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Salpingostomy: Results of two Different Methods of Treatment*
Vol. 28, No. 11, November 1977 Printed in U.S.A.
FERTILITY AND STERILITY Copyright' 1977 The American Fertility Society
SALPINGOSTOMY: RESULTS OF TWO DIFFERENT METHODS OF TREATMENT*
ANTHONY C. COMNINOS, M.D., F.A.C.S.
"Marika Eliadi" Maternity Hospital, Athens, Greece
In 30 selected identical cases of infertility due to bilateral tubal occlusion at the distal portion of the tube, salpingostomies were performed by the same operator using, for reasons of comparison, two different methods. The 30 cases were divided into two equal groups: In the first group no protective plastic material was used to cover the tubes, and no medication other than antibiotics was issued. In the second group the scurasil salpingoplasty device of Cog nat was used to cover the tubes, and corticosteroids were issued in addition to antibiotics. Hydrotubations were performed postoperatively in all patients. In a minimal follow-up period of 2 years the following results have been obtained: In the first group, four patients showed tubal patency (two bilaterally and two unilaterally). Three patients conceived, and altogether there were five pregnancies (one ectopic and four intrauterine). Of the four intrauterine pregnancies, one ended in abortion and three went to term and resulted in three living children. In the second group, eight patients showed tubal patency (five bilaterally and three unilaterally). Five patients conceived, and altogether there were eight pregnancies (one ectopic and seven intrauterine). Of the seven intrauterine pregnancies, two ended in abortion and five went to term and resulted in five living children.
Statistics on plastic operations on the tubes are constantly criticized because of the great variability and differences in material and parameters used in evaluating the results, such as the patient's age, years of marital life, type and duration of infertility, preoperative infertility investigation and treatment, location and extent of tubal obstruction, tubal pathology, presence of other gynecologic abnormalities, operative methods, experience of the surgeon, postoperative care, length of follow-up, and control and evaluation of the results. The purpose of our work was to investigate the results of two different methods of salpingostomy performed in a number of patients matching in most of the parameters, and to re-evaluate the usefulness of salpingostomy in the treatment of infertility. Received April 18, 1977; revised June 24, 1977; accepted June 24, 1977. *Presented at the Ninth World Congress on Fertility and Sterility and the Thirty-Third Annual Meeting of The American Fertility Society, April 12 to 16, 1977, Miami Beach, Fla.
MATERIALS AND METHODS
In 30 selected identical cases of infertility due to bilateral obstruction at the distal portion of the tubes, salpingostomies were performed by one operator using, for reasons of comparison, two different operative methods. Each patient was subjected to a complete infertility investigation and was carefully selected to match the above-mentioned parameters. Only patients who had no identifiable absolute cause of infertility other than obstruction of the tubes at the distal portion were included in the study. Patients who, in addition to tubal obstruction, had other gynecologic abnormalities such as uterine fibroids, endometriosis, or ovarian cysts were excluded. The ages of the patients ranged from 21 to 30 years, a decade span that is considered to be a highly fertile period in the reproductive life of a woman. The duration of infertility ranged from 2 to 4 years. The infertility investigation revealed bilateral tubal obstruction at the distal ends of the 1211
1212
COMNINOS
tubes to be the only cause of the infertility in all patients. This diagnosis was made by hysterosalpingography. In a number of cases the hysterosalpingographic results were verified by laparoscopy. Ovarian function was normal in all patients. Ovulation was diagnosed by recordings of the basal body temperature for a period of not less than 2 months, cervical mucus examination, timed endometrial biopsy, and in several instances by direct inspection of a recent corpus luteum during laparoscopy. Postcoital tests in all instances were satisfactory, and results of semen analyses were within normal limits in all husbands. Before surgery, an attempt was made in each patient to overcome the tubal obstruction through hydrotubation. This procedure was performed during three consecutive cycles (four hydrotubations per cycle), using a normal saline solution containing 50 mg of hydrocortisone and 500 mg of ampicillin. The operation was always performed a few days after the end of menstruation because bleeding is usually lighter during the early proliferative phase of the cycle. Salpingostomy was performed through an oblique circular incision by resection of the obstructed distal end of the tube, eversion of the cuff, and suturing of the serosa with 5-0 to 7-0, slowly absorbable catgut. Suturing of the mucosa was avoided. Great attention was paid to limiting bleeding as much as possible. This was achieved by gentle manipulation, the use of fine instruments for cutting and separating adhesions, and the use of microelectrodes for coagulation and hemostasis. Patency of the tubes was ascertained by descending pertubation. The 30 patients were divided into two equal groups. Group I comprised six cases of primary infertility and nine cases of secondary infertility. Group II consisted of five cases of primary infertility and ten cases of secondary infertility. None of the patients with secondary infertility had a living child. The infertility had become apparent in each case after an induced abortion. In the first group of patients, after the termination of the salpingostomy no protective plastic material was used to cover the tubes and no medications other than broad-spectrum antibiotics were issued. Postoperatively three hydrotubations were performed in these patients, on days 3, 5, and 7. A normal saline solution was used
November 1977
FIG. 1. The Michell Cognat device. 1, Conical hood; 2, fine tubule; 3, extraction tubule.
which contained 50 mg of hydrocortisone but no antibiotics, as these were taken orally. In the second group of patients the scurasil salpingoplasty device of CognatI, 2 was used to cover the tubes and, in addition to antibiotics, corticosteroids were administered preoperatively, locally during the operation, and postoperatively according to the scheme described by Swolin. 3 The scurasil salpingostomy device is composed of a conical hood placed in the middle of the device and attached to a fine tubule on one end and to a larger tubule on the other (Fig. 1). The conical hood is articulated to the two tubules in such a way that it can be everted and folded toward the fine tubule in a sleeve. Its base is marked by a perforation line which permits adjustment of the hood to the size of the fallopian tube by cutting the base of the hood accordingly. The fine tubule ends in a blunt, straight, atraumatic needle which helps in catheterization ofthe fallopian tube. This fine tubule is used for fixing the device at the serosa of the fallopian tube and the uterine fundus. The large tubule is affixed to the abdominal wall and is used mainly for extraction of the device by simple traction, avoiding in this way the necessity for a second operation to remove the hood. This tubule serves also in the intra-abdominal injection of antibiotics and corticosteroids postoperatively (Fig. 1). Postoperatively, on days 3, 5, and 7, these patients had intra-abdominal peritubal irrigations through the large tubule of the salpingoplasty device which was affixed to the abdominal wall. A normal saline solution containing 50 mg of hydrocortisone was used for irrigation. On the 12th postoperative day the scurasil salpingoplasty
SALPINGOSTOMY: RESULTS OF TWO DIFFERENT METHODS OF TREATMENT
Vol. 28, No. 11
device was removed by simple traction of the abdominal tubule. Tubal patency was assessed by hysterosalpingography performed during the first cycle after the operation and in a number of cases by secondlook laparoscopy and injection of methylene blue into the uterine cavity. The minimal follow-up period was 2 years. Patients who did not become pregnant within 1 year after the operation submitted to four hydrotubations per month for a period of 4 months, followed by second-look laparoscopy and a tubal patency test. RESULTS
In group I, four patients (26.6%) showed tubal patency (Table 1). Two of these patients showed bilateral tubal patency and two unilateral. Of these four patients, three (20.0%) conceived five pregnancies (Table 2). Of the three patients who conceived, two became pregnant during the 1st postoperative year and one 3 years later. Of the five pregnancies, one was ectopic and four were intrauterine (Table 3). Of the four intrauterine pregnancies, one ended in abortion and three went to term and resulted in three living children. In group II, eight patients (53.3%) showed tubal patency, five bilaterally and three unilaterally (Table 1). Of these eight patients, five (33.3%) conceived eight pregnancies (Table 2). Of the five patients who conceived, three became pregnant during the 1st postoperative year, one during the 2nd, and one during the 4th. Of the total eight pregnancies, one was ectopic and seven were intrauterine (Table 3). Ofthe seven intrauterine pregnancies, two ended in abortion and five went to term and resulted in five living children. DISCUSSION
The collection of a substantial number of cases matching in all of the parameters needed for comparison is difficult, and in this study the number of patients in each group is too small to permit TABLE 1. Salpingostomy: Postoperative Tubal Patency Group and operative method
No. of patients
Group I: salpingostomy without salpingoplasty device Group II: salpingostomy with salpingoplasty device
15
Total
30
15
No. with patent tubes
4 (26.6%) Bilateral 2 Unilateral 2 8 (53.3%) Bilateral 5 Unilateral 3 12 (40.0%)
1213
TABLE 2. Salpingostomy: Postoperative Pregnancy Rates Total
Group and operative method
No. of patients
No. of patients conceiving
Group I: salpingostomy without salpingoplasty device Group II: salpingostomy with salpingoplasty device
15
3 (20.0%)
5 (33.3%)
15
5 (33.3%)
8 (53.3%)
Total
30
8 (26.6%)
13 (43.3%)
pregnancies
statistically valid conclusions. However, in comparing the two groups of patients treated by two different methods, the results in the second group of patients appear to be better. Apparently the use of the salpingoplasty device of Cognat, L 2 the administration of corticosteroids, postoperative hydrotubations, and irrigation of the tubes with corticosteroids restrict the formation of adhesions and protect the patency of the new stoma. The tubal patency rate achieved in the first group of patients was 26.6% and in the second group 53.3%. Three patients conceived in the first group and five in the second. Most patients (six of eight) conceived during the 1st postoperative year, one patient conceived during the 2nd postoperative year, and one during the 3rd postoperative year. Similar observations have been reported by others.4, 5 Some patients conceived twice, raising the total number of pregnancies achieved to 13. This figure, however, is of no value as it does not represent the cure of infertility-motherhood. Of the total of 30 patients operated upon, only six became mothers, two in the first group and four in the second. The rates of ectopic pregnancy and abortion were high in both groups of patients, as was expected from similar previous reports. 4-7 Forty years have elapsed since Greenhills published his first discouraging results of tubal plastic operations in 818 cases. Since then, many efforts have been made to modify the old procedures and to introduce new operative as well as conservative methods to treat blocked tubes. From our work it is evident that, despite the progress made in operative techniques for tuboplastic operations, the introduction of protective plastic material, and the use of broad-spectrum antibiotics, hydrotubation, and corticosteroids the end results of salpingostomy cannot be considered satisfactory. Salpingostomy actually is considered to be the operation which gives the least satisfactory results owing to destruction of the
--
~
~
-
COMNINOS
1214
November 1977
TABLE 3. Pregnancy Outcome after Salpingostomy Group and operative method
No. of patients
Total pregnancies
Group I: salpingostomy without salpingoplasty device Group II: salpingostomy with salpingoplasty device
15
5 (33.3%)
15
8 (53.3%)
Total
30
13 (43.3%)
fimbriae and to inflammatory intrinsic damage to the tubes. The patency percentage in our series of cases (40.0%) is good, but the over-all pregnancy rate (26.6% )-in particular the motherhood percentage (20.0%), which represents the real cure of infertility-is still low. We believe that there is still much to be done to convince ourselves of the usefulness of salpingostomy in any case of tubal obstruction at the distal end. In our opinion, salpingostomy is most effective when it is performed in selected cases by an experienced person and when it is combined with the use of a salpingoplasty device and the administration of corticosteroids and hydrotubations.
Ectopic pregnancies
Abortions
Living children
1
1 (6.6%)
3 (20.00'0)
1
2 (13.3%)
5 (33.3%)
2 (6.6%)
3 (10.00'0)
8 (26.6%)
REFERENCES 1. Cognat M: Presentation d'une prothese-drain destinee a la chirurgie tubulaire pour sterilite. Bull Fed Soc Gynecol Obstet Fr 23:4, 1971 2. Cognat M, Palmer R, Mints M, Papathanassiou S: Presentation d'un nouveau dispositif pour salpingoplastie. Rapport preliminaire. Gynecologie 24:2, 1973 3. Swolin K: 50 Sterilitiitsoperationen. Acta Obstet Gynecol Scand 46:1, 1976 4. Grant A: Infertility surgery of the oviduct. Fertil Steril 22:496, 1971 5. Umezaki C, Katayama KP, Jones HW Jr: Pregnancy rates after reconstructive surgery of the fallopian tubes. Obstet Gynecol 43:3, 1974 6. Comninos AC: Salpingostomy. Treatment of female sterility. Fertil Steril 5:4, 1954 7. Roland ML: Tuboplasty in 130 patients. Obstet Gynecol 39:57,1972 8. Greenhill JP: Evaluation of salpingostomy and tubal implantation for treatment of sterility. Am J Obstet Gynecol 33:39,1937
FERTILITY AND STERILITY Copyright' 1977 The American Fertility Society
SALPINGOSTOMY: RESULTS OF TWO DIFFERENT METHODS OF TREATMENT*
ANTHONY C. COMNINOS, M.D., F.A.C.S.
"Marika Eliadi" Maternity Hospital, Athens, Greece
In 30 selected identical cases of infertility due to bilateral tubal occlusion at the distal portion of the tube, salpingostomies were performed by the same operator using, for reasons of comparison, two different methods. The 30 cases were divided into two equal groups: In the first group no protective plastic material was used to cover the tubes, and no medication other than antibiotics was issued. In the second group the scurasil salpingoplasty device of Cog nat was used to cover the tubes, and corticosteroids were issued in addition to antibiotics. Hydrotubations were performed postoperatively in all patients. In a minimal follow-up period of 2 years the following results have been obtained: In the first group, four patients showed tubal patency (two bilaterally and two unilaterally). Three patients conceived, and altogether there were five pregnancies (one ectopic and four intrauterine). Of the four intrauterine pregnancies, one ended in abortion and three went to term and resulted in three living children. In the second group, eight patients showed tubal patency (five bilaterally and three unilaterally). Five patients conceived, and altogether there were eight pregnancies (one ectopic and seven intrauterine). Of the seven intrauterine pregnancies, two ended in abortion and five went to term and resulted in five living children.
Statistics on plastic operations on the tubes are constantly criticized because of the great variability and differences in material and parameters used in evaluating the results, such as the patient's age, years of marital life, type and duration of infertility, preoperative infertility investigation and treatment, location and extent of tubal obstruction, tubal pathology, presence of other gynecologic abnormalities, operative methods, experience of the surgeon, postoperative care, length of follow-up, and control and evaluation of the results. The purpose of our work was to investigate the results of two different methods of salpingostomy performed in a number of patients matching in most of the parameters, and to re-evaluate the usefulness of salpingostomy in the treatment of infertility. Received April 18, 1977; revised June 24, 1977; accepted June 24, 1977. *Presented at the Ninth World Congress on Fertility and Sterility and the Thirty-Third Annual Meeting of The American Fertility Society, April 12 to 16, 1977, Miami Beach, Fla.
MATERIALS AND METHODS
In 30 selected identical cases of infertility due to bilateral obstruction at the distal portion of the tubes, salpingostomies were performed by one operator using, for reasons of comparison, two different operative methods. Each patient was subjected to a complete infertility investigation and was carefully selected to match the above-mentioned parameters. Only patients who had no identifiable absolute cause of infertility other than obstruction of the tubes at the distal portion were included in the study. Patients who, in addition to tubal obstruction, had other gynecologic abnormalities such as uterine fibroids, endometriosis, or ovarian cysts were excluded. The ages of the patients ranged from 21 to 30 years, a decade span that is considered to be a highly fertile period in the reproductive life of a woman. The duration of infertility ranged from 2 to 4 years. The infertility investigation revealed bilateral tubal obstruction at the distal ends of the 1211
1212
COMNINOS
tubes to be the only cause of the infertility in all patients. This diagnosis was made by hysterosalpingography. In a number of cases the hysterosalpingographic results were verified by laparoscopy. Ovarian function was normal in all patients. Ovulation was diagnosed by recordings of the basal body temperature for a period of not less than 2 months, cervical mucus examination, timed endometrial biopsy, and in several instances by direct inspection of a recent corpus luteum during laparoscopy. Postcoital tests in all instances were satisfactory, and results of semen analyses were within normal limits in all husbands. Before surgery, an attempt was made in each patient to overcome the tubal obstruction through hydrotubation. This procedure was performed during three consecutive cycles (four hydrotubations per cycle), using a normal saline solution containing 50 mg of hydrocortisone and 500 mg of ampicillin. The operation was always performed a few days after the end of menstruation because bleeding is usually lighter during the early proliferative phase of the cycle. Salpingostomy was performed through an oblique circular incision by resection of the obstructed distal end of the tube, eversion of the cuff, and suturing of the serosa with 5-0 to 7-0, slowly absorbable catgut. Suturing of the mucosa was avoided. Great attention was paid to limiting bleeding as much as possible. This was achieved by gentle manipulation, the use of fine instruments for cutting and separating adhesions, and the use of microelectrodes for coagulation and hemostasis. Patency of the tubes was ascertained by descending pertubation. The 30 patients were divided into two equal groups. Group I comprised six cases of primary infertility and nine cases of secondary infertility. Group II consisted of five cases of primary infertility and ten cases of secondary infertility. None of the patients with secondary infertility had a living child. The infertility had become apparent in each case after an induced abortion. In the first group of patients, after the termination of the salpingostomy no protective plastic material was used to cover the tubes and no medications other than broad-spectrum antibiotics were issued. Postoperatively three hydrotubations were performed in these patients, on days 3, 5, and 7. A normal saline solution was used
November 1977
FIG. 1. The Michell Cognat device. 1, Conical hood; 2, fine tubule; 3, extraction tubule.
which contained 50 mg of hydrocortisone but no antibiotics, as these were taken orally. In the second group of patients the scurasil salpingoplasty device of CognatI, 2 was used to cover the tubes and, in addition to antibiotics, corticosteroids were administered preoperatively, locally during the operation, and postoperatively according to the scheme described by Swolin. 3 The scurasil salpingostomy device is composed of a conical hood placed in the middle of the device and attached to a fine tubule on one end and to a larger tubule on the other (Fig. 1). The conical hood is articulated to the two tubules in such a way that it can be everted and folded toward the fine tubule in a sleeve. Its base is marked by a perforation line which permits adjustment of the hood to the size of the fallopian tube by cutting the base of the hood accordingly. The fine tubule ends in a blunt, straight, atraumatic needle which helps in catheterization ofthe fallopian tube. This fine tubule is used for fixing the device at the serosa of the fallopian tube and the uterine fundus. The large tubule is affixed to the abdominal wall and is used mainly for extraction of the device by simple traction, avoiding in this way the necessity for a second operation to remove the hood. This tubule serves also in the intra-abdominal injection of antibiotics and corticosteroids postoperatively (Fig. 1). Postoperatively, on days 3, 5, and 7, these patients had intra-abdominal peritubal irrigations through the large tubule of the salpingoplasty device which was affixed to the abdominal wall. A normal saline solution containing 50 mg of hydrocortisone was used for irrigation. On the 12th postoperative day the scurasil salpingoplasty
SALPINGOSTOMY: RESULTS OF TWO DIFFERENT METHODS OF TREATMENT
Vol. 28, No. 11
device was removed by simple traction of the abdominal tubule. Tubal patency was assessed by hysterosalpingography performed during the first cycle after the operation and in a number of cases by secondlook laparoscopy and injection of methylene blue into the uterine cavity. The minimal follow-up period was 2 years. Patients who did not become pregnant within 1 year after the operation submitted to four hydrotubations per month for a period of 4 months, followed by second-look laparoscopy and a tubal patency test. RESULTS
In group I, four patients (26.6%) showed tubal patency (Table 1). Two of these patients showed bilateral tubal patency and two unilateral. Of these four patients, three (20.0%) conceived five pregnancies (Table 2). Of the three patients who conceived, two became pregnant during the 1st postoperative year and one 3 years later. Of the five pregnancies, one was ectopic and four were intrauterine (Table 3). Of the four intrauterine pregnancies, one ended in abortion and three went to term and resulted in three living children. In group II, eight patients (53.3%) showed tubal patency, five bilaterally and three unilaterally (Table 1). Of these eight patients, five (33.3%) conceived eight pregnancies (Table 2). Of the five patients who conceived, three became pregnant during the 1st postoperative year, one during the 2nd, and one during the 4th. Of the total eight pregnancies, one was ectopic and seven were intrauterine (Table 3). Ofthe seven intrauterine pregnancies, two ended in abortion and five went to term and resulted in five living children. DISCUSSION
The collection of a substantial number of cases matching in all of the parameters needed for comparison is difficult, and in this study the number of patients in each group is too small to permit TABLE 1. Salpingostomy: Postoperative Tubal Patency Group and operative method
No. of patients
Group I: salpingostomy without salpingoplasty device Group II: salpingostomy with salpingoplasty device
15
Total
30
15
No. with patent tubes
4 (26.6%) Bilateral 2 Unilateral 2 8 (53.3%) Bilateral 5 Unilateral 3 12 (40.0%)
1213
TABLE 2. Salpingostomy: Postoperative Pregnancy Rates Total
Group and operative method
No. of patients
No. of patients conceiving
Group I: salpingostomy without salpingoplasty device Group II: salpingostomy with salpingoplasty device
15
3 (20.0%)
5 (33.3%)
15
5 (33.3%)
8 (53.3%)
Total
30
8 (26.6%)
13 (43.3%)
pregnancies
statistically valid conclusions. However, in comparing the two groups of patients treated by two different methods, the results in the second group of patients appear to be better. Apparently the use of the salpingoplasty device of Cognat, L 2 the administration of corticosteroids, postoperative hydrotubations, and irrigation of the tubes with corticosteroids restrict the formation of adhesions and protect the patency of the new stoma. The tubal patency rate achieved in the first group of patients was 26.6% and in the second group 53.3%. Three patients conceived in the first group and five in the second. Most patients (six of eight) conceived during the 1st postoperative year, one patient conceived during the 2nd postoperative year, and one during the 3rd postoperative year. Similar observations have been reported by others.4, 5 Some patients conceived twice, raising the total number of pregnancies achieved to 13. This figure, however, is of no value as it does not represent the cure of infertility-motherhood. Of the total of 30 patients operated upon, only six became mothers, two in the first group and four in the second. The rates of ectopic pregnancy and abortion were high in both groups of patients, as was expected from similar previous reports. 4-7 Forty years have elapsed since Greenhills published his first discouraging results of tubal plastic operations in 818 cases. Since then, many efforts have been made to modify the old procedures and to introduce new operative as well as conservative methods to treat blocked tubes. From our work it is evident that, despite the progress made in operative techniques for tuboplastic operations, the introduction of protective plastic material, and the use of broad-spectrum antibiotics, hydrotubation, and corticosteroids the end results of salpingostomy cannot be considered satisfactory. Salpingostomy actually is considered to be the operation which gives the least satisfactory results owing to destruction of the
--
~
~
-
COMNINOS
1214
November 1977
TABLE 3. Pregnancy Outcome after Salpingostomy Group and operative method
No. of patients
Total pregnancies
Group I: salpingostomy without salpingoplasty device Group II: salpingostomy with salpingoplasty device
15
5 (33.3%)
15
8 (53.3%)
Total
30
13 (43.3%)
fimbriae and to inflammatory intrinsic damage to the tubes. The patency percentage in our series of cases (40.0%) is good, but the over-all pregnancy rate (26.6% )-in particular the motherhood percentage (20.0%), which represents the real cure of infertility-is still low. We believe that there is still much to be done to convince ourselves of the usefulness of salpingostomy in any case of tubal obstruction at the distal end. In our opinion, salpingostomy is most effective when it is performed in selected cases by an experienced person and when it is combined with the use of a salpingoplasty device and the administration of corticosteroids and hydrotubations.
Ectopic pregnancies
Abortions
Living children
1
1 (6.6%)
3 (20.00'0)
1
2 (13.3%)
5 (33.3%)
2 (6.6%)
3 (10.00'0)
8 (26.6%)
REFERENCES 1. Cognat M: Presentation d'une prothese-drain destinee a la chirurgie tubulaire pour sterilite. Bull Fed Soc Gynecol Obstet Fr 23:4, 1971 2. Cognat M, Palmer R, Mints M, Papathanassiou S: Presentation d'un nouveau dispositif pour salpingoplastie. Rapport preliminaire. Gynecologie 24:2, 1973 3. Swolin K: 50 Sterilitiitsoperationen. Acta Obstet Gynecol Scand 46:1, 1976 4. Grant A: Infertility surgery of the oviduct. Fertil Steril 22:496, 1971 5. Umezaki C, Katayama KP, Jones HW Jr: Pregnancy rates after reconstructive surgery of the fallopian tubes. Obstet Gynecol 43:3, 1974 6. Comninos AC: Salpingostomy. Treatment of female sterility. Fertil Steril 5:4, 1954 7. Roland ML: Tuboplasty in 130 patients. Obstet Gynecol 39:57,1972 8. Greenhill JP: Evaluation of salpingostomy and tubal implantation for treatment of sterility. Am J Obstet Gynecol 33:39,1937