Objective
To compare postoperative pain after laparoscopic and vaginal hysterectomy for benign disease.
Study Design
A prospective randomized trial was designed to compare laparoscopic hysterectomy and vaginal hysterectomy in patients with uterine volume ≤14 weeks of gestation. Postoperative pain was measured using the visual analog scale (VAS) at 1, 3, 8, and 24 hours postoperatively. Intra- and postoperative outcomes were carefully recorded, including the need for postoperative rescue doses of analgesia.
Results
A total of 82 patients were enrolled. Patients who underwent vaginal hysterectomy complained of higher postoperative pain at each VAS evaluation (VAS-1 hour, P < .0001; VAS-3 hour, P < .0001; VAS-8 hour, P < .0001; VAS-24 hour, P = .0003) with a higher need for rescue analgesia ( P < .0001) and a longer hospitalization ( P = .001). The other perioperative characteristics were comparable between the 2 groups.
Conclusion
Laparoscopic hysterectomy provides an advantage over vaginal hysterectomy in terms of postoperative pain, need for rescue analgesia and hospital stay, with similar perioperative outcomes.
The International Association for the Study of Pain defines pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.” Surgery can be considered as a controlled injury, because it inevitably causes tissue trauma and the release of potent mediators of inflammation and pain. Postoperative pain is consequently the expected, but nonetheless undesirable product of all surgical procedures. An effective management of postsurgical pain has been clearly related with patient satisfaction, earlier mobilization, shortened hospital stay, and reduced costs. For these reasons, the reduction of postoperative pain should be considered 1 of the priorities in the routine surgical practice.
During the last 2 decades, several studies have tried to define the best surgical approach to hysterectomy for benign conditions. Accumulating evidence demonstrates that abdominal hysterectomy has a higher incidence of complications, a longer hospital stay, and a slower convalescence in comparison with both vaginal (VH) and laparoscopic hysterectomy (LH). The main advantage of nonopen procedures is the absence of a wide abdominal scar, which results in fewer wound-related complications and in a deep reduction of postoperative pain. However, it is yet to be determined which of the 2 alternative and less invasive approaches (LH and VH) should be preferred. In particular, only few randomized trials have compared VH and total LH, and none has focused on postoperative pain as the primary outcome of the study.
We have therefore designed the present prospective randomized trial to specifically investigate differences in postoperative pain after VH and total LH.
Materials and Methods
From February to September 2009, consecutive patients referred to the Department of Gynecology and Obstetrics of the University of Insubria with an indication for hysterectomy for a supposed benign gynecologic condition were asked to participate in the current study. Exclusion criteria were as follows: uterine volume >14 weeks of gestation at clinical evaluation, suspicion of malignancy, concomitant presence of large adnexal masses (maximum diameter >4 cm at preoperative ultrasonography) and pelvic organ prolapse > stage 1 according to POP-Q classification. To avoid any possible confounder in the quantification of postoperative pain, patients with history of chronic pelvic pain and/or suspicion of endometriosis or pelvic inflammatory disease were also excluded. Obesity (body mass index [BMI] ≥30 kg/m 2 ), ≥1 previous caesarean sections, and history of previous abdominal surgery were not considered as contraindications to the vaginal approach.
All patients underwent clinical and ultrasonographic examination preoperatively, including Papanicolaou (PAP) smear test to exclude cervical pathology. An outpatient diagnostic hysteroscopy was scheduled before surgery in all patients complaining of abnormal uterine bleeding. The study protocol has been approved by the local Ethic Committee and Institutional Review Board approval (IRB 619-09) was obtained. All patients enrolled were thoroughly counseled about the 2 different procedures. Written informed consent to participation was obtained. Patients were randomly assigned to undergo LH or VH using a computer-generated list. The treatment allocation was concealed until the day of surgery.
The intraoperative anesthesiology protocol was strictly standardized and followed in all cases. All patients were monitored by electrocardiogram, noninvasive blood pressure, end-tidal CO 2 , and oxygen saturation. Anesthesia was induced with propofol (2 mg/kg) and fentanyl (1-2 mcg/kg). Rocuronium (0.6 mg/kg) was given to facilitate intubation. Patients were ventilated with 50% air in oxygen in volumetric mode (V T 8-10 mL/kg, respiratory rate 12-14/minute to have an end-tidal CO 2 of 35 mm Hg).
After induction patients received preemptive analgesia (ketorolac 30 mg) and prophylaxis for postoperative nausea and vomiting (desametasone 4 mg). Anesthesia was maintained with sevoflurane (MAC 1.2) and fentanyl. Additional doses of fentanyl (50 mcg) have been administered in case of intraoperative pain, assessed by changes in mean blood pressure and heart rate.
All women received a single-dose prophylactic antibiotic 1 hour preoperatively and antithrombotic prophylaxis with low-molecular-weight heparin for the duration of 1 week beginning from the day before surgery. Patients wore compression stockings until full mobilization.
Surgical operations have been performed by the same surgical team with extensive experience in advanced laparoscopic procedures and with a long tradition in vaginal surgery.
Operative technique
Total laparoscopic hysterectomy (TLH)
An intrauterine manipulator (RUMI System; CooperSurgical, Trumbull, CT) in conjunction with a Koh cup (Koh Colpotomizer System; CooperSurgical) was inserted. After pneumoperitoneum was created a 5-mm 0° operative laparoscope was introduced at the umbilical site. Under direct visualization, three 5-mm ancillary trocars were inserted, 1 suprapubically and 2 laterally to the epigastric arteries, in the left and right lower abdominal quadrants, respectively. Hysterectomy was started with coagulation and section of the round ligaments and the infundibulopelvic ligaments using a 5-mm bipolar coagulation forceps (Karl Storz GmbH KG, Tuttlingen, Germany). The broad ligament was opened up to the uterovescical fold that was then incised with caudal reflection of the bladder. Afterward the uterine arteries, the cardinal ligaments, and the uterosacral ligaments were coagulated and transected. Hysterectomy was completed performing a circular colpotomy with a monopolar hook. The uterus was then extracted from the vagina with the intrauterine manipulator still in place. Vaginal cuff closure was performed in a single layer with No. 0 syntetic reabsorbable suture.
VH. VH was performed with the patient lying in lithotomic position and the legs placed in Allen stirrups. After disinfection and sterile coverage, the vagina was inspected and the cervix was grasped with 2 tenacula, to exert adequate traction. A circumferential incision was performed around the cervix at the vaginal fornices. By sharp and blunt dissection, the anterior cul-de-sac was incised, and the bladder was reflected cranially. An incision was then performed posteriorly and the peritoneum of the posterior cul-de-sac was opened. The uterosacral and cardinal ligaments were clamped, cut, and ligated separately. In case there was any vessel not included in the clamp on the cardinal ligament, an additional clamp was placed on it, with separate cut and ligation. At this moment, the fundus of the uterus was pulled out anteriorly or posteriorly to expose the round and uteroovarian ligaments and the salpinges, which were then clamped, cut, and ligated. After the removal of the uterus, the adnexa were inspected. In case of concomitant salpingo-oophorectomy the infundibulopelvic ligament was then clamped, cut, and tied. The peritoneum was finally tied to the vagina circumferentially and the cuff was closed with a continuous suture.
Foley catheter was removed at the end of surgery in all cases and the voiding function recovery was monitored according to our institutional protocol.
Data about surgical outcomes were recorded in a specifically designed form. Operative time was measured from the surgical incision to the closure of the vaginal cuff for VH and to the closure of the skin for LH. Postoperative pain was treated with paracetamol 1 g intravenously every 6 hours (starting from approximately 30 minutes before the end of surgery). Pain was evaluated by administering a 10-cm visual analog scale (VAS), where 0 means no pain and 10 cm means unbearable pain, at 1, 3, 8, and 24 hours after the procedure.
Rescue analgesia (morphine 10 mg subcutaneously) was provided according to the patient’s request. Hospital discharge was decided in the presence of normal abdominal and vaginal objectivity, temperature <37°C, lack of urinary problems, and patient comfort.
Statistical analysis
Statistical analysis was performed with SPSS version 17.0 (SPSS, Inc, Chicago, IL), GraphPad version 5.00 (GraphPad Software, San Diego CA) and G*Power version 3.0.1 (Kiel University, Kiel, Germany) for Windows. Normality testing (D’Agostino and Pearson test) was performed to determine whether data were sampled from a Gaussian distribution. Continuous variables are presented as mean ± standard deviation or as median (range) if sampled from a Gaussian or non-Gaussian distribution, respectively. The t test and the Mann Whitney U test were used to compare continuous parametric and nonparametric variables, respectively. Fisher’s exact test was used to analyze proportions. The primary hypothesis of the current study was that laparoscopic hysterectomy is associated with less postoperative pain when compared to vaginal hysterectomy. Sample size calculation was based on the mean VAS pain score after VH reported by Candiani et al on postoperative day 0. With an alpha error of 5% and a power of 95%, at least 40 patients in each group were needed to detect a 50% decrease in the mean postoperative pain on day 0 in patients who underwent LH. Uni- and multivariate analysis have been then performed to identify factors associated with an increased need for analgesic administration and with a longer hospital stay; for this purpose, we dichotomized variables either arbitrarily (ie, elderly age ≥65 years, estimated blood loss ≤100 mL, obesity: BMI >30) or using receiver operating characteristic (ROC) curves (ie, operative time, VAS scores, uterine weight). Factors showing a significant ( P < .05) or borderline ( P between .05 and .10) association with the 2 outcomes of interest on univariate analysis were entered into a multiple logistic regression model, to identify variables independently associated with analgesic request and hospital stay. Statistical significance was considered achieved for P < .05.
Results
During the study period a total of 123 patients underwent total hysterectomy for benign gynecologic disease at our department. Eighty-two patients (66.7%) met the inclusion criteria and were included in the current study. Five patients (4.1%) refused enrollment. Forty-one patients were randomly assigned to undergo LH and 41 to undergo VH. Figure 1 describes the study flow chart and the reasons for exclusion. In particular, 15 (12.1%) patients were excluded because they had uteri larger than 14 weeks of gestation, 5 (4.1%) patients were excluded because of concomitant adnexal masses larger than 4 cm of diameter, and 16 (13%) were excluded because they had history of endometriosis or chronic pelvic pain. The excluded cases were all successfully treated by laparoscopic hysterectomy. The baseline characteristics of the study population are summarized in Table 1 : the 2 groups were comparable for demographic characteristics and for indication for surgery. Table 2 shows the perioperative outcomes of the 2 study groups. The median (range) operative time was 55 (35–120) and 50 (20-105) minutes for the LH and VH group, respectively ( P = .04). No intraoperative complications or conversion to laparotomy occurred in both groups. No differences were found in terms of postoperative complication ( P = .34). In particular, febrile morbidity occurred in no patients in the LH group and in 2 (4.9%) patients in the VH group; these patients were both successfully managed with the administration of antibiotics. Other postoperative complications included postoperative urinary retention, which occurred in 2 (4.9%) and 1 (2.4%) patients in the VH and LH group, respectively; voiding dysfunction regressed spontaneously after 1 extemporary catheterization. The median (range) hospital stay was 1 (0–2) and 2 (1–6) days in the LH and VH groups, respectively ( P = .01).
| Characteristics | LH n = 41 | VH n = 41 | P value |
|---|---|---|---|
| Age, y | 48 (32–77) | 48 (39–53) | .71 a |
| Elderly (age ≥65 y) | 7 (17.1%) | 4 (9.8%) | .52 b |
| BMI, kg/m 2 | 25.3 ± 4.7 | 25.3 ± 4.2 | .97 c |
| Obese (BMI ≥30 kg/m 2 ) | 5 (12.2%) | 7 (17.1%) | .76 b |
| Nulliparous | 18 (43.9%) | 11 (26.8%) | .17 b |
| Previous vaginal deliveries | 1 (0–4) | 2 (0–4) | .19 a |
| Previous cesarean sections | 9 (22.0%) | 9 (22.0%) | > .99 b |
| Previous abdominal surgeries | 27 (65.9%) | 22 (53.7%) | .37 b |
| Indication to surgery | |||
| Uterine fibroids | 29 (70.7%) | 27 (65.9%) | .82 b |
| Endometrial hyperplasia | 4 (9.8%) | 7 (17.1%) | .52 b |
| Adenomyosis | 3 (7.3%) | 1 (2.4%) | .62 b |
| CIN 3 | 1 (2.4%) | 5 (12.2%) | .20 b |
| Adnexal pathology | 4 (9.8%) | 1 (2.4%) | .36 b |
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