Anders Mellgren

Is local excision adequate therapy for early rectal cancer

PURPOSE: Radical surgery of rectal cancer is associated with significant morbidity, and some patients with low-lying lesions must accept a permanent colostomy. Several studies have suggested satisfactory tumor control after local excision of early rectal cancer. The purpose of this study was to compare recurrence and survival rates after treating early rectal cancers with local excision and radical surgery. METHODS: One hundred eight patients with T1 and T2 rectal adenocarcinomas treated by transanal excision were compared with 153 patients with T1N0 and T2N0 rectal adenocarcinomas treated with radical surgery. Neither group received adjuvant chemoradiation. Mean follow-up time was 4.4 years after local excision and 4.8 years after radical surgery. RESULTS: The estimated five-year local recurrence rate was 28 percent (18 percent for T1 tumors and 47 percent for T2 tumors) after local excision and 4 percent (none for T1 tumors and 6 percent for T2 tumors) after radical surgery. Overall recurrence was also higher after local excision (21 percent for T1 tumors and 47 percent for T2 tumors) than after radical surgery (9 percent for T1 tumors and 16 percent for T2 tumors). Twenty-four of 27 patients with recurrence after local excision underwent salvage surgery. The estimated five-year overall survival rate was 69 percent after local excision (72 percent for T1 tumors and 65 percent after T2 tumors) and 82 percent after radical surgery (80 percent for T1 tumors and 81 percent for T2 tumors). Differences in survival rate between local excision and radical surgery were statistically significant in patients with T2 tumors. CONCLUSIONS: Local excision of early rectal cancer carries a high risk of local recurrence. Salvage surgery is possible in most patients with local recurrence, but may be effective only in patients with T1 tumors. When compared with radical surgery, local excision may compromise overall survival in patients with T2 rectal cancers.

Accuracy of Endorectal Ultrasonography in Preoperative Staging of Rectal Tumors

PURPOSE: Preoperative staging of rectal tumors is considered essential to tailor treatment for individual patients. The aim of the present study was to evaluate the accuracy of endorectal ultrasonography in preoperative staging of rectal tumors. METHODS: Eleven hundred eighty-four patients with rectal adenocarcinoma or villous adenoma underwent endorectal ultrasonography evaluation at a single institution during a ten-year period. We compared the endorectal ultrasonography staging with the pathology findings based on the surgical specimens in 545 patients who had surgery (307 by transanal excision, 238 by radical proctectomy) without adjuvant preoperative chemoradiation. Comparisons between groups were performed using chi-squared tests and logistic regression analysis. RESULTS: Overall accuracy in assessing the level of rectal wall invasion was 69 percent, with 18 percent of the tumors overstaged and 13 percent understaged. Accuracy depended on the tumor stage and on the ultrasonographer. Overall accuracy in assessing nodal involvement in the 238 patients treated with radical surgery was 64 percent, with 25 percent overstaged and 11 percent understaged. CONCLUSION: The accuracy of endorectal ultrasonography in assessing the depth of tumor invasion, particularly for early cancers, is lower than previously reported. The technique is more precise in distinguishing between benign tumors and invasive cancers and between tumors localized to the rectal wall and tumors with transmural invasion. Differences in image interpretation may in part explain discrepancies in accuracy between studies.

Local excision of rectal cancer without adjuvant therapy: A word of caution

OBJECTIVE To evaluate the results of local excision alone for the treatment of rectal cancer, applying strict selection criteria. BACKGROUND DATA Several retrospective studies have demonstrated that tumor control in properly selected patients with rectal cancer treated locally is comparable to that observed after radical surgery. Although there is a consensus regarding the need for patient selection for local excision, the specific criteria vary among centers. METHODS The authors reviewed 82 patients with T1 (n = 55) and T2 (n = 27) rectal cancer treated with transanal excision only during a 10-year period. At pathologic examination, all tumors were localized to the rectal wall, had negative excision margins, were well or moderately differentiated, and had no blood or lymphatic vessel invasion, nor a mucinous component. End points were local and distant tumor recurrence and patient survival. RESULTS Ten of the 55 patients with T1 tumors (18%) and 10 of the 27 patients with T2 tumors (37%) had recurrence at 54 months of follow-up. Average time to recurrence was 18 months in both groups. Seventeen of the 20 patients with local recurrence underwent salvage surgery. The survival rate was 98% for patients with T1 tumors and 89% for patients with T2 tumors. Preoperative staging by endorectal ultrasound did not influence local recurrence or tumor-specific survival. CONCLUSION Local excision of early rectal cancer, even in the ideal candidate, is followed by a much higher recurrence rate than previously reported. Although most patients in whom local recurrence develops can be salvaged by radical resection, the long-term outcome remains unknown.

Sacral spinal nerve stimulation for faecal incontinence: multicentre study

BACKGROUND In patients with faecal incontinence in whom conservative treatment fails, options are limited for those with a functionally deficient but morphologically intact sphincter. We investigated the effect of sacral nerve stimulation on continence and quality of life. METHODS In this multicentre prospective trial, 37 patients underwent a test stimulation period, followed by implantation of a neurostimulator for chronic stimulation in 34. Effect on continence was assessed by daily bowel-habit diaries over a 3-week period and on quality of life by the disease-specific American Society of Colon and Rectal Surgeons (ASCRS) questionnaire and the standard short form health survey questionnaire (SF-36). Every patient served as his or her own control. FINDINGS Frequency of incontinent episodes per week fell (mean 16.4 vs 3.1 and 2.0 at 12 and 24 months; p<0.0001) for both urge and passive incontinence during median follow-up of 23.9 months. Mean number of days per week with incontinent episodes also declined (4.5 vs 1.4 and 1.2 at 12 and 24 months, p<0.0001), as did staining (5.6 vs 2.4 at 12 months; p<0.0001) and pad use (5.9 vs 3.7 at 12 months; p<0.0001). Ability to postpone defecation was enhanced (at 12 months, p<0.0001), and ability to completely empty the bowel was slightly raised during follow-up (at 12 months, p=0.4122). Quality of life improved in all four ASCRS scales (p<0.0001) and in seven of eight SF-36 scales, though only social functioning was significantly improved (p=0.0002). INTERPRETATION Sacral nerve stimulation greatly improves continence and quality of life in selected patients with morphologically intact or repaired sphincter complex offering a treatment for patients in whom treatment options are limited.

Sacral nerve stimulation for fecal incontinence: Results of a 120-patient prospective multicenter study

Background:Sacral nerve stimulation has been approved for use in treating urinary incontinence in the United States since 1997, and in Europe for both urinary and fecal incontinence (FI) since 1994. The purpose of this study was to determine the safety and efficacy of sacral nerve stimulation in a large population under the rigors of Food and Drug Administration-approved investigational protocol. Methods:Candidates for SNS who provided informed consent were enrolled in this Institutional Review Board-approved multicentered prospective trial. Patients showing ≥50% improvement during test stimulation received chronic implantation of the InterStim Therapy (Medtronic; Minneapolis, MN). The primary efficacy objective was to demonstrate that ≥50% of subjects would achieve therapeutic success, defined as ≥50% reduction of incontinent episodes per week at 12 months compared with baseline. Results:A total of 133 patients underwent test stimulation with a 90% success rate, and 120 (110 females) of a mean age of 60.5 years and a mean duration of FI of 6.8 years received chronic implantation. Mean follow-up was 28 (range, 2.2–69.5) months. At 12 months, 83% of subjects achieved therapeutic success (95% confidence interval: 74%–90%; P < 0.0001), and 41% achieved 100% continence. Therapeutic success was 85% at 24 months. Incontinent episodes decreased from a mean of 9.4 per week at baseline to 1.9 at 12 months and 2.9 at 2 years. There were no reported unanticipated adverse device effects associated with InterStim Therapy. Conclusion:Sacral nerve stimulation using InterStim Therapy is a safe and effective treatment for patients with FI.

Defecography : results of investigations in 2,816 patients

PURPOSE: This study was designed to analyze the frequency of different findings at defecography in patients with defecation disorders and see in what way the evaluation could be improved. METHODS: The reports of investigations in 2,816 patients were analyzed. RESULTS: Twenty‐three percent of the investigations were considered normal. Thirty‐one percent of the patients had rectal intussusception, 13 percent had rectal prolapse, 27 percent had rectocele, and 19 percent had enterocele. Twenty‐one percent of the patients had a combination of two or three of these diagnoses. The combination of rectocele and enterocele was rare. The majority of patients with enterocele had other concomitant findings. Patients with or without abnormal perineal descent had similar frequencies of rectal prolapse, rectal intussusception, and enterocele. Rectocele was more common in patients with abnormal perineal descent. CONCLUSIONS: Defecography is valuable when investigating patients with defecation disorders. Pathologic findings were found in 77 percent of the patients. A standardized protocol should ensure a complete evaluation of defecography.

Late adverse effects of short-course preoperative radiotherapy in rectal cancer.

Preoperative radiotherapy improves local control and survival in rectal cancer, but there are few reports on long‐term morbidity. The aims of this study were to compare long‐term morbidity and quality of life in patients undergoing rectal cancer surgery with or without preoperative radiotherapy.

Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial

BACKGROUND Injection of a bulking agent in the anal canal is an increasingly used treatment for faecal incontinence, but efficacy has not been shown in a controlled trial. We aimed to assess the efficacy of injection of dextranomer in stabilised hyaluronic acid (NASHA Dx) for treatment of faecal incontinence. METHODS In this randomised, double-blind, sham-controlled trial, patients aged 18-75 years from centres in USA and Europe were randomly assigned (2:1) to receive either transanal submucosal injections of NASHA Dx or sham injections. Randomisation was stratified by sex and region in blocks of six, and managed with a computer generated, real-time, web-based system. Patients and investigators were masked to assignment for 6 months when the effect on severity of faecal incontinence and quality of life was assessed with a 2-week diary and clinical assessments. The primary endpoint was response to treatment based on the number of incontinence episodes. A response to treatment was defined as a reduction in number of episodes by 50% or more. Patients in the active treatment group are still being followed up. This trial was registered with ClinicalTrials.gov, number NCT00605826. FINDINGS 278 patients were screened for inclusion, of whom 206 were randomised assigned to receive NASHA Dx (n=136) or sham treatment (n=70). 71 patients who received NASHA Dx (52%) had a 50% or more reduction in the number of incontinence episode, compared with 22 patients who received sham treatment (31%; odds ratio 2·36, 95% CI 1·24-4·47, p=0·0089). We recorded 128 treatment-related adverse events, of which two were serious (1 rectal abscess and 1 prostatic abscess). INTERPRETATION Anal injection of NASHA Dx is an effective treatment for faecal incontinence. A refinement of selection criteria for patients, optimum injected dose, ideal site of injection, and long-term results might further increase the acceptance of this minimally invasive treatment. FUNDING Q-Med AB.

Consensus conference on the stapled transanal rectal resection (STARR) for disordered defaecation

An international working party was convened in Rome, Italy on 16–17 June, 2005, with the purpose of developing a consensus on the application of the circular stapling instrument to the treatment of certain rectal conditions, the so‐called Stapled Transanal Rectal Resection (STARR). Since the procedure has been submitted to only limited objective analysis it was felt prudent to hold a meeting of interested individuals for the purpose of evaluating the current status and to make conclusions and recommendations concerning the applicability of this new approach.

Transanal endoscopic microsurgery versus conventional transanal excision for patients with early rectal cancer.

Objective:To compare transanal endoscopic microsurgery (TEMS) with conventional transanal excision (TAE) in terms of the quality of resection, local recurrence, and survival rates in patients with stage I rectal cancer. Background:Although TEMS is often considered a superior surgical technique to TAE, it is poorly suited for excising tumors in the lower third of the rectum. Such tumors may confer a worse prognosis. Methods:We retrospectively reviewed information on all patients with stage pT1 and pT2 rectal adenocarcinoma who underwent local excision from 1997 through mid-2006. We excluded patients with node-positive, metastatic, recurrent, previously irradiated, or snare-excised tumors. Results:Our study included 42 TEMS and 129 TAE patients. We found no significant differences in patient characteristics, adjuvant therapy, tumor stage, or adverse histopathologic features. In the TAE group, 52 (40%) of tumors were <5 cm from the anal verge (AV); in the TEMS group, only 1 (2%) (P = 0.0001). Surgical margins were less often positive in the TEMS group (2%) than in the TAE group (16%) (P = 0.017). For patients with tumors ≥5 cm from the AV, the estimated 5-year disease-free survival (DFS) rate was similar between the TEMS group (84.1%) and the TAE group (76.1%) (P = 0.651). But within the TAE group, the estimated 5-year DFS rate was better for patients with tumors ≥5 cm from the AV (76.1%) vs. <5 cm from the AV (60.5%) (P = 0.029). In our multivariate analysis, the tumor distance from the anal verge, the resection margin status, the T stage, and the use of adjuvant therapy—but not the surgical technique (i.e., TEMS or TAE) itself—were independent predictors of local recurrence and DFS. Conclusions:The quality of resection is better with TEMS than with TAE. However, the apparently better oncologic outcomes with TEMS can be partly explained by case selection of lower-risk tumors of the upper rectum.