A prospective randomized study on management of suction drains in patients undergoing modified radical mastectomy

Background and Objectives: Seroma, a subcutaneous collection of serous fluid, is the most common morbidity after modified radical mastectomy. Closed suction drains are used for drainage of serous fluid after MRM to obliterate the space beneath skin flaps and thus to decrease seroma formation. Amongst various factors that influence the amount of postoperative drainage, the negative suction pressure applied to the axillary drain has been reported to be of significance. The aim of this study was to evaluate the correlation between duration of negative suction pressure and timing of drain removal on amount and duration of axillary drain fluid and seroma formation in patients undergoing Modified Radical Mastectomy. Design: A prospective randomized study from September 2012 to December 2014. Setting: Department of General Surgery, Pt. B.D. Sharma PGIMS, Rohtak. Material and methods: Seventy five patients of primary breast cancer who underwent modified radical mastectomy with axillary lymphadenectomy performed up to level III were randomized into three groups of 25 each. Surgery was performed by the same surgical team using a standardized technique with electrocautery in all the patients. In Group A-Pectoral drain was removed on 2nd post-operative day and negative suction was also removed from axillary drain on the same 2nd postoperative day while in Group BPectoral drain removed on 2nd postoperative day and negative suction was removed from axillary drain on 5th post-operative day. In Group C-Pectoral drain was removed on 5th post-operative day and negative suction was continued on axillary drain till its removal. In all the patients’ axillary drain was removed once last 24 hour output falls below 30cc. Following discharge patients were assessed for seroma formation on OPD basis up to 1 month and seroma was managed with needle aspiration. Main outcome measure: Postoperative seroma formation, correlation of duration of negative suction pressure and timing of drain removal with period of seroma formed. Statistical methods used: Data was analysed using IBM SPSS STATISTICS version 20 using ANOVA, independent t-test, and correlation (Pearson’s coefficient of correlation) test Results: Incidence of seroma formation in our study was 40%. Axillary drainage of 1st two days correlated positively with subsequent seroma formation (p=0.044), however, total axillary drainage volume was not associated significantly with formation of seroma after removal of drains (p=0.137) Incidence of seroma formed (A= 48% vs. B=32% vs. C= 40%) as well as volume of seroma formed (A=143 cc v/s B= 173 cc v/s C=129 cc) was not related to duration of negative suction pressure and it was statistically not significant (p=0.672) amongst the groups. There is no added advantage of keeping pectoral drain for more than for 48 hrs, rather its presence increases the total drain output and subsequent in-patient stay (p International Journal of Enhanced Research in Medicines & Dental Care ISSN: 2349-1590, Vol. 2 Issue 11, November-2015 Page | 10 INTRODUCTION Surgery has been the principal mode of treatment for management of the breast cancer and it has evolved from radical mastectomy to modified radical mastectomy and now to breast conservation surgery. 1 However, Modified Radical Mastectomy (MRM) is still the gold standard treatment for breast cancer and is the most common surgery performed in patients of breast cancer in India. Axillary lymph node dissection (ALND) performed up to level III during MRM is standard treatment for positive axilla. Modified Radical Mastectomy is associated with several complications such as infection, hematoma, wound breakdown and flap necrosis. The complications like arm edema, decreased range of shoulder movements, paraesthesia of the medial arm and axilla, breast shoulder dysfunction and seroma formation are attributed to Axillary Lymph Node Dissection (ALND) performed during MRM. Seroma formation is the most frequent postoperative complication seen after mastectomy with an incidence of 3% to 85% depending on the definition of seroma or assessment methods.It is so common that it is now believed to be a side effect of surgery rather than a complication.In clinical practice, the term seroma is used for any collection created in dead space after any surgery. Different terminologies have been used regarding fluid collection in the dead space under flap and axilla after mastectomy. This fluid has been variously called as axillary drain fluid or seroma.In this study, the word axillary drain fluid is used for the serous fluid drained till the drains are in-situ while the word seroma is used for subcutaneous palpable collection of serous fluid which occurs under the skin flaps or in the axillary dead space once the drains are removed. The origin of seroma remains unclear but several risk factors and predictors are age, breast size, co-morbid conditions, presence and number of malignant nodes in the axilla, extent of surgery and previous surgical biopsy; thus, leading to varying incidence of seroma in different studies.It has been hypothesized that seroma form as an exudate from an acute inflammatory reaction following surgical trauma to increase serous fluid collection in response to increased fibrinolytic activity in serum and lymph. Seroma formation typically delays recovery and adds to morbidity such as increased length of hospital stay, delay in the initiation of adjuvant therapy, increased predisposition to wound infection, delayed wound healing and has also been linked to lymph edema of the arm and the over-stretching of the health budget. Although association with morbidity and financial problems are clear, the optimal ways to reduce the incidence of seroma formation are not well known. There have been various methods for preventing seroma collection, such as prolonged suction drainage, shoulder immobilisation, suturation of dead place, perioperative use of tranexamic acid, octreotide usage, dressing compression, tissue sealers, etc., but these methods for the prevention and treatment of seroma remain varied and inconclusive. Drains are important factor in affecting the hospital stay as the patients are often discharged only after their removal. It has not been proven that prolonged drainage prevents subsequent seroma formation. The use of closed suction drainage in patients who underwent mastectomy accelerates wound healing and is also associated with a lower incidence of wound infection, necrosis, and breakdown. 10,11 Closed suction drains have been widely practiced and usually two drains are placed: one under the flap in the pectoral region and one in the axilla to obliterate the space beneath skin flaps and thus to decrease seroma formation. The length of hospital stay after modified radical mastectomy mainly depends upon the drain management of the patient, although some surgeons advocate discharge with the drain in-situ. The appropriate duration of time needed to drain the axilla after modified radical mastectomy varies according to institution and surgical practices therefore still, there is no uniformity about number of drains to be placed after modified radical mastectomy and timing of drain removal. Drains are often left in place until the volume of drainage is minimal (<30 mL/ day). Amongst various factors that influence the amount of postoperative drainage, the negative suction pressure applied to the drain has been reported to be of significance. While a high negative suction pressure is expected to drain the collection, and reduce the dead space promptly and prevent the seroma formation it may also prevent the leaking lymphatics from closing and ultimately leading to longer hospital stay. The present study has been conducted to correlate the timing of drain removal and effect ofduration of negative suction pressure on amount and duration of axillary drain fluid and seroma formation in patients undergoing Modified Radical Mastectomy. MATERIAL AND METHODS This prospective study was conducted in the department of surgery, Pt.B.D.Sharma PGIMS, Rohtak on patients of primary breast cancer who presented in the time period from September 2012 to December 2014. Seventy five patients of primary breast cancer having histologically proven invasive carcinoma of the breast in whom modified radical mastectomy (MRM) was planned were included in the study. Patients of primary breast cancer with metastatic spread, those who have received prior radiotherapy or who were planned for immediate breast reconstruction or breast conserving surgery were excluded. International Journal of Enhanced Research in Medicines & Dental Care ISSN: 2349-1590, Vol. 2 Issue 11, November-2015 Page | 11 The patients in whom breast cancer was suspected tissue diagnosis of carcinoma breast was established either by Fine Needle Aspiration Cytology (FNAC) or by Trucut biopsy. If patient had already underwent lumpectomy outside; the blocks and slides were reviewed in the institute to confirm the malignancy. Clinical TNM staging was done and metastatic work was performed depending upon clinical stage of the patient on outpatient basis. Patients of locally advanced breast cancer (LABC) were given neoadjuvant chemotherapy (CEF / Taxane based) before contemplating surgery. Modified radical mastectomy was performed by the same surgical team using a standardized technique with electrocautery in all the patients. Axillary dissection was performed upto level III following Aushincloss method of axillary dissection, sparing both pectoralis major and pectoralis minor. Electrocautery was used to control all small blood vessels and lymphatics. Once adequate hemostasis was achieved, two silicone tube drains (Romson’s 14 Fr) one in the pectoral region and one in the axilla were inserted intraoperatively in all the patients via two different stab wounds. The end of the axillary drain was placed in the top of the axilla and a flap drain was kept below the inferior flap. A single negative suction drain set (Romo Vac Set) was used and the two drains: axillary and pectoral were connected with a Y-connector to the negative suction drainage set. No attempts were made to close the dead space in the axilla or the breast wound by additional measures. Incisions were closed in a standard fashion using proximate skin stapler 35w and standard perioperative antibiotics were used in all the patients. 75 cases of modified radical mastectomy were randomised (using randomly ordered sealed envelopes, which were opened immediately before the closure of the wound)in three equal groups of 25 each, Group A and Group B served as study groups while Group C served as control. In group ‘A’ pectoral drain was removed on 2 post-operative day along with removal of negative suction on axillary drain on the same day. In group ‘B’ pectoral drain removed on 2 post-operative day but negative suction on axillary drain was removed on 5 post-operative day. In the control group ‘C’ pectoral drain was removed on 5 post-operative day and negative suction was continued on axillary drain till its removal. In all the patients, daily drain output was recorded and the axillary drain was removed once last 24 hour output fell below 30cc. Following axillary drain removal patients were discharged from ward and each patient had one scheduled OPD visits in the first postoperative week, and weekly thereafter or more frequently as needed. At each visit, the pectoral region and axilla was assessed for seroma formation and signs of infection. The following information were recorded: age, sex, any comorbidity, BMI, clinical and pathologic stage, neoadjuvant chemotherapy, total amount of drainage post operatively, timing of removal of negative suction from drains, timing of drain removal, total duration of stay in hospital post operatively. For each patient we calculated total volume of seroma formed and number of aspirations done. Other complications, including hematoma, flap necrosis or wound infections were also recorded. STATISTICAL ANALYSIS Data was compiled and analysed using IBM SPSS STATISTICS version 20 using ANOVA, independent t-test, and correlation (Pearson’s coefficient of correlation) test. For continuous variables the mean value and its range were evaluated. Categorical variables were described in terms of number and percentage of each subgroup. Pearson coefficient of correlation was used to evaluate linear correlations. Analysis of variance (ANOVA) is a collection of statistical models used to analyse the differences between group means and their associated procedures. ANOVA provides a statistical test of whether or not the means of several groups are equal, and therefore generalizes the t-test to more than two groups.