Institute of Obstetrics and Gynaecology, Policlinico di Modena, Via del Pozzo, 71 41100 Modena, Italy
1 To whom correspondence should be addressed. e-mail: cagnacci{at}unimore.it
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Abstract |
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Key words: laparoscopy/laparotomy/minilaparotomy/myomectomy
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Introduction |
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Beside operative hysteroscopy, which represents a valid approach for submucous myomas, or vaginal myomectomy, four different operative techniques have been described for the surgical approach to myomas: laparotomy (LT), laparoscopy (LA), minilaparotomy (MLT) and laparoscopically assisted minilaparotomy (LA-MLT) (Vollenhoven et al., 1990). All four of these techniques can be used depending upon the surgeons preference, but few studies have specifically compared their clinical outcome.
Ours is a prospective randomized study aimed to compare the outcome in the first 7 days after surgery of myomectomy performed with three different laparotomic techniques: LT, MLT and LA-MLT. In order to have a biochemical evaluation of the surgical stress induced by the three procedures, the increase of stress hormones induced by surgery, i.e. cortisol (Plumpton et al., 1969), prolactin (Frantz et al., 1972
), and the reduction of insulin sensitivity (Brandi et al., 1993
), was also considered.
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Materials and methods |
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LT is performed with a 1012 cm supra-pubic incision. The s.c. fat and abdominal fascia are opened crosswise and the abdominal muscle is opened longitudinally on the midline. The parietal peritoneum is visualized and it is opened longitudinally to reach the pelvic cavity. Subsequently, a separator is inserted through the abdominal breach and an intestinal compress is inserted. After examination of the uterus and adnexa, myomectomy is performed. No pharmacological vasoconstriction or mechanical vascular occlusion technique is used before uterine incision. When possible, uterine incisions are performed on the anterior wall or the fundus in an attempt to reduce post-operative adhesions. The uterine defects are closed in a single or double layer with interrupted sutures of Vicryl 10 polyglactin 910 (Ethicon SpA, Italy). The serosa is approximated with Vicryl 30. During the procedure the uterus is continuously irrigated with a Ringer lactate solution. After the control of haemostasis and repeated washing of the pelvic cavity, InterceedTM (Ethicon Inc.) is placed on the uterine suture to prevent adhesions. Laparotomy is closed in separate layers.
MLT is performed with an 5 cm incision, 12 cm above the pubic symphysis. The abdominal fascia is opened crosswise or longitudinally. A uterine manipulator is used to elevate the uterus toward the suprapubic incision. Trans-peritoneal palpation is used to identify a major myoma, and a corkscrew manipulator is inserted into it blindly, through the peritoneum. The parietal peritoneum is then incised just above the myoma during the traction performed on the corkscrew, and the myoma along with the uterus is forced out of the peritoneum and the minilaparotomic incision. Myomectomy and uterus reconstruction is performed directly outside the peritoneum, as in the LT procedure. To prevent adhesions, InterceedTM is placed on the uterine suture. Then the uterus is replaced in the pelvic cavity, and after an accurate rinsing the abdominal incision is closed in multiple layers.
In the LA-MLT, a pneumoperitoneum is obtained with carbon dioxide insufflation through a Veress needle. A 10 mm port is inserted through the umbilicus to introduce the laparoscope, which is connected to a camera for video monitoring. An accessory 5 mm trocar is inserted into the abdomen to the left of the umbilicus. The video camera is used to identify the myoma and to obtain visual guidance for the insertion of the corkscrew through the peritoneum. The accessory trocar is used to insert operative instruments and the suction irrigator cannula. During formation of the pneumoperitoneum, the minilaparotomic incision is performed, as in the MLT procedure. Thereafter, the surgical times follow those previously described for MLT. After the closure of peritoneum, haemostasis is further controlled under videolaparoscopy, and an accurate rinsing of the pelvic cavity is performed via a suction-irrigator. No peritoneal or incisional instillation of topical analgesics is used in either laparotomy or laparoscopy procedures. For the first 12 h after surgery, each subject receives an i.v. analgesic therapy. Analgesics consist of ketoprofen (45 mg/12 h) and tramadol (150 mg/12 h). Thereafter, analgesics are suspended and administered only on a patients demand.
The primary outcome of the study was the comparison between the three surgical procedures of the time of paralytic ileus and time of discharge from the hospital. Time of discharge was evaluated both as absolute time and as number of women discharged 3 days after operation. Secondary outcomes were differences in time of operation, maximal fever, duration of fever (body temperature >37°C), post-operative use of analgesics after the first 12 h post-surgery, use of antipyretics, blood loss, post-operative stress and post-operative pain. Evaluation of blood loss was performed by means of the 24 h, 48 h and 7 day haemoglobin modification. Post-operative stress was assessed after 24 h, 48 h and 7 days, by modifications of the stress hormones cortisol (Plumpton et al., 1969) and prolactin (Frantz et al., 1972
), and by the modification of insulin resistance (Brandi et al., 1993
), roughly evaluated by the fasting glucose/insulin ratio (Caro, 1991
). A visual analogue scale (VAS), applicable both to the entire abdomen and specifically to the laparotomic and laparoscopic sutures, was used to evaluate post-operative pain. The VAS consisted of a non-graduated 10 cm line ranging from no pain to pain as bad as it could be. Adequate explanation of the method was given to the patients before surgery.
Statistical analyses
A power calculation revealed that 17 subjects for each group were necessary to detect a difference of
10 h in time of canalization or discharge, with a probability of type I error of 0.05 and type II error of 0.20. Statistical analysis was performed with the statistical package StatView 5.0.1 for Apple Macintosh (SAS Institute Inc., USA, 1998). All analyses were performed blindly except those referring to pain at the laparotomic or laparoscopic sutures. Parametric tests were used after having evaluated the normal distribution of the data to be analysed. Analysis of variance (ANOVA) was used to compare baseline characteristics and net modifications at single time-points observed in the three groups. When significant, Fishers post-hoc test was used to identify significant comparisons. The modifications in time observed in the three groups were compared by ANOVA for repeated measures. The numbers of subjects who used analgesics or antipyretics or who were discharged at day 3 after operation were compared between the three groups by contingency tables and
2-test. For all statistical evaluation, P < 0.05 was used to reject the null hypothesis.
Results are expressed as the mean ± SEM.
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Results |
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The VAS score at the supra-pubic incision was similar in the three procedures from operation to the 7th day after surgery (Figure 3). In LA-MLT, VAS score at site of optical and accessory trocars was <0.3 for all the period after surgery. At the 24 h and 48 h evaluation, the VAS score for abdominal pain was similar in all three procedures, but at the 7 day evaluation it was significantly higher (P < 0.05) after LT (3.0 ± 0.6) than after MLT (0.5 ± 0.2) or LA-MLT (0.9 ± 0.4) (Figure 3).
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Discussion |
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In two retrospective non-randomized studies, LA-MLT induced a similar blood loss, but fewer days of hospitalization, fewer days to resume normal activity (Nezhat et al., 1994; Goldberg et al., 1999
) and less post-operative use of analgesics (Goldberg et al., 1999
). To our knowledge, ours is the first randomized study reporting that MLT and LA-MLT offer advantages in comparison with classic LT. Indeed, despite a similar operation time, MLT and LA-MLT had a reduced time of paralytic ileus and discharge from the hospital. In contrast to time of paralytic ileus, time of discharge offers a composite picture of the post-intervention period, taking into consideration time of canalization, extent and duration of fever, needs of medical treatment, general clinical conditions of the individual and willing patient. Obviously, clinical judgement is not completely objective, but in this study variation was reduced by the same clinical criteria applied to all individuals by the same medical personnel. In all cases the clinical judgement was rather conservative, and it is likely that a shorter length of hospitalization can be achieved for all three procedures. Of the three procedures, LA-MLT showed the shortest time to patients discharge from the hospital. Interestingly, the mean time to discharge after LA-MLT (81.5 h) was very close to that reported by Serracchioli et al. (2000
) after laparoscopic myomectomy (75.6 h). The number of patients discharged from the hospital 3 days after LA-MLT was
60 versus 0% after LT. This rate is slightly lower than that reported by Mais et al. (1996
) of 90% after laparoscopy versus 10% after LT.
It is noteworthy that our MLT technique differs from that previously described (Nezhat et al., 1994; Benedetti-Panici, 1996
). A corkscrew placed into a major myoma is used to force the myoma and the uterus through a small incision of the peritoneum, an incision that is performed during myoma traction. The peritoneum is not opened in advance, and no intestinal compress is inserted into the abdomen. Accordingly, this technique is very close to laparoscopy in terms of contamination of the peritoneal cavity and manipulation of the intestine.
Post-operative stress was evaluated by serum modification of stress hormones including cortisol (Plumpton et al., 1969) and prolactin (Frantz et al., 1972
), and by the acquired resistance to insulin (Brandi et al., 1993
). This allowed us a more objective evaluation of the surgical stress associated with the different procedures. In our hands, single cortisol measurements did not prove to be useful to evaluate post-operative stress. Prolactin was lower in LA-MLT than LT and even MLT, and insulin sensitivity at 7 days was significantly reduced only by LT but not by MLT or LA-MLT. Accordingly, the results indicate an overall lower post-operative surgical stress after the two minilaparotomic approaches, particularly LA-MLT. Data on abdominal pain at 7 days confirm this view.
Among the three procedures, it was LA-MLT that showed the lowest blood loss, the shortest duration of fever, the shortest time of paralytic ileus and discharge from the hospital, and no post-operative increase in the stress hormone prolactin. All these indices, apart from time of discharge, were slightly but not significantly different from those obtained with MLT. It cannot be excluded that statistical significance is achieved by increasing the number of interventions. In addition, LA-MLT allows a clear vision of the pelvic cavity, furnishes a visual guidance to the trans-peritoneal insertion of the corkscrew manipulator into the myoma, and permits adhesiolysis. It may be associated with complications linked to the blind insertion of the Veress needle and the optical trocar (Mayol et al., 1997; Schefer et al., 2001
), but these may be greatly reduced by the use of technical variants such as open laparoscopy (Mayol et al., 1997
; Hasson et al., 2000
).
Myomectomy by MLT or LA-MLT is more feasible than by laparoscopy. It allows an accurate uterine repair, as during LT, but in comparison with the latter, it seems to induce a reduced post-operative stress. In particular, LA-MLT furnishes a more accurate cleaning of the pelvic cavity, because after peritoneum closure, homeostasis is further controlled under videolaparoscopy, and repeated washings are performed for complete debris removal, as is the case during classic laparoscopy. This probably contributes to a further reduction of the post-surgical stress, which allows a prompter recovery and a reduced hospitalization time. Prospective randomized studies are required to confirm the results of this study, and to compare the early and late clinical outcome of myomectomy by MLT or LA-MLT with that performed by laparoscopy.
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References |
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Submitted on April 14, 2003; accepted on August 8, 2003.