Vol. 55, No.5, May 1991

FERTILITY AND STERILITY

Printed on acid-free paper in U.S.A.

Copyright © 1991 The American Fertility Society

Adhesion formation after laparoscopic surgery in tubal pregnancy: a randomized trial versus laparotomy*

Per Lundorff, M.D.t Mats Hahlin, M.D., Ph.D. Bjorn Kallfelt, M.D., Ph.D.

Jane Thorburn, M.D., Ph.D. Bo Lindblom, M.D., Ph.D.

Department of Obstetrics and Gynecology, University of G6teborg, G6teborg, Sweden

Objective: Women with ectopic pregnancy (EP) who have been operated on by laparoscopy are thought to have improved subsequent fertility, probably because of less adhesion formation. We aimed to evaluate the adhesion formation after laparoscopy as compared with laparotomy in a randomized trial. Design: One hundred five patients with tubal pregnancy were stratified with regard to age and risk factors and randomized to surgery by laparoscopy or laparotomy. To evaluate adhesion formation and tubal status, 73 patients with strong desire of pregnancy underwent a second-look laparoscopy. The adhesion status at the ipsilateral and contralateral side at primary surgery was compared with the status at second-look laparoscopy. Results: Patients operated on by laparotomy developed significantly more adhesions at the operated side than patients operated on by laparoscopy (P < 0.001). Substantially more patients in the laparotomy group underwent adhesiolysis at second-look laparoscopy than did patients in the laparoscopy group. Tubal patency did not differ between the groups. Conclusions: Laparoscopic treatment of EP results in less impairment of the pelvic status compared with conventional conservative surgery. Fertil Steril 55:911, 1991

The laparoscopic approach for treatment of ectopic pregnancy (EP) has suggested improved fertility, maybe on the basis ofless adhesion formation because laparoscopy avoids drying of the serous peritoneal membrane.! Yet, a previous retrospective study from our clinic did not reveal any differences in the extent of adhesion formation or tubal patency after various surgical methods, including laparoscopic surgery. 2 Our intention with the present controlled investigation was to study the extent of pelvic adhesion formation after laparoscopic treatment of EP as compared with conventional surgery, evaluated by

Received September 4, 1990; revised and accepted January 22, 1991. * Supported by grant 8683 from The Swedish Medical Research Council, Sweden, and by the Goteborg Medical Society, Goteborg, Sweden. t Reprint requests: Per Lundorff, M.D., Department of Obstetrics and Gynecology, University of Goteborg, Sahlgrenska Hospital, S-413 45 Goteborg, Sweden. Vol. 55, No.5, May 1991

a second-look laparoscopy in a prospective randomized trial. To our knowledge, no controlled trial concerning this important matter has been conducted previously. MATERIALS AND METHODS

During a 2-year period between May 1987 and June 1989, 105 women with tubal pregnancy, stratified according to age and risk determinants, were randomized in a prospective trial to surgery by laparoscopy or laparotomy. The design of the study was described recently.3 In 73 cases with a desire for pregnancy (laparoscopy n = 31; laparotomy n = 42) a second-look laparoscopy was performed 12 weeks (1 to 29) after primary surgery. In the remaining 32 patients, no second-look laparoscopy was performed. Eighteen of these had no desire for pregnancy, 9 conceived before planned second-look laparoscopy, and 5 were recommended in vitro fertilization after EP surgery because of extensive pelvic adhesions. Lundorff et al.

Adhesions after ectopic pregnancy

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f

In the laparoscopy group, all 31 patients had a linear salpingotomy performed, which was left open for secondary healing. In five cases, additional lysis of adhesions was undertaken, in one case on the ipsilateral side and in four other cases on the contralateral side (Table 1). In the laparotomy group (n = 42), 34 patients had a linear salpingotomy performed, 3 were treated with "milking" of the tube, 4 patients had a tubal resection, and 1 had a salpingectomy performed. Further, 1 patient underwent salpingectomy at a second intervention because of bleeding. Three patients were subjected to lysis of adhesions on the ipsilateral side and two others on the contralateral side (Table 1). In all cases, tubal surgery was preceded by vasopressin injection of 5 IU in 10 mL of saline into the mesosalpinx to avoid bleeding. In case of laparoscopy, salpingotomy was performed using a diathermy knife and a suction/irrigation instrument (Aquapurator, Wisap, Sauerlach, Germany) via inserted separate trocars in the suprapubic region. In case of laparotomy an atraumatic technique, including nonwoven sponges and peritoneal lavage was used. Both at EP surgery and at second-look laparoscopy, the anatomic conditions of the pelvis were registered on a preprinted form and lysis of adhesions was noted. At second-look laparoscopy, tubal patency was tested by dye solution. The affected tube was not scored at EP surgery because we found it dubious to make a proper clas-

sification and compare a pregnant tube accurately with the nonpregnant organ. The adhesions on both sides and the tubal status on the contralateral side were evaluated, thus constituting the "adhesion and tubal score," both at EP surgery and at second-look laparoscopy. The evaluation was performed by using a modification ofthe score system described by Mage et a1. 4 (Table 2). Grade 1 implies normal condition and grade 4 the most severe damage. To study impairments or improvements, a score change was calculated for each patient. Statistics

Comparisons were performed by Fisher's twosided permutation test. 5 A P value < 0.05 was considered to be statistically significant. RESULTS

In comparison between the surgical procedures, improvements of adhesions and of tubal status were regarded as an unchanged status because improvement was considered a result of lysis of adhesions at primary surgery and not a consequence of the surgical method per se. Presentation of the Adhesions

The distribution of adhesion scores at the time for EP surgery and second-look surgery for the two surgical methods is presented in Table 1. On the

Table 1 Adhesions and Lysis of Adhesions in Patients Operated on by Laparoscopy and Laparotomy at Time for EP Surgery and Second-look Laparoscopy

No. of cases bilaterally free of adhesions Laparoscopy (n = 31) Laparotomy (n = 42)

EP surgery

Second-look laparoscopy

16 (52)" 25 (60)

13 (42)

Ipsilateral side No. of cases with diagnosed periadnexal adhesions Laparoscopy Laparotomy Adhesiolysis Laparoscopy Laparotomy Recurrence of adhesions at second-look laparoscopy Laparoscopy Laparotomy

9 (21)

Contralateral side

Ipsilateral side

Contralateral side

10

11

16

10

13 32

21

1

4 2

8 22

8 13

o

3 2

3

1

15

" Values in parentheses are percents.

912

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Adhesions after ectopic pregnancy

Fertility and Sterility

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Table 2

Scoring System a Surface involved

Adhesion scoring system b Ovary Filmy Vascular Dense

Proximal tube Filmy Vascular Dense Distal tube Filmy Vascular Dense

1/4

2/4

3/4

4/4

1 2 5

1 4 10

1 6 15

1 8 20

1/3

2/3

3/3

1 2 3

1 4 5

1 6 10

1 2 5

1 4 10

1 6 15 Score

Tubal scoring system' Infundibulum Normal Phimosis Sactosalpinx Ampullary tubal wall Normal Thin Thick or rigid Patency

o 2

5

o 5 10 Yes/no

Modified from Mage et aI.' Grade 1 (absence): 0; grade 2 (mild): 1 to 9; grade 3 (moderate): 10 to 20; grade 4 (severe): >20. , Grade 1 (absence): 0 to 2; grade 2 (mild): 5; grade 3 (moderate): 7 to 10; grade 4 (severe): 12 to 15. a

b

ipsilateral side in the laparoscopy group, an impairment was noted in 5 patients (16%). Twenty-five patients (81%) had an unchanged status, and 1 patient (3%) had an improved status. On the contralateral side, 5 patients (16%) had an impaired status, 23 had an unchanged status (74%), and 3 had an improved status (10%) (Fig. 1). All 4 patients with improvement of the status had adhesiolysis performed at EP surgery. In the laparotomy group on the ipsilateral side, 22 patients (52%) had an impaired status, 18 patients (43%) had status quo, and 2 patients (5%) were improved, both of whom had adhesiolysis performed at EP surgery. On the contralateral side, 13 patients had impairment of the status (31%), 29 patients status quo (69%), and no patient improved the status (Fig. 1). Patients operated on by laparoscopy developed less adhesions than those patients treated by lapaVol. 55, No.5, May 1991

rotomy. On the ipsilateral side, the difference was statistically significant (P < 0.001). In both surgical groups, recurrence of adhesions was noticed in 3 of 5 patients (60%) who had adhesiolysis performed either on ipsilateral or contralateral side (Table 1). Yet, in the case of laparoscopy, the adhesions were not as severe as before lysis. At EP surgery, 52% of the patients in the laparoscopy group and 60% in the laparotomy group presented with no adhesions at all. At second-look laparoscopy, these frequencies were reduced to 42% and 21 %, respectively (Table 1). Presentation of Tubal Status

The distribution of the tubal scores (contralateral side) is seen in Table 3. Impairment of the tubal status was found in one of 28 patients (4%) in the laparoscopy group. An unchanged status was seen in 25 of 28 patients (89%). In 2 patients (7%), who had lysis of adhesions performed at primary surgery, improvement of the status was noticed (Table 1 and Fig. 1). Three patients were not evaluated because of previous salpingectomy. Impairment of the status in the laparotomy group was found in 6 of 39 patients (15%), and 33 of 39 patients (85%) had an unchanged status with no improvement seen. Three patients were not evaluated because of previous salpingectomy (Table 3 and Fig. 1). There was no statistically significant difference between the surgical techniques with regard to the tubal score. Tubal Patency Laparoscopy Group

On the ipsilateral side, 29 of 31 patients were evaluated for patency by dye solution. In 22 of 29 Percent 60

***

50 40 30 20 10 0 laparoscopy

laparotomy

Figure 1 The percentage distribution of impairments in adhesion and tubal conditions between EP surgery and second-look laparoscopy. Laparoscopy group (n = 31). Laparotomy group (n = 42) . • , impairment of adhesions on the ipsilateral side. D, impairment of adhesions on the contralateral side. ~, impairment of the tubal status on the contralateral side. ***, P < 0.001. Lundorff et al.

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f

Table 3 Adhesion and Tubal Scores in 31 Patients Operated on by Laparoscopy and in 42 Patients Operated on by Laparotomy at Time for EP Surgery and Second-look Laparoscopy EP surgery Ipsilateral side

Laparoscopy (n = 31) Adhesion score Tubal score b Laparotomy (n = 42) Adhesion score Tubal score b a

Second-look laparoscopy

Contralateral side

1

2

3

4

1

2

3

4

1

2

3

21

6

4

0

20 21

7 3

0 0

4 4 (3)

18 21

8 2

4 5

26

11

4

1

32 33

7 3

3 3

0 0(3)

10 32

19 1

11 3

Grade 1, no adhesions; grade 4, most severe adhesions.

cases (76%), the tube was patent. Two patients could not be evaluated for technical reasons. In 7 of 29 patients (24%) the tube was obstructed. On the contralateral side, 27 of 31 patients were examined, and patency was found in 20 of 27 patients (74%). Four patients could not be evaluated; 3 because of previous salpingectomy and 1 for technical or medical reasons. In 7 of 27 patients, (26%) the tube was obstructed. Laparotomy Group

On the ipsilateral side, 36 of 42 patients were examined, and patency was found in 31 of 36 patients (86%). In those 6 patients not examined, 2 previously had a salpingectomy performed, 1 had severe adhesions, and 3 because of ongoing menstrual bleeding. In 5 of 36 patients (14 %), the tube was occluded. On the contralateral side, 34 of 42 patients were examined, and patency was found in 26 of 34 (76%) patients. Eight patients could not be evaluated, 3 because of previous salpingectomy and 5 because of technical or medical factors. In 8 patients (24%), the tube was occluded. There was no statistically significant difference between the two surgical methods with regard to patency neither on the ipsilateral side nor on the contralateral side. In five cases operated on by laparoscopy and in one case operated on by laparotomy, fluid leakage from the salpingotomy was noticed. DISCUSSION

Periadnexal adhesion formation is suggested as an important factor in infertility after pelvic surgery,fH! and evaluation of the etiology and prevention of adhesion formation have been the major goal for 914

Lundorff et al.

Ipsilateral side

Adhesions after ectopic pregnancy

Contralateral side 4

1

2

3

4

1 3

16 23

8 2

5 1

2 2 (3)

2 4 (2)

21 28

14 4

5 6

2 1 (3)

b Values in parentheses indicate the number of patients not evaluated for tubal scores because of previous salpingectomy.

many investigations.9 ,l0 To avoid tissue ischemia and consequently adhesion formation in the operation field, Levinson and Swolin9 advocated nontraumatic techniques with bloodless entry into the abdominal cavity by use of electrosurgery, peritoneal lavage, and complete excision of diseased tissue. It has been suggested that laparoscopic surgery could reduce the degree of adhesion formation because of less peritoneal damage. 1 Recently, Mecke et alY found that laparoscopic treatment of EP does not completely prevent the development of postoperative adhesions. Furthermore, a retrospective report from our clinic did not demonstrate differences in the development of adhesions in patients operated on by laparoscopy compared with conservative laparotomy.2 Mecke et al. l l found that concomitant adhesiolysis reduces the degree of severity of recurring adhesions. This is in agreement with our results because we found that concomitant adhesiolysis reduces the recurrence of adhesions both in patients treated by laparoscopy and by laparotomy. Yet, in case oflaparoscopy, the degree of severity of the adhesions was reduced. One might argue that it would be more proper to compare adhesion formations only in those patients who underwent salpingotomy. However, this was not the intention with the study and would jeopardize the nature of this randomized trial. The timing of the second-look laparoscopy after fertility surgery is a matter of controversy. An early second look, i.e., after 1 to 2 weeks simplifies adhesiolysis,12 but it is not clear to what extent new adhesions are formed. A late laparoscopy, i.e., after 2 to 3 months probably implies that the process of adhesion formation has been completed and this would give a more accurate estimation of the score change. A further expansion of the time interval to Fertility and Sterility

the second-look laparoscopy would increase the risk of a new ectopic. For these reasons, we intended to perform the second-look laparoscopy within 15 weeks. Laparoscopic management of tubal pregnancy in this study caused significantly fewer adhesions postoperatively on the treated side. In addition, fewer adhesions were seen on the contralateral adnexa, but the degree was not significantly different from the laparotomy group. Adhesiolysis at EP surgery is a useful method for reducing the formation of postoperative adhesions. Whether this reduction will increase subsequent fertility in such patients has not been ascertained.

REFERENCES 1. Bruhat MA, Manhes H, Mage G, Pouly JL: Treatment of ectopic pregnancy by means of laparoscopy. Fertil Steril 33: 411, 1980 2. Lundorff P, Thorburn J, Lindblom B: Second-look laparoscopy after ectopic pregnancy. Fertil Steril 53:604, 1990 3. Lundorff P, Thorburn J, Hahlin M, Kiillfelt B, Lindblom B: Evaluation of modern surgical management of tubal pregnancy. A randomized prospective clinical trial of laparoscopy

I'

1i 1

:1

Ii,

I

~

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versus laparotomy. (Abstr. 111) Presented at the Seventh World Congress on Human Reproduction, Helsinki, Finland, June 26 to July 1, 1990. Published by Kirjapaino Tapo Oy, Helsinki, in the Program Supplement of the VII World Congress on Human Reproduction, 1990 4. Mage G, Pouly J-L, Bouquet de Joliniere J, Chabrand S, Riouallon A, Bruhat M-A: A preoperative classification to predict the intrauterine and ectopic pregnancy rates after distal tubal microsurgery. Fertil Steril46:807, 1986 5. Bradley JW: Distribution-Free Statistical Test. Englewood Cliffs, New Jersey, Prentice Hall, 1968, p 68 6. Bronson RA, Wallach EE: Lysis of periadnexal adhesions for correction of infertility. Fertil Steril 28:613, 1977 7. Caspi E, Halperin Y, Bukovsky I: The importance of periadnexal adhesions in tubal reconstructive surgery for infertility. Fertil Steril 31:296, 1979 8. Diamond E: Lysis of postoperative pelvic adhesions in in-. fertility. Fertil Steril 31:287, 1979 9. Levinson CJ, Swolin K: Postoperative adhesions; etiology, prevention and therapy. Clin Obstet Gynecol 23:1213, 1980 10. Myhre-Jensen 0, Larsen SB, Astrup T: Fibrinolytic activity in serosal and synovial membranes. Arch Pathol 88:623, 1969 11. Mecke K, Semm K, Freys I, Argirion CH, Gent H -I: Incidence of adhesions in the true pelvis after pelvioscopic operative treatment of tubal pregnancy. Gynecol Obstet Invest 28:202, 1989 12. Trimbos-Kemper TCM, Trimbos JB, van Hall EV: Adhesion formation after tubal surgery: results of the eighth-day laparoscopy in 188 patients. Fertil Steril 43:395, 1985

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Adhesion formation after laparoscopic surgery in tubal pregnancy: a randomized trial versus laparotomy.

Women with ectopic pregnancy (EP) who have been operated on by laparoscopy are thought to have improved subsequent fertility, probably because of less...
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