Minilaparoscopic Versus Standard Laparoscopic Hysterectomy for Uteri ≥16 Weeks of Gestation: Surgical Outcomes,Postoperative Quality of Life,and Cosmesis

Abstract

Objective:

Hysterectomy for enlarged uteri is a surgical challenge. Our aim was to compare perioperative outcomes, cosmesis, and postoperative quality of life following laparoscopic hysterectomy for large uteri using minilaparoscopic 3-mm versus conventional laparoscopic 5-mm instruments.

Subjects and Methods:

We prospectively enrolled women with a uterus between 16 and 20 weeks of gestation at the preoperative examination. These patients underwent laparoscopic procedures using either 3-mm (minilaparoscopy group) or 5-mm (standard laparoscopy group) instruments. Five months after surgery, patients were called back to fill out the validated Italian translation of the Short Form 12-item Health Survey. Data about the cosmetic outcome of the procedure were also collected, using a Numeric Rating Scale (NRS) from 0 to 10.

Results:

Seventy-eight women were included (27 in the 3-mm and 51 in the 5-mm groups). Perioperative characteristics were comparable between groups. The median uterus weight was 575 (range, 440–1050) g and 550 (400–1000) g in the 3-mm and 5-mm groups, respectively. No minilaparoscopic procedure was converted to standard 5-mm or to an open approach. One (2%) conversion to open abdominal surgery was needed in the conventional laparoscopy group. A better subjective cosmetic outcome was found in the 3-mm (NRS, 9.7±0.4) versus the 5-mm (NRS, 8.9±1.2) group (P=.01). Postoperative quality of life was comparable between groups.

Conclusions:

Minilaparoscopic hysterectomy is feasible, even in the case of an enlarged-size uterus. Moreover, it is associated with a better cosmetic outcome, compared with conventional laparoscopy.

Introduction

There is no consensus in the literature about the strict definition of “minilaparoscopy,” although several reports have suggested that the word be reserved only for laparoscopic operations performed entirely using 3-mm trocars with the only possible exception of the umbilical port.^1,2 Minilaparoscopic surgery had been introduced several years ago, but it was initially reserved for exclusively diagnostic procedures,³ whereas interventional use of 3-mm instruments was mainly considered as a mere complementary addition to standard 5–10-mm trocars. With the refinement of surgical endoscopic techniques and the advances in equipment and materials, considerable numbers of procedures have become possible using minilaparoscopic instrumentation only. In the field of gynecologic surgery, the first operative applications regarded adnexal procedures⁴ and hysterectomies.^1,5–7 Surgeons then proceeded to staging of endometrial cancer,⁸ ending up (for the time being) with total minilaparoscopic radical hysterectomy.^1,9,10 One of the main contributors to these advancements has been the introduction of efficient bipolar coagulation that can warrant adequate hemostatic control of moderate-caliber blood vessels, as in the case of the uterine pedicles.

As witnessed by an increasing body of literature, miniaturization of the instruments has allowed for maximization of the well-known benefits of standard minimally invasive techniques.^11–13 The introduction of 3-mm trocars for laparoscopic hysterectomy procedures has proven to be as effective as standard-caliber accesses.^1,6 However, in analyzing the literature, there are only a few described cases of hysterectomies for large uteri,¹ and the majority of the available reports limit the use of minilaparoscopy to specimens of less than 200 g.^6,7

As shown in a recent article on more than 1500 hysterectomies performed at our institution, the need to remove an enlarged uterus is not an uncommon event in everyday clinical practice.¹⁴

Standard laparoscopy has been demonstrated to be feasible and safe even in the case of giant uteri weighing more than 1 kg.¹⁵ Because no differences were encountered between 5-mm and 3-mm instruments in unselected patients undergoing hysterectomy,¹ it appears logical to hypothesize that even large uteri could be effectively managed by minilaparoscopy.

The aims of the present study are (1) to present our technique for 3-mm total laparoscopic hysterectomy (TLH) in the case of uterine size of 16 weeks of gestation or more and (2) to compare minilaparoscopic versus standard-caliber laparoscopic operations in terms of surgical data, postoperative quality of life, and cosmetic outcomes, in the case of enlarged-size uteri.

Subjects and Methods

Between January 2012 and December 2013, we prospectively enrolled all women with a uterus size between 16 and 20 weeks of gestation who underwent laparoscopic hysterectomy for benign uterine conditions at the Obstetrics and Gynecology Department of the University of Insubria, Varese, Italy. Patients' demographic characteristics (parity, body mass index, previous abdominal surgery, indication for hysterectomy), intraoperative details (operative time, estimated blood loss, the need for conversion to open surgery, uterine weight, intraoperative complications), and postoperative data (hospital stay, postoperative complications, re-admissions, and re-operations) were collected in our surgical database. The data were prospectively maintained by trained residents and updated on a regular basis.

No patient scheduled to have minimally invasive hysterectomy was refused TLH for reasons of age, obesity, prior surgical history, or anticipated difficulty of resection. Women with uteri over the umbilical transverse line (i.e., uterus size over 20 weeks of gestation) at vaginal preoperative examination with uterine prolapse or with suspected uterine malignancy were excluded from the present study.

In the cases of complex gynecological procedures, our surgical team consists of three skilled laparoscopic surgeons (Surgeon A, Surgeon B, and Surgeon C), all with high-level experience in endoscopic techniques. Prior to beginning the study, each surgeon had successfully accomplished a minimum of 150 TLHs. In the case of large uteri, laparoscopic hysterectomies are performed by two of these three surgeons with the aid of a third operator (a resident during his or her period of surgical training). Before starting the present investigation, we arbitrarily decided that 3-mm procedures would have been performed only when Surgeon A and B were contemporaneously present. In the other two possible combinations (Surgeon A and C or Surgeon B and C), standard 5-mm laparoscopic procedures would have been carried out.

All women included in the study gave their written consent to the surgical procedures and to the use of personal information for research purposes. Institutional Review Board approval was obtained. Preoperatively, all women underwent routine assessment, including physical examination, Papanicolau smear, and pelvic ultrasound scan. Diagnostic hysteroscopy was scheduled in all patients complaining of abnormal uterine bleeding. Every woman received a single dose of antibiotic prophylaxis 1 hour prior to surgery.

Details regarding our technique for laparoscopic and minilaparoscopic hysterectomy have been reported elsewhere.¹ With the exception of the trocar size, TLHs and total minilaparoscopic hysterectomies were both performed with the same four-port standard technique following similar surgical steps. An intrauterine manipulator (RUMI System; CooperSurgical, Trumbull, CT) in conjunction with a Koh cup (Koh Colpotomizer System; CooperSurgical) was inserted transvaginally at the start of the operation. A Veress needle was introduced through the umbilicus, and CO₂ was insufflated to distend the peritoneal cavity. After the pneumoperitoneum was created, a 0° 5-mm or 3-mm laparoscope was introduced at the umbilical site. Under direct visualization, three 5-mm or 3-mm ancillary trocars were inserted, one suprapubically and two laterally to the epigastric arteries, in the left and right lower abdominal quadrants, respectively. Pneumoperitoneum was maintained with a dual-tubing insufflation system delivering CO₂ through both the umbilical port and an ancillary port in order to avoid loss of intraabdominal pressure.

Hysterectomy started with coagulation and section of the round ligaments. In the case of concomitant bilateral adnexectomy, the suspensory ligament was coagulated and sectioned. If the ovaries were to be preserved, the tubes were removed by coagulating and sectioning the mesosalpinx and the utero-ovarian ligament. The broad ligament was opened up to the uterovescical fold, which was then incised with caudal reflection of the bladder. Subsequently, the uterine vessels, the cardinal ligaments, and the uterosacral ligaments were coagulated and transected. Hysterectomy was accomplished by performing a circular colpotomy. The uterus was then extracted through the vagina. To reduce the volume of the surgical specimen, the uterus was morcellated through the vagina using a cold knife and scissors. Vaginal cuff closure was performed tranvaginally with a single-layer medium-term reabsorbable suture as described in previous reports.^16,17 Hemostasis was achieved laparoscopically. The trocars were always extracted under direct vision. Incisions were approximated with surgical strips.

Operative time was recorded from the first incision to the last skin approximation. Estimated blood loss was established from the contents of suction devices. Hospital stay was counted starting from the first postoperative day. Organ damage, blood loss exceeding 500 mL, and conversion to laparotomy or conventional 5-mm laparoscopy were considered as intraoperative complications.

Patients were blinded to the caliber of the instruments used. In order to avoid missing data, the present study includes only women living in the province of Varese (the geographic area around our institution) and who received the first postoperative clinical evaluation at our department (vaginal inspection and ultrasound examination) from 1 to 3 months after surgery.

A comparison between the conventional 5-mm laparoscopy and 3-mm minilaparoscopy was made, specifically focused on the differences in terms of intra- and postoperative details.

Cosmetic outcomes of the two procedures were compared using a Numeric Rating Scale (NRS). Patients were contacted 5 months postsurgery and were asked to express their subjective feeling about the cosmetic outcome in relation to the procedure (paying particular attention to the scars at the site of trocar insertion) by giving a numerical assessment between 0 (worst possible cosmetic outcome) and 10 (best possible cosmetic outcome). Then, functional health and well-being from the patient's point of view were evaluated by asking them to fill out the Short Form 12-item Health Survey (SF-12). This is a psychometric questionnaire that expresses the perceived status of health and quality of life. The SF-12 is composed of two parts: the Physical Component Summary (PCS) and the Mental Component Summary (MCS), which evaluate the physical and psychological aspects of the health status, respectively.¹⁸ The health survey was administered by phone, and women were asked to answer 12 short questions about their current condition. Once the survey was completed, the information was collected in a dedicated database for scientifically valid scoring and interpretation. PCS and MCS were computed using the scores of 12 questions ranging from 0 to 100, where 0 indicated the lowest level of health measured by the scale and 100 the highest level of health, as indicated in the SF-12 measurement model.^19,20 For the purposes of the present study, we used the validated Italian translation of this survey.¹⁸

Statistical analysis was performed using GraphPad^® Prism^® version 5.00 for Windows software (GraphPad Software, San Diego, CA). Incidences of intra- and postoperative events among the groups as well as all binomial variables were analyzed for statistical significance by using Fisher's exact test. A P value of <.05 was considered statistically significant. Odds ratios and 95% confidence intervals were calculated for each comparison. Normality testing (D'Agostino and Pearson test) was performed to determine whether data were sampled from a Gaussian distribution. The t test and the Mann–Whitney U test were used to compare continuous parametric and nonparametric variables, respectively.

Results

Eighty-one women who underwent laparoscopic hysterectomy for benign conditions during the study period matched the characteristics to be eligible in the present study. No patients with a uterus between 16 and 20 weeks of size were initially approached by open surgery during the study period. Three (3.7%) of the initial 81 patients had to be excluded from this analysis because they did not live in the geographic area of our institution and could not attend the first postoperative visit at our department (two of them were in the 5-mm group and one in the 3-mm group; no surgical conversion was needed in these 3 excluded patients, and the outcomes compared well with those of the patients enrolled). Therefore, in total, 78 patients were included: 27 (34.6%) and 51 (65.4%) had 3-mm minilaparoscopic hysterectomy and the conventional 5-mm laparoscopic approach, respectively. Demographic characteristics of the patients included are summarized in Table 1. No changes in terms of age (P=.62), body mass index (P=.64), percentage of obese patients (P=.69), and previous open abdominal surgery (P=.32) were observed.

Table 1.

Demographic Characteristics of Patients Undergoing Mini-Total Laparoscopic Hysterectomy Versus Conventional Total Laparoscopic Hysterectomy

	3-mm	5-mm	P value
Number of patients	27	51
Age (years)	48 (40–58)	47 (37–66)	.82
Age ≥50 years old	8 (29.6%)	16 (31.4%)	1.00
BMI (kg/m²)	23.7 (17.6–37.4)	23.9 (19.1–41.4)	.64
Obese (BMI ≥30 kg/²)	3 (11.1%)	4 (7.8%)	.69
Nulliparous	6 (22.2%)	8 (15.7%)	.54
Previous cesarean section	6 (22.2%)	12 (23.5%)	1.00
Previous LPT	7 (25.9%)	20 (39.2%)	.32

Procedures using 5-mm instruments were conventional total laparoscopic hysterectomies; procedures using 3-mm instruments were mini-total laparoscopic hysterectomies. Data are expressed as median (range) or absolute number (%) as indicated.

BMI, body mass index; LPT, laparotomy.

Perioperative details are summarized in Table 2. No conversion (either to standard 5-mm or to the open approach) was necessary in the minilaparoscopic group, whereas one (2%) conversion to open abdominal surgery was needed in the 5-mm group, due to dense intraabdominal adhesions with failure to visualize the pelvic structures. No intraoperative complication occurred in the 5-mm group, and one intraoperative complication occurred in the 3-mm group (severe bradycardia at the time of pneumoperitoneum induction, requiring temporary evacuation of CO₂ and intravenous atropine administration; after resolution of bradycardia, the procedure then proceeded as usual). No damage to the bladder, bowel, ureter, or blood vessels was reported in either group. No significant differences were observed between groups in terms of both intra- and postoperative complications.

Table 2.

Operative Data for Patients Undergoing Mini-Total Laparoscopic Hysterectomy Versus Conventional Total Laparoscopic Hysterectomy

	3-mm	5-mm	P value
Number of patients	27	51
Uterus weight (g)	575 (440–1050)	550 (400–1000)	.31
Salpingectomy	17 (63%)	31 (60.8%)
Salpingo-oophorectomy	10 (27%)	22 (43.1%)	.81
Operative time (minutes)^a	70 (40–140)	80 (30–260)	.21
EBL (mL)	100 (10–1000)	100 (10–1500)	.45
EBL >500 mL	2 (7.4%)	5 (9.8%)	1.00
Transfusion	0 (0%)	2 (3.9%)	.54
CO₂ (L)	167 (51–452)	237 (75–816)	.006
Conversion to open	0 (0%)	1 (2%)	1.00
Complications
Intraoperative	1 (3.7%)	0 (0%)	.35
Postoperative	2 (7.4%)	4 (7.8%)	1.00
Hospital stay (days)	1 (1–2)	1 (1–6)	.08

Measured from first skin incision to last skin closure/approximation.

EBL, estimated blood loss.

There was no case of unsuspected malignancy discovered at definitive histology. Median uterus weight, operative time, and estimated blood loss were comparable between the two groups. Two (3.9%) women who had conventional 5-mm laparoscopic hysterectomy received blood transfusions postoperatively. They both underwent surgery for menorrhagia with preoperative anemia. Two (7.4%) early postoperative complications occurred in the 3-mm group: one (3.7%) woman had urinary retention, which spontaneously resolved after a 24-hour catheterization, whereas in 1 case (3.7%), a patient had nausea and vomiting after surgery. Four (7.8%) postoperative complications occurred in the conventional 5-mm group: two (3.9%) women had anemia treated with iron supplements, one (2%) patient had fever in the first postoperative day that resolved spontaneously without antibiotics administration, and in 1 case (2%) a 4-cm hematoma of an ancillary suprapubic trocar access was observed (conservative treatment was performed, and no blood transfusion was needed). The total amount of CO₂ insufflated was lower in the minilaparoscopic versus the standard laparoscopic group (P=.006). No revision/secondary operation, deep vein thrombosis, or wound healing disorder was reported at follow-up examinations.

Twenty-two (81.5%) and 39 (74.5%) women in the 3-mm and 5-mm groups, respectively, answered the phone questions regarding status of health and cosmesis (Table 3). Patients of the two groups were demonstrated to have a fast recovery from the surgical procedure, in both physical and mental status, with no statistically significant difference between the 3-mm and 5-mm procedures. In particular, the PCS was 50.7±and 47.4±7.7 (P=.13), and the MCS was 55±10.4 and 51.5±9.6 (P=.13) in the 3-mm and 5-mm groups, respectively. The cosmetic results (measured with the 0–10 scored NRS) were extremely satisfactory in both the 5-mm and 3-mm groups; median NRS values were higher in the 3-mm versus the 5-mm group (9.7±0.4 versus 8.9±1.2; P=.01).

Table 3.

Results of the Survey Conducted by Phone for Patients Who Underwent Mini-Total Laparoscopic Hysterectomy Versus Conventional Total Laparoscopic Hysterectomy

	3-mm	5-mm	P value
Number of patients	22/27 (81.5%)	39/51 (76.5%)	—
PCS	50.7±6.4	47.4±7.7	.13
MCS	55.0±10.4	51.5±9.6	.13
Cosmetic results^a	9.7±0.4	8.9±1.2	.01

Procedures using 5-mm instruments were conventional total laparoscopic hysterectomies; procedures using 3-mm instruments were mini-total laparoscopic hysterectomies. Data are mean±standard deviation values or number (%) as indicated.

On a scale of 0–10.

MCS, Mental Component Summary; PCS, Physical Component Summary.

Discussion

Main findings

The present study demonstrates that minilaparoscopic hysterectomies using 3-mm instruments can be safely and effectively performed even in the presence of enlarged uteri (i.e., uteri between 16 and 20 gestational weeks), with perioperative outcomes that are similar to the conventional 5-mm approach. Postoperative quality of life measured using the SF-12 appears similar between 3-mm and 5-mm instruments, whereas cosmetic outcomes are slightly, but significantly, better when smaller-caliber instruments are used.

Large uteri represent a challenge to the surgeon, irrespective of the surgical approach chosen (whether open or endoscopic), because they obstruct the pelvis and cause difficulties in visualizing anatomical structures and obtaining adequate exposure of ligaments and vascular pedicles. When a large uterus is to be removed, open surgery is by far the elective approach in the majority of centers.²¹ More than 10 years ago, we started a policy of systematic implementation of minimally invasive surgery at our institution. This strategy enabled us to reach a rate of non–open hysterectomies approaching 100% since 2006. Details and outcomes of our efforts to minimize unnecessary laparotomic procedures have been published previously.¹⁴ In parallel to the demonstration that even extremely large uteri (≥1 kg) can be safely and effectively approached laparoscopically,¹⁵ we designed the present study with the aim of assessing whether downsizing all the ancillary instruments to 3-mm would have impacted our ability to perform these difficult operations.

The findings of the present cohort study corroborate the results of earlier series that previously showed that 3-mm hysterectomy is feasible and safe in cases of modest uterus size.^1–7 In fact, we can extend the validity of this assumption to cases in which large uteri are to be managed. As a consequence, the present investigation represents, in our opinion, a further advance toward the validation of minilaparoscopy in gynecological practice. Some detractors of this ultra-minimally invasive technique could argue that the statistically significant amelioration of postoperative cosmetic outcomes in favor of 3-mm surgery is not sufficient enough to prefer minilaparoscopic surgery in the cases of large uteri. Indeed, the present series shows that the outcomes of 5-mm instrument are overall extremely good in case of uteri between 16 and 20 weeks. However, we strongly believe that in dedicated settings, minilaparoscopy may represent a step forward in the attempt to reach an increasingly less traumatic surgery, even in the technically demanding setting of bulky uteri.

Strengths and limitations

The major merit of the present analysis is the demonstration that, in the hands of experienced surgeons, outcomes of minilaparoscopy are superimposable on those of conventional 5-mm instruments, in terms of surgical details and postoperative quality of life, and that they are even superior in terms of cosmesis.

It should be mentioned that the present analysis was performed on an unselected population of consecutive women and that no patient was refused laparoscopy for uteri approaching 20 weeks of gestation.

We acknowledge that 3-mm instruments are more flexible than 5-mm ones. As a consequence, we decided (for the moment) to avoid their use in case of uteri over the transverse umbilical line. Nevertheless, the present investigation shows that the use of minilaparoscopic devices, including those for bipolar coagulation, is effective in the management of uteri weighing in a range between 400 g and more than 1 kg. Among the possible limitations of the present analysis, we should mention the fact that our surgical team is composed by three highly experienced surgeons and that all the operations involved two of them, thus reducing the generalizability of our conclusions. However, it is our opinion that, with adequate training, minilaparoscopic hysterectomy for large uteri can become available for the vast majority of gynecological laparoscopists.

Another possible weakness is represented by the absence of randomization. Indeed, it should be underlined that it is extremely hard to perform randomized trials when surgical techniques have to be tested. Moreover, when we were designing the present study, Surgeon C was moderately skeptical regarding the possibility of adopting minilaparoscopy in all cases of very large uteri and proposed a gradual implementation starting with selected cases. The main reason for Surgeon C's skepticism was the fear of possible failure of bipolar coagulation while sealing big uterine vessels, rather than to the lack of confidence with minilaparoscopic surgery. To overcome the criticism by Surgeon C, and contemporaneously to avoid any delay in the realization of the present research, we chose the current study design. Due to the results of the present study, Surgeon C is now convinced of the feasibility and safety of minilaparoscopic hysterectomy for large uteri.

In our opinion, the design of the present study almost approximates attribution to either treatment arm by chance. In fact, the three surgeons involved had a considerable laparoscopic background, and the choice as to whether a patient had to undergo 3-mm or 5-mm procedures was not based on the surgeon's experience or ability or on expected difficulty of the case.

Interpretation

The reliability and safety of minilaparoscopy have been already shown in general surgical, urological, and gynecological procedures.^{2,9,10,22–24} In recent years, several complex operations have become available also using 3-mm instruments, such as endometrial cancer staging and radical hysterectomy.^2,8–10 One of the main advantages of minilaparoscopy is that, compared with other innovative techniques such as single-site surgery and natural orifice translumenal endoscopic surgery (NOTES^®; American Society for Gastrointestinal Endoscopy [Oak Brook, IL] and Society of American Gastrointestinal and Endoscopic Surgeons [Los Angeles, CA]), it allows a better dexterity without increasing equipment costs. The initial expense of purchasing minilaparoscopic instruments is similar to that for conventional 5-mm laparoscopy, whereas triangulation of the instruments (a crucial condition in endoscopic surgery) is not impaired by reducing their caliber. In other words, when an endoscopic surgeon decides to embrace minilaparoscopic techniques, advantages can be taken by previous experience, without the need to change the steps of the procedure, surgical setup, positioning of the instruments, and ergonomics. Several publications have shown the superiority of these tiny instruments over single-site surgery and conventional laparoscopy in terms of postoperative pain.^7,11,12

Although our study was not designed to detect small differences in the rate of extremely rare complications, it is logical to hypothesize that the reduction in the caliber of the trocars can be associated not only with better cosmetic results, but also with reduced operative trauma and a lower rate of wound complications. In particular, it should not be neglected that, up to now, no incisional hernias have been described through 3-mm incisions among adults, whereas several reports have shown that 5-mm trocars are at risk of this threatening complication and that its likelihood is related to the size of the accesses.^25,26

Conclusions

In conclusion, the present study represents a further advancement in the knowledge of the possible applications of minilaparoscopy. In a dedicated setting, with high-level proficiency in the field of minimally invasive surgery, large uteri with a size between 16 and 20 weeks of gestation can be safely and effectively managed using 3-mm instruments with no shortcomings compared with conventional laparoscopy and with better cosmetic outcomes.

Footnotes

Disclosure Statement

No competing financial interests exist.

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