hysteroscopy

Although hysteroscopic myomectomy as a safe and effective intervention is recommended for myoma resection, its effect on infertile patients who need the ICSI or IUI is not clearly defined. The present study was conducted aimed to evaluate the effect of hysteroscopic myomectomy on the outcome of pregnancy in in infertile patients who were candidates for IUI, ICSI, and FET cycles.

In this cohort study, 330 women underwent hysteroscopic myomectomy, of them 204 patients had history of infertility and 154 were candidates for ICSI cycles, 33 for FET cycles, and 17 for IUI cycles  at two tertiary teaching hospital and Royan institute between February 2008-February2012. Primary outcomes were chemical and clinical pregnancy rates.

Among 204 patients with a history of infertility, 116 (75.4%) had primary and 38 (24.6%) secondary infertility. In ICSI group, 129 patients had one myoma, 18 cases two myoma, 5 cases three myoma and 2 cases had five intracavitary myoma. In FET group, there were 27 cases with one and 6 cases with two intracavitary myoma. In IUI group, there were 15 cases with one and two cases with two intracavitary myoma. In the ICSI group, there were 17% clinical pregnancy, 1% missed abortion, 4% blighted ovum, and 2% chemical pregnancy. In FET group, the clinical pregnancy was detected in 28.6% of women including 7 clinical pregnancy, one blighted ovum and one chemical pregnancy. In IUI group, pregnancy failure rate was 100%.

Hysteroscopic myomectomy in addition to a safe and effective intervention for myoma resection, can improve pregnancy outcomes in infertile women.

 In situations where misoprostol is not available or its use is contraindicated, hyoscine can be an alternative option. The present study was conducted with aim to compare the effect of vaginal hyoscine butyl bromide and versus vaginal misoprostol on cervical ripening before hysteroscopy.

 This double-blind randomized clinical trial study was conducted on 150 patients who were candidates for diagnostic or therapeutic hysteroscopy and were divided into two groups. In group one, 75 patients received 20 mg of Hyosin vaginally 4 hours before surgery, and in group 2, 200 micrograms of misoprostol was administered vaginally 4 hours before surgery. The two groups were compared in terms of passage of Hegar dilator number 5, amount of cervical dilatation, operation length, postoperative pain and drug side effects.

 The passage rate of Hegar dilator number 5 in the misoprostol group was 51 (68%) and in the hyoscine group was 44 (58.7%). Also, the mean pain in the misoprostol group was 5.32±2.16 and in the hyosin group was 5.68±1.61. The mean operation length in the misoprostol group was 38.36±6.14 minutes and the in the hyosin group was 40.23±6.41 minutes. The mean amount of cervical dilatation in the misoprostol group was 5.43±1.53 cm and in the hyosin group was 4.97±1.44 cm.

 Hyoscine for cervical ripening for diagnostic and therapeutic hysteroscopy had no significant difference with misoprostol. Also, there was no significant difference between the two groups in surgical complications, duration of surgery, postoperative pain, and the amount of cervical dilatation. Therefore, considering the low cost and availability of hyoscine, its use for ripening the cervix before hysteroscopy seems logical.

The role of laparoscopy and hysteroscopy in managing unexplained infertility (UI) is debatable because ofthe improved success rate of assisted reproductive technologies (ART). This study aims to assess the findings of laparoscopyand hysteroscopy in selected women diagnosed with UI to determine the frequency of such pathological conditionsin order to manage them properly. The current cross-sectional study was conducted on 96 women who attended an infertilityclinic at the educational hospitals of Isfahan University of Medical Sciences from March 2018 to February 2020. Theparticipants had one or more of the following conditions: had failed to conceive after 2-3 cycles of ovulation inductionwith clomiphene citrate and intrauterine insemination (IUI), had a history of pelvic infection, pelvic surgery, or ectopicpregnancy (EP). Laparoscopy and hysteroscopic findings were recorded for all participants. Fifty-nine (61.4%) women had primary infertility, while 37 (38.6%) suffered from secondary infertility. In patientswith primary and secondary infertility, 42.3 and 43.2% had laparoscopic abnormalities, respectively. Additionally,33.8 and 21.6% of the participants had hysteroscopic abnormalities in the primary and secondary groups, respectively.The most common findings in the two groups of infertility who had done laparoscopy were endometriosis (21.8%,P=0.201) followed by tubal pathology (13.5%, P=0.952). Also, the most common intrauterine pathology found in bothgroups were uterine septum (7.2%, P=0.753) and endometritis (6.2%, P=0.241). Based on the findings of this study, laparoscopy is recommended in UI after three failed IUI and ovarianstimulation, a history of pelvic pain, pelvic surgery, or pelvic infection; however, it seems that further investigation isrequired to recommend universal hysteroscopy to all women with UI. Nonetheless, it is still emphasized that regionalpractice in one's local settings may also be effective concerning the prevalence of these pathologies.

To assess the impact of a hysteroscopic myoma resection (HMR) two-day training course on non-technical (cognitive) surgical skills among gynecologists.

A 2-day educational course was held in which 95 consultant gynecologic surgeons and beginner infertility fellowship residents took part. Among all 80 participants (84.2%) had ever performed diagnostic hysteroscopy and 30 (31.3%) had performed non-resectoscopic operative hysteroscopy. The training program included instructive speeches, simulated surgical presentations, and a live hands-on myomectomy workshop. Non-technical skills were assessed two times, once before and the other after the course through two written tests with 10 multiple-choice questions for each.

Concerning the 95 participants, 43 (47.3%) took the pre-course test and all of them (100%) took the post-course one. The mean score improved significantly from 3 (interquartile range [IQR],
0–4.0) to 7 (IQR, 5.0– 8.0) [bootstrap p<0.0001] for each of the randomly chosen pairings. The majority of candidates showed significantly improved cognitive skills after the HMR course despite their poor cognitive skills before the course. According to further analysis, there were significant enhancements in grades for all topics, especially regarding the basic principles of the procedure and management of complications (bootstrap p<0.0001). The odds ratio for the pre- versus post-course mean test results was 5.23. Due to the confidentiality stipulation, the pre- and post-course scores were not matched.

A two-day continuing medical educational course could be efficient in improving the non-technical (cognitive) skills for HMR.

Background &  The administration of tamoxifen to post-menopausal patients with breast cancer may lead to vaginal bleeding, necessitating a thorough understanding of associated factors. Our objective was to investigate sonographic, hysteroscopic, and pathologic findings in breast cancer patients experiencing vaginal bleeding following tamoxifen use.Materials &  In this cross-sectional study, we evaluated women with post-menopausal breast cancer reporting vaginal bleeding while undergoing tamoxifen treatment for more than six months. Data collection involved a checklist encompassing ultrasonographic, hysteroscopic, and pathologic findings. The study included 100 patients with a mean age of 56.2 ± 2.9 years and a mean endometrial thickness of 14.5 ± 3.4 mm. Notably, 25% of the patients exhibited abnormally large uterine size. Ultrasonography revealed polyps and myomas in 36% and 15% of cases, respectively. Positive hysteroscopy findings were observed in 72%, comprising polyps in 36%, hyperplasia in 32%, and atrophy in 4%. Pathological assessment identified abnormal features in 31% as polyps, 34% as hyperplasia, 4% as atrophy, and 5% as cancerous lesions. Patients who received tamoxifen had high endometrial thickness due to endometrial polyp, it seems that clinicians can consider using hysteroscopy with dilation and curettage in these patients.

This study aimed to evaluate the short-term and long-term outcomes of adopting two types of resectoscopes and hysteroscopic scissors metroplasty methods.

In this prospective, comparative, and cohort study, participants who were candidates for septum resection were recruited during 2015-2018. The uterine septum was removed using hysteroscopic scissors or a resectoscope. The second-look hysteroscopy was performed in the follicular phase after two months. In the second-look hysteroscopy, surgery outcomes were evaluated, and the residual septa or adhesions were removed in case of incidence. The study followed participants for up to five years to observe pregnancy outcomes. This involved recording the duration from hysteroscopy to pregnancy and determining if these pregnancies led to live births.

A total of 119 female patients with a mean age of 30.20±6.14 years were enrolled in this study, out of who 62 cases (52.1%) were in the hysteroscopic scissors group, and 57 cases (47.9%) were in the resectoscope group. The 63 (52.9%) cases had primary infertility, and the prevalence of abortion was 46 (38.7%). During the second look, hysteroscopy adhesion was diagnosed in 18 cases (15.1%), and septum residue was seen in 49 cases (67.1%). The adhesion rate in the hysteroscopic scissors group was higher than that in the resectoscope group, but it was insignificant (P=0.223). At the second follow-up stage, only 85 patients out of 119 ones were available. The successful pregnancy rate was 46 out of 85 (54.1%). The mean age of the patients in the successful pregnancy group was significantly lower than that in the unsuccessful pregnancy group (P<0.001).

There were no differences among resectoscope and hysteroscopic scissor methods’ outcomes in term of metroplasty associated with septate uterus (SU).

Endometrial cancer is the most common type of reproductive system cancer. The present study aimed to investigate the diagnostic value of abnormal hysteroscopic findings in endometrial lesions.

In this retrospective cohort study, 669 cases with suspected endometrial lesions detected by B-scan ultrasonography were further examined using hysteroscopy. The biopsy results were considered the gold standard, and the diagnostic value of abnormal hysteroscopic findings and diagnostic efficacy of specific hysteroscopic findings in endometrial lesions were compared and analyzed. Moreover, the clinical features of the participants were evaluated.

Among patients, the complete coincidence rate between diagnosis made by hysteroscopy and pathological diagnosis was 91.33% (611/669), and the Kappa value of the consistency test was 0.951 (2). Regarding the major abnormalities detected under hysteroscopy, the most common finding in patients with normal endometrium, validated by biopsy results, was irregular thickening of the endometrium. In patients with endometrial hyperplasia, validated by the biopsy results, abnormality of the blood vessel was the most common finding. However, it should be noted that the sensitivity was low. Abnormality of blood vessels was also the most common finding in patients with endometrial carcinoma. The sensitivity and positive predictive values (<50%) were low. (3) The age difference between patients with normal endometrium and endometrial hyperplasia was statistically significant (P<0.01). There was a statistically significant difference between the patients with normal endometrium and In cases with normal endometrium and endometrial lesions, the morbidity difference was statistically significant between the group of patients with either obesity or hyperlipidemia and the group without comorbidities (X2=231.253, P<0.01, X2=106.086, P<0.01). There was a statistically significant difference between patients with endometrial hyperplasia and those with endometrial cancer in terms of morbidity of obesity or hyperlipidemia (P=0.042).

Hysteroscopy has high accuracy and stable diagnostic efficiency in the diagnosis of endometrial diseases. Nevertheless, the diagnostic value of abnormal blood vessels seen under hysteroscopy is insufficient for the diagnosis of endometrial lesions. Therefore, it cannot be used as the sole criterion for the diagnosis of endometrial lesions. Patients with irregular thickening of the endometrium are more likely to have a normal endometrium, and such patients can avoid unnecessary biopsy if they have no other risk factors. Obesity and hyperlipidemia are significant independent risk factors for endometrial cancer.

Chronic endometritis (CE) can contribute to infertility and reproductive outcome. Currently there is a lack of information about the prevalence of CE and diagnostic value of hysteroscopy in the CE in infertile women in Iran.

To determine the CE prevalence in female candidates for in-vitro fertilization (IVF) and evaluate hysteroscopy’s sensitivity, specificity, and accuracy in diagnosing CE.

This cross-sectional study enrolled90womencandidates for IVF undergoing hysteroscopy by consecutive sampling in the infertility clinic of Vali-e-Asr Hospital, Tehran, Iran from October 2019 to February 2020. Hysteroscopic features of CE were recorded, and endometrial specimens were taken for histological study. Data analysis was done using descriptive and chi-square tests and specificity, sensitivity, negative and positive predictive value were calculated.

Chronic endometritis prevalence was identified in 19 (21.1%) women by histology. A significant relationship was found between CE and vaginal discharge (P = 0.03), pelvic inflammatory disease (PID) (P = 0.01), and abnormal uterine bleeding (AUB) (P = 0.001). Sensitivity, specificity, negative and positive predictive value (NPV and PPV), and accuracy of hysteroscopy for diagnosis of CE were 68.4%, 87.3%, 91.17%, 59.1%, and 83.3%, respectively.

Considering the good specificity, NPV, and accuracy of hysteroscopy in diagnosing CE, an endometrial biopsy can be avoided in infertile women without risk factors for CE and with normal hysteroscopy. However, it should be considered for CE diagnosis in patients with vaginal discharge, dyspareunia, PID, and positive hysteroscopy findings.

Endometrial scratching (ES) remains controversial regarding its potential effectiveness in improvingpregnancy rates. The objective of the present study was to assess the impact of endometrial fundal incision (EFI) duringhysteroscopy on reproductive outcomes in a population of oocyte recipients. A randomized controlled trial was conducted between 2020 and 2023 at the Third Departmentof Obstetrics and Gynecology, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessalonikiand “Assisting Nature Centre of Reproduction and Genetics”. The study population consisted of women whounderwent hysteroscopy randomly assigned in a 1:1 ratio to either EFI (one to three months before embryotransferwith donor oocytes) or no intervention throughout office hysteroscopy. Clinical pregnancy and live birth rates werethe primary outcomes. After the exclusion of patients with intraoperative diagnosed endometrial pathology, a total of 124 womenunderwent randomization. The pregnancy test was positive in 79% (n=49/62) of the women in the EFI compared to59.7% (n=37/62) in the hysteroscopy-only group (P=0.019), while the live birth rates did not differ between the twogroups (58.1%, n=36/62 vs. 51.6%, n=32/62, P=0.470). EFI during hysteroscopy seems to improve pregnancy rates in oocyte recipients without intrauterinepathology, while live birth rates are not affected by the EFI. These results should be interpreted with caution beforethe implementation of EFI in the routine in vitro fertilization (IVF) practice (registration number: NCT04580056).

 Endometrial scratch (ES) has been suggested to improve assisted reproductive techniques success rates by investigating implantation failure.

 In this study, we evaluated the effect of ES on the outcomes of frozen embryo transfer (FET) in women with at least 2 failed embryo transfer cycles.

 In this historical cohort study, medical data of 236 infertile women who underwent in-vitro fertilization-FET at Ebne-sina Infertility Center, Tehran, Iran, from January 2015-December 2021 was extracted from their medical records. Based on having ES before FET, they were assigned to either the scratch (n = 118) or the no-scratch group (n = 118). We compared these groups regarding pregnancy rates and outcomes.

 The demographic characteristics were similar in both groups regarding weight, body mass index, the number of previous embryo transfers, and the duration of infertility. However, the scratch group had a slightly higher mean age (32.31 vs. 29.96 yr, p < 0.001). No statistically significant difference was observed between groups regarding pregnancy rate (p = 0.89). No significant association was observed between scratch, infertility duration, the number of previous FET attempts, and the likelihood of pregnancy in a logistic regression model. No major complications were observed.

 Hysteroscopic endometrial scratching with scissors probably has no effect on FET outcomes, including pregnancy or live birth rates.

Verification bias is a common bias in the diagnostic accuracy of diagnostic tests and occurs when a number of individuals do not perform the gold standard test. In this study, we review the correcting methods of verification bias.

In a cross-sectional study in 2020, 567 infertile women who were referred to Royan Research Institute were evaluated. The ultrasound is the performed test and the gold standard are hysteroscopy for some, and pathology for other abnormalities. For correcting verification bias conventional, Begg and Greens, Zhou, and logistic regression methods were used.

In the gold standard hysteroscopy test, the sensitivity (SEN) and specificity (SPEC) obtained in conventional, Begg and Greens, Zhou, and logistics Regression methods were (50%, 90.3%), (48%, 96%), (22%, 77%), (50%, 90%), and (72.8, 77) respectively. Furthermore, the area under the curve (AUC) index and kappa statistics were calculated as 70.2%, and 43.6% respectively. In the pathology gold standard test, the SEN and SPEC for the conventional methods, Begg and Greens, Zhou and logistics regression were (67.7%, 86.7%), (66%, 88%), (29%, 70%), (66.9%, 87.6%), and (73%, 83.9%) respectively. Also, the AUC index and kappa statistics were 77%, and 55% respectively.

In the study on endometrial abnormalities in infertile women, assuming that the missing data mechanism is random, the amount of bias in calculating SEN and SPEC is very low in the diagnostic tests calculated before and after correction, using Begg and Greens and logistic regression method. But Zhou's method gives rather large biased estimates.

Abnormal uterine bleeding (AUB) that is any irregularity in menstrual cycles causes women to refer to clinics. This study aimed to compare the efficacy, safety, and complications of endometrial ablation by the thermal balloon (Cavaterm) method with the hysteroscopy loop resection method in the treatment of AUB. The present study is an open-label, randomized clinical trial that was performed in the two hospitals, Shahid Akbarabadi and Hazrat Rasoul Akram, of Tehran, Iran, from December 2019 to October 2020. Patients were randomly allocated to the two groups of interventions by a simple randomization method. The proportion of amenorrhea (as primary outcome) and consequent hysterectomy and patient satisfaction (as secondary outcomes) was assessed using the Chi-square test and independent t test. There was no significant difference between the two groups in the baseline characteristics. The percentage of intervention failure was statistically higher in the hysteroscopy group (24%) in comparison with the Cavaterm group [8.2%, P=0.03, relative risk (RR)=1.63, 95% confidence interval (CI): 1.13-2.36]. Mean ± standard deviation of satisfaction based on the Likert score in the Cavaterm group and hysteroscopy group were 4.3 ± 1.21 and 3.7 ± 1.56, respectively, that showed a significant difference (P=0.04). Assessing the procedural complications, the rate of spotting, bloody discharge, and malodor discharge was significantly higher in the Cavaterm group. In contrast, postoperative dysmenorrhea is more common in the hysteroscopy group. Cavaterm ablation is accompanied by a higher success rate of amenorrhea and patients’ satisfaction than hysteroscopy ablation (registration number: IRCT20220210053986N1).

Endometrial stromal sarcoma is a rare condition, constituting nearly 0.2% of all reproductive tract malignancies. The condition mainly affects the peri-menopausal population; however, it can occasionally be found in younger women and adolescents. Here, this is a case of a 20-year-old primiparous female who was referred to us with the main complaint of vaginal bleeding (menometrorrhagia), ongoing for 6 months after delivery. Her sonography report indicated a 5 cm intra-cavitary mass suspicious for myoma or placental polyp. Given the pathology report of low-grade endometrial stromal sarcoma (LGESS) on samples obtained through hysteroscopy and D&C, she underwent total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH+BSO). Endometrial stromal sarcoma is a rare uterine malignancy of mesenchymal origin that should be considered, even in very young patients.

One of the most prevalent benign tumors in women is uterine leiomyoma. Large quantities of fluid absorbed during myomectomy may cause serious problems such as volume overload and hyponatremia. The aim was to see how intraoperative oxytocin infusion affected irrigation fluid absorption in individuals having hysteroscopic myomectomy.

50 women between 25-45 years who underwent hysteroscopic myomectomy and had an American Society of Anesthesiologists class I or II were evaluated in this randomized, double-blind clinical trial study. A 250 mL ringer solution containing 15 units of oxytocin was administered at a 125 mL/h in the oxytocin group (group S). In contrast, the placebo group (group P) received 1.5 mL of normal saline in the same amount of Ringer solution. Intraoperative hemodynamic alterations, fluid deficit, decreased hemoglobin, hematocrit, sodium, and albumin levels from baseline, complications, and the incidence of toxicity with the administered solutions were assessed intraoperative and 24 hours later.

Group S had considerably reduced irrigation fluid volume (P=0.021) and volume deficit (P=0.001). The frequency of hypotension in individuals receiving oxytocin did not differ significantly from the placebo group (P=0.26). In group S, serum hematocrit (P=0.036) and sodium (P=0.026) were decreased significantly.

Intraoperative oxytocin infusion during hysteroscopic myomectomy may be associated with reduced irrigation fluid absorption and the problems that come with it. As a result, this approach might decrease the risks associated with high amounts of irrigation fluid being absorbed during hysteroscopic myomectomy.

Herbal medicine could be effective at treating various illnesses. Hysteroscopy can be as an effective method for assessing the uterus in terms of anatomical, physiological and pathological anomalies.

This study aims to evaluate the effect of evening primrose oil (EPO) on cervical preparation in women candidates for hysteroscopy.

This study was a double-blind, randomized controlled clinical trial including 160 women candidates for diagnostic hysteroscopy who were referred to Al-zahra hospital from August 2019-March 2020. They were divided in 2 groups. Group A received 100 mg EPO as a soft gel capsule 6 hr before the hysterectomy in the posterior vaginal fornix. Group B received a placebo. After receiving the treatment, primary and secondary outcomes were evaluated in gropus.

The average Hegar size in the EPO group was larger than in the control group (p < 0.001, for both). Also, the need for mechanical dilation, the time taken until the first resistance and the time of dilatation completion in the EPO group were significantly less than in the placebo group (p < 0.008 for all). There was also greater ease of dilatation in the EPO group. Side effects such as uterine rupture, false passage, cervical rupture, allergic reaction, abdominal pain, nausea, diarrhea, headache and increase of bowel movements were not reported in any cases.

Based on the findings of the present study, EPO is effective for cervical preparation in women undergoing hysteroscopy.

The aim of this study was to evaluate the rate and severity of intrauterine adhesions (IUAs) and their association with septum morphology following the hysteroscopic resection of the uterine septum.

This cross-sectional study was conducted on patients with septate uteri undergoing hysteroscopic septolysis with scissors. Two months after the surgery, the second look hysteroscopy was performed and the intrauterine cavity was evaluated for IUAs and residual septum. Afterward, the rate and severity of adhesions and residual septum and their association with the septal morphology were studied as well.

In general, 30 patients were entered into the study. The incidence rate of adhesions following septoplasty was 23.3%. It was mild and moderate in 16.7% and 6.7%, respectively. The incidence rate of adhesions was not related to the length and width of the septum (P=0.281, P=0.495). The rate of the residual septum in second-look hysteroscopy was 56.7%, which was less than 0.5 cm in most cases (33.3%). It was not more than 1 cm in any case. The possibility of the residual septum was significantly higher in long septa (P=0.045) whereas it was not related to the septum width (P=0.087).

IUA following hysteroscopic septolysis is a possibility, especially in infertile patients which is often mild. The presence of a uterine factor in such patients may justify the risk of increased IUAs in our study in comparison to others. Therefore, it is able to perform second-look hysteroscopy in infertile patients with a septate uterus for the diagnosis and early treatment of IUAs.

Recurrence of endometrial polyp following the hysteroscopic polypectomy is a significant concern for both the patients and physicians. This study aimed to evaluate the efficacy of combining hysteroscopic polypectomy with endometrial resection in reducing the rate of recurrence in women over 40 years old.

In a single-blinded clinical trial, 94 women with endometrial polyps who were unwilling to future pregnancy were identified and randomly allocated to the intervention (hysteroscopic‎ polypectomy + endometrial resection) ‎and control group (hysteroscopic‎ polypectomy alone) group (n=47/each). Randomization was done using a simple randomization technique‎. The primary outcome measure was the polyp recurrence. The secondary outcome measure was the number of adverse events.

In total, polyp recurrence occurred in two (4.3%) patients of the intervention group and nine patients (19.1%) of the control group (P=0.019). All the recurrences occurred in the premenopausal patients (P=0.012). No adverse event was observed in any patients of both groups.

Adding endometrial resection to hysteroscopic polypectomy, especially in postmenopausal women, is a safe method that significantly reduces the risk of recurrence of the endometrial polyp.

Concurrent bleeding or existing clots usually obscure the vision field and decrease the hysteroscopy success rate. Therefore, any efforts made to have a clear view during the hysteroscopy will improve the diagnostic or treatment outcomes. We examined the effect of preoperative clot evacuation on hysteroscopy related outcomes.

In this parallel-group randomized clinical trial conducted in Al-Zahra hospital, Tabriz, Iran, 114 women with uterine bleeding were randomly assigned to receive either clot evacuation before standard operative hysteroscopy or after that from December 2018 to September 2019. The study outcomes were the clarity of vision, amount of bleeding, the volume of required distension media, duration of the procedure, and postoperative complications.

There were statistically significant differences in the frequency of the clear vision (P<0.001), the severity of bleeding, mean procedure time (P<0.001), mean used distension media and the mean postoperative hematocrit levels in favour of women with pre-hysteroscopy intrauterine evacuation. There was no difference in in-hospital stay and anaesthetic complications among the two groups. The procedure was successfully performed on all participants of both groups with no post-operative complications.

Removal of clots and other uterine contents before the insertion of the hysteroscope rendered better and faster access to the uterine wall to observe existing abnormalities. This additional surgical step could significantly impact surgical and clinical outcomes.