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"Gynecology, Operative"
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Effectiveness and safety of an absorbable modified polymer starch powder hemostat versus usual care in gynecology procedures: A prospective, multi-center, and randomized study
by
Ponce, Jordi
,
Fedele, Camilla
,
Barahona, Marc
in
Equipment and supplies
,
Gynecology, Operative
,
Methods
2025
To evaluate the safety and effectiveness of an absorbable modified polymer starch powder hemostat (AMP-SPH) compared with standard care to control hemostasis when used in adult subjects during open or laparoscopic gynecological procedures for both benign and malignant diseases. Methods: Prospective, multi-center, randomized, and interventional phase IV study conducted on consecutive patients, aged [greater than or equal to]18 years, who underwent an open or laparoscopic gynecological procedure between November 2015 and July 2017 in a third-level Hospital. Study participants were randomly assigned (1:1) to receive either treatment with an AMP-SPH (AMP group) or usual standard care (SC group). The hemostatic treatment administered to the SC group was at the investigator's discretion. The primary effectiveness endpoint of the study was the achievement of hemostasis (yes/no) within 10 minutes. Results: Ninety patients, 44 (48.9%) in the AMP group and 46 (51.1%) in the SC group were included in the analysis. the AMP group, 97.7% (43/44) of patients achieved hemostasis as compared to the 93.5% (43/46) of subjects in the SC group (mean difference: 4.2%; 95%CI: -4.1% to 12.6%; p = .337). The time required to achieve hemostasis was lower in the AMP group (1.91 ± 1.15 minutes) than in the SC group (2.28 ± 2.09 minutes), although not significant (p = .309). A higher proportion of patients in the SC group (17.9%) was observed to require blood products compared to those in the AMP group (4.8%).A total of 29 adverse events (AEs) (24 non-serious and 5 serious AEs) were reported, 12 AEs in the AMP group and 17 in the SC group. According to the results of this study, AMP-SPH was not inferior to standard care in the control of bleeding for patients undergoing gynecology procedures and the cessation of bleeding was trending to be faster with the use of AMP-SPH than with standard methods.
Journal Article
Bonney's Gynaecological Surgery
Surgery is a core element of the clinical practice of gynaecology. Bonney's Gynaecological Surgery has been a firm favourite for gynaecological surgical practice since 1911. Specifically tailored for trainees in obstetrics and gynaecology, the text focuses on the most commonly performed procedures. The 12th edition will include a colour photo section. With greater emphasis on fundamental clinical skills and major updates on laparoscopic and robotic surgery, this classic text will be brought right up to date for the current trainee or junior consultant physician. Each chapter follows a consistent plan, guiding the reader through each procedure from anatomy and indications to post-op considerations and complications. The text is also accompanied by surgical illustrations of unparalleled quality, ensuring that this volume will remain a valuable resource for all clinicians specializing in gynaecological surgery.
Comparative outcomes of laparoscopic lateral suspension, sacrocolpopexy, and transvaginal mesh for advanced apical prolapse: A retrospective cohort study
by
Li, Huihua
,
Guo, Haichun
,
Wang, Binan
in
Comparative analysis
,
Gynecology, Operative
,
Methods
2025
To compare perioperative outcomes and long-term anatomical/functional efficacy of laparoscopic lateral suspension (LLS), laparoscopic sacrocolpopexy (LSC), and transvaginal mesh (TVM) procedures in women with POP-Q stage III-IV apical prolapse. This retrospective cohort included 98 participants undergoing surgical repair between 1/1/2021 and 30/12/2021: 34 TVM, 35 LSC, and 29 LLS. Concomitant hysterectomy or uterine preservation was performed based on clinical indications. Anatomical outcomes were assessed via Pelvic Organ Prolapse Quantification (POP-Q) measurements, while functional outcomes and quality of life (QoL) were evaluated using Pelvic Floor Distress Inventory Questionnaire (PFDI-20) and Pelvic Floor Impact Questionnaire (PFIQ-7) questionnaires preoperatively and at 2-year follow-up. Multivariable regression adjusted for age, BMI, parity, and surgical approach. LLS demonstrated superior perioperative outcomes, including shorter operative time (3.07 ± 0.15 vs. 4.59 ± 0.13 hours for LSC, p < 0.05), reduced blood loss (64.48 ± 4.62 vs. 116.18 ± 8.10 mL for TVM, p < 0.05), and shorter hospitalization (5.17 ± 0.20 vs. 6.21 ± 0.27 days for TVM, p < 0.05). Groin pain incidence was higher in TVM (21% vs. 0% in LSC/LLS, p < 0.05). All groups achieved significant anatomical restoration (POP-Q points p < 0.001) and QoL improvements (PFDI-20: TVM 97.31 [right arrow] 8.37, LSC 108.92 [right arrow] 5.76, LLS 110.89 [right arrow] 6.64; PFIQ-7: TVM 103.86 [right arrow] 3.45, LSC 113.24 [right arrow] 9.28, LLS 122.99 [right arrow] 8.04; p < 0.001). No intergroup differences persisted after adjusting confounders. Notably, TVM participants with uterine preservation reported significantly better PFIQ-7 scores than hysterectomy subgroups (0.96 ± 0.52 vs. 6.60 ± 3.46, p < 0.05), whereas LSC/LLS showed no such disparity. LLS, LSC, and TVM effectively restore anatomy and QoL in advanced apical prolapse, with LLS offering optimal perioperative safety. Uterine preservation during TVM enhances postoperative satisfaction, suggesting individualized surgical planning is critical. Long-term complications and durability require further investigation.
Journal Article
Comparative outcomes of laparoscopic lateral suspension, sacrocolpopexy, and transvaginal mesh for advanced apical prolapse: A retrospective cohort study
by
Li, Huihua
,
Guo, Haichun
,
Wang, Binan
in
Comparative analysis
,
Gynecology, Operative
,
Methods
2025
To compare perioperative outcomes and long-term anatomical/functional efficacy of laparoscopic lateral suspension (LLS), laparoscopic sacrocolpopexy (LSC), and transvaginal mesh (TVM) procedures in women with POP-Q stage III-IV apical prolapse. This retrospective cohort included 98 participants undergoing surgical repair between 1/1/2021 and 30/12/2021: 34 TVM, 35 LSC, and 29 LLS. Concomitant hysterectomy or uterine preservation was performed based on clinical indications. Anatomical outcomes were assessed via Pelvic Organ Prolapse Quantification (POP-Q) measurements, while functional outcomes and quality of life (QoL) were evaluated using Pelvic Floor Distress Inventory Questionnaire (PFDI-20) and Pelvic Floor Impact Questionnaire (PFIQ-7) questionnaires preoperatively and at 2-year follow-up. Multivariable regression adjusted for age, BMI, parity, and surgical approach. LLS demonstrated superior perioperative outcomes, including shorter operative time (3.07 ± 0.15 vs. 4.59 ± 0.13 hours for LSC, p < 0.05), reduced blood loss (64.48 ± 4.62 vs. 116.18 ± 8.10 mL for TVM, p < 0.05), and shorter hospitalization (5.17 ± 0.20 vs. 6.21 ± 0.27 days for TVM, p < 0.05). Groin pain incidence was higher in TVM (21% vs. 0% in LSC/LLS, p < 0.05). All groups achieved significant anatomical restoration (POP-Q points p < 0.001) and QoL improvements (PFDI-20: TVM 97.31 [right arrow] 8.37, LSC 108.92 [right arrow] 5.76, LLS 110.89 [right arrow] 6.64; PFIQ-7: TVM 103.86 [right arrow] 3.45, LSC 113.24 [right arrow] 9.28, LLS 122.99 [right arrow] 8.04; p < 0.001). No intergroup differences persisted after adjusting confounders. Notably, TVM participants with uterine preservation reported significantly better PFIQ-7 scores than hysterectomy subgroups (0.96 ± 0.52 vs. 6.60 ± 3.46, p < 0.05), whereas LSC/LLS showed no such disparity. LLS, LSC, and TVM effectively restore anatomy and QoL in advanced apical prolapse, with LLS offering optimal perioperative safety. Uterine preservation during TVM enhances postoperative satisfaction, suggesting individualized surgical planning is critical. Long-term complications and durability require further investigation.
Journal Article
COMET
by
Geoffrion, Roxana
,
Hyakutake, Momoe
,
Brotto, Lori A
in
Evidence-based medicine
,
Gynecology, Operative
,
Methods
2024
Pelvic organ prolapse (POP) increases in incidence and severity with aging. At least 1 in 4 women seek pelvic floor care and many more suffer with concurrent symptoms of bowel, bladder and sexual dysfunction, which can have a large impact on quality of life. It is estimated that 1 in 5 women will undergo surgery for POP. POP is difficult to cure with existing surgeries and therefore treatment failure and reoperations are common. Surgical innovation in this area is urgently needed and we have developed a novel technique of bilateral sacrospinous vaginal vault fixation with synthetic mesh arms (BSSVF-M). Based on preliminary studies it may be more successful, durable and cost-effective than standard sacrospinous ligament suspension with sutures (SSLS). Preliminary development and exploration studies showed safety and efficacy of BSSVF-M. Following an established framework for research in surgical innovations, we now wish to conduct a randomized comparative effectiveness trial for assessment of this novel technique. This is a multi-center randomized controlled trial in Canada comparing the surgical techniques of BSSVF-M vs. SSLS to address apical prolapse. In total, 358 women with symptomatic POP at five centers will be randomized with 80% power to detect a 15% difference in primary composite outcome and accounting for a 15% loss to follow-up over 2 years. The primary objective is to investigate BSSVF-M vs. SSLS using an established composite of 3 objective signs and 1 subjective symptom of POP measured 2 years postoperatively. Secondary objectives: 1) To determine changes in condition-specific pelvic symptoms, quality of life, pain and condition-specific body image post BSSVF-M vs. SSLS using validated questionnaires; 2) To determine changes in sexuality post BSSVF-M vs. SSLS; 3) To determine global impression of improvement, adverse events (validated classification scheme), reoperations and health utility post BSSVF-M vs. SSLS; 4) To determine the cost-effectiveness of BSSVF-M vs SSLS. Study Registration at clinicaltrials.gov (NCT02965313). There is a need for innovation to improve the surgical approach to vaginal apical suspension. Despite controversies with mesh, it has been shown to be safe when used appropriately and to have higher durability when compared with sutures. As well, the importance of restoring anatomy and tension-free surgical approach in pelvic reconstructive surgery has led to better long-term outcomes and fewer side effects. These principles have been applied when developing the novel BSSVF-M technique. Anticipated challenges of this trial include recruitment, compliance problems and loss to follow up However, the robust methodology will provide evidence on the best surgical approach to correct POP, a common condition among aging women.
Journal Article
COMET
by
Brotto, Lori A.
,
Geoffrion, Roxana
,
Hyakutake, Momoe
in
Evidence-based medicine
,
Gynecology, Operative
,
Methods
2024
Pelvic organ prolapse (POP) increases in incidence and severity with aging. At least 1 in 4 women seek pelvic floor care and many more suffer with concurrent symptoms of bowel, bladder and sexual dysfunction, which can have a large impact on quality of life. It is estimated that 1 in 5 women will undergo surgery for POP. POP is difficult to cure with existing surgeries and therefore treatment failure and reoperations are common. Surgical innovation in this area is urgently needed and we have developed a novel technique of bilateral sacrospinous vaginal vault fixation with synthetic mesh arms (BSSVF-M). Based on preliminary studies it may be more successful, durable and cost-effective than standard sacrospinous ligament suspension with sutures (SSLS). Preliminary development and exploration studies showed safety and efficacy of BSSVF-M. Following an established framework for research in surgical innovations, we now wish to conduct a randomized comparative effectiveness trial for assessment of this novel technique. This is a multi-center randomized controlled trial in Canada comparing the surgical techniques of BSSVF-M vs. SSLS to address apical prolapse. In total, 358 women with symptomatic POP at five centers will be randomized with 80% power to detect a 15% difference in primary composite outcome and accounting for a 15% loss to follow-up over 2 years. The primary objective is to investigate BSSVF-M vs. SSLS using an established composite of 3 objective signs and 1 subjective symptom of POP measured 2 years postoperatively. Secondary objectives: 1) To determine changes in condition-specific pelvic symptoms, quality of life, pain and condition-specific body image post BSSVF-M vs. SSLS using validated questionnaires; 2) To determine changes in sexuality post BSSVF-M vs. SSLS; 3) To determine global impression of improvement, adverse events (validated classification scheme), reoperations and health utility post BSSVF-M vs. SSLS; 4) To determine the cost-effectiveness of BSSVF-M vs SSLS. Study Registration at clinicaltrials.gov (NCT02965313). There is a need for innovation to improve the surgical approach to vaginal apical suspension. Despite controversies with mesh, it has been shown to be safe when used appropriately and to have higher durability when compared with sutures. As well, the importance of restoring anatomy and tension-free surgical approach in pelvic reconstructive surgery has led to better long-term outcomes and fewer side effects. These principles have been applied when developing the novel BSSVF-M technique. Anticipated challenges of this trial include recruitment, compliance problems and loss to follow up However, the robust methodology will provide evidence on the best surgical approach to correct POP, a common condition among aging women.
Journal Article
COMET
by
Brotto, Lori A.
,
Geoffrion, Roxana
,
Hyakutake, Momoe
in
Evidence-based medicine
,
Gynecology, Operative
,
Methods
2024
Pelvic organ prolapse (POP) increases in incidence and severity with aging. At least 1 in 4 women seek pelvic floor care and many more suffer with concurrent symptoms of bowel, bladder and sexual dysfunction, which can have a large impact on quality of life. It is estimated that 1 in 5 women will undergo surgery for POP. POP is difficult to cure with existing surgeries and therefore treatment failure and reoperations are common. Surgical innovation in this area is urgently needed and we have developed a novel technique of bilateral sacrospinous vaginal vault fixation with synthetic mesh arms (BSSVF-M). Based on preliminary studies it may be more successful, durable and cost-effective than standard sacrospinous ligament suspension with sutures (SSLS). Preliminary development and exploration studies showed safety and efficacy of BSSVF-M. Following an established framework for research in surgical innovations, we now wish to conduct a randomized comparative effectiveness trial for assessment of this novel technique. This is a multi-center randomized controlled trial in Canada comparing the surgical techniques of BSSVF-M vs. SSLS to address apical prolapse. In total, 358 women with symptomatic POP at five centers will be randomized with 80% power to detect a 15% difference in primary composite outcome and accounting for a 15% loss to follow-up over 2 years. The primary objective is to investigate BSSVF-M vs. SSLS using an established composite of 3 objective signs and 1 subjective symptom of POP measured 2 years postoperatively. Secondary objectives: 1) To determine changes in condition-specific pelvic symptoms, quality of life, pain and condition-specific body image post BSSVF-M vs. SSLS using validated questionnaires; 2) To determine changes in sexuality post BSSVF-M vs. SSLS; 3) To determine global impression of improvement, adverse events (validated classification scheme), reoperations and health utility post BSSVF-M vs. SSLS; 4) To determine the cost-effectiveness of BSSVF-M vs SSLS. Study Registration at clinicaltrials.gov (NCT02965313). There is a need for innovation to improve the surgical approach to vaginal apical suspension. Despite controversies with mesh, it has been shown to be safe when used appropriately and to have higher durability when compared with sutures. As well, the importance of restoring anatomy and tension-free surgical approach in pelvic reconstructive surgery has led to better long-term outcomes and fewer side effects. These principles have been applied when developing the novel BSSVF-M technique. Anticipated challenges of this trial include recruitment, compliance problems and loss to follow up However, the robust methodology will provide evidence on the best surgical approach to correct POP, a common condition among aging women.
Journal Article
Risk factors for surgical site infection in patients undergoing obstetrics and gynecology surgeries: A meta-analysis of observational studies
by
Wang, Dong
,
Yang, Min
,
Liu, Yin
in
Care and treatment
,
Complications and side effects
,
Gynecology, Operative
2024
The aim of this study was to identify the risk factors for surgical site infection (SSI) in patients undergoing obstetrics and gynecology surgeries through meta-analysis. Relevant original studies published from January 1945 to May 2023 were searched the CBM, PubMed, Embase, WOS, CNKI, Wanfang, vip, and Cochrane Library databases. Studies eligible were evaluated by two investigators following Newcastle-Ottawa Scale(NOS) criteria. Review Manager 5.3 software was used to analyse the combined effect sizes and test for heterogeneity, and Stata 14.0 software's Begg's Test and Egger's Test were used to test for bias. 13 case-control articles, including 860 cases in the case group and 13574 cases in the control group, met the inclusion criteria. Eventually, Our meta-analysis showed that SSI in patients undergoing obstetrics and gynecology surgeries was correlated with body mass index (BMI)[greater than or equal to]24 (OR = 2.66; P < 0.0001), malignant lesions (OR = 4.65; P < 0.0001), operating time[greater than or equal to]60min (OR = 2.58; P < 0.0001), intraoperative bleeding[greater than or equal to]300ml (OR = 2.54; P < 0.0001), retained urinary catheter (OR = 4.45; P < 0.0001), and vaginal digital examination[greater than or equal to]3times (OR = 2.52; P < 0.0001). In this study, BMI[greater than or equal to]24, intraoperative bleeding[greater than or equal to]300ml, malignant lesions, operating time[greater than or equal to]60min, retained urinary catheter, and vaginal digital examination[greater than or equal to]3times were considered as independent risk factors for SSI in obstetrics and gynecology surgery. It is recommended that scholars be rigorous in designing the experimental process when conducting case-control or experimental studies in order to improve the quality of the study. Controlling patients' weight before obstetrical and gynecological surgery, shortening the operation time intraoperatively, and strictly controlling the indications of vaginal digital examination and retained urinary catheter can effectively reduce the incidence of SSI.
Journal Article
Risk factors for surgical site infection in patients undergoing obstetrics and gynecology surgeries: A meta-analysis of observational studies
by
Wang, Dong
,
Yang, Min
,
Liu, Yin
in
Care and treatment
,
Complications and side effects
,
Gynecology, Operative
2024
The aim of this study was to identify the risk factors for surgical site infection (SSI) in patients undergoing obstetrics and gynecology surgeries through meta-analysis. Relevant original studies published from January 1945 to May 2023 were searched the CBM, PubMed, Embase, WOS, CNKI, Wanfang, vip, and Cochrane Library databases. Studies eligible were evaluated by two investigators following Newcastle-Ottawa Scale(NOS) criteria. Review Manager 5.3 software was used to analyse the combined effect sizes and test for heterogeneity, and Stata 14.0 software's Begg's Test and Egger's Test were used to test for bias. 13 case-control articles, including 860 cases in the case group and 13574 cases in the control group, met the inclusion criteria. Eventually, Our meta-analysis showed that SSI in patients undergoing obstetrics and gynecology surgeries was correlated with body mass index (BMI)[greater than or equal to]24 (OR = 2.66; P < 0.0001), malignant lesions (OR = 4.65; P < 0.0001), operating time[greater than or equal to]60min (OR = 2.58; P < 0.0001), intraoperative bleeding[greater than or equal to]300ml (OR = 2.54; P < 0.0001), retained urinary catheter (OR = 4.45; P < 0.0001), and vaginal digital examination[greater than or equal to]3times (OR = 2.52; P < 0.0001). In this study, BMI[greater than or equal to]24, intraoperative bleeding[greater than or equal to]300ml, malignant lesions, operating time[greater than or equal to]60min, retained urinary catheter, and vaginal digital examination[greater than or equal to]3times were considered as independent risk factors for SSI in obstetrics and gynecology surgery. It is recommended that scholars be rigorous in designing the experimental process when conducting case-control or experimental studies in order to improve the quality of the study. Controlling patients' weight before obstetrical and gynecological surgery, shortening the operation time intraoperatively, and strictly controlling the indications of vaginal digital examination and retained urinary catheter can effectively reduce the incidence of SSI.
Journal Article
Effect of music on preoperative anxiety and postoperative pain in patients undergoing gynecological surgery: A meta-analysis
2025
Preoperative anxiety and postoperative pain often afflict patients and may impact surgical safety and postoperative recovery. Therefore, we studied the influence of music for patients with preoperative anxiety and postoperative pain, in order to provide an effective and safe non-pharmacological intervention for patients. Studies on music and gynecological operation were searched in PubMed, EMBASE, Web of Science, and the Cochrane Library. NOS and the modified Jadad Scale were used to evaluate the quality of the studies, and the evidence quality was evaluated and graded according to GRADE guidelines. Stata 12.0 software was used for data analysis. We compared the difference in preoperative anxiety between the experimental group and the control group. The results showed that anxiety symptoms were significantly relieved in the experimental group that listened to music(WMD = -6.78, 95% CI (-7.54 - -6.03), P = 0.000). This difference was statistically significant, and the quality of evidence was rated as intermediate. We compared the difference in anxiety symptoms before and after listening to music in the experimental group (WMD = -4.39, 95% CI (-5.14 - -3.64), P = 0.000). The results indicated a significant relief in anxiety symptoms after listening to music. The difference was statistically significant, and the quality of evidence was rated as intermediate and low, respectively. We compared the differences in postoperative pain between the experimental group and the control group (WMD = -0.26, 95% CI (-0.43--0.10), P = 0.002). The results showed that the pain symptoms of the experimental group, who listened to music, were significantly relieved. The difference was statistically significant, and the quality of evidence was rated as intermediate. This meta-analysis showed that listening to music significantly improved preoperative anxiety and postoperative pain during gynecological surgery. Therefore, operating room nurses should perform music intervention in patients undergoing gynecological surgery before and after surgery.
Journal Article