Biomechanical features of bidirectional-barbed suture: a randomized laboratory analysis.

The aim of the current prospective study was to evaluate the biomechanical stability of barbed suture vs. conventional suture. Biomechanical stability of a 14x14-cm PDO/polydioxanone, with a half circle and 36-mm needle, bidirectional barbed 0-Quill suture (Angiotech, Vancouver, British Columbia, Canada) vs. 1-Poliglecaprone 25 (Monocryl, Ethicon, Inc, Somerville, NJ) suture was evaluated on biological specimens. The 1-Monocryl suture was chosen because it is widely used by gynecological surgeons in the repair either of the vaginal cuff or the uterine wall defects. Forty specimens of aponeurotic muscle, obtained from abdominal wall of a lamb, were prepared, and randomly assigned to 1 of 2 repair groups: Group A (n = 20) classic repair with 1-Monocryl suture; Group B (n = 20) 0-Quill barbed suture. Each specimen was transected at the midpoint and then repaired. Biomechanical stability of the repaired specimen was verified on a CMT6000 electromechanical universal testing machine (SANS, MTS SYSTEMS, China Co., Ltd., Shenzhen, China), with a 1kN cell. Biomechanical tests showed that maximum force was similar for 1-Monocryl and 0-Quill respectively (p = non-significant). This randomized laboratory study shows that biomechanical stability of the sutures is comparable.

Tranexamic acid versus oxytocin prophylaxis in reducing post-partum blood loss, in low-risk pregnant women: TRANOXY STUDY, a phase III randomized clinical trial.

Background: To assess the equivalence of tranexamic acid (TRAN) versus synthetic oxytocin (OXY) in reducing post-partum blood loss, in full-term patients (37-42 weeks), at low risk of post-partum hemorrhage, with vaginal childbirth. Methods: Phase III, randomized (1:1), open-label, longitudinal, multi-center, prospective clinical trial (Prot. n 63209, ClinicalTrials.gov Identifier: NCT02775773). From January 7, 2020, to June 30, 2023, a total of 256 women were enrolled at two general urban community hospitals in Italy, serving a multi-ethnic patient population with National Health Insurance. The primary outcome was to explore a potential equivalence between the two treatments (OXY and TRAN) in preventing total blood loss. Therefore, we randomized 231 women into two groups: Group A (OXY), 127 women who were administered 10UI intramuscularly within 5 min from childbirth; Group B (TRAN), 104 women to whom 1-g slow intravenous infusion was administered within 5 min from childbirth. Findings: At the time of delivery, mean blood loss for OXY group versus TRAN group was 269.12 mL versus 263.88 mL, respectively, with equivalence between the two groups. Similarly, there was equivalence in total blood loss between the OXY and the TRAN group (397.66 mL versus 405.64 mL, respectively. No statistical differences between Hb levels at admission and discharge in the two groups were reported. No difference was found in terms of additional uterotonic and surgical therapies between the two groups of patients. Neither group showed thrombotic complications at check-up performed after 7 days or after a questionnaire regarding adverse effects, subjected after 40 days. Interpretation: The study shows the equivalence of tranexamic acid versus synthetic oxytocin in post-partum blood loss prophylaxis in term patients at low risk of PPH with vaginal childbirth. The safety profiles of OXY and TRAN were similar. Funding: None.

Minilaparoscopic myomectomy: a mini-invasive technical variant.

OBJECTIVE: We propose a mini-invasive technical variant for laparoscopic myomectomy, which is currently less invasive and more feasible. STUDY DESIGN: This was a prospective, controlled, randomized trial, involving 170 patients, who underwent laparoscopic myomectomy. Patients were randomized into two groups: Group A (n=98) underwent standard laparoscopic myomectomy, and Group B (n=72) underwent the mini-invasive technique. The current mini-invasive variant is performed with a 10-mm umbilical trocar and only two 5-mm ancillary trocars. Morcellation is transumbilical: a 0° 5-mm optical system is used and is inserted either in the left or in the right iliac trocar according to the surgeon's preference. RESULTS: The degree of surgical difficulty, evaluated using a visual analog scale (VAS), was similar in the two groups (P=nonsignificant). Postoperative pain measured on a VAS scale showed there was less pain experienced in patients in Group B than in Group A (P<.01). Esthetic results measured on a VAS scale showed a higher compliance for patients in Group B than Group A (P<.01). CONCLUSIONS: The mini-invasive laparoscopic myomectomy described is, in our opinion, currently less invasive and more feasible than techniques usually used. Finally, this technique is a valid approach for the surgeon, and it gives women very acceptable aesthetic results.

Bidirectional barbed suture in laparoscopic myomectomy: clinical features.

OBJECTIVE: To compare bidirectional knotless barbed suture versus standard sutures, with either extracorporeal or intracorporeal knots, and to assess the feasibility, safety, and rapidity in repairing a uterine wall defect after laparoscopic myomectomy. SUBJECTS AND METHODS: This was a randomized clinical study having a Canadian Task Force Classification of I. In tertiary-care university-based teaching hospitals, 117 women who underwent laparoscopic myomectomy were enrolled. In accord with randomization, uterine wall defects were closed with either extracorporeal (poliglecaprone 25; Monocryl™-1; Ethicon Inc., Somerville, NJ) or intracorporeal (polyglactin 910; Vicryl™-1; Ethicon Inc.) knots or a bidirectional knotless barbed suture (Quill™-0; Angiotech Pharmaceuticals, Inc., Vancouver, BC, Canada). RESULTS: Time required to suture was significantly lower in the group operated on with a bidirectional suture than in groups with traditional sutures (P<.001). No significant difference was observed in operative time among the study groups. The degree of surgical difficulty was significantly lower in the Quill group than in the other groups. CONCLUSIONS: Use of barbed sutures reduces the time required to repair a uterine wall defect during laparoscopic myomectomy. In a follow-up of patients carried out at 3 months, 6 months, and 1 year after the surgery, there were no wound dehiscence, no bleeding, and no other potential major complications.

Bidirectional barbed suture in total laparoscopic hysterectomy and lymph node dissection for endometrial cancer: technical evaluation and 1-year follow-up of 61 patients.

OBJECTIVE: This randomized clinical study compared the feasibility and safety of the shortest suture for bidirectional knotless barbed versus standard sutures, with either extracorporeal or intracorporeal knots, for vaginal cuff closure following total laparoscopic hysterectomy (TLH) and lymph node dissection for early endometrial cancer. SUBJECTS AND METHODS: The study design was Canadian Task Force Classification I. In tertiary-care university-based teaching hospitals, 61 women underwent TLH and lymph node dissection. In accord with randomization, the vaginal cuff in TLH was closed with either extracorporeal or intracorporeal knots (1-Monocryl(®); Ethicon Inc., Somerville, NJ) and a bidirectional knotless barbed suture (0-Quill™; Angiotech Pharmaceuticals, Inc., Vancouver, BC, Canada). All patients were evaluated at 3-month, 6-month, and 1-year follow-up. RESULTS: Time required to suture was significantly lower in the group treated with bidirectional suture than in groups with traditional sutures (P<.001). No significant difference was observed in the operative time between the study groups. The degree of surgical difficulty was significantly lower in the bidirectional barbed suture group than in the other groups. At 1-year follow-up all patients presented no wound dehiscence, no bleeding, dyspareunia, and other potential major complications such as ureteric, bladder, or bowel injury. CONCLUSIONS: Use of a barbed suture reduces the time required to repair the vaginal cuff during TLH. At follow-up of patients, carried out 3 months, 6 months, and 1 year after the surgery, no wound dehiscence, no bleeding, or no other potential major surgical complications had occurred.

Laparoscopic myomectomy of a subserous pedunculated fibroid at 14 weeks of pregnancy: a case report.

INTRODUCTION: Uterine leiomyomas are seen in 1.6% to 4% of pregnancies. With the increasing age of obstetric patients, more cases are being encountered during pregnancy. CASE PRESENTATION: We report the case of a 31-year-old Caucasian woman with acute recurrent abdominal pain due to a subserous fundic myoma, measuring 48 × 52 × 63 mm, with an implantation base of 22 × 18 mm, which was successfully treated by laparoscopy at 14 weeks of pregnancy. At a gestational age of week 40, the patient spontaneously delivered a healthy 3216 g girl baby. CONCLUSION: As far as we know, this is the first reported case of laparoscopic myomectomy this early during a pregnancy. Our experience together with an analysis of cases reported in the literature suggests that myomectomy during pregnancy may be considered safe, but only in the hands of experienced laparoscopic surgeons. There are a few reports in the literature about laparoscopic myomectomy during the first half of pregnancy that demonstrate its feasibility in selected cases. Some technical tools could improve the procedure with a minimum of risk for the ongoing pregnancy.

CYP17 and CYP19 gene polymorphisms in women affected with endometriosis.

OBJECTIVE: To investigate whether CYP17 T>C polymorphism and polymorphisms C1558T and Val80 of CYP19 are related to endometriosis. DESIGN: Clinical study. PATIENT(S): Women affected with endometriosis (n = 104) and control group (n = 86). The diagnosis of endometriosis was confirmed by the histologic examination of the endometriotic lesions. RESULT(S): In patients affected with endometriosis, we observed that AA and CC genotypes were significantly represented in Val80 and C1558T polymorphisms of CYP19. CONCLUSION(S): The molecular mechanisms that underlie the development of endometriosis are unclear. Both environmental and genetic factors are involved in the pathogenesis of the disease. The inheritable susceptibility to endometriosis justifies the growing interest in identifying genes and/or genetic polymorphisms that predispose women to an increased risk of developing endometriosis. The identification of single-nucleotide polymorphism (SNP), probably linked to endometriosis, could help to explain its pathogenesis.

Arg72Pro p53 polymorphism in Italian women: no association with endometriosis.

p53 codon 72 polymorphism in Italian women have a minor role in determining genetic susceptibility to endometriosis. The racial differences, in association with other risk factors, might be underlined in endometriotic disease.

Comparative gene expression profiling reveals partially overlapping but distinct genomic actions of different antiestrogens in human breast cancer cells.

Antiestrogens used for breast cancer (BC) treatment differ among each other for the ability to affect estrogen receptor (ER) activity and thereby inhibit hormone-responsive cell functions and viability. We used high-density cDNA microarrays for a comprehensive definition of the gene pathways affected by 17beta-estradiol (E2), ICI 182,780 (ICI), 4OH-tamoxifen (Tamoxifen), and raloxifene (RAL) in ER-positive ZR-75.1 cells, a suitable model to investigate estrogen and antiestrogen actions in hormone-responsive BC. The expression of 601 genes was significantly affected by E2 in these cells; in silico analysis reveals that 86 among them include one or more potential ER binding site within or near the promoter and that the binding site signatures for E2F-1, NF-Y, and NRF-1 transcription factors are significantly enriched in the promoters of genes induced by estrogen treatment, while those for CAC-binding protein and LF-A1 in those repressed by the hormone, pointing to novel transcriptional effectors of secondary responses to estrogen in BC cells. Interestingly, expression of 176 E2-regulated mRNAs was unaffected by any of the antiestrogens tested, despite the fact that under the same conditions the transcriptional and cell cycle stimulatory activities of ER were inhibited. On the other hand, of 373 antiestrogen-responsive genes identified here, 52 were unresponsive to estrogen and 25% responded specifically to only one of the compounds tested, revealing non-overlapping and clearly distinguishable effects of the different antiestrogens in BC cells. As some of these differences reflect specificities of the mechanism of action of the antiestrogens tested, we propose to exploit this gene set for characterization of novel hormonal antagonists and selective estrogen receptor modulators (SERMs) and as a tool for testing new associations of antiestrogens, more effective against BC.