Pub Date : 2015-10-14eCollection Date: 2015-01-01DOI: 10.1186/s13022-015-0015-0
Michel Gagner
Background: Partial bypass of the GI tract may promote weight loss by decreased absorption of nutrients and changes in incretins. The aim of the study was to evaluate the safety and efficacy of performing a side-to-side duodeno-ileal anastomosis.
Methods: Seven 40-50 kg female Yorkshire pigs were allocated to a duodeno-ileal anastomosis (DIA), and were compared to a control group (SHAM). Swine's weights were followed for 56 days. Gastroscopies were also performed at 28 days. Blood samples were also taken at regular intervals (CBC and Basic biochemistry profiles). At autopsy, gross changes and histological changes of the liver, duodenum and ileum samples were performed.
Results: While the SHAM group gained 33.2 % more weight at 56 days, the DIA group had shown a weight loss of -6.8 %, for a difference of 40.0 % between the 2 groups (p < 0.05). One pig developed an incisional hernia. Gastroscopies demonstrated normal healing without ulceration or inflammation at 28 days. Histological examination of the anastomosis at 56 days showed normal and smooth healing, with absence of liver toxicity.
Conclusion: In this porcine model with short follow-up, a side-to-side duodeno-ileal anastomosis provided excellent weight loss without apparent nutritional or grossly aberrant histological changes.
{"title":"Safety and efficacy of a side-to-side duodeno-ileal anastomosis for weight loss and type-2 diabetes: duodenal bipartition, a novel metabolic surgery procedure.","authors":"Michel Gagner","doi":"10.1186/s13022-015-0015-0","DOIUrl":"https://doi.org/10.1186/s13022-015-0015-0","url":null,"abstract":"<p><strong>Background: </strong>Partial bypass of the GI tract may promote weight loss by decreased absorption of nutrients and changes in incretins. The aim of the study was to evaluate the safety and efficacy of performing a side-to-side duodeno-ileal anastomosis.</p><p><strong>Methods: </strong>Seven 40-50 kg female Yorkshire pigs were allocated to a duodeno-ileal anastomosis (DIA), and were compared to a control group (SHAM). Swine's weights were followed for 56 days. Gastroscopies were also performed at 28 days. Blood samples were also taken at regular intervals (CBC and Basic biochemistry profiles). At autopsy, gross changes and histological changes of the liver, duodenum and ileum samples were performed.</p><p><strong>Results: </strong>While the SHAM group gained 33.2 % more weight at 56 days, the DIA group had shown a weight loss of -6.8 %, for a difference of 40.0 % between the 2 groups (p < 0.05). One pig developed an incisional hernia. Gastroscopies demonstrated normal healing without ulceration or inflammation at 28 days. Histological examination of the anastomosis at 56 days showed normal and smooth healing, with absence of liver toxicity.</p><p><strong>Conclusion: </strong>In this porcine model with short follow-up, a side-to-side duodeno-ileal anastomosis provided excellent weight loss without apparent nutritional or grossly aberrant histological changes.</p>","PeriodicalId":87428,"journal":{"name":"Annals of surgical innovation and research","volume":"9 ","pages":"6"},"PeriodicalIF":0.0,"publicationDate":"2015-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s13022-015-0015-0","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34262305","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-09-02eCollection Date: 2015-01-01DOI: 10.1186/s13022-015-0014-1
Reinhold Lang, Petra Baumann, Claudia Schmoor, Erich K Odermatt, Moritz N Wente, Karl-Walter Jauch
Background: Intra-abdominal surgical intervention can cause the development of intra-peritoneal adhesions. To reduce this problem, different agents have been tested to minimize abdominal adhesions; however, the optimal adhesion prophylaxis has not been found so far. Therefore, the A-Part(®) Gel was developed as a barrier to diminish postsurgical adhesions; the aim of this randomized controlled study was a first evaluation of its safety and efficacy.
Methods: In this prospective, controlled, randomized, patient-blinded, monocenter phase I-II study, 62 patients received either the hydrogel A-Part-Gel(®) as an anti-adhesive barrier or were untreated after primary elective median laparotomy. Primary endpoint was the occurrence of peritonitis and/or wound healing impairment 28 ± 10 days postoperatively. As secondary endpoints anastomotic leakage until 28 days after surgery, adverse events and adhesions were assessed until 3 months postoperatively.
Results: A lower rate of wound healing impairment and/or peritonitis was observed in the A-Part Gel(®) group compared to the control group: (6.5 vs. 13.8 %). The difference between the two groups was -7.3%, 90 % confidence interval [-20.1, 5.4 %]. Both treatment groups showed similar frequency of anastomotic leakage but incidence of adverse events and serious adverse events were slightly lower in the A-Part Gel(®) group compared to the control. Adhesion rates were comparable in both groups.
Conclusion: A-Part Gel(®) is safe as an adhesion prophylaxis after abdominal wall surgery but no reduction of postoperative peritoneal adhesion could be found in comparison to the control group. This may at least in part be due to the small sample size as well as to the incomplete coverage of the incision due to the used application.
{"title":"A-Part Gel, an adhesion prophylaxis for abdominal surgery: a randomized controlled phase I-II safety study [NCT00646412].","authors":"Reinhold Lang, Petra Baumann, Claudia Schmoor, Erich K Odermatt, Moritz N Wente, Karl-Walter Jauch","doi":"10.1186/s13022-015-0014-1","DOIUrl":"https://doi.org/10.1186/s13022-015-0014-1","url":null,"abstract":"<p><strong>Background: </strong>Intra-abdominal surgical intervention can cause the development of intra-peritoneal adhesions. To reduce this problem, different agents have been tested to minimize abdominal adhesions; however, the optimal adhesion prophylaxis has not been found so far. Therefore, the A-Part(®) Gel was developed as a barrier to diminish postsurgical adhesions; the aim of this randomized controlled study was a first evaluation of its safety and efficacy.</p><p><strong>Methods: </strong>In this prospective, controlled, randomized, patient-blinded, monocenter phase I-II study, 62 patients received either the hydrogel A-Part-Gel(®) as an anti-adhesive barrier or were untreated after primary elective median laparotomy. Primary endpoint was the occurrence of peritonitis and/or wound healing impairment 28 ± 10 days postoperatively. As secondary endpoints anastomotic leakage until 28 days after surgery, adverse events and adhesions were assessed until 3 months postoperatively.</p><p><strong>Results: </strong>A lower rate of wound healing impairment and/or peritonitis was observed in the A-Part Gel(®) group compared to the control group: (6.5 vs. 13.8 %). The difference between the two groups was -7.3%, 90 % confidence interval [-20.1, 5.4 %]. Both treatment groups showed similar frequency of anastomotic leakage but incidence of adverse events and serious adverse events were slightly lower in the A-Part Gel(®) group compared to the control. Adhesion rates were comparable in both groups.</p><p><strong>Conclusion: </strong>A-Part Gel(®) is safe as an adhesion prophylaxis after abdominal wall surgery but no reduction of postoperative peritoneal adhesion could be found in comparison to the control group. This may at least in part be due to the small sample size as well as to the incomplete coverage of the incision due to the used application.</p><p><strong>Trial registration: </strong>NCT00646412.</p>","PeriodicalId":87428,"journal":{"name":"Annals of surgical innovation and research","volume":"9 ","pages":"5"},"PeriodicalIF":0.0,"publicationDate":"2015-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s13022-015-0014-1","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33975132","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Hepatocellular carcinoma (HCC) is among the commonest cancers in the world. Metastasis is one of the most significant factors affecting prognosis. Common sites of extrahepatic metastases include lungs, regional lymph nodes and less commonly bone.
Case presentation: A 56-year-old male presented with a painless occipital scalp lump of three months duration, with recent rapid enlargement. His skull x-ray showed a lytic lesion over occipital bone and the contrast CT scan of the brain showed a scalp mass with destruction of the adjacent skull. Core biopsy of the lesion revealed a metastatic deposit from a hepatocellular carcinoma.
Conclusion: Primary presentation with skeletal metastases are rare in HCC with only a few reported cases. Here we report a case of HCC presenting as a solitary scalp lump.
{"title":"Solitary scalp metastasis - a rare presentation of hepatocellular carcinoma.","authors":"Duminda Subasinghe, Chathuranga Tisara Keppetiyagama, Hemantha Sudasinghe, Saman Wadanamby, Niranthi Perera, Sivasuriya Sivaganesh","doi":"10.1186/s13022-015-0013-2","DOIUrl":"https://doi.org/10.1186/s13022-015-0013-2","url":null,"abstract":"<p><strong>Introduction: </strong>Hepatocellular carcinoma (HCC) is among the commonest cancers in the world. Metastasis is one of the most significant factors affecting prognosis. Common sites of extrahepatic metastases include lungs, regional lymph nodes and less commonly bone.</p><p><strong>Case presentation: </strong>A 56-year-old male presented with a painless occipital scalp lump of three months duration, with recent rapid enlargement. His skull x-ray showed a lytic lesion over occipital bone and the contrast CT scan of the brain showed a scalp mass with destruction of the adjacent skull. Core biopsy of the lesion revealed a metastatic deposit from a hepatocellular carcinoma.</p><p><strong>Conclusion: </strong>Primary presentation with skeletal metastases are rare in HCC with only a few reported cases. Here we report a case of HCC presenting as a solitary scalp lump.</p>","PeriodicalId":87428,"journal":{"name":"Annals of surgical innovation and research","volume":"9 ","pages":"4"},"PeriodicalIF":0.0,"publicationDate":"2015-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s13022-015-0013-2","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33380203","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-05-19DOI: 10.1186/S13022-015-0012-3
R. Rathinaezhil, F. Ugolini, H. Osman
{"title":"Early experience with implant based breast reconstruction for early breast cancer in ptotic breasts with non biological mesh and lower pole dermal sling","authors":"R. Rathinaezhil, F. Ugolini, H. Osman","doi":"10.1186/S13022-015-0012-3","DOIUrl":"https://doi.org/10.1186/S13022-015-0012-3","url":null,"abstract":"","PeriodicalId":87428,"journal":{"name":"Annals of surgical innovation and research","volume":"9 1","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2015-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/S13022-015-0012-3","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65746318","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Insufficient arterial blood flow is the one cause of flap necrosis. Cilostazol is an inhibitor of phosphodiesterase III and increases cyclic AMP level in vascular smooth muscle cell causing vasodilation. Therefore, effect of cilostazol is expected to improve the viability of the flap.
Methods: Double blinded randomized controlled trial was conducted. The study was to compare the survival of dorsal rat flaps between preoperative cilostazol supplemented diet and regular diet. The flap survival area was measured using PixArea Image software on post operative day 1,3,5 and 7. Fluorescein injection was performed to evaluate the exactly area of flap survival on postoperative day 7 and morphology of arterioles and venules were examined by histopathologic examination.
Results: A statistical significance was found in the percentage of area of flap survival between cilostazol supplemented diet and control group on postoperative day 3, 5 and 7 (p < 0.05). Fluorescein injection showed the higher area of flap survival in cilostazol group than the control group (p < 0.05). Histopathologic examination showed dilation of vessels in the cilostazol group.
Conclusion: Preoperative cilostazol in rats can enhance skin flap survival.
{"title":"An experimental study of the effect of pre-operative administration of cilostazol on random skin flap survival in rats: double blinded randomized controlled trial.","authors":"Chairat Burusapat, Janjira Paengnoi, Kantang Satayasoontorn","doi":"10.1186/s13022-015-0011-4","DOIUrl":"https://doi.org/10.1186/s13022-015-0011-4","url":null,"abstract":"<p><strong>Background: </strong>Insufficient arterial blood flow is the one cause of flap necrosis. Cilostazol is an inhibitor of phosphodiesterase III and increases cyclic AMP level in vascular smooth muscle cell causing vasodilation. Therefore, effect of cilostazol is expected to improve the viability of the flap.</p><p><strong>Methods: </strong>Double blinded randomized controlled trial was conducted. The study was to compare the survival of dorsal rat flaps between preoperative cilostazol supplemented diet and regular diet. The flap survival area was measured using PixArea Image software on post operative day 1,3,5 and 7. Fluorescein injection was performed to evaluate the exactly area of flap survival on postoperative day 7 and morphology of arterioles and venules were examined by histopathologic examination.</p><p><strong>Results: </strong>A statistical significance was found in the percentage of area of flap survival between cilostazol supplemented diet and control group on postoperative day 3, 5 and 7 (p < 0.05). Fluorescein injection showed the higher area of flap survival in cilostazol group than the control group (p < 0.05). Histopathologic examination showed dilation of vessels in the cilostazol group.</p><p><strong>Conclusion: </strong>Preoperative cilostazol in rats can enhance skin flap survival.</p>","PeriodicalId":87428,"journal":{"name":"Annals of surgical innovation and research","volume":"9 ","pages":"2"},"PeriodicalIF":0.0,"publicationDate":"2015-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s13022-015-0011-4","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33271558","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-02-11eCollection Date: 2015-01-01DOI: 10.1186/s13022-015-0010-5
Gholam Ali Gholami, Hadi Gholami, Reza Amid, Mahdi Kadkhodazadeh, Amir Reza Mehdizadeh, Navid Youssefi
This article proposes a combined technique including bone grafting, connective tissue graft, and coronally advanced flap to create some space for simultaneous bone regrowth and root coverage. A 23 year-old female was referred to our private clinic with a severe class II Miller recession and lack of attached gingiva. The suggested treatment plan comprised of root coverage combined with xenograft bone particles. The grafted area healed well and full coverage was achieved at 12-month follow-up visit. Bone-added periodontal plastic surgery can be considered as a practical procedure for management of deep gingival recession without buccal bone plate.
{"title":"Bone-added periodontal plastic surgery: a new approach in esthetic dentistry.","authors":"Gholam Ali Gholami, Hadi Gholami, Reza Amid, Mahdi Kadkhodazadeh, Amir Reza Mehdizadeh, Navid Youssefi","doi":"10.1186/s13022-015-0010-5","DOIUrl":"https://doi.org/10.1186/s13022-015-0010-5","url":null,"abstract":"<p><p>This article proposes a combined technique including bone grafting, connective tissue graft, and coronally advanced flap to create some space for simultaneous bone regrowth and root coverage. A 23 year-old female was referred to our private clinic with a severe class II Miller recession and lack of attached gingiva. The suggested treatment plan comprised of root coverage combined with xenograft bone particles. The grafted area healed well and full coverage was achieved at 12-month follow-up visit. Bone-added periodontal plastic surgery can be considered as a practical procedure for management of deep gingival recession without buccal bone plate. </p>","PeriodicalId":87428,"journal":{"name":"Annals of surgical innovation and research","volume":"9 ","pages":"1"},"PeriodicalIF":0.0,"publicationDate":"2015-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s13022-015-0010-5","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33123172","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2014-12-19eCollection Date: 2014-01-01DOI: 10.1186/s13022-014-0009-3
Renee L Arlow, Dirk F Moore, Chunxia Chen, John Langenfeld, David A August
Background: The objective of this study is to describe the system and technical factors that enabled our moderate size transhiatal esophagectomy program to achieve low mortality rates.
Methods: A retrospective chart review was conducted on 200 consecutive patients who underwent transhiatal esophagectomy at Robert Wood Johnson University Hospital. Primary outcomes included operative times, estimated blood loss, frequency and nature of complications, and lengths of stay in the hospital and the intensive care unit.
Results: In general, surgical outcomes tended to improve over the course of this study. We identified decreased operative time, intra-operative blood loss, frequency of complications, and lengths of intensive care unit and hospital stay as the program matured. Through coordinated actions of the surgical and anesthesia teams, all intraoperative injuries were responded to in an effective, emergent fashion and all but one patient was saved. This resulted in an inhospital and 30-day mortality rate of only 0.5%.
Conclusions: Our study suggests that a dual attending approach, focus on avoiding "failure to rescue", increased volume, and a surgeon driven commitment to quality improvement may lead to low mortality rates after transhiatal esophagectomy.
{"title":"Outcome-volume relationships and transhiatal esophagectomy: minimizing \"failure to rescue\".","authors":"Renee L Arlow, Dirk F Moore, Chunxia Chen, John Langenfeld, David A August","doi":"10.1186/s13022-014-0009-3","DOIUrl":"https://doi.org/10.1186/s13022-014-0009-3","url":null,"abstract":"<p><strong>Background: </strong>The objective of this study is to describe the system and technical factors that enabled our moderate size transhiatal esophagectomy program to achieve low mortality rates.</p><p><strong>Methods: </strong>A retrospective chart review was conducted on 200 consecutive patients who underwent transhiatal esophagectomy at Robert Wood Johnson University Hospital. Primary outcomes included operative times, estimated blood loss, frequency and nature of complications, and lengths of stay in the hospital and the intensive care unit.</p><p><strong>Results: </strong>In general, surgical outcomes tended to improve over the course of this study. We identified decreased operative time, intra-operative blood loss, frequency of complications, and lengths of intensive care unit and hospital stay as the program matured. Through coordinated actions of the surgical and anesthesia teams, all intraoperative injuries were responded to in an effective, emergent fashion and all but one patient was saved. This resulted in an inhospital and 30-day mortality rate of only 0.5%.</p><p><strong>Conclusions: </strong>Our study suggests that a dual attending approach, focus on avoiding \"failure to rescue\", increased volume, and a surgeon driven commitment to quality improvement may lead to low mortality rates after transhiatal esophagectomy.</p>","PeriodicalId":87428,"journal":{"name":"Annals of surgical innovation and research","volume":"8 1","pages":"9"},"PeriodicalIF":0.0,"publicationDate":"2014-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s13022-014-0009-3","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32942902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2014-11-22eCollection Date: 2014-01-01DOI: 10.1186/s13022-014-0008-4
Lulzim Vokrri, Xhavit Krasniqi, Arsim Qavdarbasha, Nexhmi Hyseni, Philippe Cinquin, Paolo Porcu, Carmine Sessa
Background: In recent years, several methods and new techniques have been studied and proposed for establishment of sutureless vascular anastomoses, streaming use of sutureless vascular surgery in the future.
Presentation of the hypothesis: The new vascular connector (NVC) is a hypothetical design of a vascular device, proposed for creation and maintenance of sutureless vascular anastomosis. Implication of NVC would introduce a new device and technique in establishment of sutureless vascular anastomosis in which surgical approach is minimized and so post-operation disorders. It would eliminate need for suture; shorten clampage and operation time, consequently reducing stress for both, the surgeon and the patient. It enables the creation of vascular anastomosis fast, simple, safe, reliable, with satisfactory patency and stability of anastomosis.
Testing the hypothesis: Efficacy of NVC needs to be evaluated in further studies, in order to be confirmed for clinical use. The effectiveness of NVC should be verified firstly in vitro and in vivo tests; and by animal experiments. The likelihood of its negative influence in thrombogenicity should be well evaluated.
Implications of the hypothesis: Implication of the new vascular connector (NVC) would be of interest to both patients and the surgeon due to the following main achievements: 1) enables the creation of vascular anastomosis fast and simple, 2) significant shortening of clampage time of blood vessels and operation time-this assumption would be followed by reduced risk of operative and post-operative complications and length of hospital stay or admission to Intensive care unit, 3) safe and reliable, 4) compatible with any blood vessel and standard vascular graft, 5) using the NVC we will reduce in minimum need for replaced blood volume, 6) reduces the cost of treatment. It is anticipated that the NVC would provide shorter operation time and least operative and post-operative complications in creation of sutureless vascular anastomosis.
{"title":"The vascular connector, design of a new device for sutureless vascular anastomosis.","authors":"Lulzim Vokrri, Xhavit Krasniqi, Arsim Qavdarbasha, Nexhmi Hyseni, Philippe Cinquin, Paolo Porcu, Carmine Sessa","doi":"10.1186/s13022-014-0008-4","DOIUrl":"10.1186/s13022-014-0008-4","url":null,"abstract":"<p><strong>Background: </strong>In recent years, several methods and new techniques have been studied and proposed for establishment of sutureless vascular anastomoses, streaming use of sutureless vascular surgery in the future.</p><p><strong>Presentation of the hypothesis: </strong>The new vascular connector (NVC) is a hypothetical design of a vascular device, proposed for creation and maintenance of sutureless vascular anastomosis. Implication of NVC would introduce a new device and technique in establishment of sutureless vascular anastomosis in which surgical approach is minimized and so post-operation disorders. It would eliminate need for suture; shorten clampage and operation time, consequently reducing stress for both, the surgeon and the patient. It enables the creation of vascular anastomosis fast, simple, safe, reliable, with satisfactory patency and stability of anastomosis.</p><p><strong>Testing the hypothesis: </strong>Efficacy of NVC needs to be evaluated in further studies, in order to be confirmed for clinical use. The effectiveness of NVC should be verified firstly in vitro and in vivo tests; and by animal experiments. The likelihood of its negative influence in thrombogenicity should be well evaluated.</p><p><strong>Implications of the hypothesis: </strong>Implication of the new vascular connector (NVC) would be of interest to both patients and the surgeon due to the following main achievements: 1) enables the creation of vascular anastomosis fast and simple, 2) significant shortening of clampage time of blood vessels and operation time-this assumption would be followed by reduced risk of operative and post-operative complications and length of hospital stay or admission to Intensive care unit, 3) safe and reliable, 4) compatible with any blood vessel and standard vascular graft, 5) using the NVC we will reduce in minimum need for replaced blood volume, 6) reduces the cost of treatment. It is anticipated that the NVC would provide shorter operation time and least operative and post-operative complications in creation of sutureless vascular anastomosis.</p>","PeriodicalId":87428,"journal":{"name":"Annals of surgical innovation and research","volume":"8 1","pages":"8"},"PeriodicalIF":0.0,"publicationDate":"2014-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s13022-014-0008-4","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32897500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2014-10-18eCollection Date: 2014-01-01DOI: 10.1186/s13022-014-0007-5
Hans-Jörg Meisel, Konrad Seller, Achim L Th, Karin B Ttner-Janz, Peter Stosberg, Alexander Moser, Larry E Miller, Jon E Block, Luiz Pimenta
Background: The zygapophysial (facet) joint is the primary pain generator in one third of chronic low back pain cases. Current treatment options include temporarily palliative nonsurgical approaches, facet injections, radiofrequency denervation, and, rarely, lumbar arthrodesis. The purpose of this study was to assess the safety and effectiveness of a minimally invasive implant intended to restore facet joint function in patients with chronic lumbar facetogenic pain.
Methods: This prospective, multi-center feasibility study enrolled patients with confirmed lumbar facetogenic joint pain at 1 or 2 levels who underwent at least 6 months of unsuccessful nonoperative care. Patients received a minimally invasive implant (Glyder® Facet Restoration Device, Zyga Technology, Inc., Minnetonka, MN) intended to restore facet joint function while preserving the native anatomy. Main outcomes included back pain severity using a visual analogue scale, back-specific disability using the Oswestry Disability Index (ODI), and adverse events adjudicated by an independent Clinical Events Committee.
Results: Of 40 enrolled patients, 37 patients received the facet restoration implant and 34 patients had complete 1-year follow-up data available. Over the 1-year follow-up period, back pain severity decreased 41% and ODI decreased 34%, on average. Freedom from a device- or procedure-related serious adverse event through 1 year was 84%. Implant migration was observed in 3 patients and implant expulsion from the facet joint occurred in 3 patients. In total, 2 (5.4%) patients underwent implant removal through 1 year post-treatment.
Conclusions: A minimally invasive facet restoration implant is a promising treatment option in select patients with chronic lumbar zygapophysial pain who have exhausted nonsurgical treatments, with therapeutic benefit persisting at 1 year follow-up.
{"title":"Minimally invasive facet restoration implant for chronic lumbar zygapophysial pain: 1-year outcomes.","authors":"Hans-Jörg Meisel, Konrad Seller, Achim L Th, Karin B Ttner-Janz, Peter Stosberg, Alexander Moser, Larry E Miller, Jon E Block, Luiz Pimenta","doi":"10.1186/s13022-014-0007-5","DOIUrl":"10.1186/s13022-014-0007-5","url":null,"abstract":"<p><strong>Background: </strong>The zygapophysial (facet) joint is the primary pain generator in one third of chronic low back pain cases. Current treatment options include temporarily palliative nonsurgical approaches, facet injections, radiofrequency denervation, and, rarely, lumbar arthrodesis. The purpose of this study was to assess the safety and effectiveness of a minimally invasive implant intended to restore facet joint function in patients with chronic lumbar facetogenic pain.</p><p><strong>Methods: </strong>This prospective, multi-center feasibility study enrolled patients with confirmed lumbar facetogenic joint pain at 1 or 2 levels who underwent at least 6 months of unsuccessful nonoperative care. Patients received a minimally invasive implant (Glyder® Facet Restoration Device, Zyga Technology, Inc., Minnetonka, MN) intended to restore facet joint function while preserving the native anatomy. Main outcomes included back pain severity using a visual analogue scale, back-specific disability using the Oswestry Disability Index (ODI), and adverse events adjudicated by an independent Clinical Events Committee.</p><p><strong>Results: </strong>Of 40 enrolled patients, 37 patients received the facet restoration implant and 34 patients had complete 1-year follow-up data available. Over the 1-year follow-up period, back pain severity decreased 41% and ODI decreased 34%, on average. Freedom from a device- or procedure-related serious adverse event through 1 year was 84%. Implant migration was observed in 3 patients and implant expulsion from the facet joint occurred in 3 patients. In total, 2 (5.4%) patients underwent implant removal through 1 year post-treatment.</p><p><strong>Conclusions: </strong>A minimally invasive facet restoration implant is a promising treatment option in select patients with chronic lumbar zygapophysial pain who have exhausted nonsurgical treatments, with therapeutic benefit persisting at 1 year follow-up.</p>","PeriodicalId":87428,"journal":{"name":"Annals of surgical innovation and research","volume":"8 1","pages":"7"},"PeriodicalIF":0.0,"publicationDate":"2014-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4665199/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65746302","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2014-08-27DOI: 10.1186/S13022-014-0006-6
M. A. W. Stam, C. Mulder, E. Consten, J. Tuynman, C. Buskens, W. Bemelman
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