Subcutaneous heparin and postoperative wound hematomas. A prospective, double-blind, randomized study

A prospective, double-blind, controlled study was conducted to assess the incidence of postoperative wound hematomas associated with low-dose subcutaneous heparin therapy among patients undergoing surgery for a single inguinal hernia. The groups were well matched. The results indicate that low-dose heparin therapy is associated with more wound hematomas. Complications of low-dose heparin therapy and new ways to avoid these complications are discussed. The indications for the prophylactic administration of low-dose heparin therapy need careful assessment.     

A prospective randomized trial for postoperative vs. preoperative adjuvant radiotherapy for muscle-invasive bladder cancer

PurposeAlthough radical cystectomy is considered to be the primary treatment for muscle-invasive bladder cancer, it is associated with unfavorable outcome. Local recurrence is still a major problem. Survival rates as well as quality of live are far from being satisfactory. Postoperative radiotherapy is considered the standard adjuvant treatment in the NCI-Egypt. This is a prospective randomized study conducted to compare preoperative with postoperative radiotherapy as regard the survival and complication rates.Patients and methodsIn the period from May, 2004 to June 2007, 100 eligible patients were included into the study, 50 patients in each treatment arm. Pelvic irradiation was identical in both groups aiming at 50 Gy/25 Fs/5 wk. Radical cystectomy was the standard surgery. Locoregional control, survival rates, and complications rates were compared in both arms.ResultsPatients had a median follow-up period of 32 months (range 0–69 months). Patients had an average age of 54.8 ± 9.5 years with a male/female ratio 3:1. In the present study, transitional cell carcinoma constitutes (51%), while squamous cell carcinoma was reported in 46% of cases. Grades II and III pathology were 81% and 17%, respectively. Pathological stage P_2b was encountered in 39.5% of the patients followed by P₃b (33.3%) and P₃a (14.6%). For the preoperative group, the 3-year overall survival, disease-free survival, locoregional control, and metastases-free survival rates were 53.4%, 47.4%, 89.3%, and 61.5%, respectively. The corresponding figures for the postoperative group were 51.8%, 34.1%, 80.6%, and 55.7% for the postoperative group. None of the patients had serious radiation reactions.ConclusionIn our study, preoperative radiotherapy was almost equivalent to postoperative radiation therapy as regard OS, DFS, as well as complication rates. Given the recent physical developments in radiation therapy techniques and the biological rationale for treating the pelvis after cystectomy, adjuvant radiotherapy should be re-evaluated world wide. Preoperative radiotherapy may re-emerge as a useful tool for adjuvant treatment.     

Negative effect of Metoclopramide in postoperative adynamic ileus. A prospective, randomized, double blind study

In a double blind controlled study including 60 patients it was found that Metoclopramide has a negative effect upon the resolution of postoperative adynamic ileus. Metoclopramide causes a delay in the time from operation to the first passage of flatus.     

The effects of metoclopramide on postoperative ileus. A randomized double-blind study.

Metoclopramide or placebo was administered postoperatively in a randomized, double-blind fashion to 115 patients undergoing laparotomy. The effect of metoclopramide on postoperative adynamic ileus (PAI) was evaluated. The patients were stratified into two groups: Group A--those with laparotomy without a gastrointestinal anastomosis or ostomy procedure, and group B--those with laparotomy undergoing an anastomosis or ostomy procedure. Metoclopramide reduced nausea and emesis postoperatively. However, the only significant effect on postoperative adynamic ileus was an earlier return to tolerance of solid foods in the patients in Group A.     

A randomized trial of postoperative radiotherapy versus observation in stage II and III renal adenocarcinoma. A study by the Copenhagen Renal Cancer Study Group

Between 1979 and 1984 the Copenhagen Renal Cancer Study Group randomized 72 patients nephrectomized for stages II and III renal adenocarcinoma in a prospective study of postoperative radiotherapy versus observation. Radiotherapy was 50 Gy in 20 fractions to the kidney bed, ipsi- and contralateral lymph nodes. 7/72 were excluded from further analysis because of major protocol violations. 33/65 were in stage II, 32/65 in stage III. Relapse was found in 31/65 = 48% during the follow-up period without any difference between the two groups. 12/27 = 44% had significant complications from stomach, duodenum or liver, median 5 mo., range 1-44 mo. after radiotherapy. In 5/27 = 19% did the postirradiatory complications contribute to the death of the patients. Patients with stage II tumours survived significantly better than those with stage III tumours (p less than 0.05), but no significant differences in survival could be demonstrated between patients randomized to postoperative radiotherapy or observation. It is concluded that postoperative radiotherapy as given in the present study is without any beneficial effect on relapse rate and survival. Moreover, the treatment is associated with an unacceptable complication rate.     

Preoperative use of povidone-iodine. A prospective, randomized study

One hundred one adult orthopedic surgical patients were studied in a randomized, prospective clinical trial to compare the effectiveness of the standard povidone-iodine scrub and paint with povidone-iodine painting alone for presurgical skin preparation. No infections occurred in either group. The scrub-plus-paint group showed a 0.601 logarithmic reduction in bacteria counts, compared with 0.622 with painting alone. Further, 36.8% of the patients in the scrub-plus-paint group had skin counts that actually increased after preparation, compared with 13.8% of patients in the paint-only group. The preparation bacterial counts among inpatients, who received preoperative hexachlorophene showers, were significantly lower than that of outpatients, who did not receive preoperative showers. The data support the use of the preoperative hexachlorophene shower and the omission of scrubbing from the surgical skin preparation technique.     

A prospective randomized study of abdominal aortic surgery without postoperative nasogastric decompression

Nasogastric decompression following abdominal aortic aneurysmectomy or bypass, for 3–4 days, is a routine part of postoperative care in many centers. A prospective randomized study of 80 patients undergoing abdominal aortic surgery was performed in order to determine the necessity of prolonged nasogastric decompression. Patients were divided evenly between removal of the nasogastric tube upon tracheal extubation and retention of the tube until the passage of flatus. Preoperative risk factors, aortic cross-clamp time, estimated blood loss, length of procedure, length of intensive care unit stay, numbers of days with nasogastric tube, number of days until clear liquid and regular diets commenced, and the length of hospital stay were recorded for all patients. There were no significant differences in any of the measured variables between the two groups. The length of hospital stay was similar in both groups and three patients in each group required a nasogastric tube or reinsertion of one. In conclusion, the routine postoperative use of nasogastric tubes for abdominal aortic procedures is unnecessary. Copyright © 1996 The International Society for Cardiovascular Surgery.     

Automated control of postoperative hypertension: a prospective, randomized multicenter study

Hypertension after a cardiac operation is a frequent phenomenon. Complications resulting from this include bleeding, disruption of vascular suture lines, subendocardial ischemia, and possible cerebrovascular accidents. Treatment with sodium nitroprusside has become accepted practice to prevent these complications. To improve control of arterial blood pressure, a closed-loop system for sodium nitroprusside administration was developed. A prospective, randomized multicenter study was carried out postoperatively in 180 cardiac surgical patients to evaluate the performance of this system compared with manual control of infusion. Adherence of mean arterial blood pressure to +/- 10% of the target blood pressure occurred 85% of the time with the automatic system and 61% of the time with manual regulation (p less than 0.0001). With the automatic system, there was less hypertension (9% versus 22%; p less than 0.0001) and hypotension (6% versus 22%; p less than 0.0001). The superior control of hypertension was achieved more rapidly with less requirement for nurse regulation of infusion rate. The superior control of blood pressure resulted in less chest tube drainage in the automatic mode (720 mL versus 840 mL; p less than 0.05).     

A prospective, randomized trial of cognitive intervention for postoperative pain

A single-blind, randomized prospective trial was performed at a university hospital to determine if preoperative relaxation training will decrease pain and narcotic demand postoperatively. A convenience sample of 49 patients undergoing lumbar and cervical spine surgery was randomized to receive instruction on relaxation techniques or routine preoperative information before surgery. Pain score and narcotic demand in the first 48 hours after surgery were the primary outcomes. Pain scores were higher in the relaxation (4.8 +/- 1.7) versus the standard preparation group (3.9 +/- 1.7) on postoperative day one (POD) 1, but lower on POD 2 (3.9 +/- 1.9 vs 4.1 +/- 1.9), whereas narcotic use (milligrams of IV morphine per hour) was higher in the relaxation group on POD 1 (1.14 +/- 0.94 vs 0.54 +/- 0.55) and POD 2 (0.86 +/- 0.73 vs 0.50 +/- 0.61). The differences were significant for narcotic demand (P = 0.01) but not for pain (P = 0.94). In conclusion, our results could not support the use of relaxation training for reducing postoperative pain and narcotic demand in this selected surgical population.     

Cooling for the reduction of postoperative pain: prospective randomized study

Hernia surgery has been associated with severe pain within the first 24 h postoperatively. The application of cold or cryotherapy has been in use since at least the time of Hippocrates. The physiological and biological effects from the reduction of temperature in various tissues include local analgesia, inhibited oedema formation and reduced blood circulation. Our hypothesis was that cold therapy, applied by means of ice packs, following inguinal hernia surgery, controlled pain postoperatively. Forty patients scheduled for inguinal hernia repair were enrolled in a double-blind, randomized study. Postoperatively, chipped ice in a plastic bag (cold group), and a plastic bag containing only room temperature water (control) were placed over the incision for 20 min. Postoperative pain data were collected at 2, 6 and 24 h after operation according to the well validated visual analogue scale (VAS). The highest pain levels were recorded 2 h postoperatively for both groups. Pain levels then gradually decreased for both the trial groups during the first 24 h postoperatively. There were significant differences in the VAS scores between the groups at 2, 6 and 24 h. We conclude that local cooling is a safe and effective technique for providing analgesia following inguinal hernia repair.     

Intracoronary shunt reduces postoperative troponin leaks: a prospective randomized study.

OBJECTIVE: The purpose of this study was to evaluate whether intracoronary shunt usage reduced the myocardial damage on the basis of the cardiac markers when compared with the shuntless anastomosis in off-pump coronary artery bypass grafting (OPCABG) surgery of isolated left anterior descending artery lesions. METHODS: Forty patients who had stable angina with isolated left anterior descending (LAD) coronary artery lesion undergoing OPCABG surgery were randomized into two groups. Shunt group consisted of 20 patients who had OPCABG using intracoronary shunt, whereas the shuntless group consisted of 20 patients who underwent OPCABG without using intracoronary shunt. Cardiac troponin I, CK, and CK-MB before and 24h after the surgery were assessed in the groups. RESULTS: There were no deaths in the study. The two groups were similar with respect to sex and age. Duration of LIMA-LAD anastomosis was significantly higher in the shunt group (p=0.01). There was no significant difference between the groups concerning the preoperative and postoperative CK and CK-MB levels. The preoperative troponin I levels of the groups were not different (p=0.238; NS), whereas postoperative levels of this marker was significantly higher in the shuntless group (p=0.003). CONCLUSION: Intracoronary shunt reduced the postoperative troponin I levels significantly, so it may be indicated in the patients who are thought to be susceptible to transient ischemia.     

Topical use of antifibrinolytic agents reduces postoperative bleeding: a double-blind, prospective, randomized study.

OBJECTIVE: Postoperative bleeding is still one of the most common complications of cardiac surgery. Antifibrinolytic agents successfully reduce bleeding, but there are controversies concerning adverse effects after their systemic use. By topical application of antifibrinolytic agents in pericardial cavity, most of these effects are avoided. We compared the effects of topically applied aprotinin, tranexamic acid and placebo on postoperative bleeding and transfusion requirements. METHODS: In this single-center prospective, randomized, double-blind trial, 300 adult cardiac patients were randomized into three groups to receive one million IU of aprotinin (AP group), 2.5g of tranexamic acid (TA group) or placebo (PL group) topically before sternal closure. Groups were comparable with respect to all preoperative and intraoperative variables. Postoperative bleeding, transfusion requirements and hematologic parameters were evaluated. RESULTS: Postoperative bleeding within first 12-h period (AP group 433+/-294 [350; 360]ml, TA group 391+/-255 [350; 305]ml, PL group 613+/-505 [525; 348]ml), as well as cumulative blood loss within 24h (AP group 726+/-432 [640; 525]ml, TA group 633+/-343 [545; 335]ml, PL group 903+/-733 [800; 445]ml), showed statistically significant inter-group differences (both p<0.001). Bleeding rates values were significantly higher in placebo group compared to the groups treated with antifibrinolytic agents (AP and TA groups) concerning both variables. Although TA group showed the lowest values, no statistical differences between TA and AP groups were found. Inter-group difference of blood product requirements was not statistically significant. CONCLUSIONS: Topical use of either tranexamic acid or aprotinin efficiently reduces postoperative bleeding. TA seems to be at least as potent as aprotinin, but potentially safer and with better cost-effectiveness ratio.     

Efficacy of low-dose propranolol in preventing postoperative supraventricular tachyarrhythmias: a prospective, randomized study.

A prospective, randomized study was performed in 100 consecutive patients undergoing coronary artery bypass surgery to assess the efficacy of the early reinstitution of propranolol in reducing the incidence of postoperative supraventricular tachyarrhythmias (SVT). Patients were randomized to receive propranolol 10 mg every 6 hours enterally starting the morning after surgery (Group I, 50 patients) or to serve as controls (Group II, 50 patients). No patient was excluded because of poor ventricular function, need for urgent revascularization, or transient necessity for ionotropic support. Both groups had a comparable incidence of risk factors, previous infarction, unstable angina, and abnormal ventricular function. The extent of coronary disease, preoperative propranolol dose, and number of grafts performed were also similar. SVT occurred in 3/50 (6%) patients in Group I compared with 14/50 (28%) in Group II (p less than 0.01). There were no preoperative or intraoperative discriminators to predict the occurrence of SVT. In addition, perioperative infarction and the need for mechanical or pharmacologic circulatory support did not predispose to SVT. The data indicate that early administration of propranolol should be given to all patients after myocardial revascularization to decrease the incidence of these postoperative rhythm disturbances.     

The "ideal" cholecystectomy. A prospective, randomized study

200 patients undergoing elective cholecystectomy were studied in a prospective randomized manner. This study suggests that the nasogastric tube and postoperative iv-infusions are unnecessary. We continue to use a subhepatic drain. Exception: the senior surgeon in a straightforward case.     

Colloid versus crystalloid cardioplegia. A prospective, randomized clinical study

The effects of adding colloid (dextran 40, Rheomacrodex) to cardioplegic solution were studied in 55 men undergoing bypass grafting for uncomplicated coronary artery disease. The patients were randomly allocated to group I (n = 27), in which 35 g dextran 40 was added to the St Thomas II cardioplegic solution, or group II (n = 28), which received a standard crystalloid cardioplegic solution. The groups were comparable in regard to preoperative and intraoperative data. In group I the pulmonary vascular resistance index was transiently elevated after extracorporeal circulation and both oxygen consumption and arteriovenous oxygen content difference 2 hours postoperatively were greater than in group II, suggesting better microcirculation. Postoperative normalization of the chest X-rays was more rapid in group I. The clinical course was similar in the two groups.     

A prospective, randomized study of endothelin and postoperative recovery in off-pump versus conventional coronary artery bypass surgery

OBJECTIVE: The objectives are 2-fold: (1). to serially determine endothelin (ET) levels in arterial vascular compartments in patients undergoing coronary artery bypass surgery using either cardiopulmonary bypass or off-pump techniques, and (2). to define potential relationships between endothelial levels and specific perioperative parameters of patient recovery. METHODS: In a prospective, randomized study, endothelin plasma content was measured from patients undergoing coronary artery bypass grafting using either off-pump techniques (OPCAB group, n = 25) or conventional cardiopulmonary bypass (CPB group, n = 25) before surgery, before and after coronary artery anastomosis, and 6 and 24 hours postoperatively. Specific indices of patient recovery including pulmonary artery pressures, ventilation requirement, and hospital stay were documented for patients in both study groups. RESULTS: Postoperative systemic arterial ET levels were significantly increased by 200% in the CPB group and 50% in the OPCAB group. ET levels remained significantly higher in the CPB group relative to the OPCAB group throughout the postoperative period of observation (p < 0.05). Pulmonary artery pressures, ventilation requirement, and hospital stay were significantly increased in patients in the CPB group. CONCLUSIONS: Postoperative ET levels were higher in patients who underwent CPB for coronary artery bypass surgery. Increased ET in the postoperative period may contribute to a more complex recovery from coronary artery bypass surgery in patients undergoing cardiopulmonary bypass.