Tisseel® as a Reinforcement of Esophagojejunal Anastomoses
NCT ID: NCT03733639
Last Updated: 2020-07-23
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE4
Total Enrollment
146 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-07-21
Study Completion Date
2022-07-01
Brief Summary
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Background:
The dehiscence of esophagojejunal anastomoses is one of the most serious complications after total gastrectomy in patients with gastric cancer. Any method of avoiding this problem will affect not only the postoperative course but also the prognostic of disease.
Methods:
This is a prospective, randomized and multicenter trial, within the Spanish EURECCA Esophagogastric Cancer Group, to investigate the efficacy of Tisseel® in reducing the rate of esophagojejunal anastomosis leakage in patients with gastric cancer. The rate of anastomosis leak will be measured with clinical, radiological and analytic parameters.
Objective:
Analyze the efficacy of Tisseel® as a reinforcement in reducing the rate of anastomotic esophagojejunal anastomoses.
The dehiscence of esophagojejunal anastomoses is one of the most serious complications after total gastrectomy in patients with gastric cancer. Any method of avoiding this problem will affect not only the postoperative course but also the prognostic of disease.
Methods:
This is a prospective, randomized and multicenter trial, within the Spanish EURECCA Esophagogastric Cancer Group, to investigate the efficacy of Tisseel® in reducing the rate of esophagojejunal anastomosis leakage in patients with gastric cancer. The rate of anastomosis leak will be measured with clinical, radiological and analytic parameters.
Objective:
Analyze the efficacy of Tisseel® as a reinforcement in reducing the rate of anastomotic esophagojejunal anastomoses.
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Detailed Description
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Introduction The dehiscence of the esophagojejunal anastomosis is one of the most serious complications after a total gastrectomy not only in the short term but it has been shown to be an independent risk factor for survival. The rate of esophagojejunal anastomosis leakage after cancer gastrectomies is described to be between 1-12.3%.
Any method to prevent this complication would be of vital importance to improve the evolution of these patients. Likewise, when the dehiscence has been established, early detection could contribute to an early intervention, avoiding more serious consequences and, therefore, improving the short and long term prognosis.
Little progress has been made during recent decades in the prevention of anastomotic leakage in high-risk digestive tract anastomosis. Some authors have tried the use of new methods of suture, reinforcements or patches in the anastomosis. Fibrin adhesives were introduced more than 30 years ago, in order to favor hemostasis and tissue adhesion. Numerous studies have demonstrated their effectiveness in reducing surgical bleeding in cardiovascular surgery but its role as a sealant in gastrointestinal anastomosis is more debated. There have been some experimental studies that have shown a possible protective effect of this material in enteric anastomoses. With the evolution of bariatric surgery and with the high volume of surgeries handled, several studies have been published that assess the effect of fibrin sealants on gastrojejunal anastomoses. In esophagogastric surgery, the number of published studies is reduced and there are only 2 studies that assess the effect of fibrin sealants on esophagojejunal anastomosis. The results of these studies seem to indicate that the application of fibrin sealants in this anastomosis could have a favorable effect in reducing the number of anastomotic dehiscences.
There are different definitions for the concept of "anastomotic dehiscence". The dehiscence of the esophago-jejunal anastomotic can be defined as any clinical and / or radiological evidence of dehiscence of the anastomosis. Although early diagnosis is key to avoiding major consequences, in clinical practice, the diagnosis of anastomotic dehiscence is often delayed. Direct observation of the debit of surgical drainage, fever or persistent ileus or clear symptoms of peritonitis are indirect signs that make us suspect a possible anastomotic dehiscence. The possibility of having a parameter that allows us to diagnose early a problem in the suture would allow us to act earlier and, therefore, improve the prognosis of these patients in the short and long term.
In colorectal surgery, serological parameters such as procalcitonin or C-reactive protein have been studied as early predictors of anastomotic dehiscence. In esophagogastric surgery, publications are scarce and all of them analyze results in esophagogastric anastomoses.
Furthermore, the determination of amylases in drainage has also been used for the detection of postoperative fistula. It is a simple and low cost method and is a parameter widely used in pancreatic surgery for the detection and evolutionary control of pancreatic fistulas. It has also been shown to be useful in esophageal surgery and in bariatric surgery. However, in gastric cancer it has only been used for the diagnosis of pancreatic fistula as a complication in total gastrectomies with associated splenectomy.
Finally, the use of radiology with oral contrast routinely in the postoperative period of esophagogastric surgery has been shown to have a low sensitivity for the early detection of anastomotic dehiscence. CT with oral contrast seems to have greater sensitivity and positive predictive value in esophageal surgery for this purpose, but the need to perform a postoperative test to evaluate the anastomosis without clinical evidence of dehiscence is unclear.
For all these reasons, we believe that a multicenter randomized study will contribute to improve the clinical results of esophagogastric surgery and the knowledge of the diagnosis of complications, by studying the efficacy of Tisseel® in reducing the rate of anastomotic leakage, but also analyzing the role of drain amylases, serum CRP (C-reactive protein), procalcitonin and white blood cell levels in the early detection and prediction of anastomotic leak, and the role of CT with oral contrast as a routine assessment of anastomotic integrity.
Objective Analyze the efficacy of Tisseel® in reducing the rate of anastomotic leakage diagnosed in the postoperative period using clinical and / or radiological parameters.
Methods This is a prospective, randomized and multicenter trial, within the Spanish EURECCA Esophagogastric Cancer Project, to investigate the efficacy of Tisseel® in reducing the rate of esophagojejunal anastomosis leakage in patients with gastric cancer.
Participation study will be offered to all centers that are currently part of the Spanish EURECCA Esophagogastric Cancer Group. Those hospitals that show their desire to participate must sign the Letter of Commitment. In the same way, the study must sign off by European Medicine Agency and Spanish Agency of Medicines.
Once the patient is included in the study the surgeon performs a total gastrectomy as usual procedure. Once the esophagojejunal anastomosis is done the patient is randomized (Tisseel® vs no product). Surgeon dispenses Tisseel® all over the anastomosis following data sheet if applicable. The rest of the surgical procedure is as usual. In the postoperative period the investigator collects the data commented in following sections.
The evidence of an anastomotic leak will be tested with analytical and radiological parameters:
1. Blood samples will be taken from patients at:
* Immediate preoperative (blood count, procalcitonin and C-reactive protein)
* Days 1, 3, 5 and 7 postoperative (blood count, procalcitonin and C-reactive protein).
2. A sample of surgical drainage will be collected for the determination of amylases on days: 1,3,5, and 7 postoperative or until drainage is withdrawn.
3. An abdominal CT with oral contrast will be performed within the first 5 postoperative days. The date and the result will be collected.
Any method to prevent this complication would be of vital importance to improve the evolution of these patients. Likewise, when the dehiscence has been established, early detection could contribute to an early intervention, avoiding more serious consequences and, therefore, improving the short and long term prognosis.
Little progress has been made during recent decades in the prevention of anastomotic leakage in high-risk digestive tract anastomosis. Some authors have tried the use of new methods of suture, reinforcements or patches in the anastomosis. Fibrin adhesives were introduced more than 30 years ago, in order to favor hemostasis and tissue adhesion. Numerous studies have demonstrated their effectiveness in reducing surgical bleeding in cardiovascular surgery but its role as a sealant in gastrointestinal anastomosis is more debated. There have been some experimental studies that have shown a possible protective effect of this material in enteric anastomoses. With the evolution of bariatric surgery and with the high volume of surgeries handled, several studies have been published that assess the effect of fibrin sealants on gastrojejunal anastomoses. In esophagogastric surgery, the number of published studies is reduced and there are only 2 studies that assess the effect of fibrin sealants on esophagojejunal anastomosis. The results of these studies seem to indicate that the application of fibrin sealants in this anastomosis could have a favorable effect in reducing the number of anastomotic dehiscences.
There are different definitions for the concept of "anastomotic dehiscence". The dehiscence of the esophago-jejunal anastomotic can be defined as any clinical and / or radiological evidence of dehiscence of the anastomosis. Although early diagnosis is key to avoiding major consequences, in clinical practice, the diagnosis of anastomotic dehiscence is often delayed. Direct observation of the debit of surgical drainage, fever or persistent ileus or clear symptoms of peritonitis are indirect signs that make us suspect a possible anastomotic dehiscence. The possibility of having a parameter that allows us to diagnose early a problem in the suture would allow us to act earlier and, therefore, improve the prognosis of these patients in the short and long term.
In colorectal surgery, serological parameters such as procalcitonin or C-reactive protein have been studied as early predictors of anastomotic dehiscence. In esophagogastric surgery, publications are scarce and all of them analyze results in esophagogastric anastomoses.
Furthermore, the determination of amylases in drainage has also been used for the detection of postoperative fistula. It is a simple and low cost method and is a parameter widely used in pancreatic surgery for the detection and evolutionary control of pancreatic fistulas. It has also been shown to be useful in esophageal surgery and in bariatric surgery. However, in gastric cancer it has only been used for the diagnosis of pancreatic fistula as a complication in total gastrectomies with associated splenectomy.
Finally, the use of radiology with oral contrast routinely in the postoperative period of esophagogastric surgery has been shown to have a low sensitivity for the early detection of anastomotic dehiscence. CT with oral contrast seems to have greater sensitivity and positive predictive value in esophageal surgery for this purpose, but the need to perform a postoperative test to evaluate the anastomosis without clinical evidence of dehiscence is unclear.
For all these reasons, we believe that a multicenter randomized study will contribute to improve the clinical results of esophagogastric surgery and the knowledge of the diagnosis of complications, by studying the efficacy of Tisseel® in reducing the rate of anastomotic leakage, but also analyzing the role of drain amylases, serum CRP (C-reactive protein), procalcitonin and white blood cell levels in the early detection and prediction of anastomotic leak, and the role of CT with oral contrast as a routine assessment of anastomotic integrity.
Objective Analyze the efficacy of Tisseel® in reducing the rate of anastomotic leakage diagnosed in the postoperative period using clinical and / or radiological parameters.
Methods This is a prospective, randomized and multicenter trial, within the Spanish EURECCA Esophagogastric Cancer Project, to investigate the efficacy of Tisseel® in reducing the rate of esophagojejunal anastomosis leakage in patients with gastric cancer.
Participation study will be offered to all centers that are currently part of the Spanish EURECCA Esophagogastric Cancer Group. Those hospitals that show their desire to participate must sign the Letter of Commitment. In the same way, the study must sign off by European Medicine Agency and Spanish Agency of Medicines.
Once the patient is included in the study the surgeon performs a total gastrectomy as usual procedure. Once the esophagojejunal anastomosis is done the patient is randomized (Tisseel® vs no product). Surgeon dispenses Tisseel® all over the anastomosis following data sheet if applicable. The rest of the surgical procedure is as usual. In the postoperative period the investigator collects the data commented in following sections.
The evidence of an anastomotic leak will be tested with analytical and radiological parameters:
1. Blood samples will be taken from patients at:
* Immediate preoperative (blood count, procalcitonin and C-reactive protein)
* Days 1, 3, 5 and 7 postoperative (blood count, procalcitonin and C-reactive protein).
2. A sample of surgical drainage will be collected for the determination of amylases on days: 1,3,5, and 7 postoperative or until drainage is withdrawn.
3. An abdominal CT with oral contrast will be performed within the first 5 postoperative days. The date and the result will be collected.
Conditions
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Gastric Cancer
Anastomotic Leak
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Participants
Patients won't know if his anastomoses has been reinforced with Tisseel®.
Study Groups
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Tisseel®
Once the esophagojejunal anastomosis is done the patient is randomized (Tisseel® vs no product). In the arm "Tisseel®" surgeon dispenses the product all over the anastomosis. The rest of the surgical procedure is as usual.
Group Type
ACTIVE_COMPARATOR
Tisseel
Intervention Type
DRUG
Reinforcement of esophagojejunal anastomoses after total gastrectomy with the product.
no Tisseel®
Once the esophagojejunal anastomosis is done the patient is randomized (Tisseel® vs no product). In the arm " noTisseel®" surgeon performs the surgical procedure as usual.
Group Type
OTHER
No Tisseel
Intervention Type
DEVICE
No reinforcement of esophagojejunal anastomoses after total gastrectomy
Interventions
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Tisseel
Reinforcement of esophagojejunal anastomoses after total gastrectomy with the product.
Intervention Type
DRUG
No Tisseel
No reinforcement of esophagojejunal anastomoses after total gastrectomy
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Patients over 18 years diagnosed with gastric adenocarcinoma and scheduled for a total gastrectomy with curative intent in EURECCA Esophagogastric Cancer Group who agree to participate in the study and sign the informed consent
Exclusion Criteria
* Patients with non-epithelial neoplasms, with metastases, not resected or undergoing palliative resections. Patients who do not sign informed consent.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Germans Trias i Pujol Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Elisenda Garsot Savall
Head of Upper Gastrointestinal Surgery Unit
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Elisenda Garsot
Role: PRINCIPAL_INVESTIGATOR
Germans Trias i Pujol Hospital
Locations
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Elisenda Garsot Savall
Badalona, Barcelona, Spain
Site Status
RECRUITING
Countries
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Spain
Central Contacts
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Facility Contacts
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References
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Aurello P, Magistri P, D'Angelo F, Valabrega S, Sirimarco D, Tierno SM, Nava AK, Ramacciato G. Treatment of esophagojejunal anastomosis leakage: a systematic review from the last two decades. Am Surg. 2015 May;81(5):450-3.
Reference Type
BACKGROUND
Migita K, Takayama T, Matsumoto S, Wakatsuki K, Enomoto K, Tanaka T, Ito M, Nakajima Y. Risk factors for esophagojejunal anastomotic leakage after elective gastrectomy for gastric cancer. J Gastrointest Surg. 2012 Sep;16(9):1659-65. doi: 10.1007/s11605-012-1932-4. Epub 2012 Jun 12.
Reference Type
BACKGROUND
De Stefano A, Bettarini F, Di Mare G, Neri A. [Enteric anastomosis and Tachosil(R)]. Minerva Chir. 2011 Jun;66(3):183-8. Italian.
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Yuan Y, Zeng X, Hu Y, Xie T, Zhao Y. Omentoplasty for esophagogastrostomy after esophagectomy. Cochrane Database Syst Rev. 2012 Nov 14;11:CD008446. doi: 10.1002/14651858.CD008446.pub2.
Reference Type
BACKGROUND
Borst HG, Haverich A, Walterbusch G, Maatz W. Fibrin adhesive: an important hemostatic adjunct in cardiovascular operations. J Thorac Cardiovasc Surg. 1982 Oct;84(4):548-53.
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BACKGROUND
Kjaergard HK, Fairbrother JE. Controlled clinical studies of fibrin sealant in cardiothoracic surgery--a review. Eur J Cardiothorac Surg. 1996;10(9):727-33. doi: 10.1016/s1010-7940(96)80332-0.
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BACKGROUND
Matthew TL, Spotnitz WD, Kron IL, Daniel TM, Tribble CG, Nolan SP. Four years' experience with fibrin sealant in thoracic and cardiovascular surgery. Ann Thorac Surg. 1990 Jul;50(1):40-3; discussion 43-4. doi: 10.1016/0003-4975(90)90080-p.
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BACKGROUND
Bonanomi G, Prince JM, McSteen F, Schauer PR, Hamad GG. Sealing effect of fibrin glue on the healing of gastrointestinal anastomoses: implications for the endoscopic treatment of leaks. Surg Endosc. 2004 Nov;18(11):1620-4. doi: 10.1007/s00464-004-8803-3. Epub 2004 Oct 11.
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BACKGROUND
Silecchia G, Boru CE, Mouiel J, Rossi M, Anselmino M, Morino M, Toppino M, Gaspari A, Gentileschi P, Tacchino R, Basso N. The use of fibrin sealant to prevent major complications following laparoscopic gastric bypass: results of a multicenter, randomized trial. Surg Endosc. 2008 Nov;22(11):2492-7. doi: 10.1007/s00464-008-9885-0. Epub 2008 Mar 26.
Reference Type
BACKGROUND
Upadhyaya VD, Gopal SC, Gangopadhyaya AN, Gupta DK, Sharma S, Upadyaya A, Kumar V, Pandey A. Role of fibrin glue as a sealant to esophageal anastomosis in cases of congenital esophageal atresia with tracheoesophageal fistula. World J Surg. 2007 Dec;31(12):2412-5. doi: 10.1007/s00268-007-9244-7.
Reference Type
BACKGROUND
Saldana-Cortes JA, Larios-Arceo F, Prieto-Diaz-Chavez E, De Buen EP, Gonzalez-Mercado S, Alvarez-Villasenor AS, Prieto-Aldape MR, Fuentes-Orozco C, Gonzalez-Ojeda A. Role of fibrin glue in the prevention of cervical leakage and strictures after esophageal reconstruction of caustic injury. World J Surg. 2009 May;33(5):986-93. doi: 10.1007/s00268-009-9949-x.
Reference Type
BACKGROUND
Fernandez Fernandez L, Tejero E, Tieso A. Randomized trial of fibrin glue to seal mechanical oesophagojejunal anastomosis. Br J Surg. 1996 Jan;83(1):40-1. doi: 10.1002/bjs.1800830111. No abstract available.
Reference Type
BACKGROUND
Lago Oliver J, Arjona Medina I, Martin Garcia-Almenta E, Martin Gil J, Sanz Sanchez M, Perez Diaz MD, Alonso Poza A, Turegano Fuentes F, Torres Garcia A. [Use of fibrin based biological adhesives in the prevention of anastomotic leaks in the high risk digestive tract: preliminary results of the multicentre, prospective, randomised, controlled, and simple blind phase IV clinical trial: Protissucol001]. Cir Esp. 2012 Dec;90(10):647-55. doi: 10.1016/j.ciresp.2012.05.007. Epub 2012 Jun 27. Spanish.
Reference Type
BACKGROUND
Bruce J, Krukowski ZH, Al-Khairy G, Russell EM, Park KG. Systematic review of the definition and measurement of anastomotic leak after gastrointestinal surgery. Br J Surg. 2001 Sep;88(9):1157-68. doi: 10.1046/j.0007-1323.2001.01829.x.
Reference Type
BACKGROUND
Yoo HM, Lee HH, Shim JH, Jeon HM, Park CH, Song KY. Negative impact of leakage on survival of patients undergoing curative resection for advanced gastric cancer. J Surg Oncol. 2011 Dec;104(7):734-40. doi: 10.1002/jso.22045. Epub 2011 Jul 25.
Reference Type
BACKGROUND
Garcia-Granero A, Frasson M, Flor-Lorente B, Blanco F, Puga R, Carratala A, Garcia-Granero E. Procalcitonin and C-reactive protein as early predictors of anastomotic leak in colorectal surgery: a prospective observational study. Dis Colon Rectum. 2013 Apr;56(4):475-83. doi: 10.1097/DCR.0b013e31826ce825.
Reference Type
BACKGROUND
Giaccaglia V, Salvi PF, Antonelli MS, Nigri G, Pirozzi F, Casagranda B, Giacca M, Corcione F, de Manzini N, Balducci G, Ramacciato G. Procalcitonin Reveals Early Dehiscence in Colorectal Surgery: The PREDICS Study. Ann Surg. 2016 May;263(5):967-72. doi: 10.1097/SLA.0000000000001365.
Reference Type
BACKGROUND
Hayati F, Mohd Azman ZA, Nasuruddin DN, Mazlan L, Zakaria AD, Sagap I. Serum Procalcitonin Predicts Anastomotic Leaks in Colorectal Surgery. Asian Pac J Cancer Prev. 2017 Jul 27;18(7):1821-1825. doi: 10.22034/APJCP.2017.18.7.1821.
Reference Type
BACKGROUND
Noble F, Curtis N, Harris S, Kelly JJ, Bailey IS, Byrne JP, Underwood TJ; South Coast Cancer Collaboration-Oesophago-Gastric (SC-OG). Risk assessment using a novel score to predict anastomotic leak and major complications after oesophageal resection. J Gastrointest Surg. 2012 Jun;16(6):1083-95. doi: 10.1007/s11605-012-1867-9. Epub 2012 Mar 15.
Reference Type
BACKGROUND
Dutta S, Fullarton GM, Forshaw MJ, Horgan PG, McMillan DC. Persistent elevation of C-reactive protein following esophagogastric cancer resection as a predictor of postoperative surgical site infectious complications. World J Surg. 2011 May;35(5):1017-25. doi: 10.1007/s00268-011-1002-1.
Reference Type
BACKGROUND
Hoeboer SH, Groeneveld AB, Engels N, van Genderen M, Wijnhoven BP, van Bommel J. Rising C-reactive protein and procalcitonin levels precede early complications after esophagectomy. J Gastrointest Surg. 2015 Apr;19(4):613-24. doi: 10.1007/s11605-015-2745-z. Epub 2015 Feb 7.
Reference Type
BACKGROUND
Reid-Lombardo KM, Farnell MB, Crippa S, Barnett M, Maupin G, Bassi C, Traverso LW; Pancreatic Anastomotic Leak Study Group. Pancreatic anastomotic leakage after pancreaticoduodenectomy in 1,507 patients: a report from the Pancreatic Anastomotic Leak Study Group. J Gastrointest Surg. 2007 Nov;11(11):1451-8; discussion 1459. doi: 10.1007/s11605-007-0270-4. Epub 2007 Aug 21.
Reference Type
BACKGROUND
Perry Y, Towe CW, Kwong J, Ho VP, Linden PA. Serial Drain Amylase Can Accurately Detect Anastomotic Leak After Esophagectomy and May Facilitate Early Discharge. Ann Thorac Surg. 2015 Dec;100(6):2041-6; discussion 2046-7. doi: 10.1016/j.athoracsur.2015.05.092. Epub 2015 Aug 25.
Reference Type
BACKGROUND
Baker EH, Hill JS, Reames MK, Symanowski J, Hurley SC, Salo JC. Drain amylase aids detection of anastomotic leak after esophagectomy. J Gastrointest Oncol. 2016 Apr;7(2):181-8. doi: 10.3978/j.issn.2078-6891.2015.074.
Reference Type
BACKGROUND
Berkelmans GH, Kouwenhoven EA, Smeets BJ, Weijs TJ, Silva Corten LC, van Det MJ, Nieuwenhuijzen GA, Luyer MD. Diagnostic value of drain amylase for detecting intrathoracic leakage after esophagectomy. World J Gastroenterol. 2015 Aug 14;21(30):9118-25. doi: 10.3748/wjg.v21.i30.9118.
Reference Type
BACKGROUND
Maher JW, Bakhos W, Nahmias N, Wolfe LG, Meador JG, Baugh N, Kellum JM. Drain amylase levels are an adjunct in detection of gastrojejunostomy leaks after Roux-en-Y gastric bypass. J Am Coll Surg. 2009 May;208(5):881-4; discussion 885-6. doi: 10.1016/j.jamcollsurg.2008.12.022. Epub 2009 Mar 26.
Reference Type
BACKGROUND
Sano T, Sasako M, Katai H, Maruyama K. Amylase concentration of drainage fluid after total gastrectomy. Br J Surg. 1997 Sep;84(9):1310-2.
Reference Type
BACKGROUND
Cools-Lartigue J, Andalib A, Abo-Alsaud A, Gowing S, Nguyen M, Mulder D, Ferri L. Routine contrast esophagram has minimal impact on the postoperative management of patients undergoing esophagectomy for esophageal cancer. Ann Surg Oncol. 2014 Aug;21(8):2573-9. doi: 10.1245/s10434-014-3654-1. Epub 2014 Mar 28.
Reference Type
BACKGROUND
Struecker B, Chopra S, Heilmann AC, Spenke J, Denecke C, Sauer IM, Bahra M, Pratschke J, Andreou A, Biebl M. Routine Radiologic Contrast Agent Examination After Gastrectomy for Gastric Cancer Is Not Useful. J Gastrointest Surg. 2017 May;21(5):801-806. doi: 10.1007/s11605-017-3384-3. Epub 2017 Feb 15.
Reference Type
BACKGROUND
Strauss C, Mal F, Perniceni T, Bouzar N, Lenoir S, Gayet B, Palau R. Computed tomography versus water-soluble contrast swallow in the detection of intrathoracic anastomotic leak complicating esophagogastrectomy (Ivor Lewis): a prospective study in 97 patients. Ann Surg. 2010 Apr;251(4):647-51. doi: 10.1097/SLA.0b013e3181c1aeb8.
Reference Type
BACKGROUND
Jones CM, Clarke B, Heah R, Griffiths EA. Should routine assessment of anastomotic integrity be undertaken using radiological contrast swallow after oesophagectomy with intra-thoracic anastomosis? Best evidence topic (BET). Int J Surg. 2015 Aug;20:158-62. doi: 10.1016/j.ijsu.2015.06.076. Epub 2015 Jul 10.
Reference Type
BACKGROUND
Other Identifiers
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Tisseel
Identifier Type: -
Identifier Source: org_study_id
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Seal-G/ Seal-G MIST Long-Term Follow-up PMCF (Continue) Study
NCT07100886
NOT_YET_RECRUITING
Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy
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RECRUITING
NA
A Study Comparing Skin Adhesive With Staple for Surgical Incision Closure After Laparoscopic / Robotic Bowel Resection
NCT04969016
UNKNOWN
NA
Study of DERMABOND ProPen in Closure of Colectomy Wounds
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TERMINATED
PHASE2