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NOTES® Ligation of Intraabdominal Organs with Absorbable Polydioxanone Loops
Abstracts
T1468 Transgastric Laparoscopic Assisted Endoscopic Cholecystectomy: A Safe and Inevitable Bridge to NOTESÒ Rogier P. Voermans, Willem Bemelman, Paul Fockens, Mark I. Van Berge Henegouwen
T1470 NOTESÒ Ligation of Intraabdominal Organs with Absorbable Polydioxanone Loops Georg F. Kaehler, Markus B. Schoenberg, Axel Eickhoff, Daniel Von Renteln, Hans U. Rudolph
Background: NOTES cholecystectomy is increasingly being performed. However, since it is very challenging to obtain the essential critical view of safety (CVS) with current endoscopic technology, safe NOTES cholecystectomy cannot be ensured. Although a hybrid procedure is not considered true NOTES, it might, by using 2 mm instruments aid acquiring CVS. Simultaneously it could avoid enlargement of the abdominal incision because the duct and artery can be clipped endoscopically and the gallbladder is removed through the stomach. Aim: To evaluate feasibility and safety of transgastric laparoscopic assisted NOTES cholecystectomy using 2 mm instruments. Methods: Experiments were performed in a live porcine model. Laparoscopic access to the abdominal cavity was obtained by two 2 mm (left and right upper abdomen) and one 5 mm trocars (umbilical). Gastric access was created under laparoscopic control by a needle knife puncture followed by balloon dilation up to 18 mm. Exposure of Calot’s triangle was obtained endoscopically assisted retracting the fundus with an endoscopic grasper. After obtaining CVS the cystic duct and artery were clipped endoscopically. The gallbladder was dissected from the liver bed, using endoscopic assistance. After dissection, the specimen was grasped with an endoscopic snare, the bile was evacuated with a 19G needle and it was then extracted via the stomach. The gastrotomy was closed endoscopically using the Over-The-Scope-Clip (Ovesco). Experiments were planned first in 6 acute and later in 16 survival pigs. Sample size for survivals was based on the assumption of a success rate of 100% and fact that the lower end of the 95%-CI of success must be at least above the 80%. In the survival experiments necropsy was performed after 10 days with inspection of peritoneal cavity, liver and the gastrotomy site. Results: Hybrid cholecystectomy was successful in all 12 experiments performed until 11/08. Mean procedural time was 82 minutes (SD 25). In all experiments CVS was obtained satisfactorily. Bleeding occurred in 2 animals and was managed endoscopically in both cases. The gallbladder was perforated in 1 animal. All 6 survival animals thrived during 10 days follow up. At necropsy there were no signs of infection or other complications. Conclusions: Transgastric endoscopic assisted laparoscopic cholecystectomy with mini-instruments is feasible, safe and results in optimal CVS. This procedure seems to be a safe candidate for translation into human clinical trials, serving as a bridge to ‘real’ NOTES.
Introduction: Natural orifice transluminal endoscopic surgery (NOTES) is believed to decrease adhesion formation after surgery thus reducing patients’ morbidity. Absorbable Materials in NOTES procedures might reduce inflammatory reaction thus preventing intraabdominal adhesions abs abscess formation. In this study we introduce the first absorbable NOTES-loop for ligation of intraabdominal structures. The aim of this study was to assess intraabdominal ligation with a flexible absorbable NOTES-Loop in a survival study in pigs. Materials and Methods: Transgastric ligation and dissection of the uterus horns or the fallopian tubes was evaluated in 12 female pigs. The percutaneous endoscopic gastrostomy (PEG) technique and a 18mm controlled radial expansion (CRE (TM)) balloon dilatator were used to achieve a gastrotomy. Then the fallopian tubes or the uterus horns on both sides were identified and ligated either with an absorbable NOTESloop or a non-absorbable Endoloop. Altogether 24 structures were ligated. 4 Pigs underwent a tubectomy on both ligated sides. After an observation period of 17 to 21 days the pigs were examined macroscopically and pathologic changes were assessed. Results: All except for one single ligation (non-absorbable Endoloop) could be carried out safely and were tight. The operation time ranged from 45 to 170 min resulting in a median time of 112.5 min. In 11/12 (92%) pigs the observation period was uneventful. One pig had to be sacrificed on day 4 because of perforation of the gallbladder and following peritonitis. 10/11 (91%) pigs gained 0.68 0.25 kg whereas one pig lost 0.9 kg. Necropsy showed no evidence of bleeding, organ injury or peritonitis. 4/11 (36%) pigs however suffered from a very small amount of ascites. Near all non-absorbable Endoloops pus and an increased tissue response could be observed. Consequently adhesions formed much less around the absorbable NOTES-loops than around the non-absorbable Endoloops. Conclusion: Absorbable NOTES-Loops are a save way to ligate intraabdominal structures. Our pathological findings support the clinical experience that absorbable threads prevent adhesions. Therefore absorbable NOTES-loops are feasible for the ligation of intraabdominal structures in NOTES procedures.
T1469 Hybrid Transgastric NOTESÒ Cholecystectomy in a Porcine Model Using a Magnetically Anchored Cautery and Novel Instrumentation Antonio O. Castellvi, Shou Jiang Tang, Deborah C. Hogg, Lisa A. Hollett, Richard Bergs, Raul Fernandez, Jeffrey A. Cadeddu, Daniel J. Scott Introduction: The purpose of this study was to determine the utility of novel instrumentation for transgastric NOTES cholecystectomy in a porcine model. Methods: Anesthetized pigs (nZ4) underwent non-survival cholecystectomy procedures. A prototype articulating 90cm access port and a 2T endoscope were passed transorally and through a gastrotomy created using a needle knife/balloon dilation technique. Through a transabdominal trocar, a 2mm laparoscope was used for initial visualization and a prototype 2 mm laparoscopic grasper was used for tissue manipulation. A prototype endoscopic T-tag suturing system was used to fixate the gallbladder fundus to the abdominal wall near the diaphragm (retraction) and for gastrotomy closure. Dissection was performed using prototype straight or articulating endoscopic instruments (hook cautery, clip applier, scissors, injection needle; pigs 1-2) and/or a magnetic anchoring and guidance system (MAGS) cautery device (inserted transorally; pigs 3-4). A live video manipulation (LVM) system was used to adjust horizontal image orientation (pigs 2-4). Gallbladder specimens were retrieved transorally using a snare. Values are mean s.d. Results: All 4 procedures were completed, achieving partial cholecystectomy in pigs 1-2 and complete cholecystectomy in pigs 3-4; operative time was 281 74 minutes, blood loss was 63 48 cc, and bile spillage was minimal. Gastrotomy creation and access port insertion were straightforward in 2 cases (20-25 min) and difficult in 2 cases (70-120 min., temporary use of an additional 3mm laparoscopic grasper was required). The LVM system readily overcame problems with image disorientation and greatly diminished the workload of the team. T-tag gallbladder retraction was successful in all cases and required 13 12 minutes. The prototype laparoscopic grasper provided excellent infundibulum retraction. A saline lift was used to aid in dissection for pigs 1-2 but was unnecessary in pigs 3-4 when the MAGS cautery device was used. Gallbladder perforations occurred in pigs 1-3 but not in pig 4. Gastrotomy closure required 39 14 minutes, with placement of 9 3 T-tags, and yielded grossly adequate closure in all cases. At autopsy, no major complications were noted. Discussion: Transgastric cholecystectomy is a difficult but feasible NOTES procedure. Combining prototype endoscopic and magnetically anchored instruments, along with digital image manipulation, overcomes many procedural obstacles. Further investigations regarding these technologies are warranted.
AB304 GASTROINTESTINAL ENDOSCOPY Volume 69, No. 5 : 2009
T1471 A Comparison of Three Endoscopic Suturing Devices for Natural Orifice Translumenal Endoscopic Surgery Gastrotomy Closure Joseph A. Trunzo, Michael F. Mcgee, Leandro T. Cavazzola, Tripurari Mishra, Steve J. Schomisch, Jessica J. Bailey, Jeffrey L. Ponsky, Jeffrey M. Marks Background: With the heightened concern for post-surgical leak, the standard practice of repairing hollow viscous injuries with suture should be mimicked in natural orifice translumenal endoscopic surgery (NOTES) closure. This study aimed to compare 3 endoscopic suturing devices in a survival porcine model. Methods: Three groups of 10 pigs each were assigned a NOTES gastrotomy closure by either a tissue plicating device (TPD), tissue anchoring (t-tag) device (TAD), or flexible suturing device (FSD). The TPD requires an individual intubation for each plication applied (2-4 per closure). The TAD and FSD require pre-gastrotomy suture placement to facilitate their tissue closure. A uniform gastrotomy was created, and a brief peritoneoscopy was performed prior to closure. Procedure times were recorded. TAD and FSD times were adjusted for overall comparison secondary to pre- and post-gastrotomy steps required. An upper GI fluoroscopy was administered to assess for gastric leak on post-operative days 0, 2, and 7. Animals were survived to 14 days when a necropsy and gastric burst pressure test was performed. Results: The recorded closure times (min: sec) were 45:00 16: 42 (meanSD), 25: 27 9: 31, and 35: 35 21: 46 for TPD, TAD, and FSD, respectively. Though not statistically significant, pre-gastrotomy suture placement in the latter groups provided improved gastric insufflation and endoscopic visualization resulting in shorter closure times. Only one fluoroscopic leak was revealed in the TAD group resulting in abdominal sepsis and death on day 7. One other early death also occurred in the TAD group on day 4 from a pulmonary complication unrelated to surgery. Abscesses developed in 10 animals: TPD (nZ1), TAD (nZ5) and FSD (nZ4). Of them, half were large (O2 cm) or diffuse collections: TAD (nZ3) and FSD (nZ2). Two adjacent organ injuries were also identified: TPD (nZ1) and TAD (nZ1). Mean bursting pressures were 85 16, 93 33, and 81 22 mmHg for TPD, TAD, and FSD, respectively (pZNS). Conclusion: The 3 endoscopic suturing devices offer feasible closure options by providing a reproducible surgical closure. Though procedure times were statistically similar, placement of a pre-gastrotomy suture provided a technical advantage to the TAD and FSD and trended toward a more efficient closure. Continued experience and engineering improvements of these devices will likely improve results. The prevalence of abscess formation without evidence of leak, however, requires close attention in the ongoing development of closure tools for human NOTES trials.
www.giejournal.org
T1468 Transgastric Laparoscopic Assisted Endoscopic Cholecystectomy: A Safe and Inevitable Bridge to NOTESÒ Rogier P. Voermans, Willem Bemelman, Paul Fockens, Mark I. Van Berge Henegouwen
T1470 NOTESÒ Ligation of Intraabdominal Organs with Absorbable Polydioxanone Loops Georg F. Kaehler, Markus B. Schoenberg, Axel Eickhoff, Daniel Von Renteln, Hans U. Rudolph
Background: NOTES cholecystectomy is increasingly being performed. However, since it is very challenging to obtain the essential critical view of safety (CVS) with current endoscopic technology, safe NOTES cholecystectomy cannot be ensured. Although a hybrid procedure is not considered true NOTES, it might, by using 2 mm instruments aid acquiring CVS. Simultaneously it could avoid enlargement of the abdominal incision because the duct and artery can be clipped endoscopically and the gallbladder is removed through the stomach. Aim: To evaluate feasibility and safety of transgastric laparoscopic assisted NOTES cholecystectomy using 2 mm instruments. Methods: Experiments were performed in a live porcine model. Laparoscopic access to the abdominal cavity was obtained by two 2 mm (left and right upper abdomen) and one 5 mm trocars (umbilical). Gastric access was created under laparoscopic control by a needle knife puncture followed by balloon dilation up to 18 mm. Exposure of Calot’s triangle was obtained endoscopically assisted retracting the fundus with an endoscopic grasper. After obtaining CVS the cystic duct and artery were clipped endoscopically. The gallbladder was dissected from the liver bed, using endoscopic assistance. After dissection, the specimen was grasped with an endoscopic snare, the bile was evacuated with a 19G needle and it was then extracted via the stomach. The gastrotomy was closed endoscopically using the Over-The-Scope-Clip (Ovesco). Experiments were planned first in 6 acute and later in 16 survival pigs. Sample size for survivals was based on the assumption of a success rate of 100% and fact that the lower end of the 95%-CI of success must be at least above the 80%. In the survival experiments necropsy was performed after 10 days with inspection of peritoneal cavity, liver and the gastrotomy site. Results: Hybrid cholecystectomy was successful in all 12 experiments performed until 11/08. Mean procedural time was 82 minutes (SD 25). In all experiments CVS was obtained satisfactorily. Bleeding occurred in 2 animals and was managed endoscopically in both cases. The gallbladder was perforated in 1 animal. All 6 survival animals thrived during 10 days follow up. At necropsy there were no signs of infection or other complications. Conclusions: Transgastric endoscopic assisted laparoscopic cholecystectomy with mini-instruments is feasible, safe and results in optimal CVS. This procedure seems to be a safe candidate for translation into human clinical trials, serving as a bridge to ‘real’ NOTES.
Introduction: Natural orifice transluminal endoscopic surgery (NOTES) is believed to decrease adhesion formation after surgery thus reducing patients’ morbidity. Absorbable Materials in NOTES procedures might reduce inflammatory reaction thus preventing intraabdominal adhesions abs abscess formation. In this study we introduce the first absorbable NOTES-loop for ligation of intraabdominal structures. The aim of this study was to assess intraabdominal ligation with a flexible absorbable NOTES-Loop in a survival study in pigs. Materials and Methods: Transgastric ligation and dissection of the uterus horns or the fallopian tubes was evaluated in 12 female pigs. The percutaneous endoscopic gastrostomy (PEG) technique and a 18mm controlled radial expansion (CRE (TM)) balloon dilatator were used to achieve a gastrotomy. Then the fallopian tubes or the uterus horns on both sides were identified and ligated either with an absorbable NOTESloop or a non-absorbable Endoloop. Altogether 24 structures were ligated. 4 Pigs underwent a tubectomy on both ligated sides. After an observation period of 17 to 21 days the pigs were examined macroscopically and pathologic changes were assessed. Results: All except for one single ligation (non-absorbable Endoloop) could be carried out safely and were tight. The operation time ranged from 45 to 170 min resulting in a median time of 112.5 min. In 11/12 (92%) pigs the observation period was uneventful. One pig had to be sacrificed on day 4 because of perforation of the gallbladder and following peritonitis. 10/11 (91%) pigs gained 0.68 0.25 kg whereas one pig lost 0.9 kg. Necropsy showed no evidence of bleeding, organ injury or peritonitis. 4/11 (36%) pigs however suffered from a very small amount of ascites. Near all non-absorbable Endoloops pus and an increased tissue response could be observed. Consequently adhesions formed much less around the absorbable NOTES-loops than around the non-absorbable Endoloops. Conclusion: Absorbable NOTES-Loops are a save way to ligate intraabdominal structures. Our pathological findings support the clinical experience that absorbable threads prevent adhesions. Therefore absorbable NOTES-loops are feasible for the ligation of intraabdominal structures in NOTES procedures.
T1469 Hybrid Transgastric NOTESÒ Cholecystectomy in a Porcine Model Using a Magnetically Anchored Cautery and Novel Instrumentation Antonio O. Castellvi, Shou Jiang Tang, Deborah C. Hogg, Lisa A. Hollett, Richard Bergs, Raul Fernandez, Jeffrey A. Cadeddu, Daniel J. Scott Introduction: The purpose of this study was to determine the utility of novel instrumentation for transgastric NOTES cholecystectomy in a porcine model. Methods: Anesthetized pigs (nZ4) underwent non-survival cholecystectomy procedures. A prototype articulating 90cm access port and a 2T endoscope were passed transorally and through a gastrotomy created using a needle knife/balloon dilation technique. Through a transabdominal trocar, a 2mm laparoscope was used for initial visualization and a prototype 2 mm laparoscopic grasper was used for tissue manipulation. A prototype endoscopic T-tag suturing system was used to fixate the gallbladder fundus to the abdominal wall near the diaphragm (retraction) and for gastrotomy closure. Dissection was performed using prototype straight or articulating endoscopic instruments (hook cautery, clip applier, scissors, injection needle; pigs 1-2) and/or a magnetic anchoring and guidance system (MAGS) cautery device (inserted transorally; pigs 3-4). A live video manipulation (LVM) system was used to adjust horizontal image orientation (pigs 2-4). Gallbladder specimens were retrieved transorally using a snare. Values are mean s.d. Results: All 4 procedures were completed, achieving partial cholecystectomy in pigs 1-2 and complete cholecystectomy in pigs 3-4; operative time was 281 74 minutes, blood loss was 63 48 cc, and bile spillage was minimal. Gastrotomy creation and access port insertion were straightforward in 2 cases (20-25 min) and difficult in 2 cases (70-120 min., temporary use of an additional 3mm laparoscopic grasper was required). The LVM system readily overcame problems with image disorientation and greatly diminished the workload of the team. T-tag gallbladder retraction was successful in all cases and required 13 12 minutes. The prototype laparoscopic grasper provided excellent infundibulum retraction. A saline lift was used to aid in dissection for pigs 1-2 but was unnecessary in pigs 3-4 when the MAGS cautery device was used. Gallbladder perforations occurred in pigs 1-3 but not in pig 4. Gastrotomy closure required 39 14 minutes, with placement of 9 3 T-tags, and yielded grossly adequate closure in all cases. At autopsy, no major complications were noted. Discussion: Transgastric cholecystectomy is a difficult but feasible NOTES procedure. Combining prototype endoscopic and magnetically anchored instruments, along with digital image manipulation, overcomes many procedural obstacles. Further investigations regarding these technologies are warranted.
AB304 GASTROINTESTINAL ENDOSCOPY Volume 69, No. 5 : 2009
T1471 A Comparison of Three Endoscopic Suturing Devices for Natural Orifice Translumenal Endoscopic Surgery Gastrotomy Closure Joseph A. Trunzo, Michael F. Mcgee, Leandro T. Cavazzola, Tripurari Mishra, Steve J. Schomisch, Jessica J. Bailey, Jeffrey L. Ponsky, Jeffrey M. Marks Background: With the heightened concern for post-surgical leak, the standard practice of repairing hollow viscous injuries with suture should be mimicked in natural orifice translumenal endoscopic surgery (NOTES) closure. This study aimed to compare 3 endoscopic suturing devices in a survival porcine model. Methods: Three groups of 10 pigs each were assigned a NOTES gastrotomy closure by either a tissue plicating device (TPD), tissue anchoring (t-tag) device (TAD), or flexible suturing device (FSD). The TPD requires an individual intubation for each plication applied (2-4 per closure). The TAD and FSD require pre-gastrotomy suture placement to facilitate their tissue closure. A uniform gastrotomy was created, and a brief peritoneoscopy was performed prior to closure. Procedure times were recorded. TAD and FSD times were adjusted for overall comparison secondary to pre- and post-gastrotomy steps required. An upper GI fluoroscopy was administered to assess for gastric leak on post-operative days 0, 2, and 7. Animals were survived to 14 days when a necropsy and gastric burst pressure test was performed. Results: The recorded closure times (min: sec) were 45:00 16: 42 (meanSD), 25: 27 9: 31, and 35: 35 21: 46 for TPD, TAD, and FSD, respectively. Though not statistically significant, pre-gastrotomy suture placement in the latter groups provided improved gastric insufflation and endoscopic visualization resulting in shorter closure times. Only one fluoroscopic leak was revealed in the TAD group resulting in abdominal sepsis and death on day 7. One other early death also occurred in the TAD group on day 4 from a pulmonary complication unrelated to surgery. Abscesses developed in 10 animals: TPD (nZ1), TAD (nZ5) and FSD (nZ4). Of them, half were large (O2 cm) or diffuse collections: TAD (nZ3) and FSD (nZ2). Two adjacent organ injuries were also identified: TPD (nZ1) and TAD (nZ1). Mean bursting pressures were 85 16, 93 33, and 81 22 mmHg for TPD, TAD, and FSD, respectively (pZNS). Conclusion: The 3 endoscopic suturing devices offer feasible closure options by providing a reproducible surgical closure. Though procedure times were statistically similar, placement of a pre-gastrotomy suture provided a technical advantage to the TAD and FSD and trended toward a more efficient closure. Continued experience and engineering improvements of these devices will likely improve results. The prevalence of abscess formation without evidence of leak, however, requires close attention in the ongoing development of closure tools for human NOTES trials.
www.giejournal.org