ORIGINAL ARTICLE
Laparoscopic surgery in ectopic pregnancy
-D-
A randomized trial versus laparotomy PER
LUNDORFF, JANE THOREURN, MATSHAHUN,6JORN KALLFELT AND BO LlND6LOM.
Acta Obstet Gynecol Scand Downloaded from informahealthcare.com by Nyu Medical Center on 06/21/15 For personal use only.
From the Department of Obstetrics and Gynecology, University of Goteborg, Viborg Hospital, Sweden
Acta Obstet Gynecol Scand 1991; 70: 343-348 A randomized, prospective clinical trial was conducted to compare the efficacy of
laparoscopic treatment with conventional conservative abdominal surgery for tubal pregnancy. Entry criteria were: size of the ectopic gestation < 4 cm, hemodynamic stability, accessibility for laparoscopic treatment and a trained laparoscopist on duty. There was no difference between the groups regarding gestational duration, size and location of the ectopic gestation, or the mean preoperative hCG values. The groups differed with respect to total operation time (73 min for the laparoscopy group vs. 88 min for the laparotomy group), hospital stay (2.2 vs. 5.4 days) and convalescence period (11 vs. 24 days). The rates of elimination of hCG was similar in the groups, and there were no statistical difference in the rate of second intervention.
Key words: ectopic pregnancy; laparoscopic treatment; short term events; randomized trial Submitted November 12, 1990 Accepted April 10, 1991
During the last decade, various new methods for the treatment of ectopic pregnancy (EP) have been developed (1). This progress has been facilitated by improved diagnostic methods for EP, i.e. endovaginal sonography (2-4), and by the widespread use of hCG assays (5-7). Identification of risk determinants is also of advantage for early recognition before rupture occurs (8). As fertility prospects after EP are still poor (%lo), efforts are also being made to improve surgical management. Laparoscopic surgery may offer short-term benefits in terms of shorter operative time, shorter postoperative hospital stay and shorter convalescence (11). The economic gain from laparoscopic treatment seems substantial (12). The reported incidence of postoperative cornplications in terms of persistent trophoblastic activity after conservative surgery for tubal pregnancy is reported to be some 5-10% (13-16). Provided the rate of complications after laparoscopic surgery vis-a-vis traditional conservative surgery is not increased, the laparoscopic approach should be the preferred treat-
ment. Thus far, studies describing laparoscopic treatment of EP seem to be promising regarding subsequent fertility although reports in general comprise selected cases without well-defined control groups (15,17,18). To study whether treatment of EP by laparoscopy results in the above benefits, we conducted a prospective randomized trial. This report presents the basic data of the material and the short - term efficacy of laparoscopy vs. laparotomy.
Material and methods During the 2-year period May 1, 1987 to June 30, 1989, 264 patients were treated for E P at Sahlgrenska Hospital, Goteborg, Sweden. Of these, 109 women fulfilled the entry criteria (see below) and joined the study. All patients undergoing diagnostic laparoscopy because of suspected E P were informed about the study and were given information about the surgical Acta Obstet Gynecol Scand 70 (1991)
344
P. Lundorff et al.
Table I. Risk model for identification of patients with increased risk for ectopic pregnancy Risk determinants Previous ectopic pregnancy (A)
Number
0
1
22
Risk points
0
1.91
3.82
no
yes
Risk points
0
1.75
Years
2
Risk points
0
0.72
1.44
Number
0
1
22
Risk points
0
0.70
1.40
IUCD in situ (B)
Acta Obstet Gynecol Scand Downloaded from informahealthcare.com by Nyu Medical Center on 06/21/15 For personal use only.
History of infertility (C)
Previous abdominal operations (D)
Risk score value = sum of risk points A + B + C + D “Low-risk’’:
C1.75
(no increased risk of EP in case of pregnancy)
“High-risk”:
1.75-3.33 3.34-5.94 >5.94
(-10% risk) (-20% risk) (-100% risk)
procedures. All 109 women agreed to join the study. Anamnestic data and diagnostic procedures were recorded on a preprinted form including 18 items. A previous study at our Department has shown that the fertility outcome after EP is correlated to the presence of risk determinants and to the pelvic status, and that the method of surgery is less important for the subsequent fertility outcome (9). To establish comparable groups for future fertility evaluation, the women were therefore stratified into six different subgroups on the basis of risk determinants (8) (Table I), and age (19). Entry criteria were: (1) diameter of the tuba1 gestation < 4 cm, (2) ampulTable 11. Stratification with regard to age and risk determinants and randomization of 105 patients with EP to either laparoscopy or laparotomy Risk groups
Method of surgery
Age (years) 31
Laparoscopy
4
8
7
19
Laparotomy
7
12
9
28
“High-risk’’ Laparoscopy (n=58) Laparotomy
2
9
18
29
1
7
21
29
14
36
52
105
Total
”Low-risk”: risk score value
Laparoscopic surgery in ectopic pregnancy
-D-
A randomized trial versus laparotomy PER
LUNDORFF, JANE THOREURN, MATSHAHUN,6JORN KALLFELT AND BO LlND6LOM.
Acta Obstet Gynecol Scand Downloaded from informahealthcare.com by Nyu Medical Center on 06/21/15 For personal use only.
From the Department of Obstetrics and Gynecology, University of Goteborg, Viborg Hospital, Sweden
Acta Obstet Gynecol Scand 1991; 70: 343-348 A randomized, prospective clinical trial was conducted to compare the efficacy of
laparoscopic treatment with conventional conservative abdominal surgery for tubal pregnancy. Entry criteria were: size of the ectopic gestation < 4 cm, hemodynamic stability, accessibility for laparoscopic treatment and a trained laparoscopist on duty. There was no difference between the groups regarding gestational duration, size and location of the ectopic gestation, or the mean preoperative hCG values. The groups differed with respect to total operation time (73 min for the laparoscopy group vs. 88 min for the laparotomy group), hospital stay (2.2 vs. 5.4 days) and convalescence period (11 vs. 24 days). The rates of elimination of hCG was similar in the groups, and there were no statistical difference in the rate of second intervention.
Key words: ectopic pregnancy; laparoscopic treatment; short term events; randomized trial Submitted November 12, 1990 Accepted April 10, 1991
During the last decade, various new methods for the treatment of ectopic pregnancy (EP) have been developed (1). This progress has been facilitated by improved diagnostic methods for EP, i.e. endovaginal sonography (2-4), and by the widespread use of hCG assays (5-7). Identification of risk determinants is also of advantage for early recognition before rupture occurs (8). As fertility prospects after EP are still poor (%lo), efforts are also being made to improve surgical management. Laparoscopic surgery may offer short-term benefits in terms of shorter operative time, shorter postoperative hospital stay and shorter convalescence (11). The economic gain from laparoscopic treatment seems substantial (12). The reported incidence of postoperative cornplications in terms of persistent trophoblastic activity after conservative surgery for tubal pregnancy is reported to be some 5-10% (13-16). Provided the rate of complications after laparoscopic surgery vis-a-vis traditional conservative surgery is not increased, the laparoscopic approach should be the preferred treat-
ment. Thus far, studies describing laparoscopic treatment of EP seem to be promising regarding subsequent fertility although reports in general comprise selected cases without well-defined control groups (15,17,18). To study whether treatment of EP by laparoscopy results in the above benefits, we conducted a prospective randomized trial. This report presents the basic data of the material and the short - term efficacy of laparoscopy vs. laparotomy.
Material and methods During the 2-year period May 1, 1987 to June 30, 1989, 264 patients were treated for E P at Sahlgrenska Hospital, Goteborg, Sweden. Of these, 109 women fulfilled the entry criteria (see below) and joined the study. All patients undergoing diagnostic laparoscopy because of suspected E P were informed about the study and were given information about the surgical Acta Obstet Gynecol Scand 70 (1991)
344
P. Lundorff et al.
Table I. Risk model for identification of patients with increased risk for ectopic pregnancy Risk determinants Previous ectopic pregnancy (A)
Number
0
1
22
Risk points
0
1.91
3.82
no
yes
Risk points
0
1.75
Years
2
Risk points
0
0.72
1.44
Number
0
1
22
Risk points
0
0.70
1.40
IUCD in situ (B)
Acta Obstet Gynecol Scand Downloaded from informahealthcare.com by Nyu Medical Center on 06/21/15 For personal use only.
History of infertility (C)
Previous abdominal operations (D)
Risk score value = sum of risk points A + B + C + D “Low-risk’’:
C1.75
(no increased risk of EP in case of pregnancy)
“High-risk”:
1.75-3.33 3.34-5.94 >5.94
(-10% risk) (-20% risk) (-100% risk)
procedures. All 109 women agreed to join the study. Anamnestic data and diagnostic procedures were recorded on a preprinted form including 18 items. A previous study at our Department has shown that the fertility outcome after EP is correlated to the presence of risk determinants and to the pelvic status, and that the method of surgery is less important for the subsequent fertility outcome (9). To establish comparable groups for future fertility evaluation, the women were therefore stratified into six different subgroups on the basis of risk determinants (8) (Table I), and age (19). Entry criteria were: (1) diameter of the tuba1 gestation < 4 cm, (2) ampulTable 11. Stratification with regard to age and risk determinants and randomization of 105 patients with EP to either laparoscopy or laparotomy Risk groups
Method of surgery
Age (years) 31
Laparoscopy
4
8
7
19
Laparotomy
7
12
9
28
“High-risk’’ Laparoscopy (n=58) Laparotomy
2
9
18
29
1
7
21
29
14
36
52
105
Total
”Low-risk”: risk score value
