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Benefits of cesarean section stapling device understated?
266
Letters
the recurrence of endodermal sinus tumor at an early stage. We awaited further maturation of the child until caesarean section was done in the 33rd week of gestation. Kim et al. chose to treat their patient during pregnancy with a regimen of vincristine, actinomycin D, and cyclophosphamide (VAC) to avoid the use of cisplatin during pregnancy. In a recent review Nash and Young' stated that, although only randomized prospective trials can definitively establish survival advantages between the VAC and PVB (cisplatin, vincristine, and bleomycin) regimens, the cumulative experience from the existing literature seems to indicate that PVB is a more active regimen." 5 These authors tend to prefer the BEP (cisplatin, etoposide, and bleomycin) regimen, which we used in our patient, because the results are comparable to those of PVB but with less long-term toxicity.4 We were fully aware of a high risk of recurrence of the endodermal sinus tumor after surgical resection without adjuvant chemotherapy. However, the availability of cisplatin-containing regimens with well-known high efficacy, which result in survival rates of 96% in stages I and II and 79% in stages III and IV, enabled us to postpone chemotherapy until after the delivery of the child.' We were able to treat the mother with the chemotherapeutic regimen with the highest efficacy and to omit unknown potential carcinogenic damage to the fetus . To date, the mother and her 4-year-old child are doing well. Ate GJ. van der Zee, MD, Pax R.B. Willemse, MD, and Elisabeth G.E. de Vries, MD Departments of Gynecology and Medical Oncology, University Hospital, Oostersingel59, 9713 EZ Groningen, The N etherlands
REFERENCES l. Jones SE. Stringer CA, Dorr RT, Senzer NN . Cancer and
pregnancy. Am Soc Clin Oneol 1991:228-37. 2. Reynoso EE, Sheperd FA, Messner HA. Farquarson HA. Garvey MB. Baker MA. Acute leukemia during pregnancy: the Toronto leukemia study group experience with long term follow-up of children exposed in utero to chemotherapeutic agents. J Clin Oneol 1987;5:1098-186. 3. Loescher LJ, Welch-McCaffrey D, Leigh SA. Hoffman B, Meyskens FL. Surviving adult cancers. Part 1:physiologic effects. Ann Intern Med 1989;111:411-32. 4. Nash JD, Young RC. Gyneeological malignancies. In: Pinedo HM , Longo DL, Chabner BA, eds. Cancer chemotherapy and biological response modifiers. Amsterdam. The Netherlands: Elsevier Science. 1990:484-509. 5. Willemse PHB. Aalders JG, Bouma J, et al. Long term survival after vinblastine, bleomycin. and cisplatin treatment in patients with germ cell tumors of the ovary: an update. Gyneeol Oneol 1987;28:268-77.
Benefits of cesarean section stapling device understated? To the Editors: I read the article by Villeneuve et al. (Villeneuve MG, Khalife S, Marcoux S, Blanchet P. Surgical staples in cesarean section: A randomized controlled trial. AM J OBSTET GVNECOL 1990; 163: 1641-6) with interest. However, a few points need further clarification. Although the instrument depicted in Fig. 1 is
J anuary 1992 Am J Obsret Gynecol
the device used in their study, it is no longer available in Canada and has never been available in the United States. Also, although Dr. Gilles Monif is a well-respected member of the obstetrics and gynecology community specializing in the treatment of infectious disease, his criteria for morbidity are not universally known, and a reference or description of his criteria for endometritis would be helpful. The study is an excellent investigation in the use of the Auto Suture Poly CS* 57 disposable surgical stapler. Although minor questions arise, such as the length of experience of the instrument's users, the study confirms the findings of earlier reports. '-4 However, the conclusions of Villeneuve et al. are not substantiated by or consistent with their own and previously reported data. Their conclusions are perhaps different because of their failure to recognize that their population may represent a specific subset of the cesarean section population in North America. Their results do not contradict those of Burkett et al. because the patient populations had several differences: Burkett et al. found a significant decrease in infectious morbidity presumably caused by their higher baseline postoperative infection rate. The decrease in postoperative infection with the use of the cesarean section stapler was significant and led to considerable cost savings. The population of Villeneuve et al. does not have a high infection rate; therefore it would take a larger number of patients to demonstrate significant benefit. However, the decrease in blood loss in the study of Villeneuve et al. was significant; I disagree with their conclusion that significant savings of blood is not beneficial. Similar studies have been performed in a low-risk infectious population, and similar significant decreases in blood loss were found. " 3 This decrease in blood in the operative field was of major benefit to the operating physicians, turning a usually bloody procedure into a safer and easier procedure for the surgeon. The significant decreases in blood loss are also beneficial to the patient in light of the decreased but ever-present risk of transfusionrelated human immunodeficiency virus and other infectious exposure. Other studies in high-risk infectious populations have demonstrated >60% decrease in postoperative infection rates with the surgical stapling device in high-risk populations similar to those studied by Burkett et al. As mentioned by Villeneuve et al. the retaining pin had the potential for causing vessel puncture, and it has been removed in the new Food and Drug Administration-approved Auto Suture Poly CS 57 instrument. Therefore, although I thought the study of Villeneuve et al. was well done, I do not agree with their conclusion that significant decreases in blood loss are not important enough to give the instrument further consideration. Their patient population was at low risk for postoperative infections; therefore their sample size *Reg. U.S. Patent and Trademark Office. Auto Suture Company, Division of United States Surgical Corporation, Norwalk, Conn.
Volume Inn Number 1, Part I
was not large enough to allow them to make comments regarding the instrument's role in reducing po~t-ce sarean section infections. Thus the question of the utility of the Auto Suture Poly CS 57 disposable uterine device still deserves further attention. Mark Marfl'1ls, ,'lID Departlllent ojObstetllo and Gynecology, UnlVeTSltyoj Texas MedICal Branch, Galveston , TX 77550
REFERENCES I. Faro S, et al. Use of an absorbable utenne stapling device
in cesarean section [Video and scientific exhibit). In: Proceedings of the thirty-sixth annual meeting of the American College of Obstetricians and Gynecologists, Boston, Ma,sachusetts, May 4, 1988. Boston: American College of Obstetricians and Gynecologists, 1981l. 2. Burkett G, Jenson LP, Lai A, et al. Evaluation of surgical staples in cesarean section A~I .I OBSTET GnlEcoL 19119; 161 :540-7. 3. van Dongen PW.J, Nijhuis .JG, .Jongsma HW. Reduced blood loss during cesarean section due to controlled stapling techmque. Eur .I Obstet Gynecol Reprod Bioi 19H9;32:95-102. 4. Meinburgh M, (;iffel.JM, Nierhaus 1\1, Saling E. Anwendung eines Klammergerates bei der abdominalen Schittentbindung. Geburtshilte Frauenheilkd 1988;48:440-2.
The uterine stapling device for cesarean section: A positive view To the Editors: In their study comparing the Auto Suture
Poly CS 57 disposable uterine stapler with the standard hysterotomy for cesarean section, Villeneuve et al. did not find reductions in operating time, risk of febrile morbidity, or length of postoperative hospital stay in the group of patients in whom the uterine stapler was used. In addition they considered that the difference in blood loss between both groups was small and of questionable clinical significance and that their results do not support the routine use of the Auto Suture Poly CS 57 in low transverse cesarean sections. I would like to comment on this article. The authors state that theirs is the first randomized study comparing the uterine stapling device with the standard suture technique for cesarean deliveries in human beings. They also mention that only one previous study, which was not a randomized controlled triaV had evaluated the Auto Suture Poly CS 57. Their statement is inaccurate. Human studies evaluating the staple device have appeared since 1988; several are randomized controlled trials. 3 All investigators found the uterine stapler principle to be unquestionably sound, and no comparative series provided an overall statistically superior result in the traditional suturing technique when compared with the uterine stapler. On the basis of the available clinical data it can be concluded that the benefits of the absorbable uterine stapler depend on surgical experience and patient population. Significant reductions in blood loss and operating time can be expected in the more experienced surgeons who are familiar with the device. In high-risk obstetric patients the instrument produces a significant
Letters
267
decrease in the rate of febrile morbidity, resulting in a shorter hospital stay and a substantial savings in hospital costs. The socioeconomic characteristics and obstetric risk factors of the stud y conducted by Villeneuve et al. were not stated in their article, It is difficult to understand the authors' high failure rate regarding the correct application of the uterine stapler (45.5 %) and their high incidence of accidental extensions (42%) and associated significant bleeding (62%), which obviously stems from their incapability of completely applying the stapler. Failure to use the entire length of the stapler cartridge will result in an incision smaller than the required 11,5 cm, In light of this, their estimated total blood loss in the cases of the study is inaccurate because no differentiation in volume of blood loss can be made between that of the uterine edges where the staples were applied and of the traumatic uterine wall bleeding. In my experience with > 100 cases, a learning curve of 3 to 6 cases seems necessary to maximally use the stapling device. 4 I concur with the author's conclusion that it is probably premature to recommend routine use of the uterine stapler for every cesarean section. Nevertheless, on the basis of current information, its use should be strongly recommended for obstetric patients in whom the expectation of blood loss during the cesarean section is greater than average, the amount of intraoperative blood loss is critical, or the risk of postoperative infectious morbidity is high . Marco A. PelOSI, MD PelOSI W01nen'5 Aletbeal Center, 350 07002
Kelllled~'
Blvd., Bayonne, NJ
Marco A. Pelo.H Ill, MD Departme1lt ojObsMn(.\ and G,VIlfcology, Infirmary-Beekman DowntOWIi H(),lpltal, 70 Wlllwm St., New York, NY 10038
REFERENCES I. Burkett G, Jensoll LP, Lai A, et al. Evaluation of surgical
staples III ce,arean section . AM J OBSTET GY:"IECOL 19H9; 161 :540-7. 2. Martens MG. Reduction ot infectious morbidity with uterine slapling device. Adv Ther 1990;7: 105-8. 3. PelOSI M. Ce,arean ,ection using the uterine ab,orbable staple device. Con temp Ob Gyn 1991;36:96-110.
To the Editors: Thank you for this opportunity to clarify some aspects of our randomized clinical trial on the Auto Suture Poly CS 57 staples used in cesarean sections. We considered febrile morbidity to be present when at least one of the following conditions was satisfied I: (I) fever 2:38 0 C on two consecutive occasions 2:4 hours apart, with the second reading 2:0.20 C higher than the first; (2) fever 2:38.5 0 C on one occasion; or (3) fever 2:38 0 C on three occasions in any 24-hour period. We do not think our conclusions would have been different had our experience with the instrument been longer. Data were reanalyzed for the first (period 1) and last (period 2) 100 patients enrolled in the study separately (Table I). Results are largely similar for the two periods. In period 2, when obstetricians had gained
Letters
the recurrence of endodermal sinus tumor at an early stage. We awaited further maturation of the child until caesarean section was done in the 33rd week of gestation. Kim et al. chose to treat their patient during pregnancy with a regimen of vincristine, actinomycin D, and cyclophosphamide (VAC) to avoid the use of cisplatin during pregnancy. In a recent review Nash and Young' stated that, although only randomized prospective trials can definitively establish survival advantages between the VAC and PVB (cisplatin, vincristine, and bleomycin) regimens, the cumulative experience from the existing literature seems to indicate that PVB is a more active regimen." 5 These authors tend to prefer the BEP (cisplatin, etoposide, and bleomycin) regimen, which we used in our patient, because the results are comparable to those of PVB but with less long-term toxicity.4 We were fully aware of a high risk of recurrence of the endodermal sinus tumor after surgical resection without adjuvant chemotherapy. However, the availability of cisplatin-containing regimens with well-known high efficacy, which result in survival rates of 96% in stages I and II and 79% in stages III and IV, enabled us to postpone chemotherapy until after the delivery of the child.' We were able to treat the mother with the chemotherapeutic regimen with the highest efficacy and to omit unknown potential carcinogenic damage to the fetus . To date, the mother and her 4-year-old child are doing well. Ate GJ. van der Zee, MD, Pax R.B. Willemse, MD, and Elisabeth G.E. de Vries, MD Departments of Gynecology and Medical Oncology, University Hospital, Oostersingel59, 9713 EZ Groningen, The N etherlands
REFERENCES l. Jones SE. Stringer CA, Dorr RT, Senzer NN . Cancer and
pregnancy. Am Soc Clin Oneol 1991:228-37. 2. Reynoso EE, Sheperd FA, Messner HA. Farquarson HA. Garvey MB. Baker MA. Acute leukemia during pregnancy: the Toronto leukemia study group experience with long term follow-up of children exposed in utero to chemotherapeutic agents. J Clin Oneol 1987;5:1098-186. 3. Loescher LJ, Welch-McCaffrey D, Leigh SA. Hoffman B, Meyskens FL. Surviving adult cancers. Part 1:physiologic effects. Ann Intern Med 1989;111:411-32. 4. Nash JD, Young RC. Gyneeological malignancies. In: Pinedo HM , Longo DL, Chabner BA, eds. Cancer chemotherapy and biological response modifiers. Amsterdam. The Netherlands: Elsevier Science. 1990:484-509. 5. Willemse PHB. Aalders JG, Bouma J, et al. Long term survival after vinblastine, bleomycin. and cisplatin treatment in patients with germ cell tumors of the ovary: an update. Gyneeol Oneol 1987;28:268-77.
Benefits of cesarean section stapling device understated? To the Editors: I read the article by Villeneuve et al. (Villeneuve MG, Khalife S, Marcoux S, Blanchet P. Surgical staples in cesarean section: A randomized controlled trial. AM J OBSTET GVNECOL 1990; 163: 1641-6) with interest. However, a few points need further clarification. Although the instrument depicted in Fig. 1 is
J anuary 1992 Am J Obsret Gynecol
the device used in their study, it is no longer available in Canada and has never been available in the United States. Also, although Dr. Gilles Monif is a well-respected member of the obstetrics and gynecology community specializing in the treatment of infectious disease, his criteria for morbidity are not universally known, and a reference or description of his criteria for endometritis would be helpful. The study is an excellent investigation in the use of the Auto Suture Poly CS* 57 disposable surgical stapler. Although minor questions arise, such as the length of experience of the instrument's users, the study confirms the findings of earlier reports. '-4 However, the conclusions of Villeneuve et al. are not substantiated by or consistent with their own and previously reported data. Their conclusions are perhaps different because of their failure to recognize that their population may represent a specific subset of the cesarean section population in North America. Their results do not contradict those of Burkett et al. because the patient populations had several differences: Burkett et al. found a significant decrease in infectious morbidity presumably caused by their higher baseline postoperative infection rate. The decrease in postoperative infection with the use of the cesarean section stapler was significant and led to considerable cost savings. The population of Villeneuve et al. does not have a high infection rate; therefore it would take a larger number of patients to demonstrate significant benefit. However, the decrease in blood loss in the study of Villeneuve et al. was significant; I disagree with their conclusion that significant savings of blood is not beneficial. Similar studies have been performed in a low-risk infectious population, and similar significant decreases in blood loss were found. " 3 This decrease in blood in the operative field was of major benefit to the operating physicians, turning a usually bloody procedure into a safer and easier procedure for the surgeon. The significant decreases in blood loss are also beneficial to the patient in light of the decreased but ever-present risk of transfusionrelated human immunodeficiency virus and other infectious exposure. Other studies in high-risk infectious populations have demonstrated >60% decrease in postoperative infection rates with the surgical stapling device in high-risk populations similar to those studied by Burkett et al. As mentioned by Villeneuve et al. the retaining pin had the potential for causing vessel puncture, and it has been removed in the new Food and Drug Administration-approved Auto Suture Poly CS 57 instrument. Therefore, although I thought the study of Villeneuve et al. was well done, I do not agree with their conclusion that significant decreases in blood loss are not important enough to give the instrument further consideration. Their patient population was at low risk for postoperative infections; therefore their sample size *Reg. U.S. Patent and Trademark Office. Auto Suture Company, Division of United States Surgical Corporation, Norwalk, Conn.
Volume Inn Number 1, Part I
was not large enough to allow them to make comments regarding the instrument's role in reducing po~t-ce sarean section infections. Thus the question of the utility of the Auto Suture Poly CS 57 disposable uterine device still deserves further attention. Mark Marfl'1ls, ,'lID Departlllent ojObstetllo and Gynecology, UnlVeTSltyoj Texas MedICal Branch, Galveston , TX 77550
REFERENCES I. Faro S, et al. Use of an absorbable utenne stapling device
in cesarean section [Video and scientific exhibit). In: Proceedings of the thirty-sixth annual meeting of the American College of Obstetricians and Gynecologists, Boston, Ma,sachusetts, May 4, 1988. Boston: American College of Obstetricians and Gynecologists, 1981l. 2. Burkett G, Jenson LP, Lai A, et al. Evaluation of surgical staples in cesarean section A~I .I OBSTET GnlEcoL 19119; 161 :540-7. 3. van Dongen PW.J, Nijhuis .JG, .Jongsma HW. Reduced blood loss during cesarean section due to controlled stapling techmque. Eur .I Obstet Gynecol Reprod Bioi 19H9;32:95-102. 4. Meinburgh M, (;iffel.JM, Nierhaus 1\1, Saling E. Anwendung eines Klammergerates bei der abdominalen Schittentbindung. Geburtshilte Frauenheilkd 1988;48:440-2.
The uterine stapling device for cesarean section: A positive view To the Editors: In their study comparing the Auto Suture
Poly CS 57 disposable uterine stapler with the standard hysterotomy for cesarean section, Villeneuve et al. did not find reductions in operating time, risk of febrile morbidity, or length of postoperative hospital stay in the group of patients in whom the uterine stapler was used. In addition they considered that the difference in blood loss between both groups was small and of questionable clinical significance and that their results do not support the routine use of the Auto Suture Poly CS 57 in low transverse cesarean sections. I would like to comment on this article. The authors state that theirs is the first randomized study comparing the uterine stapling device with the standard suture technique for cesarean deliveries in human beings. They also mention that only one previous study, which was not a randomized controlled triaV had evaluated the Auto Suture Poly CS 57. Their statement is inaccurate. Human studies evaluating the staple device have appeared since 1988; several are randomized controlled trials. 3 All investigators found the uterine stapler principle to be unquestionably sound, and no comparative series provided an overall statistically superior result in the traditional suturing technique when compared with the uterine stapler. On the basis of the available clinical data it can be concluded that the benefits of the absorbable uterine stapler depend on surgical experience and patient population. Significant reductions in blood loss and operating time can be expected in the more experienced surgeons who are familiar with the device. In high-risk obstetric patients the instrument produces a significant
Letters
267
decrease in the rate of febrile morbidity, resulting in a shorter hospital stay and a substantial savings in hospital costs. The socioeconomic characteristics and obstetric risk factors of the stud y conducted by Villeneuve et al. were not stated in their article, It is difficult to understand the authors' high failure rate regarding the correct application of the uterine stapler (45.5 %) and their high incidence of accidental extensions (42%) and associated significant bleeding (62%), which obviously stems from their incapability of completely applying the stapler. Failure to use the entire length of the stapler cartridge will result in an incision smaller than the required 11,5 cm, In light of this, their estimated total blood loss in the cases of the study is inaccurate because no differentiation in volume of blood loss can be made between that of the uterine edges where the staples were applied and of the traumatic uterine wall bleeding. In my experience with > 100 cases, a learning curve of 3 to 6 cases seems necessary to maximally use the stapling device. 4 I concur with the author's conclusion that it is probably premature to recommend routine use of the uterine stapler for every cesarean section. Nevertheless, on the basis of current information, its use should be strongly recommended for obstetric patients in whom the expectation of blood loss during the cesarean section is greater than average, the amount of intraoperative blood loss is critical, or the risk of postoperative infectious morbidity is high . Marco A. PelOSI, MD PelOSI W01nen'5 Aletbeal Center, 350 07002
Kelllled~'
Blvd., Bayonne, NJ
Marco A. Pelo.H Ill, MD Departme1lt ojObsMn(.\ and G,VIlfcology, Infirmary-Beekman DowntOWIi H(),lpltal, 70 Wlllwm St., New York, NY 10038
REFERENCES I. Burkett G, Jensoll LP, Lai A, et al. Evaluation of surgical
staples III ce,arean section . AM J OBSTET GY:"IECOL 19H9; 161 :540-7. 2. Martens MG. Reduction ot infectious morbidity with uterine slapling device. Adv Ther 1990;7: 105-8. 3. PelOSI M. Ce,arean ,ection using the uterine ab,orbable staple device. Con temp Ob Gyn 1991;36:96-110.
To the Editors: Thank you for this opportunity to clarify some aspects of our randomized clinical trial on the Auto Suture Poly CS 57 staples used in cesarean sections. We considered febrile morbidity to be present when at least one of the following conditions was satisfied I: (I) fever 2:38 0 C on two consecutive occasions 2:4 hours apart, with the second reading 2:0.20 C higher than the first; (2) fever 2:38.5 0 C on one occasion; or (3) fever 2:38 0 C on three occasions in any 24-hour period. We do not think our conclusions would have been different had our experience with the instrument been longer. Data were reanalyzed for the first (period 1) and last (period 2) 100 patients enrolled in the study separately (Table I). Results are largely similar for the two periods. In period 2, when obstetricians had gained