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European Journal of Obstetrics & Gynecology and Reproductive Biology

journal homepage: www.elsevier.com/locate/ejogrb

Gynecologic laparoscopy in patients aged 65 or more: feasibility and safety in the presence of increased comorbidity
Andrea Ciavattini a,*, Jacopo Di Giuseppe a, Stefano Cecchi a, Dimitrios Tsiroglou a, Francesca Mancioli a, Guido Stevenazzi b, Andrea L. Tranquilli a, Pietro Litta b
a b

Womans Health Sciences Department, Polytechnic University of Marche, Ancona, Italy Department of Gynaecological Sciences and Human Reproduction, University of Padova, Padova, Italy

A R T I C L E I N F O

A B S T R A C T

Article history: Received 6 September 2013 Received in revised form 10 December 2013 Accepted 20 December 2013 Keywords: Aged Laparoscopy Gynecologic surgical procedures Previous laparotomy Obesity

Objectives: To evaluate the feasibility, operative outcome and postoperative complications of laparoscopic gynaecologic surgery in patients aged 65 or more, with increased comorbidity and obesity. Study design: The medical records of patients aged 65 or more with uterine or ovarian disease admitted to minimally invasive gynecologic surgery units from January 2009 to December 2011 were retrospectively analyzed in an observational cohort study. Surgical outcomes of the laparoscopic cohort (n = 65) were compared with the outcomes of those who had laparotomy (n = 67) at general gynecologic surgery units, and evaluated with respect to indication for surgery, medical comorbidity and obesity. Laparoscopic surgery was attempted in women who accepted minimally invasive management and who had no absolute contraindications to laparoscopy. Surgical inclusion criteria were benign and malignant uterine and adnexal pathologies; benign uterine pathologies when uterine size was less than 18 weeks gestation or myoma smaller than 10 cm; malignancies in apparent early-stage disease. There was no attempt to use laparoscopy for tumor debulking and cytoreductive surgery. Exclusion criteria were patients with emergency operations or a concomitant urogynecologic procedure. Data were analyzed using Students t-test, the Mann Whitney U test, x2 testing and the Fisher exact test. Results: Patients undergoing laparoscopy had a signicantly shorter hospital stay (p < 0.001), less intraoperative bleeding (p < 0.001), less postoperative hemoglobin decline (p < 0.001), less need for blood transfusions (p = 0.007) and a generally lower incidence of complications compared to women who had laparotomy, regardless of medical comorbidity. Obese patients who had laparoscopy had signicantly less intraoperative bleeding and a smaller postoperative hemoglobin drop; no adjunctive complication was observed. In patients over 70 (80 cases) the laparoscopic group (39 cases) maintained signicantly less intraoperative bleeding (p < 0.001) and a smaller hemoglobin drop (p < 0.001) with respect to laparotomy, with few postoperative complications. Conclusions: According to the results of the study, laparoscopic surgery appears feasible and safe in elderly patients, regardless of medical comorbidity and obesity. 2013 Elsevier Ireland Ltd. All rights reserved.

1. Introduction The latest National Institute of Statistics (ISTAT) census, carried out in Italy in 2011, estimated that 20.3% of the countrys population was over 65 [1]. A growing number of elderly women require surgical consultation and intervention. Some randomized controlled trials and prospective and retrospective studies have demonstrated the advantages of laparoscopy over open surgery in

* Corresponding author at: Gynecologic Section, Womans Health Sciences Department, Polytechnic University of Marche, Via F. Corridoni 11, 60123 Ancona, Italy. Tel.: +39 071 36745; fax: +39 071 36575. E-mail addresses: ciavattini.a@libero.it, a.ciavattini@univpm.it (A. Ciavattini). 0301-2115/$ see front matter 2013 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ejogrb.2013.12.035

elderly people in terms of intraoperative bleeding, post-operative complications, pain and hospitalization [2,3], but in gynecology, available data are limited. A previous study conrmed these ndings in women who underwent open and laparoscopic adnexectomy, with a signicantly shorter postoperative stay in the second group [4]. Ghezzi et al. [5] also reported better outcomes in terms of hospital stay, need for blood transfusion and postoperative complications in women aged 70 or more undergoing laparoscopy for gynaecologic diseases. Since laparoscopy has become the gold standard for the treatment of many gynaecologic conditions, the purpose of this observational study was to evaluate the operative outcome and postoperative complications in a cohort of women aged 65 or more undergoing laparoscopy and to compare the feasibility and surgical

Please cite this article in press as: Ciavattini A, et al. Gynecologic laparoscopy in patients aged 65 or more: feasibility and safety in the presence of increased comorbidity. Eur J Obstet Gynecol (2014), http://dx.doi.org/10.1016/j.ejogrb.2013.12.035

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outcome of laparoscopic and laparotomic gynaecologic surgery in elderly women, and those with increased comorbidity. There is little documented evidence detailing morbidity after laparoscopic hysterectomy in patients with increased medical comorbidity, obesity and previous abdominal surgery, and no detailed literature about the laparoscopic approach in these elderly women [614]. Although the denition of elderly is somewhat arbitrary, the present manuscript will focus on patients aged 65 or more because most developed world countries have accepted this chronological age as a denition of older person. 2. Material and methods The medical records of patients aged 65 or more with uterine or ovarian disease admitted to minimally invasive gynecologic surgery units at the Polytechnic University of Marche, Ancona, and the University of Padova from January 2009 to December 2011 were retrospectively analyzed in an observational multiinstitutional cohort study (II-2 Canadian Task Force Classication of Study Design). The study was approved by the institutional review board (RE: IRB-03-2012 Polytechnic University of Marche, Ancona, Italy). Laparoscopic surgery was attempted in most women who had no absolute contraindications to laparoscopy, and who accepted minimally invasive management. Specically, surgical inclusion criteria were benign and malignant uterine and adnexal pathologies (uterine broids, endometrial or cervical cancer, adnexal masses); benign uterine pathologies when the uterine size was less than 18 weeks of gestation or myoma smaller than 10 cm; malignancies in apparent early-stage disease, dened as organ-conned cancer with no evidence of gross metastatic disease based on the preoperative imaging studies or on laparoscopic inspection. There was no attempt to use laparoscopy for tumor debulking and cytoreductive surgery. No patient was refused laparoscopic surgery for reasons of tumor size, obesity, previous surgical history, or foreseen difculty of resection. Contraindications for laparoscopy were the following: anesthetic contraindication to pneumoperitoneum, limited vaginal access or/and a bulky uterus where vaginal removal might require morcellation, and the presence of gross adenopathies at magnetic resonance imaging (MRI). Patients with emergency operations or a concomitant urogynecologic procedure such as urethral suspension, vaginal repair, or sacrocolpopexy were excluded because these types of procedures have differing intraoperative and postoperative considerations. Women with documented severe cardiopulmonary disease were refused a laparoscopic approach only after consultation with a senior member of the anesthesiology team. Cardiopulmonary disease was dened as a history of cardiac failure, myocardial infarction, unstable angina, or pulmonary obstructive disease poorly controlled or contraindicating prolonged placement in the Trendelenburg position. The laparoscopic cohort was compared with subjects who did not routinely undergo laparoscopy at general gynecologic surgery units at the same medical centers (laparotomic group), who were recruited consecutively, during the same period, and with the same inclusion criteria for surgical indications, procedures and age. Both types of surgery (laparoscopy and laparotomy) were performed by senior gynecologist surgeons. Each surgeon belongs to a specic unit which electively performs only open or minimally invasive surgery. Laparoscopic procedures were performed by a senior gynecologist surgeon and a fellow with an extensive background in laparoscopy. Similarly, laparotomy procedures were performed by a senior gynecologist and a fellow belonging to the gynecological laparotomy team.

All women were counseled about the strategy before undergoing surgery and gave their approval. Written informed consent for use of personal data was obtained from each woman. Preoperative variables specically included American Society of Anesthesiologists physical status classication system (ASA score), body mass index (BMI), diabetes, hypertension, dyslipidemia and/ or cardiovascular diseases, thyroid diseases, history of malignancy, previous pregnancies, menopausal age and abdominal surgical history. A detailed description of the surgical laparoscopic and laparotomic techniques used in the treatment of the various diseases has been presented elsewhere [1517]. Operative time, intraoperative bleeding, postoperative hemoglobin and hematocrit decline, preoperative and postoperative leukocyte difference, and time of discharge were evaluated. Operative complications were dened as bowel, bladder, ureteral or vascular injuries, and included laparotomy conversion. Operative time was dened as the interval from incision to the placement of the dressing. Intraoperative bleeding was recovered in graduated containers that were checked at the end of surgery. Postoperative outcome included readmission to the hospital and reoperation for a condition related to the prior surgical procedure. Postoperative complications were dened as any adverse events resulting from the procedure and occurring within 30 days from surgery. Anemia was dened as hemoglobin levels lower than 7.5 g/dl. Fever was dened as body temperature 38 8C on two consecutive measurements at least six hours apart, excluding the rst day after surgery. The duration of hospital stay was dened as the period going from the time of admission to the time of discharge. 2.1. Statistical analysis Data were analyzed using Students t-test, the MannWhitney U test, x2 testing and the Fisher exact test. Continuous parametric variables were expressed as mean (standard deviation), and nonparametric variables were expressed as median and range. A p value < 0.05 was considered statistically signicant. 3. Results The main demographic and clinical characteristics of the study population are shown in Table 1. The mean age was 70.2 years (range: 6587 years), and increased medical comorbidity and obesity were observed in 71.2% and 21.2% of patients, without signicant differences between the laparoscopic cohort and the laparotomic group. Surgical outcomes, also according to indications to surgery, are shown in Table 2. Similar operative time was observed in both groups. Patients undergoing laparoscopy had a signicantly shorter hospital stay, a signicantly lower intraoperative bleeding, a smaller postoperative hemoglobin drop, less need for blood transfusion and a generally lower incidence of complications, compared to women who had laparotomy. Complications among patients undergoing laparoscopic surgery included vaginal cuff dehiscence (n = 1), palpitations in the absence of increased cardiac enzymes or electrocardiogram (ECG) pathological signs (n = 1), and pelvic pain, specically at the site of insertion of the left trocar in the absence of hematoma (n = 1); no conversion to laparotomy was made. Complications observed among the laparotomic group were postoperative and included wound infection with dehiscence (n = 2), vaginal cuff dehiscence (n = 2), subcutaneous hematoma (n = 5), deep venous thrombosis (n = 1) and hemoperitoneum (n = 1), which required re-laparotomy. In patients over 70 (80 cases), the laparoscopic group (39 cases), maintained signicantly less intraoperative bleeding (28.7 49.2 vs 253.1 133.4 ml;

Please cite this article in press as: Ciavattini A, et al. Gynecologic laparoscopy in patients aged 65 or more: feasibility and safety in the presence of increased comorbidity. Eur J Obstet Gynecol (2014), http://dx.doi.org/10.1016/j.ejogrb.2013.12.035

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A. Ciavattini et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology xxx (2014) xxxxxx Table 1 Characteristics of the population. LPS (n = 65) Age (years) (mean SD) ASA score  2 Previous abdominal surgery Cesarean Section (median, range) Comorbidity (at least one) Obesity (BMI  30 kg/m2) Diabetes mellitus Hypertension and cardiovascular diseases Thyroid disorders Dyslipidemia Indication to surgery Benign conditions Uterus Adnexal Malignancies Uterus Adnexal Surgical procedure Bilateral adnexectomy Simple Hysterectomy Hysterectomy + bilateral adnexectomy Hysterectomy + bilateral adnexectomy + omentectomy Hysterectomy + bilateral adnexectomy + lymphadenectomy Radical hysterectomy + lymphadenectomy 70.2 4.4 48 (73.8%) 42 (64.6%) 0 [02] 46 10 7 38 14 11 (70.7%) (15.3%) (10.7%) (58.5%) (21.5%) (16.9%) LPT (n = 67) 70.2 4.6 52 (77.6%) 44 (65.6%) 0 [02] 48 18 11 33 18 11 (71.6%) (26.8%) (16.4%) (49.2%) (26.8%) (20.9%) P 0.8 0.75 0.95 0.98 0.93 0.16 0.48 0.37 0.61 0.71 3

9 (13.8%) 38 (58.5%) 12 (18.5%) 6 (9.2%)

8 (11.9%) 39 (58.2%) 15 (22.4%) 5 (7.5%)

0.94 0.88 0.73 0.96

38 3 10 6 5 3

(58.5%) (4.6%) (15.4%) (9.2%) (7.7%) (4.6%)

28 3 11 12 8 5

(41.8%) (4.5%) (16.4%) (17.9%) (11.9%) (7.5%)

0.08 0.69 0.93 0.22 0.60 0.73

p < 0.001) and a smaller hemoglobin drop (0.7 0.6 vs 2 1 gr/dl; p < 0.001) with respect to laparotomy, with few postoperative complications (5.1% vs 12.2%; not signicant). Similarly, in the presence of obesity (BMI  30), increased medical comorbidity, or ASA score 2, the laparoscopic group maintained signicantly less intraoperative bleeding, a signicantly smaller postoperative hemoglobin drop, and a generally lower incidence of complications compared to those who had laparotomy (Table 2). When the analysis was limited to patients who had laparoscopy, however, obesity determined only a longer operative time with respect to women with BMI < 30 (153.4 71.6 vs 84.3 68.9; p < 0.01); increased medical comorbidity had no signicant negative effects on operative and postoperative outcomes, and previous laparotomies (36 cases) determined a longer hospital stay when compared with patients who had no previous surgery (23 cases) (4 (range 35) vs 3 (range 25) days; p = 0.11) or previous laparoscopy (6 cases) (4 (range 35) vs 3 (range 24) days; p = 0.029. Also, febrile morbidity and a longer operative time were more recorded in women with previous laparotomy compared to those with no previous surgery or previous laparoscopy, although this was not signicant. Postoperative complications were observed in two patients with a previous laparotomic appendicectomy with intrapelvic adhesions; the laparoscopy had longer operative times and was complicated by postoperative pelvic pain and palpitations. No difference with respect to operative and postoperative outcome was observed in patients with previous laparoscopy compared to those with no previous surgery. 4. Comments Constant improvements in healthcare and technology have increased life expectancy, particularly in Western countries. Compared to conventional and minimally invasive laparotomic procedures, laparoscopic surgery is associated with less postoperative pain, better pulmonary function, reduced ileus, and a shorter hospital stay [1821]. This study was designed to determine whether these advantages could also be applied to the elderly. Predictably, elderly patients show a signicantly higher incidence of comorbidity, such as heart diseases, diabetes, or

previous cancer, and surgical risk is directly correlated to the number of comorbidities of a patient. Although the ASA score was not originally intended for surgeons, it is directly correlated to the number of comorbidities of a patient. Signicant differences in terms of comorbidities and ASA score, which is a typical pattern of preoperative evaluation, between the laparoscopic and laparotomic groups were not recorded in this observational cohort study. Despite this, the laparoscopic group had a signicantly shorter operative time, less bleeding, and fewer postoperative complications, compared to the laparotomic one, suggesting that laparoscopic procedures can be undertaken in elderly patients without encountering any technical difculty, and with increased efcacy. It was possible to hypothesize potential adverse hemodynamic effects related to a prolonged pneumoperitoneum and extreme Trendelemburg position, especially in elderly patients who had laparoscopy, but no anesthesiological, cardiovascular or pulmonary problems were recorded during the procedures. Moreover, the outcomes analysis of the cohort demonstrates a number of shortterm advantages of laparoscopy compared with traditional open surgery. The shorter hospitalization also observed in the subgroup of patients aged 70 or more (3 days, range 25) is of particular relevance to the geriatric population. This may lead to a more rapid recovery of the baseline functional status and fewer postoperative complications than with open procedures, which is paramount in elderly women who can withstand major surgery but poorly tolerate postoperative morbidity. An interesting result of the study was the feasibility and positive outcome of the laparoscopic approach in patients with associated obesity; however, the small number of the elderly patients included in the series did not enable denitive conclusions but only interesting suggestions. Some associated comorbidities and obesity were originally seen as a relative contraindication to the laparoscopic approach [22]. This attitude has changed in recent years, since several studies have demonstrated that laparoscopic surgery in obese patients is feasible and safe [23,24]. The main problems in these patients are related to wound complications and postoperative recovery, and most of the complications associated with laparoscopy are seen in patients who were converted to laparotomy [10]. Additionally, reports have shown that obese patients are likely to benet the

Please cite this article in press as: Ciavattini A, et al. Gynecologic laparoscopy in patients aged 65 or more: feasibility and safety in the presence of increased comorbidity. Eur J Obstet Gynecol (2014), http://dx.doi.org/10.1016/j.ejogrb.2013.12.035

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Table 2 Operative and postoperative data. All study population Laparoscopy (n = 65) Operative times (min) (mean SD) Hospitalization (days) (median, range) Estimated bleeding (ml) (mean SD) Postoperative hemoglobin decline (rst postoperative day), (gr/dl) (mean SD) Blood transfusions Febrile morbidity Postoperative complications Pre- and post-operative D leukocyte (rst postoperative day) (n/mmc) (mean SD) Relative D Leukocytes (%) (mean SD) 105.7 71.4 3 (25) 19.6 37.4 0.7 0.5 Laparotomy (n = 67) 115.4 69.5 5 (39) 289.6 309.3 2.0 0.8 p 0.43 <0.001 <0.001 <0.001 BMI  30 Laparoscopy (n = 10) 153.4 71.6 4 (25) 35.5 51.3 0.6 0.4 Laparotomy (n = 18) 149.2 83.5 4 (38) 299.5 176 2.2 0.7 p 0.89 0.11 <0.001 <0.001

0 5 (7.7%) 3 (4.6%) 8706 2094

5 (7.5%) 13 (19.4%) 11 (16.4%) 9147 2325

0.007 0.08 0.05 0.25

0 1 (10%) 0 8765 1196

1 (5.5%) 4 (22.2%) 5 (27.8%) 9328 3101

0.75 0.77 0.18 0.58

41.2 23.6 Benign conditions Laparoscopy (n = 47)

45.4 51.3

0.55

35.4 28.2 Malignancies

51.4 47.6

0.34

Laparotomy (n = 47) 88.3 62.5 5 (39) 275.4 280.5 1.9 0.9

p 0.68 <0.001 <0.001 <0.001

Laparoscopy (n = 18) 148.2 64.6 3 (25) 25.2 44.3 0.9 0.4

Laparotomy (n = 20) 162.2 45.8 5 (39) 315.2 325.8 2.2 0.7

p 0.44 0.006 <0.001 <0.001

Operative times (min) (mean SD) Hospitalization (days) (median, range) Estimated bleeding (ml) (mean SD) Postoperative hemoglobin decline (rst postoperative day), (gr/dl) (mean SD) Blood transfusions Febrile morbidity Postoperative complications Pre- and post-operative D leukocyte (rst postoperative day) (n/mmc) (mean SD) Relative D Leukocytes (%) (mean SD)

94.6 85.1 3 (25) 16.2 31.7 0.6 0.5

0 2 (4.2%) 0 8624 2210

1 (2.1%) 4 (8.5%) 4 (8.5%) 9127 2250

0.98 0.66 0.12 0.27

0 3 (16.6%) 3 (16.6%) 8925 2112

4 (20%) 9 (45%) 7 (35%) 9186 2411

0.14 0.12 0.35 0.72

40.5 25.2 Associated comorbidity Laparoscopy (n = 46)

43.9 53.6

0.69

42.1 24.2 ASA score  2

48.6 53.2

0.63

Laparotomy (n = 48) 103.5 38.6 5 (39) 211.4 128.7 1.7 0.5

p 0.65 <0.001 <0.001 <0.001

Laparoscopy (n = 48) 104.6 64.6 3 (25) 24.5 51.3 0.4 0.7

Laparotomy (n = 52) 101.7 51.9 5 (39) 289.4 276.3 1.9 0.7

p 0.80 <0.001 <0.001 <0.001

Operative times (min) (mean SD) Hospitalization (days) (median, range) Estimated bleeding (ml) (mean SD) Postoperative hemoglobin decline (rst postoperative day), (gr/dl) (mean SD) Blood transfusions Febrile morbidity Postoperative complications Pre- and post-operative D leukocyte (rst postoperative day) (n/mmc) (mean SD) Relative D Leukocytes (%) (mean SD)

98.3 71.4 3 (25) 18.5 47.9 0.5 0.6

0 5 (10.9%) 3 (6.5%) 9328 1715

4 (8.3%) 8 (16.6%) 11 (22.9%) 9523 1369

0.14 0.62 0.05 0.54

0 5 (10.4%) 3 (6.2%) 8530 1722

4 (7.7%) 12 (23.1%) 11 (21.1%) 9089 2497

0.15 0.15 0.06 0.20

35.4 27.2

41.8 36.3

0.34

34.7 23.1

39.3 53.4

0.58

most from minimally invasive techniques [25]. According to these considerations it is obvious that the goal in these patients is to avoid laparotomy. No conversion to laparotomy was made in this study, and hospital stay was short. Reports suggest that a history of abdominal surgery is most closely associated with the incidence of complications during laparoscopic surgery because the conventional umbilical approach can cause damage to adherent organs [26,27]. The reported incidence of intra-abdominal adhesions after laparotomy ranges between 30% and 90% [28]. This might encourage physicians to avoid laparoscopic surgery in these patients, especially in elderly women where any complication has a major adverse effect. This study, the rst of its kind in elderly women, conrms the feasibility and positive outcome of the laparoscopic approach also after abdominal surgery. An umbilical open method that can directly visualize adherent organs under the umbilicus was used to avoid complications, and no complication due to the primary entry was recorded. However, previous abdominal surgery leads to longer operative times, a longer hospital stay and febrile morbidity, probably related to the adhesiolysis required for the laparoscopic pelvic surgery to proceed. When the previous surgery was

laparoscopic, no signicant differences in operative time and hospitalization were observed and no complication was recorded. In conclusion, laparoscopic surgery appears feasible and safe in elderly patients regardless of increased comorbidity and obesity. Caution is needed, however, in drawing rm conclusions before validating these ndings in a different, larger cohort. Conicts of interest statement Drs. Andrea Ciavattini, Jacopo Di Giuseppe, Stefano Cecchi, Dimitrios Tsiroglou, Francesca Mancioli, Guido Stevenazzi, Andrea Luigi Tranquilli, Pietro Litta know and comply with the Journals Conict of Interest Policy. No conicts of interest are declared. No sources of nancial support are declared. References
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Please cite this article in press as: Ciavattini A, et al. Gynecologic laparoscopy in patients aged 65 or more: feasibility and safety in the presence of increased comorbidity. Eur J Obstet Gynecol (2014), http://dx.doi.org/10.1016/j.ejogrb.2013.12.035