Safety and Efficacy of Sodium Hyaluronate Gel and Chitosan in Preventing Postoperative Peristomal Adhesions After Defunctioning Enterostomy: A Prospective Randomized Controlled Trials

Peristomal adhesions complicate closure of defunctioning enterostomy. The efficacy and safety of sodium hyaluronate gel and chitosan in preventing postoperative adhesion have not been extensively studied. This study aims to evaluate the safety and efficacy of sodium hyaluronate gel and chitosan in the prevention of postoperative peristomal adhesions.This was a prospective randomized controlled study. One hundred and fourteen patients undergoing defunctioning enterostomy were enrolled. Patients were randomly assigned to receive sodium hyaluronate gel (SHG group) or chitosan (CH group) or no antiadhesion treatment (CON group) during defunctioning enterostomy. The safety outcomes included toxicities, stoma-related complications, and short-term and long-term postoperative complications. Eighty-seven (76.3%) of the 114 patients received closure of enterostomy, during which occurrence and severity of intra-abdominal adhesions were visually assessed by a blinded assessor.Incidence of adhesion appears to be lower in patients received sodium hyaluronate gel or chitosan but differences did not reach a significant level (SHG group vs CH group vs CON group: 62.1% vs 62.1% vs 82.8%, P = 0.15). Compared with the CON group, severity of postoperative adhesion was significantly decreased in the SHG and CH group (SHG group vs CH group vs CON group: 31.0% vs 27.6% vs 62.1%; P = 0.01). There was no significant difference in the occurrence of postoperative complications and other safety outcomes among the 3 groups.Sodium hyaluronate gel or chitosan smeared around the limbs of a defunctioning enterostomy was safe and effective in the prevention of postoperative peristomal adhesions.     

A Prospective,Randomized, Controlled Multicenter Trial Comparing Stapled Hemorrhoidopexy and Ferguson Hemorrhoidectomy: Perioperative and One-Year Results

PURPOSE There is a growing body of evidence supporting the lesser degrees of pain with stapled hemorrhoidopexy, also called the procedure for prolapse and hemorrhoids. However, there have been few randomized comparisons assessing both perioperative and long-term outcomes of the procedure for prolapse and hemorrhoids and Ferguson hemorrhoidectomy. Results are presented here from the first prospective, randomized, multicenter trial comparing these hemorrhoid procedures in the United States.METHODS Patients with prolapsing hemorrhoids (Grade III) were randomized to undergo the procedure for prolapse and hemorrhoids or Ferguson hemorrhoidectomy by colorectal surgeons who had training in using the stapling technique. Primary end points were acute postoperative pain, and hemorrhoid symptom recurrence requiring additional treatment at one-year follow-up from surgery.RESULTS A total of 156 patients (procedure for prolapse and hemorrhoids, 77; Ferguson, 79) completed randomization and the surgical procedure, 18 (procedure for prolapse and hemorrhoids, 12; Ferguson, 6) had significant protocol violations. One hundred seventeen patients (procedure for prolapse and hemorrhoids, 59; Ferguson, 58) returned for one-year follow-up. Demographic parameters, hemorrhoid symptoms, preoperative pain scores, and bowel habits were similar between groups. There were a similar number of patients with adverse events in each group (procedure for prolapse and hemorrhoids, 28 (36.4 percent) vs. Ferguson, 38 (48.1 percent); P = 0.138). Reoperation for an adverse effect was required in six (7.6 percent) Ferguson patients and in 0 patients having the procedure for prolapse and hemorrhoids (P = 0.028). Postoperative pain during the first 14 days, pain at first bowel movement, and need for postoperative analgesics were significantly less in the procedure for prolapse and hemorrhoids group. Control of hemorrhoid symptoms was similar between groups; however, significantly fewer patients having the procedure for prolapse and hemorrhoids required additional anorectal procedures during one-year follow-up (procedure for prolapse and hemorrhoids, 2 (2.6 percent), vs. Ferguson, 11 (13.9 percent); P = 0.01). Only four of the Ferguson patients (5 interventions) required additional procedures more than 30 days after surgery.CONCLUSIONS These data demonstrate that stapled hemorrhoidopexy offers the benefits of less postoperative pain, less requirement for analgesics, and less pain at first bowel movement, while providing similar control of symptoms and need for additional hemorrhoid treatment at one-year follow-up from surgery.Supported by Ethicon Endo-Surgery, Cincinnati, Ohio.Read at the meeting of The American Society of Colon and Rectal Surgeons, Chicago, Illinois, June 3 to 8, 2002. Winner of The New England Society of Colon and Rectal Surgeons Award.     

Colonic J-Pouch-Anal Anastomosis for Rectal Cancer: A Prospective, Randomized Study Comparing Handsewn vs. Stapled Anastomosis

PURPOSE Colonic J-pouch-anal anastomosis performed after complete proctectomy and total mesorectal excision for adenocarcinoma of the rectum can be handsewn or stapled. Stapling the coloanal anastomosis is believed to shorten operating time and reduce morbidity, but there are no randomized trials comparing the techniques.METHODS Between January 1999 and May 2001, all patients with rectal adenocarcinoma requiring total mesorectal excision were randomized intraoperatively to handsewn or stapled anastomosis. Mortality, intraoperative, and postoperative findings and functional results at 3, 6, and 12 months were analyzed.RESULTS Thirty-seven patients (12 females; mean age, 60 ± 10 years) were randomized (stapled group: n = 20; handsewn group: n = 17). The two groups were comparable for age, gender, distance between the tumor and the levator ani, tumor volume, and use of preoperative radiotherapy (3 in each group). Morbidity did not differ between stapled group (3/20) and handsewn group (4/17; P > 0.05). Mean ± standard deviation operative time was shorter in stapled group (261 ± 40 minutes) than in handsewn group (314 ± 46 minutes; P = 0.0008), and median distance between the anastomosis and the anal verge was shorter in handsewn group (19 ± 9 mm) than in stapled group (27 ± 8 mm; P = 0.01). Three patients of handsewn group and none of stapled group developed an anastomotic stricture requiring a single digital dilation (not significant). Number of stools per 24 hours, urgency, incidence of fragmented stools, degree of continence, requirement for protective pad, and/or need to take medication at 3, 6, and 12 months were similar in both groups.CONCLUSIONS Stapled coloanal anastomosis is significantly faster than handsewn CAA and has similar functional results. It should be the preferred technique when it is feasible.Reprints are not available.Poster presentation at the meeting of The American Society of Colon and Rectal Surgeons, Chicago, Illinois, June 3 to 8, 2002, and at the meeting of the European Association of Coloproctology, Erlangen, Germany, September 12 to 14, 2002.     

A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Retinol Palmitate (Vitamin A) for Symptomatic Chronic Radiation Proctopathy

PURPOSE This study was designed to determine whether oral retinol palmitate (vitamin A) can reduce the symptoms of radiation proctopathy.METHODS A randomized, double-blind trial comparing retinol palmitate (10,000 IU by mouth for 90 days) to placebo was conducted. Eligible patients were more than six months postpelvic radiotherapy and had significant symptoms as measured with the Radiation Proctopathy System Assessments Scale. Nineteen patients were randomized in total: ten to retinol palmitate and nine to placebo. The Radiation Proctopathy System Assessments Scale scores before and every 30 days for 90 days were measured. Five placebo nonresponders were crossed over to the retinol palmitate for another 90 days. Response was defined as a reduction in two or more symptoms by at least two Radiation Proctopathy System Assessments Scale points.RESULTS Seven of ten retinol palmitate patients responded, whereas two of nine responded to placebo (P = 0.057). Mean pre-post-treatment change in Radiation Proctopathy System Assessments Scale ( Radiation Proctopathy System Assessments Scale) in the retinol palmitate group was 11 ± 5, whereas Radiation Proctopathy System Assessments Scale in the placebo group was 2.5 ± 3.6 (P = 0.013, Mann-Whitney U test). Additionally, all five placebo nonresponders who were crossed over to treatment with retinal palmitate responded to treatment.CONCLUSIONS In our trial, retinol palmitate significantly reduced rectal symptoms of radiation proctopathy, perhaps because of wound-healing effects. The current results can serve as the foundation for future trials examining retinol palmitate in the multi-institutional setting.Supported in part by a private grant from Arthur C. Nielsen, Jr.     

Prospective,Randomized, Controlled Trial Between a Pathway of Controlled Rehabilitation With Early Ambulation and Diet and Traditional Postoperative Care After Laparotomy and Intestinal Resection

INTRODUCTION: In an era of dwindling hospital resources and increasing medical costs, safe reduction in postoperative stay has become a major focus to optimize utilization of healthcare resources. Although several protocols have been reported to reduce postoperative stay, no Level I evidence exists for their use in routine clinical practice. METHODS: Sixty-four patients undergoing laparotomy and intestinal or rectal resection were randomly assigned to a pathway of controlled rehabilitation with early ambulation and diet or to traditional postoperative care. Time to discharge from hospital, complication and readmission rates, pain level, quality of life, and patient satisfaction scores were determined at the time of discharge and at 10 and 30 days after surgery. Subgroups were defined to evaluate those who derived the optimal benefit from the protocol. RESULTS: Pathway patients spent less total time in the hospital after surgery (5.4 vs. 7.1 days; P = 0.02) and less time in the hospital during the primary admission than traditional patients. Patients younger than 70 years old had greater benefits than the overall study group (5 vs. 7.1 days; P = 0.01). Patients treated by surgeons with the most experience with the pathway spent significantly less time in the hospital than did those whose surgeons were less experienced with the pathway (P = 0.01). There was no difference between pathway and traditional patients for readmission or complication rates, pain score, quality of life after surgery, or overall satisfaction with the hospital stay. CONCLUSIONS: Patients scheduled for a laparotomy and major intestinal or rectal resection are suitable for management by a pathway of controlled rehabilitation with early ambulation and diet. Pathway patients have a shorter hospital stay, with no adverse effect on patient satisfaction, pain scores, or complication rates. Patients younger than 70 years of age derive the optimal benefit, and increased surgeon experience improves outcome.     

Adsorptive Granulocyte/Monocyte Apheresis for the Maintenance of Remission in Patients with Ulcerative Colitis: A Prospective Randomized, Double Blind, Sham-Controlled Clinical Trial

Background/Aims

Weekly granulocyte/monocyte adsorption (GMA) to deplete elevated and activated leucocytes should serve as a non-pharmacological intervention to induce remission in patients with ulcerative colitis (UC). This trial assessed the efficacy of monthly GMA as a maintenance therapy to suppress UC relapse.

Methods

Thirty-three corticosteroid refractory patients with active UC received 10 weekly GMA sessions as a remission induction therapy. They were then randomized to receive one GMA session every 4 weeks (True, n=11), extracorporeal circulation without the GMA column every 4 weeks (Sham, n=11), or no additional intervention (Control, n=11). The primary endpoint was the rate of avoiding relapse (AR) over 48 weeks.

Results

At week 48, the AR rates in the True, Sham, and Control groups were 40.0%, 9.1%, and 18.2%, respectively. All patients were steroid-free, but no statistically significant difference was seen among the three arms. However, in patients who could taper their prednisolone dose to <20 mg/day during the remission induction therapy, the AR in the True group was better than in the Sham (p<0.03) or Control (p<0.05) groups.

Conclusions

Monthly GMA may potentially prevent UC relapse in patients who have achieved remission through weekly GMA, especially in patients on <20 mg/day PSL at the start of the maintenance therapy.     

多种消化酶制剂治疗消化不良的多中心、随机、安慰剂、双盲、平行对照研究

背景：多种消化酶制剂(商品名：达吉，含胃蛋白酶、木瓜蛋白酶、淀粉酶、纤维素酶、胰脂酶和胰酶6种消化酶以及熊去氧胆酸)对一些慢性消化系疾病(如胃肠、肝胆和胰腺疾病)的消化不良症状是否有改善作用，我国目前尚少随机对照的临床资料。目的：评价多种消化酶制剂治疗各种病因相关的慢性消化不良症状的临床疗效、安全性和依从性。方法：本研究采用多中心、随机、安慰剂、双盲、平行对照设计方案。上海市7个临床中心共收治胃肠疾病、肝源性、胆源性和胰腺疾病等相关的消化不良137例，随机分成2组。多种消化酶制剂治疗组68例，男42例，女26例；年龄48．4岁土10．7岁(19～71岁)。餐后立即服用多种消化酶制剂胶囊2粒，每日3次，疗程2周。安慰剂对照组69例，男37例，女32例；年龄46．9岁土11．0岁(24～71岁)。餐后立即服用安慰剂胶囊2粒，每日3次，疗程2周。分组治疗前每例均有2周药物清洗期。于治疗前以及疗程结束后观察消化不良症状的改善情况、安全性和依从性等。结果：2组患者均完成了规定的疗程。多种消化酶制剂治疗组各种病因相关的消化不良症状的总有效率优于安慰剂对照组(分别为92．6％和53．6％，P=0．001)；食欲不振、胃饱胀、腹部不适和腹胀症状的有效率(分别为70．6％、79，4％、77．9％和76，5％)亦均优于安慰剂对照组(46．4％、49．3％、39．1％和44．9％，P值分别为0．004、0．001、0．001和0．001)。然而，对于不同病因引起的消化不良症状，多种消化酶制剂的疗效没有显著差异。结论：多种消化酶制剂治疗胃肠疾病、肝源性、胆源性和胰腺疾病相关的消化不良症状安全有效，依从性好，无严重不良反应。     

Misoprostol and Ranitidine in the Prevention of NSAID-Induced Ulcers: A Prospective, Double-Blind, Multicenter Study

Objective: To compare ranitidine to misoprostol with respect to the prevention of gastric and duodenal ulcers in patients on chronic NSAID therapy. Methods : A multi-center, 8-wk, randomized, double-blind study. Eligible patients were on chronic NSAID therapy and were experiencing NSAID-related upper gastrointestinal (UGI) pain without UGI endoscopic evidence of gastric or duodenal ulcers. Patients enrolled in the study were randomized to either misoprostol 200 μg q.i.d. or ranitidine 150 mg b.i.d. Follow-up UGI endoscopy was performed after 4 and 8 wk of treatment. Therapeutic failure was considered the development of a gastric or duodenal ulcer ≤ 0.3 cm in diameter with perceptible depth. Results: Gastric ulcers were found in only 1/180 (0.56%) patient on misoprostol and in 11/194 (5.67%) patients on ranitidine, a difference that was statistically significant (p < 0.01). Duodenal ulcer rates were similar for the ranitidine (2/185 or 1.08%) and misoprostol (2/ 181 or 1.10%) groups. Conclusion: Misoprostol is significantly more effective than ranitidine in the prevention of NSAID-induced gastric ulcers. Ranitidine was as effective as misoprostol for the prevention of NSAID-induced duodenal ulcers. Misoprostol should be used for prophylaxis against both gastric and duodenal ulceration in patients on chronic NSAID therapy.     

Lateral Internal Sphincterotomy is Superior to Topical Nitroglycerin for Healing Chronic Anal Fissure and does not Compromise Long-Term Fecal Continence: Six-Year Follow-Up of a Multicenter,Randomized, Controlled Trial

Purpose Although there is enthusiasm for nonoperative management of anal fissures, most trials have been of short duration (6–8 weeks) and long-term outcome is unknown. The purpose of this study was to assess long-term outcome in two cohorts of patients who had participated in a randomized, controlled trial to compare the effectiveness of topical nitroglycerin with internal sphincterotomy in the treatment of chronic anal fissure. Methods Between February 1997 and October 1998, 82 patients with chronic anal fissure were accrued and randomized to 0.25 percent nitroglycerin ointment t.i.d. or lateral internal sphincterotomy. In 2004, a telephone survey of trial participants was conducted to determine symptom recurrence, the need for further medical and/or surgical treatment, and patient satisfaction. Furthermore, patients were assessed for symptoms of fecal incontinence using the Jorge and Wexner Fecal Incontinence Score and the Fecal Incontinence Quality of Life questionnaire. Results Overall, 51 of the original 82 patients (62 percent, 27 nitroglycerin, 24 lateral internal sphincterotomy) completed our survey. Mean follow-up was 79 (±1) months. Sphincterotomy patients were less likely to have experienced fissure symptoms within the past year (0 vs. 41 percent; P = 0.0004) and were less likely to require subsequent surgical treatment (0 vs. 59 percent; P < 0.0001) than patients treated with nitroglycerin. Patients in the lateral internal sphincterotomy group were more likely to say that they were “very” or “moderately” satisfied with their treatment (100 vs. 56 percent; P = 0.04) and that they would choose the same treatment again (92 vs. 63 percent; P = 0.02) than patients in the nitroglycerin group. Finally, the fecal incontinence and fecal incontinence quality of life scores at six-year follow-up were similar in both groups. Conclusions After six years of follow-up, it seems that lateral internal sphincterotomy is a more durable treatment for chronic anal fissure compared with topical nitroglycerin therapy and does not compromise long-term fecal continence. Thus, sphincterotomy continues to be a good treatment for patients with chronic anal fissure. Presented as a poster at the Tripartite Colorectal Meeting, Dublin, Ireland, July 5 to 7, 2005. Presented at the meeting of The American Society of Colon and Rectal Surgeons, Philadelphia, Pennsylvania, April 30 to May 5, 2005. Reprints are not available.     

The Efficacy of an Herbal Medicine, Carmint, on the Relief of Abdominal Pain and Bloating in Patients with Irritable Bowel Syndrome: A Pilot Study

Carmint contains total extracts of Melissa officinalis, Mentha spicata, and Coriandrum sativum, which have antispasmodic, carminative, and sedative effects. As abdominal pain/discomfort and bloating are commonly observed in patients with irritable bowel syndrome, we decided to evaluate the effectiveness of Carmint in relieving these symptoms in irritable bowel syndrome patients. We randomly assigned 32 irritable bowel syndrome patients to receive either Carmint or placebo, plus Loperamide or psyllium (based on their predominant bowel function), for 8 weeks. T-test analysis of the results showed that the severity and frequency of abdominal pain/discomfort were significantly lower in the Carmint group than the placebo group at the end of the treatment (P=0.016 and P=0.001, respectively), as were the severity and frequency of bloating (P=0.02 and P=0.002, respectively). This pilot study suggests that Carmint plus loperamide or Carmint plus psyllium (depending on the irritable bowel syndrome subtype) might be effective in these patients.     

Effect of Folic Acid, with or without Other B Vitamins, on Cognitive Decline: Meta-Analysis of Randomized Trials

Purpose

We aimed to quantify the effect of folic acid supplementation on the prevention of cognitive decline.

Methods

We conducted a meta-analysis of 9 placebo-controlled randomized trials (2835 participants, median duration 6 months) of folic acid, with or without other B vitamins, on cognitive function. Standardized mean differences in cognitive function test scores were calculated between folic acid and placebo-treated groups.

Results

The standardized mean difference in cognitive function test scores was 0.01 (95% confidence interval [95% CI], −0.08 to 0.10), or an increase of 1% (95% CI, −8% to 10%) of 1 standard deviation. The results were similar within each of the 4 categories of cognitive function (memory, speed, language, and executive function); standardized mean differences were 0.01 (95% CI, −0.08 to 0.09), −0.01 (95% CI, −0.10 to 0.13), −0.05 (95% CI, −0.15 to 0.04), and 0.03 (95% CI, −0.13 to 0.19), respectively.

Conclusion

Randomized trials show no effect of folic acid, with or without other B vitamins, on cognitive function within 3 years of the start of treatment. Trials of longer duration, recording the incidence of dementia, as well as cognitive decline, are needed.     

A Prospective Multicenter Randomized Controlled Study on Interleukin‐6 Removal and Induction by a new Hemodialyzer With Improved Biocompatibility in Hemodialysis Patients: A Pilot Study

We compared interleukin‐6 (IL‐6) removal and induction between conventional polysulfone (Con) and TORAYLIGHT NV (NV) dialyzers in hemodialysis patients. Twenty patients on Con with high IL‐6 concentrations (2.7–8.5 pg/mL) were randomized to Con or NV group. Dialyzer performance was determined in NV group while patients were on Con and after being switched onto NV. Erythropoiesis‐stimulating agent (ESA) response index (ERI) was assessed every 4 months for one year. IL‐6 clearance was comparable between Con and NV. IL‐6 removal rates were comparable for the first 1 h, but were higher with NV for the entire session (P = 0.03). Before‐to‐during‐dialysis IL‐6 concentration ratios were lower with NV on the venous side after the session (P = 0.03). During the one‐year study, hemoglobin was lower in Con group than in NV group at month 8 (P = 0.046). ERI decreased in NV and increased in Con group, with a significant difference between the groups (P = 0.002). NV and Con are comparable in removing IL‐6 and both induce IL‐6. However, the data suggest that NV induces less IL‐6, which may reduce the risk of ESA hyporesponsiveness.