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Use of Polyethylene in Tuboplasty
Use of Polyethylene in Tuhoplasty William J. Mulligan, M.D., John Rock, M.D., and Charles L. Easterday, M.D.
SINCE 1947 polyethylene in various forms has been employed at the Free Hospital for Women in an effort to maintain patency established by salpingoplastic procedures. The following report comprises an evaluation of the use of this material. Sufficient positive evidence of results following operation for complete occlusion of one or both oviducts has been possible in 69 of a group of 94 patients. In these 69 patients, a total of 93 operative procedures was performed, of which 63 were implantations and 30 fimbrioplasties. Standardization of tuboplastic procedures has been an objective of the Fertility Clinic since 1940. Another paper will review the use of other materials in association with this effort. 1 MATERIAL AND METHODS
Patients were selected for operation in whom total tubal occlusion at one or more sites had been indicated by insu:ffiation and hysterosalpingograms. Antibiotics were administered for five days preceding laparotomy and continued during the immediate postoperative period. At the start of operation an insufflation cannula was properly placed in the endocervical canal and fixed to the portio by single hooks attached to the cannula. Following celiotomy, insufflation from below by an assistant aided in further confirming findings of complete occlusion made by previous diagnostic tests and in localizing sites of occlusion. Recognizing the need for the avoidance of undue trauma to the delicate endosalpinx and fimbriae, we have gradually From the Department of Gynecology, Harvard Medical School, Boston 15, Massachusetts, and the Fertility and Endocrine Clinic, Free Hospital for Women, Brookline, Massachusetts. Presented at the First World Congress on Fertility and Sterility, New York City, May 29, 1953. 428
Vol. 4, No.5, 1953]
TUBOPLASTY
429
included in our operating kit instruments commonly used by the neuroand vascular surgeon. After release of obstruction of the fimbriated extremity of the oviduct by sharp dissection, followed by tacking back of fimbria to adjacent serosa by ( 0000) chromic catgut, utilization of polyethylene took place. In the earlier cases, polyethylene* was employed in the form of 1.7 mm. tubing
Fig. 1.
Button-shaped form in position at fimbriated end of tube. a b
c
d
f Fig. 2 A 20 em. square sheet of polyethylene film, 0.127 mm. thick, heated in its central portion and molded over an appropriate smooth form (a and b) . Dome of molded form pierced by hot needle (c). Polyethylene tubing inserted through hole in dome (d) and fused ( e and f). e
* Pure polyethylene, generously supplied by Plax Corporation, Hartford, Connecticut, was employed in this investigation. Sterilization of the plastic material was effected by immersion of tubing, forms, and film for at least 48 hours in 1: 1000 aqueous Zephiran, which was carefully washed off with normal salt solution before use.
[Fertility & Sterility
MULLIGAN ET AL.
430
f
Fig. 3.
Final form of polyethylene hood.
Fig. 4.
Hood in position.
fixed in place as an obturator and led out through the abdominal incision. to be removed four to five weeks subsequent to operation. Patients undergoing the same procedure at a later date had solid "cone-shaped" or "buttonshaped" forms fixed in place (Fig. 1) . These were removed at a second laparotomy following an interval of two to three months. Reaction in surrounding structures, interpreted as due to surface irregularities, promoted the use of polyethylene film as both an obturator and a protective envelope. Continuing evidence of peritoneal irritation resulted in the fashioning of smooth polyethylene hoods (Figs. 2, 3, 4) which have shown no tendency to affect surrounding structures, save at points where the hood-edge was sutured to mid-tubal serosa for purposes of stability. Tubal obstruction at points proximal to the fimbriated extremity was located by means of a fine smooth wire probe combined with insuffiation from below. Resection of occluded segments and anastomoses or implantation were carried out as indicated. Polyethylene tubing with an outside diameter of 1.7 mm. has been utilized in efforts to maintain patency, as illustrated in Figs. 5-9. Tubules passed through the uterus were fixed to the cervix by a nylon suture following closure of the abdominal wound and
Vol. 4, No.5, 1953]
TUBOPLASTY
431
subsequently removed as an out-patient procedure after arbitrary intervals of six to ten weeks. We have recently at reoperation localized the site of recurring obstruction in a few patients in whom implantation failed. The implanted oviduct in each instance was patent as far as the juncture between endosalpinx and endometrium. Occluding scar tissue in this area caused us to entertain the possibility that pressure necrosis and subsequent fibrosis may have occurred because of excessive diameter of the polyethylene tubule. The thought also arises that we had attempted to· conserve too much of the isthmic portion
7.
Draw tubule
through Uterus
Fig. 5. Method of developing tubal flaps and inserting plastic tubule (Cf. Fig. 9, Step 3). Fig. 6. Preparation for implanting fallopian tube through excised cornu into endometrial cavity (Cf. Fig. 9, Steps 4, 5, and 6). Fig. 7. Fallopian tube fixed in position after polyethylene tubule has been passed through cervix into vagina (Cf. Fig. 9, Steps 9 and 10). Fig. 8. Uterine defect closed after polyethylene tubule has been firmly secured (Cf. Fig. 9, Step 12).
MULLIGAN ET AL.
432
[Fertility & Sterility
of the tube and that the tip of implanted segment lacked adequate blood supply. Possibly the paucity of endosalpinx in this tiny portion of the oviduct does not make sufficiently close contact with endometrium to enable prompt fusion. We are now using only the wider outer segment of the oviduct and utilizing polyethylene tubing with an outside diameter of only 1.27 mm.
STEPS FOR IMPLANTATION USING PLASTIC TUBULES 1. 2. 3. 4.
OPEN FIMBRIATED END EXCISE ISTHMUS DEVELOP TUBAL FLAPS PLACE PLASTIC TUBULE IN TUBE AND SNAP BOTH ENDS
5. RESECT CORNU, EXPOSING ENDOMETRIUM 6. FIX TUBULE TO PROBE
7. PASS PROBE THROUGH CERVIX INTO VAGINA 8. ASSISTANT ATTACHES TUBULE TO SKIN OF THIGH 9. PLACE FINE NYLON SUTURES IN EACH TUBAL FLAP 10. SUTURE FLAPS TO ENDOMETRIUM BY PASSING SUTURES THROUGH
UTERINE WALL
AND FIXING THEM ON OUTSIDE 11. FIX TUBULE TO SEROSA OF OVIDUCT WITH (0000) CATGUT 12. CLOSE UTERINE DEFECT
Figure 9.
RESULTS Evaluation of results in tuboplastic procedures presents a formidable problem which will be discussed in another paper. 1 In many patients, one or more procedures were done, further adding to the complexity of the task of measuring success or failure. Results were considered, therefore, in terms of procedures, rather than of patients. A patient having bilateral fimbrioplasty and bilateral implantation would contribute four procedures to the total series. Postoperative salpingography showing patency of oviducts was accepted as absolute evidence, as was demonstration of patency at a subsequent operation. Definite evidence by insufflation was considered sufficient if only one functioning oviduct had been present at the time of operation. An ensuing pregnancy where one oviduct was present was also regarded as a successful result. In instances of procedures performed on both tubes, one success was claimed for procedures where insufflation was successful,
Vol. 4, No.5, 1953]
433
TUBOPLASTY
but the postoperative hysterosalpingogram had been omitted. Only one tube was considered open when bilateral tuboplasty was performed and was followed by pregnancy before postoperative salpingography had been TABLE 1. Results of Tuboplasty Using Polyethylene Tubing 93 Procedures on 69 Patients-March, 1953 Implantation
Open Closed ToTALS
Pregnant
Fimbrioplasty
No.
%
24 39
38
No. 20 10
% 67
-30
63 5 ( 48 pts.) 10
5 (2lpts.) 24
done. Table 1, therefore, presents results in terms of procedures. Of 94 patients undergoing tuboplasty where polyethylene was used, only 69 to date have presented sufficient evidence of success or failure by the above criteria to be included in this report. CONCLUSIONS Polyethylene, an inert plastic material, has been used at the Free Hospital for Women since 1947 as an adjunct in maintaining patency established by plastic operations on closed tubes. Of 94 patients with total occlusion of one or both oviducts in whom polyethylene was used, definitive results, as evidenced by hysterosalpingograms, insuffiations and pregnancy, were considered adequate enough in 69 patients to permit evaluation. In this investigation, 93 tuboplastic procedures were performed. In one instance a tubal anastomosis was done following resection of an ectopic pregnancy occupying the middle third of the oviduct. In fimbrioplasty, a polyethylene hood has been found'to be nonirritating to surrounding structures and offers considerable promise. Implantations involving the use of polyethylene as an obturator resulted in patency in 38 per cent of 63 operations. REFERENCE 1.
RocK,
plasty.
J.,
MuLLIGAN, W. J., and EASTERDAY, C. L. Use of polyethylene in tuboIn preparation for Obstetrics and Gynecology.
434
MULLIGAN ET AL.
[Fertility & Sterility
DISCUSSION* DR. LouiS M. HELLMAN, Brooklyn, N.Y.: It is somewhat presumptious for me to discuss a paper on tuboplastic operations by Dr. John Rock. He has made the most outstanding contributions to this subject and has had many years of experience. He describes here the use of a plastic cap for employment when the distal end of the tube is involved. This requires a second operation for removal. The results, however, would seem to indicate merit. There are several points of interest in Dr. Mulligan's paper which I would like to discuss. In the first place, the use of the insufRation cannula placed through the endocervical canal is awkward and frequently results in leaks at just the moment it is most needed. We have found that occlusion of the canal with a suture and the placing of a needle through the fundus and delivering carbon dioxide in this manner is much more satisfactory. The point made by Dr. Mulligan in regard to occlusion of a newly implanted tube at the proximal end due to scarring caused by excessive diameter of the polyethylene tube is a good one. I think that much more care has got to be taken with the implantation of fallopian tubes into the uterus in order to obviate this. Whether the diameter of the polyethylene tube has anything to do with it or not I cannot say, but it seems to me reasonable that the uterus should be opened and the end of the tube sutured to the mucosa in a more meticulous fashion. There is one final point that I would like to emphasize and that is the inadvisability of doing other gynecologic operations in addition to tubal plastic procedures. These cause only adhesions and nullify the sometimes meticulous surgery done on the tubes. Again may I congratulate Doctors Rock and Mulligan on the excellence of their results and the fine work in which they are engaged. DR. MARIO A. CASTALLO, Philadelphia, Pa.: I want to congratulate Doctors Rock and Mulligan for their original and outstanding contribution in the surgical approach to the reopening of closed fallopian tubes with the use of polyethylene material. While Dr. Wainer and myself were working with experimental animals, they showed the profession the way in its application to the human being. They have and are doing a greater number of these operations than have been done by any other group in the country. Most of us have done only a few cases. Doctors Rock and Mulligan have done as many as ten to fifteen times more than any of us. Their results show the importance of continued application to one problem. We are indebted to them for many of the niceties of the technic which has been evolved. I personally am indebted to Dr. Mulligan for his help and discussions of many of our common problems in the surgical technic involved in closed tube sterility in the human, following a visit with him at the Free Hospital for Women in Boston. To them goes the credit of evolving the polyethylene hood which is used in the reconstruction of the fimbriated ends of the tubes. In the only case that we
* The discussion of this paper is incomplete.
Vol. 4, No. 5, 1953]
TUBOPLASTY
435
have used it, the patient became pregnant and delivered. We have not been as fortunate in the cornual or mid-portion occlusion operations. Summarizing our findings, it has been found that polyethylene tubing has proved to be innocuous in the human as well as in experimental animals. Reports from the literature support the premise that a bridging material may be used in recanalization operations on the fallopian tubes of humans. Up to September, 1952, 170 cases have been collected by us. Ninety-one of these patients had open tubes ( 53.5 per cent), and 17 per cent of the patients operated upon became pregnant. The number of patients reported is still not sufficient to take this method out of the experimental stages, although it does show a cure rate of 17 per cent as against 6.6 per cent reported by Greenhill in 1936 after a survey of the literature. Animal experiments have shown that polyethylene tubing allows normal tube regeneration. DR. ABNER I. WEISMAN, New York, N.Y.: As with every new surgical development, new apparatuses and instruments are developed to facilitate surgical procedures. In the operation for the reimplantation of the fallopian tubes the procedure of bringing the polyethylene tubing through the uterus and out of the cervix and vagina is often difficult. To overcome this, I have devised an apparatus which I call the "Conductor Flexible" which is a thread-carrier of the polyethylene. With this simple apparatus, which is made of a malleable and flexible material, but which still retains sufficient rigidity, the bringing of the polyethylene tubing out of the vagina is simple. (Demonstration of apparatus.)
SINCE 1947 polyethylene in various forms has been employed at the Free Hospital for Women in an effort to maintain patency established by salpingoplastic procedures. The following report comprises an evaluation of the use of this material. Sufficient positive evidence of results following operation for complete occlusion of one or both oviducts has been possible in 69 of a group of 94 patients. In these 69 patients, a total of 93 operative procedures was performed, of which 63 were implantations and 30 fimbrioplasties. Standardization of tuboplastic procedures has been an objective of the Fertility Clinic since 1940. Another paper will review the use of other materials in association with this effort. 1 MATERIAL AND METHODS
Patients were selected for operation in whom total tubal occlusion at one or more sites had been indicated by insu:ffiation and hysterosalpingograms. Antibiotics were administered for five days preceding laparotomy and continued during the immediate postoperative period. At the start of operation an insufflation cannula was properly placed in the endocervical canal and fixed to the portio by single hooks attached to the cannula. Following celiotomy, insufflation from below by an assistant aided in further confirming findings of complete occlusion made by previous diagnostic tests and in localizing sites of occlusion. Recognizing the need for the avoidance of undue trauma to the delicate endosalpinx and fimbriae, we have gradually From the Department of Gynecology, Harvard Medical School, Boston 15, Massachusetts, and the Fertility and Endocrine Clinic, Free Hospital for Women, Brookline, Massachusetts. Presented at the First World Congress on Fertility and Sterility, New York City, May 29, 1953. 428
Vol. 4, No.5, 1953]
TUBOPLASTY
429
included in our operating kit instruments commonly used by the neuroand vascular surgeon. After release of obstruction of the fimbriated extremity of the oviduct by sharp dissection, followed by tacking back of fimbria to adjacent serosa by ( 0000) chromic catgut, utilization of polyethylene took place. In the earlier cases, polyethylene* was employed in the form of 1.7 mm. tubing
Fig. 1.
Button-shaped form in position at fimbriated end of tube. a b
c
d
f Fig. 2 A 20 em. square sheet of polyethylene film, 0.127 mm. thick, heated in its central portion and molded over an appropriate smooth form (a and b) . Dome of molded form pierced by hot needle (c). Polyethylene tubing inserted through hole in dome (d) and fused ( e and f). e
* Pure polyethylene, generously supplied by Plax Corporation, Hartford, Connecticut, was employed in this investigation. Sterilization of the plastic material was effected by immersion of tubing, forms, and film for at least 48 hours in 1: 1000 aqueous Zephiran, which was carefully washed off with normal salt solution before use.
[Fertility & Sterility
MULLIGAN ET AL.
430
f
Fig. 3.
Final form of polyethylene hood.
Fig. 4.
Hood in position.
fixed in place as an obturator and led out through the abdominal incision. to be removed four to five weeks subsequent to operation. Patients undergoing the same procedure at a later date had solid "cone-shaped" or "buttonshaped" forms fixed in place (Fig. 1) . These were removed at a second laparotomy following an interval of two to three months. Reaction in surrounding structures, interpreted as due to surface irregularities, promoted the use of polyethylene film as both an obturator and a protective envelope. Continuing evidence of peritoneal irritation resulted in the fashioning of smooth polyethylene hoods (Figs. 2, 3, 4) which have shown no tendency to affect surrounding structures, save at points where the hood-edge was sutured to mid-tubal serosa for purposes of stability. Tubal obstruction at points proximal to the fimbriated extremity was located by means of a fine smooth wire probe combined with insuffiation from below. Resection of occluded segments and anastomoses or implantation were carried out as indicated. Polyethylene tubing with an outside diameter of 1.7 mm. has been utilized in efforts to maintain patency, as illustrated in Figs. 5-9. Tubules passed through the uterus were fixed to the cervix by a nylon suture following closure of the abdominal wound and
Vol. 4, No.5, 1953]
TUBOPLASTY
431
subsequently removed as an out-patient procedure after arbitrary intervals of six to ten weeks. We have recently at reoperation localized the site of recurring obstruction in a few patients in whom implantation failed. The implanted oviduct in each instance was patent as far as the juncture between endosalpinx and endometrium. Occluding scar tissue in this area caused us to entertain the possibility that pressure necrosis and subsequent fibrosis may have occurred because of excessive diameter of the polyethylene tubule. The thought also arises that we had attempted to· conserve too much of the isthmic portion
7.
Draw tubule
through Uterus
Fig. 5. Method of developing tubal flaps and inserting plastic tubule (Cf. Fig. 9, Step 3). Fig. 6. Preparation for implanting fallopian tube through excised cornu into endometrial cavity (Cf. Fig. 9, Steps 4, 5, and 6). Fig. 7. Fallopian tube fixed in position after polyethylene tubule has been passed through cervix into vagina (Cf. Fig. 9, Steps 9 and 10). Fig. 8. Uterine defect closed after polyethylene tubule has been firmly secured (Cf. Fig. 9, Step 12).
MULLIGAN ET AL.
432
[Fertility & Sterility
of the tube and that the tip of implanted segment lacked adequate blood supply. Possibly the paucity of endosalpinx in this tiny portion of the oviduct does not make sufficiently close contact with endometrium to enable prompt fusion. We are now using only the wider outer segment of the oviduct and utilizing polyethylene tubing with an outside diameter of only 1.27 mm.
STEPS FOR IMPLANTATION USING PLASTIC TUBULES 1. 2. 3. 4.
OPEN FIMBRIATED END EXCISE ISTHMUS DEVELOP TUBAL FLAPS PLACE PLASTIC TUBULE IN TUBE AND SNAP BOTH ENDS
5. RESECT CORNU, EXPOSING ENDOMETRIUM 6. FIX TUBULE TO PROBE
7. PASS PROBE THROUGH CERVIX INTO VAGINA 8. ASSISTANT ATTACHES TUBULE TO SKIN OF THIGH 9. PLACE FINE NYLON SUTURES IN EACH TUBAL FLAP 10. SUTURE FLAPS TO ENDOMETRIUM BY PASSING SUTURES THROUGH
UTERINE WALL
AND FIXING THEM ON OUTSIDE 11. FIX TUBULE TO SEROSA OF OVIDUCT WITH (0000) CATGUT 12. CLOSE UTERINE DEFECT
Figure 9.
RESULTS Evaluation of results in tuboplastic procedures presents a formidable problem which will be discussed in another paper. 1 In many patients, one or more procedures were done, further adding to the complexity of the task of measuring success or failure. Results were considered, therefore, in terms of procedures, rather than of patients. A patient having bilateral fimbrioplasty and bilateral implantation would contribute four procedures to the total series. Postoperative salpingography showing patency of oviducts was accepted as absolute evidence, as was demonstration of patency at a subsequent operation. Definite evidence by insufflation was considered sufficient if only one functioning oviduct had been present at the time of operation. An ensuing pregnancy where one oviduct was present was also regarded as a successful result. In instances of procedures performed on both tubes, one success was claimed for procedures where insufflation was successful,
Vol. 4, No.5, 1953]
433
TUBOPLASTY
but the postoperative hysterosalpingogram had been omitted. Only one tube was considered open when bilateral tuboplasty was performed and was followed by pregnancy before postoperative salpingography had been TABLE 1. Results of Tuboplasty Using Polyethylene Tubing 93 Procedures on 69 Patients-March, 1953 Implantation
Open Closed ToTALS
Pregnant
Fimbrioplasty
No.
%
24 39
38
No. 20 10
% 67
-30
63 5 ( 48 pts.) 10
5 (2lpts.) 24
done. Table 1, therefore, presents results in terms of procedures. Of 94 patients undergoing tuboplasty where polyethylene was used, only 69 to date have presented sufficient evidence of success or failure by the above criteria to be included in this report. CONCLUSIONS Polyethylene, an inert plastic material, has been used at the Free Hospital for Women since 1947 as an adjunct in maintaining patency established by plastic operations on closed tubes. Of 94 patients with total occlusion of one or both oviducts in whom polyethylene was used, definitive results, as evidenced by hysterosalpingograms, insuffiations and pregnancy, were considered adequate enough in 69 patients to permit evaluation. In this investigation, 93 tuboplastic procedures were performed. In one instance a tubal anastomosis was done following resection of an ectopic pregnancy occupying the middle third of the oviduct. In fimbrioplasty, a polyethylene hood has been found'to be nonirritating to surrounding structures and offers considerable promise. Implantations involving the use of polyethylene as an obturator resulted in patency in 38 per cent of 63 operations. REFERENCE 1.
RocK,
plasty.
J.,
MuLLIGAN, W. J., and EASTERDAY, C. L. Use of polyethylene in tuboIn preparation for Obstetrics and Gynecology.
434
MULLIGAN ET AL.
[Fertility & Sterility
DISCUSSION* DR. LouiS M. HELLMAN, Brooklyn, N.Y.: It is somewhat presumptious for me to discuss a paper on tuboplastic operations by Dr. John Rock. He has made the most outstanding contributions to this subject and has had many years of experience. He describes here the use of a plastic cap for employment when the distal end of the tube is involved. This requires a second operation for removal. The results, however, would seem to indicate merit. There are several points of interest in Dr. Mulligan's paper which I would like to discuss. In the first place, the use of the insufRation cannula placed through the endocervical canal is awkward and frequently results in leaks at just the moment it is most needed. We have found that occlusion of the canal with a suture and the placing of a needle through the fundus and delivering carbon dioxide in this manner is much more satisfactory. The point made by Dr. Mulligan in regard to occlusion of a newly implanted tube at the proximal end due to scarring caused by excessive diameter of the polyethylene tube is a good one. I think that much more care has got to be taken with the implantation of fallopian tubes into the uterus in order to obviate this. Whether the diameter of the polyethylene tube has anything to do with it or not I cannot say, but it seems to me reasonable that the uterus should be opened and the end of the tube sutured to the mucosa in a more meticulous fashion. There is one final point that I would like to emphasize and that is the inadvisability of doing other gynecologic operations in addition to tubal plastic procedures. These cause only adhesions and nullify the sometimes meticulous surgery done on the tubes. Again may I congratulate Doctors Rock and Mulligan on the excellence of their results and the fine work in which they are engaged. DR. MARIO A. CASTALLO, Philadelphia, Pa.: I want to congratulate Doctors Rock and Mulligan for their original and outstanding contribution in the surgical approach to the reopening of closed fallopian tubes with the use of polyethylene material. While Dr. Wainer and myself were working with experimental animals, they showed the profession the way in its application to the human being. They have and are doing a greater number of these operations than have been done by any other group in the country. Most of us have done only a few cases. Doctors Rock and Mulligan have done as many as ten to fifteen times more than any of us. Their results show the importance of continued application to one problem. We are indebted to them for many of the niceties of the technic which has been evolved. I personally am indebted to Dr. Mulligan for his help and discussions of many of our common problems in the surgical technic involved in closed tube sterility in the human, following a visit with him at the Free Hospital for Women in Boston. To them goes the credit of evolving the polyethylene hood which is used in the reconstruction of the fimbriated ends of the tubes. In the only case that we
* The discussion of this paper is incomplete.
Vol. 4, No. 5, 1953]
TUBOPLASTY
435
have used it, the patient became pregnant and delivered. We have not been as fortunate in the cornual or mid-portion occlusion operations. Summarizing our findings, it has been found that polyethylene tubing has proved to be innocuous in the human as well as in experimental animals. Reports from the literature support the premise that a bridging material may be used in recanalization operations on the fallopian tubes of humans. Up to September, 1952, 170 cases have been collected by us. Ninety-one of these patients had open tubes ( 53.5 per cent), and 17 per cent of the patients operated upon became pregnant. The number of patients reported is still not sufficient to take this method out of the experimental stages, although it does show a cure rate of 17 per cent as against 6.6 per cent reported by Greenhill in 1936 after a survey of the literature. Animal experiments have shown that polyethylene tubing allows normal tube regeneration. DR. ABNER I. WEISMAN, New York, N.Y.: As with every new surgical development, new apparatuses and instruments are developed to facilitate surgical procedures. In the operation for the reimplantation of the fallopian tubes the procedure of bringing the polyethylene tubing through the uterus and out of the cervix and vagina is often difficult. To overcome this, I have devised an apparatus which I call the "Conductor Flexible" which is a thread-carrier of the polyethylene. With this simple apparatus, which is made of a malleable and flexible material, but which still retains sufficient rigidity, the bringing of the polyethylene tubing out of the vagina is simple. (Demonstration of apparatus.)