reported items were eligibility criteria, discussion of statistical tests, and accounting for all patients lost to follow‐up. Only 11 percent of the 2000 randomized, controlled trials reported statistical power calculations. For the other journals that were evaluated, 72 to 88 percent of items were reported, with eligibility criterion being the best consistently reported item and power calculation being the worst.CONCLUSIONS:ForDiseases of the Colon and Rectum, the number of randomized, controlled trials and the quality of reporting is improving. However, although certain research standards are reported adequately, others are not. The calculation of statistical power is clearly important when interpreting randomized, controlled trial results (whether differences are reported or not), yet only 11 percent of studies contained this information. Improving the reporting of this single item would likely lead to improving the overall quality of clinical studies in colorectal surgery. Improved reporting might be best facilitated by having authors adhere to a list of explicitly determined elements that should be included. Ko CY, Sack J, Chang JT, Fink A. Reporting randomized, controlled trials: where quality of reporting may be improved. Dis Colon Rectum 2002;45:443‐447.

ISSN:0012-3706    

出版商:OVID    

年代:2002

数据来源: OVID

摘要:

PURPOSE:Sporadic reports of epithelial dysplasia and the occasional development of adenocarcinoma in the ileal pouch mucosa have recently appeared in the literature, pointing toward yet another long‐term complication of the continent ileostomy and the pelvic pouch. The incidence of dysplasia and the risk for developing cancer has not been critically evaluated, however, and the reports are contradictory, with most having short observation times. The purpose of this study was to report long‐term mucosal adaptation patterns and the incidence of dysplasia in Kock pouches after a mean follow‐up of 30 years for patients previously operated on for ulcerative proctocolitis.METHODS:Two sets of two pathologists each (in Gothenburg, Sweden, and Manchester, United Kingdom) examined sequential, small‐intestinal biopsy specimens from 40 patients with Kock pouch to observe long‐term epithelial changes, with particular reference to the presence of dysplasia.RESULTS:There was full agreement between the two groups regarding the absence of high‐grade dysplasia and invasive carcinoma (Categories 4 and 5 of the Vienna classification). There was, however, significant disagreement in reporting the frequency of low‐grade and indefinite categories of dysplasia (Categories 2 and 3, of the Vienna classification). No attempt was made to report the differences within each set of pathologists.CONCLUSION:Because no case of high‐grade dysplasia or invasive carcinoma was found in this study after a mean follow‐up of 30 years, we conclude that it is very unlikely for invasive carcinoma to be a complication in ileal pouch mucosa. Hultén L, Willén R, Nilsson O, Safarani N, Haboubi N. Mucosal assessment for dysplasia and cancer in the ileal pouch mucosa in patients operated on for ulcerative colitis—a 30‐year follow‐up study. Dis Colon Rectum 2002;45:448‐452.

ISSN:0012-3706    

出版商:OVID    

年代:2002

数据来源: OVID

摘要:

PURPOSE:The prevalence of anal squamous intraepithelial lesions is high among human immunodeficiency virus‐positive homosexual males and, to a lesser extent, among human immunodeficiency virus‐negative homosexual males. Furthermore, the incidence of high‐grade squamous intraepithelial lesions, the putative precursor lesion to invasive cancer, is also high. We report the first prospective study of high‐resolution anoscopy‐directed surgical treatment of high‐grade squamous intraepithelial lesions.METHODS:A prospective study of patients undergoing surgical treatment of high‐grade squamous intraepithelial lesions (excision/cauterization of lesions visualized with high‐resolution anoscopy) was performed. Follow‐up anoscopy with biopsy and Papanicolaou smear was performed every three to six months.RESULTS:Patients diagnosed with high‐grade squamous intraepithelial lesions during the course of their participation in a prospective cohort study of anal squamous intraepithelial lesions were identified. From this group, 37 patients who were treated surgically between 1995 and 1999 were studied. Of these, 29 had tested positive for human immunodeficiency virus and 8 were negative for the virus. Mean patient age was 45 ± 8 years. Mean duration of follow‐up was 32.3 ± 20.6 months in the human immunodeficiency virus‐negative group and 28.6 ± 12.9 months in the human immunodeficiency virus‐positive group. No human immunodeficiency virus‐negative patient developed recurrent high‐grade squamous intraepithelial lesions. Twenty‐three of 29 human immunodeficiency virus‐positive patients had persistent or recurrent high‐grade squamous intraepithelial lesions (P= 0.003; mean time to recurrence, 12 months). Six patients underwent reoperation for high‐grade squamous intraepithelial lesions (4 recurred by 6 months). No patients developed incontinence, stenosis, postoperative infection, or significant bleeding after surgical treatment.CONCLUSIONS:Surgical intervention directed by high‐resolution anoscopy is safe and eliminates high‐grade squamous intraepithelial lesions in human immunodeficiency virus‐negative patients. The high persistence or recurrence rate in human immunodeficiency virus‐positive patients suggests that multiple staged procedures and continued surveillance may be necessary.

ISSN:0012-3706    

出版商:OVID    

年代:2002

数据来源: OVID

摘要:

PURPOSE:Adjuvant pelvic radiotherapy after radical surgery for rectal cancer may produce several side‐effects (mainly gastrointestinal) capable of affecting patient lifestyle. This prospective study evaluated by means of a diary card the toxicity and daily changes in the quality of life of patients with rectal cancer treated with postoperative pelvic radiotherapy.METHODS:We used a diary card listing ten items about lifestyle changes and side‐effects compiled by patients themselves. The patients were stratified by age (≤ 65vs.> 65 years), the presence or not of a stoma, and the administration or not of concurrent chemotherapy.RESULTS:Twenty‐seven patients were evaluable. The mean number of bowel movements increased across time, without statistically significant differences. Nausea and appetite did not significantly change during the treatment period. There was a statistically significant, progressive increase in the perception of pain (P< 0.03). Although not significantly, the anxiety scores were lower during radiotherapy than at baseline. Daily activities and compliance with therapy did not significantly change during the treatment. There was a significant worsening in overall well‐being (P< 0.04) and quality of life evaluation (P< 0.03). The patients who received chemoradiotherapy experienced a worsened lifestyle and greater side‐effects. Older patients experienced less pain but had statistically significant higher levels of anxiety. Patients with a stoma reported a better quality of life score than those without.CONCLUSIONS:The use of a diary card may be an adequate means of detecting the extent of treatment‐related changes in the lifestyle of patients with rectal cancer treated by postoperative radiotherapy.

ISSN:0012-3706    

出版商:OVID    

年代:2002

数据来源: OVID

摘要:

PURPOSE:Although outcome of resection for colorectal carcinoma has improved, about 30 percent of patients develop metastatic lesions. Small pulmonary metastases 1 cm or less in diameter now can be detected by diagnostic tests including chest radiography and computed tomography. We evaluated results of our strategy for intensive follow‐up after resection of colorectal cancer and aggressive resection of lung metastases disclosed by these periodic examinations.METHODS:Our follow‐up program for lung metastasis includes a serum carcinoembryonic antigen assay every two months and chest radiography every six months. Surgical resection of lung metastases was performed if the primary and any nonpulmonary metastases had been controlled, lung metastases numbered four or fewer, and pulmonary functional reserve was adequate. Standard operation for lung metastasis was lobectomy, and lymph node dissection was added in cases of tumor size over 3 cm. Forty‐two patients underwent 50 lung resections for metastatic colorectal cancer between 1992 and 1999. Long‐term survival was assessed in terms of clinical variables.RESULTS:Overall five‐year survival rate after resection of lung metastases from colorectal cancer was 63.7 percent. Variables significantly affecting postthoracotomy survival were primary tumor histology, number of nodules, and disease‐free interval up to appearance of the lung metastases, and primary tumor histology was an independent prognostic factor.CONCLUSION:Intensive follow‐up for lung metastases after resection of colorectal cancer and aggressive resection improved postoperative survival rate. Patients with well‐differentiated adenocarcinoma of primary tumor, a solitary metastatic nodule, and disease‐free interval of at least two years after initial surgery are likely to be long‐term survivors.

ISSN:0012-3706    

出版商:OVID    

年代:2002

数据来源: OVID

摘要:

PURPOSE:The aim of this study was to prospectively assess the accuracy of the most promising imaging and tumor marker tests in liver metastasis diagnosis on follow‐up of asymptomatic colorectal cancer patients during a median of 57 months after primary tumor resection.METHODS:One hundred patients, who were considered free of liver metastases after primary colorectal cancer resection and conventional follow‐up, were screened for liver metastases by computerized tomography, magnetic resonance and ultrasound scans, ultrasound Doppler and isotope assessment of changes in hepatic arterial and portal venous flow, and serum estimation of carcinoembryonic antigen. Patients were followed up during a median of 41 months to identify those who developed liver metastases.RESULTS:The most sensitive technique was computerized tomography (sensitivity 0.67, specificity 0.91). Computerized tomography and magnetic resonance but not ultrasound were 100 percent accurate in differentiating liver metastases from other hepatic lesions. Techniques based on changes in hepatic arterial and portal venous flow had lower diagnostic accuracies (Doppler perfusion index, sensitivity 0.58, specificity 0.57; hepatic perfusion index, sensitivity 0.50, specificity 0.55), whereas ultrasound scanning identified only 43 percent (sensitivity 0.43, specificity 0.96) and serum carcinoembryonic antigen 33 percent (sensitivity 0.33, specificity 0.81) of patients with asymptomatic liver metastasis. Sensitivity could be improved by using tests in combination but this reduced specificity.CONCLUSIONS:Computerized tomography was the most sensitive test for asymptomatic colorectal liver metastases, but only 67 percent of affected patients were identified.

ISSN:0012-3706    

出版商:OVID    

年代:2002

数据来源: OVID

摘要:

PURPOSE:Although laparoscopic colectomy has demonstrated a variety of advantages, it remains unclear whether the reductions in length of stay and faster return of bowel function will offset potential increases in cost caused by operating time and instrumentation. The purpose of this study was to compare the direct cost structure of elective open and laparoscopic resection for sigmoid diverticulitis.METHODS:We compared consecutive elective open and laparoscopic sigmoid colectomies (n = 71 and n = 61, respectively) performed from March 1, 1999, through December 31, 2000. Data collected included age, gender, body mass index, American Society of Anesthesia score, indication for surgery, morbidity, mortality, conversion (laparoscopic only), operating time, and length of hospital stay. Direct cost data were provided by Stanford's integrated hospital cost management and decision software. Indirect costs and total costs were not addressed. Data were analyzed by Student'st‐test and chi‐squared test where appropriate. Significance was set atP< 0.05. All data are presented as mean ± standard error of the mean.RESULTS:There were 132 elective sigmoid colectomies for diverticular disease (61 laparoscopic and 71 open procedures). There were no significant differences between the groups with respect to age, male/female ratio, or body mass index. Operating time was similar (109 ± 7 minutes for laparoscopic proceduresvs. 101 ± 7 minutes for open procedures). The laparoscopic group had a significantly shorter length of stay (3.1 ± 0.2vs. 6.8 ± 0.4 days), fewer pulmonary complications (1 (1.6 percent)vs. 4 (5.6 percent)) and fewer wound infections (0vs. 5 (7 percent)). Conversion to open colectomy was required in 4 (6.6 percent) of 61 patients. Readmission occurred in three laparoscopic colectomy patients (4.9 percent) and four open colectomy patients (5.6 percent). There was one operative death in the laparoscopic group (1.6 percent) and no deaths in the open group. Total direct cost per case was significantly less for laparoscopic procedures ($3,458 ± 437) than for open colectomies ($4321 ± 501;P< 0.05, Student'st‐test), and operating costs were not significantly different between the groups.CONCLUSION:The data demonstrate that laparoscopic colectomy is a cost‐effective means of electively managing sigmoid diverticular disease. This operative approach may become very important in an era of increasing constraints on hospital occupancy rates and access to nursing services in many regions of the country.

ISSN:0012-3706    

出版商:OVID    

年代:2002

数据来源: OVID

摘要:

PURPOSE:The role of laparoscopic surgery in the cure of colorectal cancer is controversial. The aim of this study was to evaluate long‐term survival after curative, laparoscopic resection of colorectal cancer. Specifically, we wanted to review those patients who now had complete five‐year follow‐up.METHODS:One hundred two consecutive patients (March 1991 to March 1996) underwent laparoscopic colon resections for cancer at one institution and now have complete five‐year survival data. Charts were retrospectively reviewed and results compared with conventional surgery,i.e., open colectomy at our institution, and with the National Cancer Data Base during a similar time period.RESULTS:Fifty‐nine male and 43 female patients with an average age of 70 (range, 34‐92) years made up the study. Complications occurred in 23 percent of patients, and one patient died (1 percent). Forty‐four laparoscopic right colectomies, 2 transverse colectomies, 36 laparoscopic left or sigmoid colectomies, 15 laparoscopic low anterior resections, and 5 laparoscopic abdominoperineal resections were performed. The average number of lymph nodes harvested was 6.6 ± 0.61 (range, 0‐22). Eight cases (7.8 percent) were “converted to open”;i.e., the typical 6‐cm extraction site was lengthened to complete mobilization, devascularization, resection, or anastomosis, or a separate incision was required to complete the procedure. There was one extraction‐site recurrence and one port‐site recurrence; both occurred before the routine use of plastic‐sleeve wound protection. The mean follow‐up for laparoscopic colon resection patients was 64.4 ± 2.8 (range, 1‐111) months. According to the TNM classification system, 27 patients had Stage I cancer, 37 had Stage II, 23 had Stage III, and 15 had Stage IV. Similar five‐year survival rates for laparoscopic and conventional surgery for cancer were noted. The five‐year relative survival rates in the laparoscopic colon resection group were 73 percent for Stage I, 61 percent for Stage II, 55 percent for Stage III, and 0 percent for Stage IV. The five‐year relative survival rates for the open colectomy and National Cancer Data Base groups were 75 and 70 percent, respectively, for Stage I, 65 and 60 percent for Stage II, 46 and 44 percent for Stage III, and 11 and 7 percent for Stage IV.CONCLUSIONS:Laparoscopic colon resection for cancer is safe and feasible in a private setting. Our data suggest that long‐term survival after laparoscopic colon resection for cancer is similar to survival after conventional surgery. Prospective, randomized trials presently under way will likely confirm these results.

ISSN:0012-3706    

出版商:OVID    

年代:2002

数据来源: OVID

摘要:

PURPOSE:Human papillomavirus causes anogenital squamous intraepithelial lesions, warts, and cancer. Treatment of squamous intraepithelial lesions to prevent cancer often requires extensive surgery. We tested a human papillomavirus‐specific immunotherapy, HspE7, as a potential alternative.METHODS:HspE7 was constructed by fusing heat shock protein Hsp65 from bacille Calmette‐Guerin to E7 protein from human papillomavirus‐16. Improvement in pathologic diagnosis of patients with persistent high‐grade squamous intraepithelial lesions was studied in an open‐label trial (HspE7 500 &mgr;g monthly ×3). Anogenital warts were not a trial parameter, but a retrospective review of the medical records of the first 22 patients enrolled at one site was undertaken to estimate the quality and frequency of responses of anogenital warts. Patients with warts by physical examination at baseline were scored at 24 weeks as to the percent reduction in wart size.RESULTS:Fourteen of the 22 patients had warts at baseline. At Week 24, 3 of the 14 patients had complete resolution of their warts, and 10 had warts reduced in size an estimated 70 to 95 percent. The remaining patient's warts increased in size. The reduction in size in most patients greatly diminished the procedure necessary for complete ablation. No serious or severe adverse events were related to HspE7.CONCLUSIONS:A retrospective review of patients' medical records suggests that HspE7 may be broadly active in anogenital warts. This activity crosses multiple human papillomavirus types. The warts improved substantially but usually did not totally disappear within six months. Patient follow‐up continues. A new randomized, placebo‐controlled trial is underway to evaluate these findings.

ISSN:0012-3706    

出版商:OVID    

年代:2002

数据来源: OVID

摘要:

PURPOSE:Quality of life, a major outcome parameter in the treatment of anal incontinence, has not been assessed after artificial sphincter implantation. The purpose of this single‐center, prospective, nonrandomized study was to assess quality‐of‐life differences in patients before and after artificial sphincter implantation and compare them with clinical incontinence scores and anal manometry.METHODS:Quality of life was assessed in 16 patients (14 females; mean age, 43 years) consecutively implanted with an Acticon NeosphincterTM. The Fecal Incontinence Quality of Life Scale, a quality‐of‐life instrument specifically designed for analysis of anal incontinence, included 27 items grouped in four domains: lifestyle, coping/behavior, depression/self‐perception, and embarrassment. Fecal Incontinence Quality of Life Scale score (0 to 1, with 1 indicating better quality of life) was calculated preoperatively and postoperatively and compared with the Fecal Incontinence Score (on a scale of 0 to 120, with 120 being complete incontinence), an evacuation score, and maximal resting pressure.RESULTS:At a mean (standard deviation) of 25 (15) months,12 patients had an activated device, and 11 had satisfactory anorectal function. Significant improvement was observed postoperatively in the four separate quality‐of‐life domains. Mean (standard deviation) Fecal Incontinence Quality of Life Scale scores increased from 0.44 (0.14) preoperatively to 0.86 (0.18), 0.94 (0.06), and 0.83 (0.16) at 6, 12, and 24 months after implantation, respectively. For the same time periods, the mean (standard deviation) Fecal Incontinence Scores were 105 (14), 24 (26), 32 (35), and 32 (28), respectively (P< 0.05). A linear correlation was found between the improvement over time in quality of life measured by the Fecal Incontinence Quality of Life Scale and clinical evaluation of incontinence measured by the Fecal Incontinence Score (r2 = 0.97;P= 0.03). Mean (standard deviation) maximal resting pressure increased similarly from 42 (24) cm H2O preoperatively to 97 (23) cm H2O at the end of follow‐up (P< 0.0001).CONCLUSION:After artificial sphincter implantation, quality of life as assessed by a new Fecal Incontinence Quality of Life Scale instrument was significantly improved. These results correlated with clinical assessment of anal incontinence and were associated with a significant increase in maximal anal resting pressure on manometry.

ISSN:0012-3706    

出版商:OVID    

年代:2002

数据来源: OVID