Drain Usage Research Articles

Randomized Multicenter Trial of Sentinel Node Biopsy Versus Standard Axillary Treatment in Operable Breast Cancer: The ALMANAC Trial

Background: Sentinel lymph node biopsy in women with operable breast cancer is routinely used in some countries for staging the axilla despite limited data from randomized trials on morbidity and mortality outcomes. We conducted a multicenter randomized trial to compare quality-of-life outcomes between patients with clinically node-negative invasive breast cancer who received sentinel lymph node biopsy and patients who received standard axillary treatment. Methods: The primary outcome measures were arm and shoulder morbidity and quality of life. From November 1999 to October 2003, 1031 patients were randomly assigned to undergo sentinel lymph node biopsy (n = 515) or standard axillary surgery (n = 516). Patients with sentinel lymph node metastases proceeded to delayed axillary clearance or received axillary radiotherapy (depending on the protocol at the treating institution). Intention-to-treat analyses of data at 1, 3, 6, and 12 months after surgery are presented. All statistical tests were two-sided. Results: The relative risks of any lymphedema and sensory loss for the sentinel lymph node biopsy group compared with the standard axillary treatment group at 12 months were 0.37 (95% confidence interval [CI] = 0.23 to 0.60; absolute rates: 5% versus 13%) and 0.37 (95% CI = 0.27 to 0.50; absolute rates: 11% versus 31%), respectively. Drain usage, length of hospital stay, and time to resumption of normal day-to-day activities after surgery were statistically significantly lower in the sentinel lymph node biopsy group (all P <.001), and axillary operative time was reduced ( P = .055). Overall patient-recorded quality of life and arm functioning scores were statistically significantly better in the sentinel lymph node biopsy group throughout (all P ≤.003). These benefits were seen with no increase in anxiety levels in the sentinel lymph node biopsy group ( P >.05). Conclusion: Sentinel lymph node biopsy is associated with reduced arm morbidity and better quality of life than standard axillary treatment and should be the treatment of choice for patients who have early-stage breast cancer with clinically negative nodes.

Sentinel node biopsy in breast cancer: The first results of the randomized multicenter ALMANAC Trial

506 Background: Sentinel node biopsy is becoming the standard of care in some centres despite a lack of randomized evidence. Methods: The ALMANAC trial is a randomized, multicenter trial in the UK comparing SNB to conventional axillary treatment in clinically node-negative breast cancer patients. The 3 main outcome measures were: a) arm and axillary morbidity b) quality of life (QoL) using FACT +B4 and Spielberger State/Trait Anxiety Inventory and c) resource costs. The randomized phase was preceded by a validation phase. Surgeons achieving a set standard in the validation phase, a localization rate of ≥90% and a false negative rate of ≤5%, proceeded to the randomized phase. From November 1999 to October 2003, 1031 patients with clinically node-negative invasive breast cancer were randomized to undergo SNB(515) or standard axillary treatment(516). Sentinel node identification used a combined technique involving blue dye and radioisotope. All patients underwent pre-operative lymphoscintigraphy. Sentinel node positive patients proceeded to axillary clearance. Patients were followed up at 1, 3, 6, 12 and 18 months post-op. Results: In the SNB group, sentinel node localization was successful in 504 patients (97.9%). Axillary metastases were detected in 115 patients (22%) in the SNB group, and in 104(20%) patients in the standard axillary treatment group. In an intention-to-treat analysis, relative risks for sensory loss and lymphoedema at 3 months in the SNB group relative to the standard management group were 0.39 and 0.28. Hospital stay, axillary operative time and drain usage were significantly reduced in the SNB group (p<0.001). Time to return to normal activities was reduced in the SNB group (p=0.002). At baseline QoL scores did not differ between groups. At 3 months assessment, overall QoL and self-rated arm morbidity were significantly better in the SNB group (p<0.01). Furthermore, these benefits were not at the cost of raised anxiety in the SNB group. Conclusion: SNB is associated with less arm morbidity and better quality of life and is cost-effective compared to standard axillary treatment. No significant financial relationships to disclose.

Sentinel node biopsy in breast cancer: The first results of the randomized multicenter ALMANAC Trial

Background: Sentinel node biopsy is becoming the standard of care in some centres despite a lack of randomized evidence. Methods: The ALMANAC trial is a randomized, multicenter trial in the UK comparing SNB to conventional axillary treatment in clinically node-negative breast cancer patients. The 3 main outcome measures were: a) arm and axillary morbidity b) quality of life (QoL) using FACT +B4 and Spielberger State/Trait Anxiety Inventory and c) resource costs. The randomized phase was preceded by a validation phase. Surgeons achieving a set standard in the validation phase, a localization rate of ≥90% and a false negative rate of ≤5%, proceeded to the randomized phase. From November 1999 to October 2003, 1031 patients with clinically node-negative invasive breast cancer were randomized to undergo SNB(515) or standard axillary treatment(516). Sentinel node identification used a combined technique involving blue dye and radioisotope. All patients underwent pre-operative lymphoscintigraphy. Sentinel node positive patients proceeded to axillary clearance. Patients were followed up at 1, 3, 6, 12 and 18 months post-op. Results: In the SNB group, sentinel node localization was successful in 504 patients (97.9%). Axillary metastases were detected in 115 patients (22%) in the SNB group, and in 104(20%) patients in the standard axillary treatment group. In an intention-to-treat analysis, relative risks for sensory loss and lymphoedema at 3 months in the SNB group relative to the standard management group were 0.39 and 0.28. Hospital stay, axillary operative time and drain usage were significantly reduced in the SNB group (p<0.001). Time to return to normal activities was reduced in the SNB group (p=0.002). At baseline QoL scores did not differ between groups. At 3 months assessment, overall QoL and self-rated arm morbidity were significantly better in the SNB group (p<0.01). Furthermore, these benefits were not at the cost of raised anxiety in the SNB group. Conclusion: SNB is associated with less arm morbidity and better quality of life and is cost-effective compared to standard axillary treatment.

Is closed-suction drain necessary in unicompartmental knee replacement? A prospective randomised study

In a prospective randomised trial we evaluated the use of a post-operative closed-suction drain in unicompartmental knee replacement (UKR). Seventy-eight patients were divided into two groups: one without a post-operative closed-suction drain (Group A) and one with a drain (Group B). Both groups were matched for age, sex and pre-operative haemoglobin. In group A we observed a lower day one post-operative analgesic requirement, smaller knee circumference 3 days post-operatively and less local wound complications. Drain usage in UKR resulted in no significant advantage in post-operative pain, range of motion and hospital stay. Post-operative drainage does, however, increase the cost of the procedure both in labour and equipment expenditure. No deep infections occurred in either group during the follow-up period. We conclude that avoiding post-operative closed-suction drainage in UKR does not influence the outcome.

Removal of retained Penrose drain under fluoroscopic guidance

An uncommon complication of Penrose drain usage is retention of the drain by a fascial suture. Removal of a retained Penrose drain can be carried out percutaneously under fluoroscopic guidance.

The use of drains for outpatient orthopaedic surgeries: Safety and efficacy

While drains have been routinely used in orthopaedic surgery for postoperative wound drainage following inpatient surgical procedures, there are no published reports on the safety or efficacy of drains for outpatient orthopaedic surgeries. This review reports our experience between July 1995 and January 1996 with the use of drains for 35 patients having outpatient orthopaedic surgery. Consequences of drain usage were determined by medical chart review and a follow-up telephone survey in which patients were asked a series of questions regarding the drains used for their operation. None of the patients had an infection or any other medical problem as a result of drain usage and there were no problems with wound healing. Patients were quite capable of managing and removing their own drains. We conclude that drains are effective and can be used safely for outpatient orthopaedic surgical procedures.

The syndrome of the fixed omentum

1. 1. The syndrome of omental attachment-fixation has been presented. 2. 2. The production of the symptoms of this entity have been explained. 3. 3. A division into clinical groups has been advocated and methods of management presented. 4. 4. A method of amputating the omentum is presented. 5. 5. The differential diagnosis of this syndrome from other lesions is discussed. 6. 6. Case reports are presented to illustrate various types of the clinical manifestations of the syndrome. 7. 7. Further conclusions follow these facts: (1) The syndrome is a very common one. (2) More discreet closure of abdominal incisions is necessary, to prevent attachment-fixation of the omentum, as is also the discreet re-peritonization of raw intraabdominal surfaces. (3) The unwarranted usage of intra-abdominal drains, unnecessary suture material or other foreign bodies must be sharply delimited. (4) The differential diagnosis of this syndrome from other intra-abdominal lesions makes the proper diagnosis of intra-abdominal pathological conditions more accurate and more inclusive, and provides assurance of surgical relief to a new and considerable group of patients. (5) Distinction should be made as to whether or not this syndrome complicates other intra-abdominal lesions; for example, when fixation-attachment of the omentum accompanies an intra-abdominal lesion, such as hernia. (6) In the preoperative analysis of these cases full consideration must be given to the estimation of bowel segment fixation and to eschar compression of the ureter.