- Email: [email protected]
Randomised clinical trials in plastic surgery: Survey of output and quality of reporting
Short reports and correspondence to the classification of the fracture type have become general, and surgical indications finally began to converge in one direction. Concerning the treatment principles of blowout fracture in children, there are still various opinions, and no consensus has been reached on surgical indications. Burnstine5 described that surgery should be selected based on symptoms, clinical findings, and informed consent after explanation of surgical risks and advantages. In patients such as ours who need supraversion for ball games, when conservative treatment is selected, possible persistent diplopia may cause inconvenience for a long period. In the first treatment (right side), since a Hess red green test showed negligible improvement in oculomotor disorder even 2 weeks after injury, an operation was performed with the consent of the patient and his family. As a result, he showed improvement and could play basketball 2 weeks after operation. In the second treatment (left side), the operation was performed 6 days after injury with adequate informed consent because of slightly less limitation in supraversion in the left eye than in the right eye, good results of the first operation, and his wish to resume basketball soon. Since the oculomotor disorder was less on the left side than on the right side, the adhesion of impacted orbital tissue was released by traction of the inferior rectus muscle prior to other procedures under general anaesthesia. As the limitation in supraversion was released, the operation was completed. As a result, he could resume basketball 2 days after operation. We evaluated the timing of surgery for blowout fracture in children. Opinions are divided into two: one recommends operation as early as possible while the other suggests that operation within 2 months after injury has adequate surgical effects.6 Concerning the cause of a delay in oculomotor improvement in children with blowout fracture, Waddell et al.7 speculated that scar formation in the orbit is marked in children, and Cope et al.8 reported that the reduction of impacted tissue is difficult because blowout fracture in children often comprises linear fracture. In addition, in children, since bone restoration mechanisms are observed early, impairment of the extraocular muscles tends to progress. It is also a widespread opinion that operation should be performed as early as possible in patients requiring surgical reduction because adhesion of the herniated and impacted orbital tissue to the surrounding tissue progresses with time. In our department, we have often encountered adult patients surgically treated 1 month or more after injury in whom fat tissue which had herniated into the maxillary cavity was white and hard, showing scar formation, adhering to the mucosa of the maxillary sinus, and its dissection was difficult. Therefore, in patients showing no oculomotor improvement even 2 weeks after injury, we recommend active surgical reduction of impacted tissue even in children. In the second operation in this patient, operation was performed considerably early (6 days after injury). This was because the sport was a main activity in his daily life, and improvement was observed soon after the previous operation on the right side. Therefore, the timing of surgery should be decided after adequate consultation with the family along with consideration of the patient’s background. We encountered a child with very rare heterochronous bilateral blowout fractures and performed treatment based
965 on the patient’s background, clinical findings, and the clinical course. In the future, the surgical indications and timing in children with blowout fracture will require adequate evaluation after talking with the family and consideration of the patient’s background.
References 1. Anderson PJ. Fractures of the facial skeleton in children. Injury 1995;26:47e50. 2. Man K, Wijngaarde R, Hes J. Influence of age on the management of blow-out fractures of the orbital floor. Int J Oral Maxillofac Surg 1991;20:330e6. 3. Charles R, Leon JR, Roger H. Bilateral blowout fractures. Ann Ophthalmol 1972;6:495e502. 4. Converse JM, Smith B. Enophthalmos and diplopia in fracture of the orbital floor. Br J Plast Surg 1957;9:265e74. 5. Burnstine MA. Clinical recommendations for repair of the isolated orbital floor fractures. Curr Opin Ophthalmol 2003;14: 236e40. 6. Leitch RJ, Burke JP, Strachan IM. Orbital blowout fractures - the infuenence of the age on surgical outcome. Acta Ophthalmol 1990;68:118e24. 7. Waddel E, Fells P, Koornneef L. The natural and unnatural histology of a blow-out fracture. Br Orthopt J 1982;39:29e32. 8. Cope MR, Moos KF, Speculand B. Does diplopia persist after blow-out fractures of the orbital floor in children? Br J Oral Maxillofac Surg 1999;37:46e51.
Shinichi Asamura Kazuhide Matunaga Hirohisa Kusuhara Takahiro Hashimoto Noritaka Isogai Department of Plastic and Reconstructive Surgery, Kinki University School of Medicine, 377-2 Ohno-higashi, Osaka-sayama, Osaka 5898511, Japan E-mail address: [email protected] ª 2007 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.bjps.2007.02.010
Randomised clinical trials in plastic surgery: Survey of output and quality of reporting We were interested to read the article by Karri1 describing the survey of randomised clinical trials in plastic surgery as we feel this is a research area in which more could and should be done. Of relevance to this review, although not published in the journals covered by the above paper, we have conducted a randomised trial comparing conventional wound dressing against an open dressing involving a herbal medicine-based preparation in 115 patients admitted to hospital for second degree burns.2,3 Interestingly, we were able to show very similar wound healing characteristics and pain control with the two strategies despite prior claims of much
966 greater effectiveness of the new approach. In relative terms, this trial was not difficult to design or to conduct, as the options were dressings for the wounds rather than surgical procedures, which contrasts rather markedly with other aspects of the work of a plastic surgery department (much untested in randomised controlled trials, RCTs). As the author points out in his comprehensive survey, very few randomised trials have been done of surgical options, the majority either of breast surgery (20 only identified) and/or of the cleft/lip and palate (eight). Indeed it has been argued for the latter that RCTs are particularly difficult to do, and perhaps unethical,4 although we have rebutted that argument forcibly.5 Nevertheless, there is no doubt that ‘surgical’ trials pose major challenges when compared to our wounddressing example. There is clearly a concern that success or otherwise will depend to a large extent on the skill of the surgical teams involved. However, it is a mistake to believe that all must be of a similar standard before a clinical trial of alternative approaches can be contemplated. To give a concrete example, we are currently conducting an international RCT jointly with colleagues from the Chang Gung Memorial Hospital, Taipei, Taiwan, comparing speech outcome between two different surgical techniques (‘VWK’ against ‘2 Flap’) and two different timings (‘Immediate’ against ‘Delay’) for surgery for the management of clefts of the secondary palate. Without going into full details, these two options provide four treatment strategies with follow up planned until the 300 children to be randomised are 17 years of age. The trial is flexible in design, thus the individual surgeons may decide NOT to randomise to the techniques but ONLY the timing option; others may make the reverse choice; while the majority (it is hoped) will randomise to both options. This flexibility is designed to encourage wider surgeon participation as well as extending the pool of eligible patients. For example, a surgeon may decide in the interests of the child that the surgery must take place immediately (rather than be delayed), but has clinical equipoise about the surgical options and thus will randomise the patient (following the due consent process) to one of the options. Equally important, or possibly more so, it will allow those parents who wish for (say) immediate surgery still to give consent to the surgical options within the trial structure. This trial has been purposely designed to reflect standard practice as much as possible, again to facilitate the recruitment and to permit follow-up routines to be little changed. However, we should not underestimate the commitment required by the clinical teams of many disciplines, the continuing support infrastructure of a dedicated clinical trials office with associated trial management and medical statistics skills at hand. As with all randomised trials, the questions posed need to be of importance and intended to influence subsequent practice. Some of the questions posed in this trial are more for the short term and, provided recruitment is satisfactory, we hope to be giving some answers sooner than in 20 years time. We would encourage other institutions to join us in this endeavour. Copies of the protocol can be obtained from any one of us.
Short reports and correspondence It has been estimated that: ‘approximately a quarter million new babies are born with clefts each year’6 so the importance of the paper by Vasu Karri in underlying the need for good quality RCTs addressing issues of major public health concern cannot be overstated.
Acknowledgement The trial is supported by National Medical Research Council, Singapore, grant number: NMRC/0733/2003.
References 1. Karri V. Randomised clinical trials in plastic surgery: Survey of output and quality of reporting. J Plast Reconstr Aesth Surg 2006;59:787e96. 2. Ang ES-W, Lee S-T, Gan CS-G, et al. Evaluating the role of alternative therapy in burn wound management: randomized trial comparing moist exposed burn ointment with conventional methods in the management of patients with second-degree burns. MedGenMed 2001;3:3. 3. Ang ES-W, Lee S-T, Gan CS-G, et al. Pain control in a randomized controlled trial comparing Moist Exposed Burn Ointment (MEBO) and conventional methods in patients with partial thickness burns. J Burn Care Rehabil 2003;24:289e96. 4. Berkowitz S. Prerandomization of clinical trials. A more ethical way for performing cleft palate research. Plast Reconstr Surg 1998;102:1724e8. 5. Machin D, Lee ST. The ethics of randomization trials in the context of cleft palate research. Plast Reconstr Surg 2000;105: 1566e8. 6. Lee ST. New treatment and research strategies for the improvement of care of cleft lip and palate patients in the new millennium. Ann Acad Med Singapore 1999;28:760e7.
Vincent K.L. Yeow Seng Teik Lee Department of Plastic, Reconstructive and Aesthetic Surgery, KK Women’s and Children’s Hospital, Singapore 229899, Singapore Plastic & Reconstructive Surgery, Singapore General Hospital, Singapore 169608, Singapore Joanne J. Cheng Cleft & Craniofacial Centre, KK Women’s and Children’s Hospital, Singapore 229899, Singapore Angeline Koh Hwee Bee Wong David Machin Clinical Trials and Epidemiology Research Unit, 226 Outram Road Blk B #02-02, Singapore 169039, Singapore E-mail address: [email protected] ª 2007 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.bjps.2007.01.067
965 on the patient’s background, clinical findings, and the clinical course. In the future, the surgical indications and timing in children with blowout fracture will require adequate evaluation after talking with the family and consideration of the patient’s background.
References 1. Anderson PJ. Fractures of the facial skeleton in children. Injury 1995;26:47e50. 2. Man K, Wijngaarde R, Hes J. Influence of age on the management of blow-out fractures of the orbital floor. Int J Oral Maxillofac Surg 1991;20:330e6. 3. Charles R, Leon JR, Roger H. Bilateral blowout fractures. Ann Ophthalmol 1972;6:495e502. 4. Converse JM, Smith B. Enophthalmos and diplopia in fracture of the orbital floor. Br J Plast Surg 1957;9:265e74. 5. Burnstine MA. Clinical recommendations for repair of the isolated orbital floor fractures. Curr Opin Ophthalmol 2003;14: 236e40. 6. Leitch RJ, Burke JP, Strachan IM. Orbital blowout fractures - the infuenence of the age on surgical outcome. Acta Ophthalmol 1990;68:118e24. 7. Waddel E, Fells P, Koornneef L. The natural and unnatural histology of a blow-out fracture. Br Orthopt J 1982;39:29e32. 8. Cope MR, Moos KF, Speculand B. Does diplopia persist after blow-out fractures of the orbital floor in children? Br J Oral Maxillofac Surg 1999;37:46e51.
Shinichi Asamura Kazuhide Matunaga Hirohisa Kusuhara Takahiro Hashimoto Noritaka Isogai Department of Plastic and Reconstructive Surgery, Kinki University School of Medicine, 377-2 Ohno-higashi, Osaka-sayama, Osaka 5898511, Japan E-mail address: [email protected] ª 2007 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.bjps.2007.02.010
Randomised clinical trials in plastic surgery: Survey of output and quality of reporting We were interested to read the article by Karri1 describing the survey of randomised clinical trials in plastic surgery as we feel this is a research area in which more could and should be done. Of relevance to this review, although not published in the journals covered by the above paper, we have conducted a randomised trial comparing conventional wound dressing against an open dressing involving a herbal medicine-based preparation in 115 patients admitted to hospital for second degree burns.2,3 Interestingly, we were able to show very similar wound healing characteristics and pain control with the two strategies despite prior claims of much
966 greater effectiveness of the new approach. In relative terms, this trial was not difficult to design or to conduct, as the options were dressings for the wounds rather than surgical procedures, which contrasts rather markedly with other aspects of the work of a plastic surgery department (much untested in randomised controlled trials, RCTs). As the author points out in his comprehensive survey, very few randomised trials have been done of surgical options, the majority either of breast surgery (20 only identified) and/or of the cleft/lip and palate (eight). Indeed it has been argued for the latter that RCTs are particularly difficult to do, and perhaps unethical,4 although we have rebutted that argument forcibly.5 Nevertheless, there is no doubt that ‘surgical’ trials pose major challenges when compared to our wounddressing example. There is clearly a concern that success or otherwise will depend to a large extent on the skill of the surgical teams involved. However, it is a mistake to believe that all must be of a similar standard before a clinical trial of alternative approaches can be contemplated. To give a concrete example, we are currently conducting an international RCT jointly with colleagues from the Chang Gung Memorial Hospital, Taipei, Taiwan, comparing speech outcome between two different surgical techniques (‘VWK’ against ‘2 Flap’) and two different timings (‘Immediate’ against ‘Delay’) for surgery for the management of clefts of the secondary palate. Without going into full details, these two options provide four treatment strategies with follow up planned until the 300 children to be randomised are 17 years of age. The trial is flexible in design, thus the individual surgeons may decide NOT to randomise to the techniques but ONLY the timing option; others may make the reverse choice; while the majority (it is hoped) will randomise to both options. This flexibility is designed to encourage wider surgeon participation as well as extending the pool of eligible patients. For example, a surgeon may decide in the interests of the child that the surgery must take place immediately (rather than be delayed), but has clinical equipoise about the surgical options and thus will randomise the patient (following the due consent process) to one of the options. Equally important, or possibly more so, it will allow those parents who wish for (say) immediate surgery still to give consent to the surgical options within the trial structure. This trial has been purposely designed to reflect standard practice as much as possible, again to facilitate the recruitment and to permit follow-up routines to be little changed. However, we should not underestimate the commitment required by the clinical teams of many disciplines, the continuing support infrastructure of a dedicated clinical trials office with associated trial management and medical statistics skills at hand. As with all randomised trials, the questions posed need to be of importance and intended to influence subsequent practice. Some of the questions posed in this trial are more for the short term and, provided recruitment is satisfactory, we hope to be giving some answers sooner than in 20 years time. We would encourage other institutions to join us in this endeavour. Copies of the protocol can be obtained from any one of us.
Short reports and correspondence It has been estimated that: ‘approximately a quarter million new babies are born with clefts each year’6 so the importance of the paper by Vasu Karri in underlying the need for good quality RCTs addressing issues of major public health concern cannot be overstated.
Acknowledgement The trial is supported by National Medical Research Council, Singapore, grant number: NMRC/0733/2003.
References 1. Karri V. Randomised clinical trials in plastic surgery: Survey of output and quality of reporting. J Plast Reconstr Aesth Surg 2006;59:787e96. 2. Ang ES-W, Lee S-T, Gan CS-G, et al. Evaluating the role of alternative therapy in burn wound management: randomized trial comparing moist exposed burn ointment with conventional methods in the management of patients with second-degree burns. MedGenMed 2001;3:3. 3. Ang ES-W, Lee S-T, Gan CS-G, et al. Pain control in a randomized controlled trial comparing Moist Exposed Burn Ointment (MEBO) and conventional methods in patients with partial thickness burns. J Burn Care Rehabil 2003;24:289e96. 4. Berkowitz S. Prerandomization of clinical trials. A more ethical way for performing cleft palate research. Plast Reconstr Surg 1998;102:1724e8. 5. Machin D, Lee ST. The ethics of randomization trials in the context of cleft palate research. Plast Reconstr Surg 2000;105: 1566e8. 6. Lee ST. New treatment and research strategies for the improvement of care of cleft lip and palate patients in the new millennium. Ann Acad Med Singapore 1999;28:760e7.
Vincent K.L. Yeow Seng Teik Lee Department of Plastic, Reconstructive and Aesthetic Surgery, KK Women’s and Children’s Hospital, Singapore 229899, Singapore Plastic & Reconstructive Surgery, Singapore General Hospital, Singapore 169608, Singapore Joanne J. Cheng Cleft & Craniofacial Centre, KK Women’s and Children’s Hospital, Singapore 229899, Singapore Angeline Koh Hwee Bee Wong David Machin Clinical Trials and Epidemiology Research Unit, 226 Outram Road Blk B #02-02, Singapore 169039, Singapore E-mail address: [email protected] ª 2007 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.bjps.2007.01.067