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The primary objective of this prospective comparative nonrandomized study was to assess the feasibility and safety of intraoperative transrectal ultrasonography (TRUS) during hysteroscopic metroplasty (HM). The secondary objective of the study was to assess whether TRUS facilitates complete removal of the uterine septum. Septate uterus was diagnosed by 3-dimensional transvaginal ultrasonography (3D-TVS) and confirmed by magnetic resonance imaging. In the control group (HM group; n = 18), patients underwent HM according to the traditional standard of operative hysteroscopy. In the study group (HM+TRUS group; n = 27), HM and TRUS were performed simultaneously; the hysteroscopic procedure was continued until a normal uterine fundus was observed. At 6 to 8 weeks after HM, 3D-TVS was performed to identify the numbers of complete resections (residual septum absent or <5 mm), suboptimal resections (residual septum 5–10 mm), and incomplete resections (residual septum > 10 mm). The 2 study groups did not differ significantly in terms of demographic and clinical characteristics, or in the volume of fluid infused and absorbed. There were no severe intraoperative or postoperative complication in either group; 2 patients in the HM+TRUS group and 1 patient in the HM group experienced urinary tract infection (p = .807). At 6 to 8 weeks after HM, the number of suboptimal resections and incomplete resections was higher in the HM group than in the HM+TRUS group (p = .031). Residual septum >10 mm (incomplete resection) was seen in 1 patient in the HM group but in no patients in the HM+TRUS group. Intraoperative TRUS can be performed safely during HM, and may increase the likelihood of complete resection of the uterine septum; however, this finding should be confirmed by larger studies.
]. To minimize the risk of uterine perforation (and of traumatic injury to abdominal organs), the surgeon may stop short of removing the septum completely, leaving a portion of the septum inside the uterus. To better assess the time to stop and to achieve a more complete septum resection, some surgeons perform HM under transabdominal [
]. However, transabdominal ultrasonography has poor resolution (particularly in obese patients), and transvaginal ultrasonography (TVS) may be technically difficult because of the presence of the hysteroscope in the vagina. Transrectal ultrasonography (TRUS) may be an alternative approach during HM.
The use of TRUS during hysteroscopic removal of submucosal uterine myomas has been described [
]. More recently, the same authors used intraoperative TRUS in a study conducted to assess the role of morphologic characteristics of the uterine septum in the prediction and prevention of abnormal healing outcomes after HM [
The primary objective of the present pilot study was to assess the feasibility and safety of intraoperative TRUS during HM. The secondary objective was to evaluate whether the use of TRUS facilitates complete removal of uterine septum.
Materials and Methods
This prospective study was performed between March 2010 and December 2013 at IRCCS AOU San Martino-IST, University of Genoa, Genoa, Italy. Participation to the study was offered to patients with a septate uterus requiring HM because they wished to conceive and had a history of 2 or more early miscarriages (<12 completed weeks), 1 late miscarriage (>12–23 completed weeks), or preterm delivery.
Patients were informed that the use of TRUS during HM should be considered experimental and that to date, no study has shown that TRUS improves the outcome of HM. Patients agreeing to undergo TRUS during HM were considered as (HM+TRUS group), and those refusing TRUS served as controls (HM group). Exclusion criteria for the study were intracavitary-associated pathologies (e.g., uterine myomas, polyps), presence of cervical or vaginal septum (because TRUS may not be useful during the resection of this portion of the septum), previous incomplete surgical treatment for septate uterus, concomitant laparoscopic procedure, precancerous state or malignancy of the reproductive organs, any contraindication to HM (e.g., active cervical or uterine infection, contraindication to anesthesia), pregnancy, and a psychiatric disorder precluding provision of informed consent.
The diagnosis of uterine septum was made by 3-dimensional (3D)-TVS using a Voluson E6 ultrasound machine (GE Healthcare, Little Chalfont, UK) and confirmed by pelvic magnetic resonance imaging. The diagnosis was made if the depth of the external fundal indentation (i.e., distance between the intercornual line and the apex of the fundal external contour) was <1 cm and the division of the uterine cavity (i.e., distance between the interostial line and the uterine fundus) was >1.5 cm in the coronal plane [
During 3D-TVS, the length and width of the uterine septum were estimated. The length of the septum was defined as the distance between the interostial line and the parallel line running through the lowest point of the septum. The width of the septum was defined as the distance between the inner contours of the apices of the horn of the uterine cavity.
Patients in the HM+TRUS group received a 133-mL monobasic sodium phosphate anhydrous enema (Clisma Lax; Sofar, Milan, Italy) on the evening before surgery. Antibacterial prophylaxis with ampicillin plus sulbactam (3 g given intravenously) was performed in both study groups.
This study was approved by the local Ethics Committee and conducted in accordance with the Declaration of Helsinki. Each patient provided signed informed consent for the procedure.
HM was performed under general anesthesia in a day surgery setting. Routine pharmacologic preparation of the endometrium was not applied. The procedure was performed during the early follicular phase of the menstrual cycle in patients who were not receiving hormonal therapy at the time of surgery. HM was performed by 2 experienced surgeons (V.R. and S.F.), using the same surgical technique in both study groups. After cervical dilatation, septum resection was performed with a bipolar straight cutting loop (Olympus America, Center Valley, PA). Normal saline solution was used to distend the uterine cavity. Infusion pressure was raised to 100 to 120 mmHg using a pneumatic cuff under manometric control. In both study groups, the septum was cut from its lower part to upper part until the optimal uterine cavity shape was obtained, tailored to the anatomy of the fundus. The procedure was monitored using a single-chip video camera, and the image was displayed on a monitor, which was placed to the left of the operator.
In the HM group, the whitish fibrotic septum was resected until the pinkish myometrial component of the uterine wall with venous myometrial vessels and a normal shape of the uterine fundus were observed. In the HM+TRUS group, HM and TRUS were performed simultaneously. The transvaginal probe (Voluson i; GE Healthcare) was placed in the rectum at the beginning of the surgical procedure. During HM, the ultrasound probe remained in the rectum, supported by a second physician standing to the right of the surgeon; the uterus was imaged in sagittal and transverse sections in bidimensional mode, with 3D and 4D live reconstructions (Video 1 and Fig. 1). Color Doppler was used during bidimensional ultrasonography to identify the limits of the septum. It has been hypothesized that, owing to its fibrotic nature, the septum has few or no detectable vessels until the border with the myometrium is reached [
]. In the HM+TRUS group, the resection of the septum was continued until TRUS showed a normal shape of the uterine fundus (with a uniform myometrial thickness of approximately 1 cm).
The primary objective of this study was to assess the feasibility and safety of TRUS during HM. This outcome was assessed by investigating the differences in operative parameters (i.e., operative time, volume of fluid infused, and volume of fluid absorbed) and incidence of complications between the 2 study groups. The operative time was defined as the interval between the dilatation of the cervical canal to the extraction of the resectoscope. The amount of absorbed fluid was calculated by subtracting the amount of fluid collected from the amount of fluid instilled. Intraoperative complications, such as mechanical trauma (uterine perforation) and hemorrhage, were assessed; fluid overload and infection were considered postoperative complications.
The secondary outcome of the study was to assess whether intraoperative TRUS facilitates complete removal of the uterine septum during HM. At 6 to 8 weeks after surgery, the patients underwent a follow-up 3D ultrasound scan to assess the results of surgery. During 3D-TVS, we assessed for the presence of residual septum, and if detected, we measured its size as the distance between the interostial line and the parallel line running through the lowest point of the indentation. Septum removal was judged to be optimal when this residual was absent or <5 mm, suboptimal when it was 5 to 10 mm, and incomplete when it was >10 mm. The physician performing the ultrasonography at follow-up was not blinded to the use of TRUS during HM; however, the 3D volumes were saved as .4dv files, which were used by a blinded investigator to assess offline the quality of uterine septum removal; these data were used for the analysis.
Continuous variables were compared using the Student t test and nonparametric Mann-Whitney U test depending on the data distribution. Categorical variables were compared using the χ2 test and Fischer's exact test. Statistical calculations were performed using the SPSS version 20.0 (IBM, Armonk, NY). A p value < .05 was considered statistically significant.
Forty-five women requiring HM were enrolled in the study, including 18 patients in the HM group and 27 patients in the HM+TRUS group. The 2 study groups did not differ significantly in terms of demographic and clinical characteristics (Table 1). There was a trend toward a longer duration of the procedure in the HM+TRUS group compared with the HM group, but the difference was not statistically significant. There was no significant between-group difference in the volume of fluid infused or volume of fluid absorbed (Table 2).
Table 1Demographic characteristics and septum characteristics of the 2 study groups
HM (n = 18)
HM+TRUS (n = 27)
Age, yr, mean ± SD
32.1 ± 3.7
32.3 ± 5.9
Parity, n (%)
Previous caesarean section, n (%)
Myometrial associated pathologies, n (%)
Use of hormonal contraception at the time of surgery, n (%)
No severe intraoperative or postoperative complications occurred in either group. Two patients in the HM+TRUS group and 1 patient in the HM group had urinary tract infection (p = .807). In all the patients in both groups, resection was judged to be complete during surgery; in no case was resection interrupted because of significant intravasation, excessive bleeding, or fear of perforation. During TRUS, vascularization was observed color Doppler ultrasonography in 81.5% of the patients (22 of 27), but this information was deemed not useful for estimating the limits of the resection.
At 6 to 8 weeks after HM, the numbers of suboptimal resections and incomplete resections were higher in the HM group compared with the HM+TRUS group (p = .031; Fig. 2). Residual septum > 10 mm (i.e., incomplete resection) was observed in 1 patient in the HM group, but in no patients in the HM+TRUS group.
This study demonstrates the feasibility of performing TRUS during HM and shows that the intraoperative use of TRUS does not increase the volume of fluid infused or absorbed or increase the risk of complications. Furthermore, our findings suggest that intraoperative TRUS during HM may facilitate complete resection of a uterine septum.
When performing HM, the surgeon strives to remove the uterine septum completely while minimizing the risk of intraoperative complications, such as uterine perforation [
] reported 24 HMs performed under transabdominal ultrasonographic guidance with excellent results in terms of no complications and a high pregnancy rate (91.7%). A subsequent study identified advantages of an ultrasound-guided approach as easier estimation of fundus thickness and the ability to perform the procedure during any phase of the menstrual cycle [
] suggested that intraoperative 3D-TVS reduces the incidence of suboptimal septal resection during HM. The use of TRUS during operative hysteroscopy was first used for hysteroscopic resection of submucosal uterine myomas. A recent trial [
] demonstrated that the use of intraoperative TRUS during HM increases the likelihood of complete 1-step removal of submucosal myomas that deeply penetrate the myometrium. More recently, another study published by the same authors reported on the use of TRUS during HM [
]; however, unlike the present study, that study aimed to assess the role of morphologic characteristics of the uterine septum in predicting and preventing abnormal healing outcomes after HM.
In the present study, intraoperative bidimensional, 3D, and 4D TRUS provided real-time visualization of the resectoscope during HM, allowing the surgeon to facilitate complete resection of the uterine septum. In the technique used in this study, a second operator held the ultrasound probe during HM, and thus HM and TRUS were performed simultaneously. In some cases, the proximity of the resectoscope and the ultrasonographic probe can interfere with surgical maneuvers. It is possible that physicians with extensive experience in hysteroscopic surgery and ultrasonography may perform HM+TRUS without the need for assistance. A limitation of this technique is that the septal resection may result in the formation of gas bubbles, which temporarily interfere with ultrasound imaging, which may contribute to an increased operative time. Color Doppler performed during TRUS detected vascularization in more than 80% of the septa, although this information was found to be not useful in identifying the limits of the resection.
Our small sample size is the major limitation of this study, which was not powered to assess whether TRUS prevents uterine perforation. The incidence of uterine perforation during HM is <5% [
]; therefore, in our study we expected to see no cases of perforation in the 2 groups, given the small sample size. Further studies with larger sample sizes are needed to assess whether the use of intraoperative TRUS actually decreases the risk of uterine perforation during HM.
Another limitation of this study is that it is not randomized. However, at the time of the study design, no previous study reported the use of TRUS during operative hysteroscopy. In this pilot study, we have demonstrated the feasibility of this technique, and our findings suggest that the use of intraoperative TRUS decreases the rate of incomplete uterine septum removal without increasing the rate of complications. Future randomized studies with larger sample size are needed to confirm these preliminary findings. In the present study, we could not investigate the clinical relevance of suboptimal or incomplete resection (i.e., residual septum > 10 mm) because of the small sample size; however, previous studies have suggested that a residual septum <10 mm does not negatively affect reproductive performance [
]. In addition, in light of the high image resolution and quality afforded by today's transabdominal ultrasound probes, which allow for live 4D images, it may be possible to carry out a comparative study of HM assisted with either TRUS or transabdominal ultrasound, which would cause less interference with surgical maneuvers compared with TVS.