A prospective randomized study of laparoscopy and minilaparotomy in the management of benign adnexal masses

Francesco Fanfani1, Anna Fagotti1, Alfredo Ercoli2, Giuseppe Bifulco1, Romina Longo2, Salvatore Mancuso2 and Giovanni Scambia1,3

1 Department of Oncology, Catholic University of the Sacred Heart, Campobasso and 2 Department of Obstetrics and Gynaecology, Catholic University of the Sacred Heart, Rome, Italy

3 To whom correspondence should be addressed at: Department of Gynaecology, Catholic University, L.go A. Gemelli, 8, 00168, Rome, Italy. Email: giovanni.scambia{at}rm.unicatt.it


    Abstract
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 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
BACKGROUND: Recent prospective and randomized studies have demonstrated that laparoscopy is better than laparotomy in the treatment of benign adnexal masses. The aim of this study is to analyse the perioperative outcomes of laparoscopy and minilaparotomy in these patients, in a prospective and randomized manner. METHODS: Between January 2003 and August 2003, 100 consecutive women with a diagnosis of presumed benign adnexal mass and requiring surgical treatment were randomly assigned to minilaparotomy and laparoscopy. Randomization was centralized and computer-based. RESULTS: All operative procedures were performed without conversion to laparotomy. In the group of patients submitted to minilaparotomy, a shorter operating time than patients submitted to operative laparoscopy (mean±SD: 71.9±31.8 versus 87.0±44.8 min; P<0.05) was found. On the other hand, there were significant differences in terms of postoperative ileus (1.1±0.4 days in laparoscopy and 1.4±0.6 in minilaparotomy P<0.023), without affecting the day of discharge. No intraoperative or early complications were registered in either group. CONCLUSIONS: Taking into account that laparoscopy has to be considered the first choice for benign adnexal surgery, our data suggest that minilaparotomy could offer the gynaecology surgeon a valid alternative in the minimally invasive surgery field, especially in specific settings.

Key words: adnexal masses/laparoscopy/minilaparotomy


    Introduction
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
Thanks to its well-known advantages such as the reduction in perioperative morbidity, hospital stay and recovery time (Canis et al., 1997Go; Hidlebaugh et al., 1997Go), laparoscopy has been used with increasing frequency in the management of benign adnexal masses over the last 10 years (Canis et al., 2002Go). The few prospective studies comparing this technique with the classical laparotomy have shown that it should replace open surgery in the treatment of benign adnexal masses (Yuen et al., 1997Go). Moreover, in spite of the reported higher costs of laparoscopy due to the surgical instruments, the longer operative time and learning curve, no significant differences in total hospital charges have been demonstrated between laparoscopy and laparotomy (Carley et al., 2003Go).

However, some specific advantages of laparotomy such as shorter operative time (Carley et al., 2003Go), a shorter learning curve, and the absence of pneumoperitoneum, which could be contraindicated in patients with severe obesity or a critical physical status (Marana et al., 2003Go), should be considered. In this context, minilaparotomy could offer the patients a less invasive surgical access than standard laparotomy (Benedetti-Panici et al., 1996Go; Fagotti et al., 2002Go). We previously demonstrated that it fulfils the criteria of minimally invasive surgery (Fagotti et al., 2002Go; Fanfani et al., 2004Go) with a very small and aesthetic abdominal incision. Moreover, in a pilot study minilaparotomy was shown to create a neuroendocrine response similar to laparoscopy but smaller than a classic laparotomy (Marana et al., 2003Go).

A retrospective evaluation of minilaparotomy in the management of benign gynaecological disease was carried out at our Department in the year before this study accrual, showing comparable results in terms of overall patient outcomes with respect to laparoscopy (Fanfani et al., 2004Go). Nevertheless, to date no studies have compared laparoscopy and minilaparotomy for surgical treatment in a randomized and prospective manner.

The aim of this study was to analyse the operative data and the perioperative complications of these two minimally invasive approaches in a consecutive series of patients with a presumed benign adnexal mass randomly assigned to each surgical route.


    Materials and methods
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 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
The study was carried out at the Department of Gynaecologic Oncology of the University of the Sacred Heart, Rome. Since January 2003 and August 2003, all women with a diagnosis of presumed benign adnexal mass and requiring surgical treatment were evaluated for the study. Absolute exclusion criteria were considered a body mass index (BMI) >32 kg/m2, the cysts with a maximum diameter >12 cm measured by ultrasonography, or whether a hysterectomy was required at the same time. Postmenopausal patients with CA 125 levels >35 UI/ml were also excluded from the study.

A written informed consent was obtained from all patients entering the study, and the randomization was performed on the day of surgery. Randomization was centralized and computer-based. Those patients randomized to laparoscopic surgery were counselled that laparotomy would be carried out if difficulties were encountered with the laparoscopic approach and if malignancy was suspected. Patients assigned to minilaparotomy were informed of the possibility of enlarging the skin incision in the same circumstances. All patients were counselled that in the case of an unexpected intraoperative diagnosis of malignancy, a classic vertical incision could be performed. The study was stopped when 100 consecutive patients were enrolled: 50 patients were allocated to each group (Figure 1). The power calculation of the study was >80%. Age, BMI, menopausal status, concomitant systemic diseases, previous surgery, operative time (minutes), estimated blood loss (millilitres), complications, and postoperative outcome were recorded prospectively.



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Figure 1. Flow diagram.

 
Standard preoperative assessment was carried out together with serum markers, and an ultrasonographic scan with colour Doppler evaluation to evaluate the size and the characteristics of the lesions.

Surgical procedures were always performed by one senior and one fellow, both for laparoscopy and minilaparotomy.

Bowel preparation and antithrombotic prophylaxis were always performed, and a short-term intraoperative prophylactic antibiotic therapy by a second generation cephalosporin was administered to all patients. When necessary, a frozen section analysis was performed, and in the case of invasive ovarian cancer disease we would switch to a standard laparotomy. The decision for oophorectomy or ovarian cystectomy depended on the age of the patient and on the surgical findings.

As previously reported (Fanfani et al., 2004Go), under general endotracheal anaesthesia, the patient was positioned in a steep Trendelenburg position and a Foley catheter was placed in the bladder. A 4–9 cm transverse (vertical in case of a previous longitudinal scar) skin incision was made 1–2 cm below the pubic hair line 2–4 cm above the pubic symphysis. In order to reduce surgical stress and prolong post-operative analgesia, the skin and the subcutaneous fat were locally infiltrated with Naropine (7.5 mg%) and Xilocaine (2 mg%) (Morisaki et al., 1996Go) before the incision, and at the end of surgery in the case of an operative time >2 h. To avoid the accidental lengthening of the incision, it was sutured at both ends. The subcutaneous fat was dissected and the abdominal fascia opened transversely 2–3 cm above the skin incision to a width of 10–12 cm. To prevent bowel and bladder injuries, the peritoneum was opened manually and dissected caudo-cranially. Only when required, the bowel was packed upward with warm, wet pads. The self-retaining retractor was replaced with two or three Deaver retractors (width 2.5–3.5 cm, length 5–24 cm). The surgical technique was basically the same as in laparotomy, but the surgeon had to perfect his/her skills in working with the instruments in a vertical position, because their wide inclination was not possible. Moreover, given the small dimension of the operative window, the affected organs were pulled toward or through the abdominal wall. Meticulous and prompt haemostasis by electro-coagulating forceps allowed the surgeon to keep the operative field bloodless and proceed safely and quickly.

When possible, the discharge of the cyst through the incision can facilitate and accelerate the procedure. Salpingo-ophorectomy and cystectomy were performed according to the classical technique.

As previously reported (Fagotti et al., 2002Go), when necessary such as in the case of an unexpected borderline malignant or ovarian tumour diagnosed by frozen section analysis, an upper abdomen exploration through a videolaparoscope is performed.

A scar measurement was made at the end of surgery, in order to check any possible lengthening due to the traction on the skin.

All laparoscopic procedures were performed through four ports, a 10 mm transumbilical port for the laparoscope and three 5 mm ports on the right and the left pelvis, and sovrapubic, respectively. Dissection was carried out with either curved dissector or scissors and haemostasis achieved by bipolar coagulation. In the case of mono- or bilateral salpingo-ophorectomy, the ureter was first identified at its entrance into the pelvis and then isolated from the infundibulo pelvis. To avoid ureteral damage due to electrosurgery, the ovarian vessels were coagulated and sectioned after opening a window into the peritoneum close to the posterior wide ligament. All procedures were carried out with a technique simulating that performed by laparotomy without intentionally puncturing the masses. The ovarian defect was left open and the edge inverted by coagulating the inner surface of the defect. Specimens were removed by a bag-retrieval technique through the transubumbilical port using a 5 mm laparoscope in the right ancillary port.

Patient-controlled analgesia with morphine chloridate and ketoralac was the primary modality of postoperative pain control.

Operative complications were defined as bowel, bladder, ureteral or vascular injuries and an estimated blood loss >200 ml. Anaemia was considered in the case of haemoglobin levels <8 g/dl and fever in the case of body temperature ≥38°C in two consecutive measurements ≥6 h apart, excluding the first day after surgery. Patients were allowed to go home when they were fully mobile, apyrexial, passing urine satisfactorily, and not requiring narcotic analgesia. Postoperative complications were defined as any adverse event occurring within 30 days from surgery and considered severe if they resulted in unplanned admission, blood transfusion, or secondary surgical procedure.

Comparison of the patients' surgical outcome and the length of recovery between the two groups was performed using the Mann–Whitney U-test and the frequency data were analysed using Fisher's exact test or {chi}2-test as appropriate. P<0.05 was considered statistically significant.


    Results
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 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
One hundred consecutive patients were enrolled in the study and were randomly assigned to laparoscopy and minilaparotomy. The two groups were similar in age, BMI, menopausal status, and preoperative diagnosis (Table I). All laparoscopies and minilaparotomies were successfully completed without conversion to classical laparotomy.


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Table I. Characteristics of patients in the study population

 
The mean±SD cyst diameter was 6.2±2.5 and 5.9±2.3 cm in the laparoscopy and minilaparotomy groups respectively (not significant). Eight patients (16%) in the laparoscopy group and five (10%) in the minilaparotomy group had bilateral disease. Cystectomy was performed in 42 cases (84%) in the laparoscopy group and 40 (80%) in the minilaparotomy group. In the remaining cases a monolateral [two (4%) in the laparoscopy group and six (12%) in the minilaparotomy group] or bilateral [six (12%) in the laparoscopy group and four (8%) in the minilaparotomy group] salpingo-ophorectomy was performed.

Based on intraoperative findings, we performed frozen section analysis in 11 (11%) cases. In eight of these cases a benign ovarian lesion (six serous and two mucinous) was intraoperatively identified. In the remaining three cases (3%), one in the minilaparotomy group and two in the laparoscopy group, unexpected mucinous ovarian borderline tumours were found. These three cases were submitted to an intensive surgical staging without conversion to classic laparotomy.

At definitive histopathological diagnosis, all except three cases were benign. In particular, endometriotic cysts were found in 33 patients (33%), benign ovarian and parasalpingo-serous cysts in 32 cases (32%), dermoid in 18 cases (18%), and benign mucinous cysts in 16 cases (16%). Excluding endometriotic cysts, the overall frequency of inadvertent rupture of the cysts during operation was 6% in the laparoscopy group and 2% in the minilaparotomy group.

Operative data are shown in Table II. The mean±SD operating time was 87.0±44.8 and 71.9±31.8 min in the laparoscopy and minilaparotomy groups respectively (P<0.05). The estimated blood loss was not significant in the two groups. No intraoperative complications were registered in either group.


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Table II. Operative data

 
As shown in Table III, no cases of postoperative fever and anaemia were found in the laparoscopy group, whereas in the minilaparotomy group there were two cases (4%) and one case (1%) with fever and with anaemia not requiring transfusion respectively. All patients were started on clear liquid diets on the evening of the day of surgery in the laparoscopy group and on postoperative day 1 in the minilaparotomy group. The mean±SD duration of ileus was 1.1±0.4 days in laparoscopy and 1.4±0.6 in minilaparotomy (P<0.023). The mean±SD days of discharge was 2.0±0.8 and 2.2±0.6 days in laparoscopy and minilaparotomy respectively (not significant). In the early postoperative course there were no statistically significant differences between minilaparotomy (mean±SD: 1.2±0.6 vials) and laparoscopy (mean±SD: 1.3±0.5 vials) in the amount of analgesics required (not significant).


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Table III. Postoperative data

 
No patients were submitted to a second surgery for early postoperative complications and no wound infections or dehiscence was registered in the 30 days after surgery.


    Discussion
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
To date, minimally invasive surgery has to be considered the gold standard in the surgical treatment of presumed benign adnexal masses (Canis et al., 1997Go). This is the first prospective study in the present literature to compare two minimally invasive approaches, such as laparoscopy and minilaparotomy, randomly assigned to patients undergoing surgery for presumed benign adnexal masses.

In this study, all operative procedures were performed without conversion to standard laparotomy, even in three cases of unexpected borderline ovarian tumours requiring an intensive surgical staging.

As far as the perioperative outcomes are concerned, it is well accepted that laparoscopy is a better operative approach than classic laparotomy in the management of benign adnexal masses (Yuen et al., 1997Go; Carley et al., 2003Go). In this context, attempts to explore less invasive transabdominal incisions, such as minilaparotomy, could represent an alternative to laparoscopy in some specific conditions, such as cardiorespiratory contraindications or the presence of an unskilled laparoscopic surgeon. We have previously demonstrated that considering the low extent of tissue trauma and the absence of retractors, minilaparotomy can elicit a neuroendocrinal response less relevant than laparotomy and similar to laparoscopy (Marana et al., 2003Go). As far as early postoperative outcome is concerned, in our study we found no significant differences in terms of the amount of analgesics required to control postoperative pain. The induction of pneumoperitoneum seems to cause serious intraoperative complications in those patients with severe obesity or with a critical physical status, suggesting that high risk patients should be treated by minilaparotomy or vaginal surgery (Hachenberg et al., 1998Go). Moreover, we have previously demonstrated that minilaparotomy fulfils the criteria of minimally invasive surgery and can be safely used in the management of benign and neoplastic disease (Fagotti et al., 2002Go; Fanfani et al., 2004Go). In the present study, in the group of patients submitted to minilaparotomy a shorter operating time than patients submitted to operative laparoscopy (71.9±31.8 versus 87.0±44.8 min; P<0.05) was observed. On the other hand, there were significant differences in terms of postoperative ileus (1.1±0.4 days in laparoscopy and 1.4±0.6 in minilaparotomy; P<0.023), without affecting the day of discharge. In addition, no intraoperative or early complications were registered in either group. These data suggest that both surgical approaches fulfil the criteria of minimally invasive surgery.

Operative laparoscopy generally requires a longer operating time, especially due to the time of specimen removal. On the other hand, during laparotomy a part of the operating time is spent in the opening and closing of the abdominal wall. As shown in our study, minilaparotomy, with a narrower surgical field, can offer a time advantage in these surgical steps. On the contrary, the presence of adnexal adhesions, due to previous abdominal surgery or endometriosis, can represent a technical limitation for the minilaparotomy that can be more easily overcome by the wider vision and the abdominal distension offered by laparoscopy (Pelosi and Pelosi, 1996Go). Furthermore, laparoscopy allows an optimal inspection of the peritoneal surface that, when required, should be performed during the surgical management of suspicious adnexal masses.

The rupture of the cysts during surgery has been demonstrated to have an unfavourable clinical impact in patients with unexpected ovarian cancer (Vergote et al., 2001Go), and laparoscopy is generally believed to increase the risk of cyst rupture and spillage of the cyst content with respect to open surgery (Flynn and Niloff, 1999Go; Pejovic and Nezhat, 2001Go). Our data confirmed this opinion, assessing that, excluding endometriotic cysts, the overall frequency of inadvertent rupture of the cysts during operation was 6% in the laparoscopy group and 2% in the minilaparotomy group.

An adequate preoperative evaluation should be carried out to exclude possible malignancy including the history, examination, ultrasonography, and measurement of ovarian tumour markers. Experienced ultrasonographers using some clinical information and their subjective assessment of ultrasonographic images can differentiate malignant from benign masses in most cases. The accuracy and the level of inter-observer agreement are both correlated with experience, varying from 82% in less experienced to 92% in the most experienced investigators (Timmerman et al., 1999Go). About 10% of adnexal masses were extremely difficult to classify, and were defined as unknown (Timmerman et al., 1999Go). We believe that an explorative laparoscopy could be considered during the surgical approach in this specific group.

In conclusion, taking into account that laparoscopy has to be considered the first choice for benign adnexal surgery, our data suggest that minilaparotomy could offer gynaecology surgeons a valid alternative in the minimally invasive surgery field, especially in specific settings. In addition, we believe that surgeon and patient preference and characteristics, rather than costs, should be the primary consideration in selecting surgical methods in all patients with an adnexal mass suitable for surgical treatment (Figure 2).



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Figure 2. Decision making algorithm.

 


    References
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
Benedetti-Panici P, Maneschi F, Cutillo G, Scambia G, Congiu M and Mancuso S (1996) Surgery by minilaparotomy in benign gynecologic disease. Obstet Gynecol 87, 456–459.[Abstract/Free Full Text]

Canis M, Pouly JL, Wattiez A, Mage G, Namhes H and Bruhat MA (1997) Laparoscopic management of adnexal masses suspicious at ultrasound. Obstet Gynecol 89, 679–683.[Abstract/Free Full Text]

Canis M, Rabischong B, Houlle C, Botchorishvili R, Jardon K, Safi A, Wattiez A, Mage G, Pouly JL and Bruhat MA (2002) Laparoscopic management of adnexal masses: a gold standard? Curr Opin Obstet Gynecol 14, 423–428.[CrossRef][ISI][Medline]

Carley ME, Klingele CJ, Genhart JB, Webb MJ and Wilson TO (2003) Laparoscopy versus laparotomy in the management of benign unilateral adnexal masses. J Am Assoc Gynecol Laparosc 9, 321–326.[ISI]

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Marana E, Scambia G, Maussier ML, Parpaglioni R, Ferrandina G, Meo F, Sciarra M and Marana R (2003) Neuroendocrine stress response in patients undergoing benign ovarian cyst surgery by laparoscopy, minilaparotomy and laparotomy. J Am Assoc Gynecol Laparosc 10, 159–165.[ISI][Medline]

Morisaki H, Masuda J, Fukushima K, Iwao Y, Suzuki K and Matsushima M (1996) Wound infiltration with lidocaine prolongs postoperative analgesia after haemorrhoidectomy with spinal anaesthesia. Can J Anaesth 43, 914–918.[Abstract]

Pejovic T and Nezhat F (2001) Laparoscopic management of adnexal masses: the opportunities and the risk. Ann NY Acad Sci 943, 255–268.[Abstract/Free Full Text]

Pelosi MA 3rd and Pelosi MA (1996) Minilaparotomy: a laparoscopic viewpoint. Am J Obstet Gynecol 175, 1676.

Timmerman D, Schwarzler P, Collins WP, Claerhout F, Coenen M, Amant F, Vergote I and Bourne TH (1999) Subjective assessment of adnexal masses with the use of ultrasonography: an analysis of interobserver variability and experience. Ultrasound Obstet Gynecol 13, 11–16.[CrossRef][ISI][Medline]

Vergote I, De Brabanter J, Fyles A, Bertelsen K, Einhorn N, Sevelda P, Gore ME, Kaern J, Verrelst H, Sjovall K et al. (2001) Prognostic importance of degree of differentiation and cyst rupture in stage I invasive epithelial ovarian carcinoma. Lancet 357, 176–182.[CrossRef][ISI][Medline]

Yuen PM, Yu KM, Yip SK, Lau WC, Rogers MS and Chang A (1997) A randomized prospective study of laparoscopy and laparotomy in the management of benign ovarian masses. Am J Obstet Gynecol 177, 109–114.[ISI][Medline]

Submitted on October 28, 2003; resubmitted on April 29, 2004; accepted on June 22, 2004.





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