***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results Abstract Background : Seromas and impaired shoulder function are well-known complications after modified radical mastectomy for breast cancer . Early postoperative physiotherapy is a common treatment to avoid shoulder dysfunction . The aim of this study was to evaluate if the frequency of postoperative seromas could be reduced , without increasing shoulder dysfunction , by delayed postoperative shoulder exercises . Methods : In a prospect i ve study 163 patients with breast cancer undergoing modified radical mastectomy  were r and omized to physiotherapy starting on postoperative day 1 or day 7 . Patients were seen by the surgeons and the physiotherapists during hospital stay and in the outpatient department . Seromas and other complications were registered by the surgeons . The physiotherapists instructed the patients pre- and postoperatively and assessed shoulder function . Results : There was a significantly higher incidence of postoperative seromas in the group of patients that started physiotherapy postoperative day 1 ( 38 % ) compared to the group that started physiotherapy postoperative day 7 ( 22 % ) ( p<0.05 ) . There was no significant difference between the groups in the late outcome of shoulder function . Conclusion : The incidence of seromas after modified radical mastectomy for breast cancer is reduced by delaying shoulder exercises one week postoperatively . Earlier postoperative physiotherapy is not necessary to avoid impaired shoulder function The role and timing of physical therapy following axillary dissection for melanoma , or in conjunction with modified radical mastectomy has not been extensively studied . A prospect i ve r and omized clinical trial was carried out over an 18-month period in the Surgery Branch , National Cancer Institute ( NCI ) and Department of Rehabilitation Medicine , Clinical Center , in which patients were assigned to receive one of two post-operative physical therapy regimens . Patients were assigned to receive graduated increases in allowed range of motion ( ROM ) , either beginning on postoperative day 1 ( early ) or day 7 ( delayed ) . All patients were advanced to full pain-free ROM when the suction catheters were removed . A total of 36 patients with 40 axillary dissections ( 19 for melanoma , 21 for breast cancer ) were included in this study . Patients r and omized to receive early motion had more total wound drainage ( 805 ± 516 cc vs. 420 ± 301 cc , p < 0.01 ) , more days of drainage ( 10.3 ± 5.3 vs. 6.2 ± 2.7 , p < 0.01 ) , and later postoperative day of discharge ( 12.8 ± 5.1 days vs. 9.2 ± 4.0 days , p < 0.02 ) than did patients who started motion on day 7 . Wound complications including infection and small areas of skin breakdown occurred more frequently in the early group ( seven patients vs. one patient , p < 0.02 ) . No significant differences in the per cent of patients achieving functional ROM could be identified between these two groups at one , three or six months after operation . Transient serratus anterior palsy ( 12 patients ) and latissimus dorsi palsy ( 2 patients ) occurred in approximately 30 % of all patients , regardless of group ( breast vs. melanoma , early vs. delayed ) , but returned to normal in all patients . The early institution of flexion and abduction exercises following axillary dissection thus appears to have a deleterious effect on wound healing and drainage . Adequate functional ROM is attained in all patients with a minimum of complications when active motion exercises are delayed for up to 7 days after axillary dissection A prospect i ve clinical trial was conducted to determine the effect of axillary node dissection for breast carcinoma on shoulder function  and seroma production . 59 Operations were carried out in 57 patients . The patients were divided into two groups . In group A , shoulder exercises were started , under the guidance of a physiotherapist , immediately following surgery , and in group B the exercises were begun on the seventh postoperative day . A full range of motion within six months was achieved in 25 patients of group A ( 81 % ) and in 22 of group B ( 79 % ) . There was no significant difference in wound drainage between the two groups . Restricted shoulder movement was often seen after local wound complications following axillary radiotherapy or after seriously disturbed wound healing A r and omized prospect i ve clinical trial has been performed to determine the effect of temporary immobilization of the shoulder on wound drainage followitig  radical mastectomy .  In 64 patients admitted to the trial the mean volume of drainage was reduced by 40 per cent in those who had shoulder movement restricted for the first 7 days afer operation when compared with the group in whom early arm exercises were encouraged . The mean drainage time was reduced by 29 per cent . Shoulder immobilization did not result in increased shoulder stiffness , although there was an increased incidence of mild lymphoedema of the arm OBJECTIVE To determine if postoperative shoulder immobilization decreases the incidence of postmastectomy seromas . DESIGN AND SETTING A prospect i ve r and omized trial of three surgeons ' experiences at a community hospital . PATIENTS Thirty-eight patients who underwent modified radical mastectomy from March 1991 through February 1993 . MAIN OUTCOME MEASURES Incidence of postmastectomy seromas and time required for patients to gain 110 degrees of shoulder abduction after surgery . RESULTS Thirteen ( 72 % ) of 18 wounds in the maximum range of motion cohort developed seromas ( 72 % ) compared with one ( 6 % ) of 17 in the minimum range of motion cohort ( P = .0005 ) . The average time required for the patients with maximum range of motion to gain 110 degrees of shoulder abduction was 2.6 weeks , whereas the patients with minimum range of motion required an average of 5.0 weeks ( P = .0127 ) . CONCLUSION Postmastectomy shoulder immobilization significantly decreases the incidence of wound seromas . Although this protocol result ed in a delay in return to normal shoulder mobility , no patients sustained long-term musculoskeletal dysfunction After biopsy confirmation of breast carcinoma , women who were scheduled to undergo a modified radical mastectomy had demographic data collected , goniometric measurements of shoulder flexion and abduction , and functional evaluation of the ipsilateral shoulder performed , and upper extremity circumferential measurements at five levels determined . Patients were then r and omly assigned either to a group that received immediate postoperative physical therapy or to one that did not . Results represent the combination of data from a pilot study and this subsequent study following appropriate statistical analysis . Sixty-four women in the treatment group showed a statistically significant increase in shoulder range of motion in both abduction and flexion as compared to 51 women who received no physical therapy . The treated group also had fewer problems with five of the six upper extremity functional tasks that were assessed . There were no significant differences between the groups for length of hospital stay , postoperative complications , or upper extremity edema . The authors conclude that early physical therapy intervention makes a significant contribution to return to normal function without increasing the incidence of postoperative complications or prolonging hospital stay Background Wound seroma is one of the most frequent complications of mastectomy , but an effective strategy Tor its prevention has not yet been established . The purpose of this study was to determine the effectiveness of delayed shoulder exercise on the prevention of wound seroma after partial or total mastectomy with axillary dissection for the treatment of cancer . Methods This study prospect ively r and omized two exercise schemes after mastectomy with axillary lymph node dissection . The  immediate exercise group ( n=58 ) started shoulder exercise on the first postoperative day . In the  delayed exercise group ( n=58 ) the movement of the upper limb was limited to usual daily activities during the first postoperative week . Results Preoperative levels of shoulder function were regained within one month when shoulder exercise was delayed for one week after operation . Significant decrease of drainage volume and lower incidence of seroma formation were seen in the delayed exercise group . Conclusion These observations suggest that seven days of unrestricted movement and avoiding active exercise of the shoulder joint , is the optimal routine reduce seroma formation after mastectomy BACKGROUND There are several factors those contribute to the amount of axillary drainage after modified radical mastectomy . The drains should be removed as early as possible . Whether the active shoulder movement of the lesion side increases the amount of axillary drainage needs to be studied prospect ively . METHODS From 1994 through 1995 , 344 consecutive patients were r and omly divided into three groups . One hundred sixteen patients in the early group performed upper arm exercises including pendulum , wall climbing and pulley exercises beginning the third post-operative day . One hundred fifteen patients in the later group patients did the same exercises beginning the sixth post-operative day and 113 patients in the delayed group did the same exercises after all the drains were removed . RESULTS There were no significant differences in patient characteristics , including age , body weight , operation methods and the pathology in the three groups . The amount of axilla fossa drainage was significantly less in the patients in the delayed group than in the early and later group ( 485 ml , 568 ml , 559 ml , respectively , p = 0.032 ) . However , there were no differences in the amount of chest wall site drainage or the number of aspiration of seroma among the three groups . The drains were removed on the average of seventh and ninth post-operative day in the delayed and early group patients , respectively ( p = 0.124 ) . Although the range of motion ( ROM ) of the shoulders in the delayed group patients was slightly limited during the first month after operation , ROM returned at 3 months and no difference was found 6 months after operation . CONCLUSION Upper arm exercise can start after the drains in the axilla are removed . The delay does not limit the shoulder function at 6 months after modified radical mastectomy A prospect i ve r and omized study was carried out to discover the influence of the timing of shoulder physiotherapy after-axillary dissection for breast cancer upon the incidence and duration of lymphatic fluid production and seroma after these operations . Sixty-eight patients underwent a modified radical mastectomy , 31 were su bmi tted to early physiotherapy and 37 to delayed physiotherapy after removal of the suction drainage .  In 32 patients this surgery was conservative of the breast ; in 16 the physiotherapy was early and in 16 delayed . The shoulder was left free when the physiotherapy was delayed . The mean volume of lymphatic fluid produced after these 100 axillary dissections was 437 cc ( range : 50 to 800 cc ) with a mean duration of 6.3 days ( range : 2 to 11 days ) . There was a linear relation between the volume and the duration of the lymphatic fluid production . This volume was significantly higher in radical mastectomy than in conservative procedures ( 486 cc vs 333 cc - p less than 0.02 ) . There was no significant difference in the production of lymphatic fluid with early or delayed physiotherapy  , whatever the group of patients : radical or conservative surgery - age - number of excised lymph nodes - lymph node involvement . Five seromas occurred in patients with delayed physiotherapy . Delaying physiotherapy after axillary dissection for breast cancer does not seem to reduce the incidence of lymphatic complication , but the use of a conservative procedure rather than a modified radical mastectomy seems to be able to do so Greater amount and duration of postoperative wound drainage after lymphadenectomy impede healing . We evaluated the influence of early vs delayed initiation of shoulder mobilization on postoperative drainage . Fifty-seven women with clinical stage I or II breast cancer were r and omized to either early ( postoperative day 2 ) or delayed ( postoperative day 5 ) shoulder motion . Early vs delayed time of exercise initiation had no effect on total amount or duration of drainage , either as an inpatient or outpatient . The two groups were determined to be homogeneous as to age , breast size , weight , height , obesity , previous biopsy , excision of pectoralis  minor  , excision of thoracodorsal complex , level of axillary dissection , total number of lymph nodes , number of positive lymph nodes , lymphatic vessel invasion ( with negative lymph nodes ) , and whether the dominant h and was on the side operated on . The two factors predicting greater drainage were large numbers of positive lymph nodes and no previous surgical biopsy ( as in one-step procedure ) A total of 144 evaluable patients with breast cancer were enrolled in a multicenter , r and omized 
    Output:
    
No significant differences were found for drainage volume or hospital stay .
Conclusion Current evidence from RCTs supports the use of a delayed program of arm exercises to reduce seroma formation .
Clinical and statistical inconsistencies between studies did not allow any conclusions to be drawn regarding the effects of delayed exercises on fluid drainage , hospital stay and immediate or long term ability to move the arm