Use of a long term complete resorbable synthetic mesh in pre-pectoral implant-based breast reconstruction - results from the learning curve period

IntroductionTwo-stage implant-based breast reconstruction is the most commonly performed postmastectomy reconstructive technique. During the first stage, a tissue expander creates a sufficiently large pocket for the definite breast implant placed in the second stage. Capsular contracture is a common long-term complication associated with implant-based breast reconstruction, causing functional complaints and often requiring reoperation. The exact aetiology is still unknown, but a relationship between the outer surface of the implant and the probability of developing capsular contracture has been suggested. The purpose of this study is to determine whether polyurethane-covered implants result in a different capsular contracture rate than textured implants.Methods and analysisThe Textured Implants versus Polyurethane-covered Implants (TIPI) trial is a multicentre randomised controlled trial with a 1:1 allocation rate and a follow-up of 10 years. A total of 321 breasts of female adults undergoing a two-stage breast reconstruction will be enrolled. The primary outcome is capsular contracture at 10-year follow-up which is graded with the modified Baker classification. It is analysed with survival analysis using a frailty model for clustered interval-censored data, with both an intention-to-treat and per-protocol approach. Secondary outcomes are other complication rates, surgical revision rate, patient satisfaction and quality of life and user-friendliness. Outcomes are measured 2 weeks, 6 months, 1, 2, 3, 5 and 10 years postoperatively. Interim analysis is performed when 1-year, 3-year and 5-year follow-up is completed.Ethics and disseminationThe trial has been reviewed and approved by the Medical Research Ethics Committee of the Erasmus MC, University Medical Centre Rotterdam (MEC-2018-126) and locally by each participating centre. Written informed consent will be obtained from each study participant. The results will be disseminated by publication in peer-reviewed journals.Trial registrationNTR7265.

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Laparoscopic pectopexy: the learning curve and comparison with laparoscopic sacrocolpopexy

International Urogynecology Journal ◽

10.1007/s00192-021-04934-4 ◽

2021 ◽

Author(s):

Fei Chi Chuang ◽

Yu Min Chou ◽

Ling Ying Wu ◽

Tsai Hwa Yang ◽

Wen Hsin Chen ◽

...

Keyword(s):

Learning Curve ◽

Operation Time ◽

Synthetic Mesh ◽

Laparoscopic Sacrocolpopexy ◽

Apical Prolapse ◽

Steep Learning Curve ◽

Surgical Method ◽

Surgical Field ◽

Uncontrolled Bleeding

Abstract Introduction and hypothesis In addition to laparoscopic sacrocolpopexy (LS), laparoscopic pectopexy (LP) is a novel surgical method for correcting apical prolapse. The descended cervix or vaginal vault is suspended with a synthetic mesh by fixing the bilateral mesh ends to the pectineal ligaments. This study was aimed at developing a learning curve for LP and to compare it with results with LS. Methods We started laparoscopic/robotic pectopexy in our department in August 2019. This retrospective study included the initial 18 consecutive women with apical prolapse receiving LP and another group undergoing LS (21 cases) performed by the same surgeon. The medical and video records were reviewed. Results The age was older in the LP group than in the LS group (65.2 vs 53.1 years). The operation time of LP group was significantly shorter than that of the LS group (182.9 ± 27.2 vs 256.2 ± 45.5 min, p < 0.001). The turning point of the LP learning curve was observed at the 12th case. No major complications such as bladder, ureteral, bowel injury or uncontrolled bleeding occurred in either group. Postoperative low back pain and defecation symptoms occurred exclusively in the LS group. During the follow-up period (mean 7.2 months in LP, 16.2 months in LS), none of the cases had recurrent apical prolapse. Conclusions Laparoscopic pectopexy is a feasible surgical method for apical prolapse, with a shorter operation time and less postoperative discomfort than LS. LP may overcome the steep learning curve of LS because the surgical field of LP is limited to the anterior pelvis and avoids encountering the critical organs.

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Learning curve in immediate breast reconstruction with Strattice acellular dermal matrix

European Journal of Surgical Oncology ◽

10.1016/j.ejso.2013.01.048 ◽

2013 ◽

Vol 39 (5) ◽

pp. 464

Author(s):

Geeta Shetty ◽

Richard Salisbury ◽

Ashu Gandhi ◽

Asid Zeiton ◽

Richard Johnson ◽

...

Keyword(s):

Breast Reconstruction ◽

Learning Curve ◽

Acellular Dermal Matrix ◽

Immediate Breast Reconstruction ◽

Dermal Matrix ◽

Acellular Dermal

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Short-term and long-term outcomes of robotic, laparoscopic and open radical gastrectomy in gastric cancer: A single-center retrospective study

10.21203/rs.2.15339/v1 ◽

2019 ◽

Author(s):

Weifan Zhang ◽

Xinhui Zhao ◽

Zhao Liu ◽

Hui Dang ◽

Lei Meng ◽

...

Keyword(s):

Gastric Cancer ◽

Lymph Nodes ◽

Learning Curve ◽

Operation Time ◽

Open Gastrectomy ◽

Short Term ◽

Term Outcome ◽

Long Term Outcome ◽

Estimated Blood Loss

Abstract Background: Few studies on the comparison among robotic, laparoscopic, and open gastrectomy had been reported in gastric cancer . The goal of this study was to evaluate the advantages of robotic-assisted gastrectomy (RAG) by comparing with laparoscopic-assisted gastrectomy(LAG) and open gastrectomy (OG). Methods: 147 gastric cancer patients who underwent gastrectomy were enrolled and retrospectively analyzed between January 2017 and July 2019. Short-term outcomes such as operation time, intraoperative estimated blood loss(EBL),number of retrieved lymph nodes, postoperative recovery, learning curve, and long-term outcome such as overall survival(OS) was compared among RAG, LAG and OG groups. Results: RAG group included 47 patients, 44 in the LAG, and 61 in the OG. Basic information such as gender, age, BMI, ASA degree were similar among three groups, and there were no statistically significances in pathological TNM staging, tumor resection extent, resection margin, methods of reconstruction( P ＞0.05). The cumulative sum(CUSUM) method showed that learning curve of RAG reached stability after 17 cases . For short-term outcomes, the RAG group had the shortest EBL( P =0.033), the shortest time to first flatus( P ＜0.001), shortest time to first intake liquid diet ( P =0.004),shortest postoperative hospital stay ( P =0.023)and the largest number of retrieved lymph nodes( P =0.044),the longest operation time( P ＜0.001), the most expensive treatment cost( P ＜0.001),however, there were no significant differences in postoperative drainage, postoperative white blood cell(WBC)count and early complications among three group( P ＞0.05). In addition to long-term outcome, similar OS was observed in three groups. Conclusion: Compared with LAG and OG, RAG has certain advantages in short-term outcomes and is a safe and reliable surgical method. But still need further prospective, multi-center research to confirm this.

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Intra-operative 3.0 T Magnetic Resonance Imaging Using a Dual-Independent Room: Long-Term Evaluation of Time-Cost, Problems, and Learning-Curve Effect

Intraoperative Imaging - Acta Neurochirurgica Supplementum ◽

10.1007/978-3-211-99651-5_21 ◽

2010 ◽

pp. 139-144 ◽

Cited By ~ 2

Author(s):

X. Pablos Martin ◽

G. Vaz ◽

E. Fomekong ◽

G. Cosnard ◽

C. Raftopoulos

Keyword(s):

Magnetic Resonance Imaging ◽

Magnetic Resonance ◽

Learning Curve ◽

Time Cost ◽

Resonance Imaging ◽

Curve Effect ◽

Term Evaluation ◽

3.0 T

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Assessing the Influence of Failed Implant Reconstruction on Patient Satisfaction and Decision Regret after Salvage Free-Flap Breast Reconstruction

Journal of Reconstructive Microsurgery ◽

10.1055/s-0041-1735224 ◽

2021 ◽

Author(s):

Ronnie L. Shammas ◽

Amanda R. Sergesketter ◽

Mahsa Taskindoust ◽

Sonali Biswas ◽

Scott T. Hollenbeck ◽

...

Keyword(s):

Patient Satisfaction ◽

Breast Reconstruction ◽

Free Flap ◽

Well Being ◽

Flap Reconstruction ◽

Free Flap Reconstruction ◽

Decision Regret ◽

History Of ◽

Implant Reconstruction

Abstract Background Free-flap breast reconstruction after failed implant reconstruction is associated with improved patient outcomes. How the level of satisfaction achieved compares between patients with and without previously failed implant reconstruction remains unknown. The aim of this study was to assess the influence of prior failed implant-based reconstruction on long-term patient-reported outcomes after free-flap breast reconstruction. Methods All patients undergoing free-flap breast reconstruction between 2015 and 2019 were identified. Patient satisfaction using the BREAST-Q and decisional regret using the Decision Regret Scale were compared between patients with and without a history of implant breast reconstruction. Results Overall, 207 patients were contacted and 131 completed the BREAST-Q and Decision Regret Scale. A total of 23 patients had a history of failed implant-based reconstruction requiring free-flap-flap salvage, most commonly due to infection (39.1%), chronic pain (34.8%), capsular contracture (26%), and implant malposition (26.1%). Following definitive free-flap reconstruction, patients with prior failed implant reconstruction had significantly lower BREAST-Q scores for satisfaction with breast (61.2 ± 16.7 vs. 70.4 ± 18.7; p = 0.04) and sexual well-being (38.5 ± 18.2 vs. 52.8 ± 24.7; p = 0.01) and reported higher decision regret (19.1 ± 18.6 vs. 9.6 ± 15.6, respectively). There were no significant differences for psychosocial well-being (p = 0.67), physical well-being (chest; p = 0.27), and physical well-being (abdomen; p = 0.91). Conclusion A history of failed implant-based reconstruction is associated with reduced satisfaction and increased decision regret with the final reconstructive outcome. This data underscores the importance of appropriate patient selection at the initial consultation, and informed preoperative counseling regarding long-term outcomes in patients presenting for free-flap reconstruction after a failed implant-based reconstruction.

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