Obstructive Colon Cancer, a Bridge to Surgery in Right Sided Obstructive Colon Cancer
NCT ID: NCT06338332
Last Updated: 2024-03-29
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
RECRUITING
Total Enrollment
110 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-01-01
Study Completion Date
2028-01-31
Brief Summary
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Rationale: Approximately 13% (range 10-28%) of all colorectal cancer patients (CRC) present with an acute obstruction. Postoperative mortality after an emergency resection is known for its high risk of morbidity and mortality. Different options can be considered in the management of obstructing right sided CRC: 1) primary resection, simultaneous treatment of obstruction and tumour resection, or 2) staged treatment of the obstruction with secondary resection of the tumour. Currently, in the Netherlands, an emergency resection has been judged to be inferior to postponing surgery. Patients who present with right sided obstructive colon cancer at one of the participating hospitals are subjected to a bridge to surgery (BTS) protocol.
Objective: The primary objective of this study is to determine the feasibility of BTS protocols in right sided obstructive colon cancer and reduce mortality- and morbidity (stoma rates, major- and minor complications) rates in potentially curable patients presenting with acute obstructing colon cancer.
Study design: This is a multicentre, prospective registration study Study population: All patients presenting with high clinical suspicion or histologically proven right sided colon cancer and signs of obstruction of the large bowel.
Intervention: Prospective registration of the implementation of bridge to surgery protocols in patients with (acute) malignant right sided obstruction of the colon, without suspicion of perforation (tumour perforation or blow out) in order to optimize patients preoperatively. The BTS approach encompasses the utilization of either ileostomy creation, stent placement or nasogastric tube for decompression, which is subsequently followed by definitive surgical treatment at a later stage. BTS also involves pre-optimization, prior to the surgical procedure, with the following approach: optimizing the nutritional health status improving the physical health status of the patient.
Main study parameters/endpoints: The primary endpoint is complication-free survival (CFS) at 90 days after hospitalization. Complication is defined here as mortality and/or development of a major complication (Clavien-Dindo classification ≥3). With a total follow up of three years. Secondary endpoints: overall mortality, morbidity (stoma rates, minor complications), in hospital stay, oncologic quality of resection and other occurring adverse events.
Objective: The primary objective of this study is to determine the feasibility of BTS protocols in right sided obstructive colon cancer and reduce mortality- and morbidity (stoma rates, major- and minor complications) rates in potentially curable patients presenting with acute obstructing colon cancer.
Study design: This is a multicentre, prospective registration study Study population: All patients presenting with high clinical suspicion or histologically proven right sided colon cancer and signs of obstruction of the large bowel.
Intervention: Prospective registration of the implementation of bridge to surgery protocols in patients with (acute) malignant right sided obstruction of the colon, without suspicion of perforation (tumour perforation or blow out) in order to optimize patients preoperatively. The BTS approach encompasses the utilization of either ileostomy creation, stent placement or nasogastric tube for decompression, which is subsequently followed by definitive surgical treatment at a later stage. BTS also involves pre-optimization, prior to the surgical procedure, with the following approach: optimizing the nutritional health status improving the physical health status of the patient.
Main study parameters/endpoints: The primary endpoint is complication-free survival (CFS) at 90 days after hospitalization. Complication is defined here as mortality and/or development of a major complication (Clavien-Dindo classification ≥3). With a total follow up of three years. Secondary endpoints: overall mortality, morbidity (stoma rates, minor complications), in hospital stay, oncologic quality of resection and other occurring adverse events.
Detailed Description
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Approximately 13% (range 8-28%) presents with acute obstructing colorectal cancer (CRC). It's known that patients with acute obstructing CRC have increased mortality and morbidity compared to patients without acute obstructing CRC. Postoperative mortality ranges from 12 to 30%, which can raise to 41% in elderly patients with two or more additional risk factors. Morbidity rates until 78% are described in older patients undergoing emergency resection for obstructing CRC.
Different treatment options have been evaluated over the years. The two main options are; 1) emergency resection, simultaneous treatment of obstruction and tumour resection, 2) staged treatment of the obstruction with secondary resection of the tumour. Postoperative mortality after an emergency resection is known for its high risk of morbidity and mortality. From the Dutch audits it is know that the risk is high, not only for left sided obstruction, but also for right sided obstruction. Until recently, an acute emergency resection was the standard treatment for patients presenting with a small bowl ileus caused by a right sided colon cancer. However, more evidence has emerged that postponing surgery with a bridge tot surgery protocol can be beneficial to the patients. The bridge to surgery approach encompasses the utilization of either ileostomy creation or stent placement for colonic decompression, which is subsequently followed by definitive surgical treatment at a later stage. Alternatively, BTS may involve the introduction of a pause, also known as preoptimization, prior to the surgical procedure. The three main options for staged surgery all have its own up- and downsides. All forms of staged treatment appears to lead to fewer morbidity and mortality.
Emergency surgery Emergency resection is associated with a high risk of mortality and morbidity. Besides that, stoma creations after emergency surgery are higher than in patients treated electively. In case of a Hartmann's procedure, (resection of a left-sided tumour and creation of a colostomy) second surgical procedure is needed to restore continuity. Continuity restore has a mean mortality of 1% (range 0-7.4%) and morbidity of 16% (range 3-50%). Alternatively, emergency resection with primary anastomosis, which has the advantage to be a definite procedure, is performed. However, this treatment can be complicated with anastomotic leakage (AL). Anastomotic leakage is higher in patients treated for obstructing CRC in comparison with staged or electively treatment. Besides that, mortality rates after anastomotic leakage after colorectal surgery varies between 5-19%. Therefore, this intervention does not align with existing treatment strategies.
Bridge to surgery Stoma creation for colonic decompression followed by definite surgical treatment in a later stadium for patients with obstructing right sided CRC is an alternative. Postoperative mortality between patients treated with emergency resection, stent or stoma followed by resection showed no differences. However, high mortality rates in elderly patients (30%) after acute resection, stress the need for alternative strategies. For right-sided colon cancer, postoperative complications for patients treated with decompressing stoma before resection are lower in comparison with acute resection. However, the creation of an ileostomy leads to a longer hospital stay. Secondly, stenting as a bridge to surgery (BTS) creates time before definite surgical treatment. However, the use of stents as a bridge to surgery has controversial results. Stents as a BTS is associated with complications like perforation, stent migration, higher recurrence rate and re-obstruction. Furthermore, three prospective trials are closed prematurely because of high morbidity rates or a high number of technical failure of the self-expandable metallic stent (SEMS) However, several studies and one meta-analysis show promising short-term outcomes for the use of stents as BTS. Besides that, promising long-term outcomes, such as oncological safety, after stents as BTS are shown. Finally, transtumoral intubation for decompression of the colon, before initial can be considered to prevent stoma creation. Thirdly, a bridge to surgery may involve the introduction of a pause, also known as preoptimization, prior the surgical procedure. This previously presented as PRE-OCC, this approach appears feasible and safe. Deteriorating physical condition caused by poor intake, vomiting, changes in electrolyte status and weight loss often results in a decreased nutritional status. Nutritional status and thereby the patients preoperative health status seems to influence the mortality risk for patients with (obstructing) colorectal cancer. Creating a pause, before surgery provides a chance to optimise the patients' medical condition, perform a complete pre-operative screening of the patient's health status and examine possible concomitant illnesses. Besides nutritional status, also the functional capacity of the patient seems to be an important factor in postoperative mortality and morbidity. Studies, in elective colorectal surgery, show promising results after improving the functional capacity of patients (prehabilitation) on the recovery after colorectal surgery. However, this third option of bridge to surgery also has some disadvantages. Preoptimization leads to an prolonged duration of stay prior to surgery in a semi acute setting, with a central venous line and potentially insufficient decompression.
This study aims to determine whether implementation of bridge to surgery protocols is feasible and reduces mortality- and morbidity (stoma rates, major- and minor complications) rates in potentially curable patients presenting with acute obstructing CRC. By prospectively collecting the data, the feasibility of the protocols will be reported and the decrease in mortality and morbidity rates can be evaluated.
Different treatment options have been evaluated over the years. The two main options are; 1) emergency resection, simultaneous treatment of obstruction and tumour resection, 2) staged treatment of the obstruction with secondary resection of the tumour. Postoperative mortality after an emergency resection is known for its high risk of morbidity and mortality. From the Dutch audits it is know that the risk is high, not only for left sided obstruction, but also for right sided obstruction. Until recently, an acute emergency resection was the standard treatment for patients presenting with a small bowl ileus caused by a right sided colon cancer. However, more evidence has emerged that postponing surgery with a bridge tot surgery protocol can be beneficial to the patients. The bridge to surgery approach encompasses the utilization of either ileostomy creation or stent placement for colonic decompression, which is subsequently followed by definitive surgical treatment at a later stage. Alternatively, BTS may involve the introduction of a pause, also known as preoptimization, prior to the surgical procedure. The three main options for staged surgery all have its own up- and downsides. All forms of staged treatment appears to lead to fewer morbidity and mortality.
Emergency surgery Emergency resection is associated with a high risk of mortality and morbidity. Besides that, stoma creations after emergency surgery are higher than in patients treated electively. In case of a Hartmann's procedure, (resection of a left-sided tumour and creation of a colostomy) second surgical procedure is needed to restore continuity. Continuity restore has a mean mortality of 1% (range 0-7.4%) and morbidity of 16% (range 3-50%). Alternatively, emergency resection with primary anastomosis, which has the advantage to be a definite procedure, is performed. However, this treatment can be complicated with anastomotic leakage (AL). Anastomotic leakage is higher in patients treated for obstructing CRC in comparison with staged or electively treatment. Besides that, mortality rates after anastomotic leakage after colorectal surgery varies between 5-19%. Therefore, this intervention does not align with existing treatment strategies.
Bridge to surgery Stoma creation for colonic decompression followed by definite surgical treatment in a later stadium for patients with obstructing right sided CRC is an alternative. Postoperative mortality between patients treated with emergency resection, stent or stoma followed by resection showed no differences. However, high mortality rates in elderly patients (30%) after acute resection, stress the need for alternative strategies. For right-sided colon cancer, postoperative complications for patients treated with decompressing stoma before resection are lower in comparison with acute resection. However, the creation of an ileostomy leads to a longer hospital stay. Secondly, stenting as a bridge to surgery (BTS) creates time before definite surgical treatment. However, the use of stents as a bridge to surgery has controversial results. Stents as a BTS is associated with complications like perforation, stent migration, higher recurrence rate and re-obstruction. Furthermore, three prospective trials are closed prematurely because of high morbidity rates or a high number of technical failure of the self-expandable metallic stent (SEMS) However, several studies and one meta-analysis show promising short-term outcomes for the use of stents as BTS. Besides that, promising long-term outcomes, such as oncological safety, after stents as BTS are shown. Finally, transtumoral intubation for decompression of the colon, before initial can be considered to prevent stoma creation. Thirdly, a bridge to surgery may involve the introduction of a pause, also known as preoptimization, prior the surgical procedure. This previously presented as PRE-OCC, this approach appears feasible and safe. Deteriorating physical condition caused by poor intake, vomiting, changes in electrolyte status and weight loss often results in a decreased nutritional status. Nutritional status and thereby the patients preoperative health status seems to influence the mortality risk for patients with (obstructing) colorectal cancer. Creating a pause, before surgery provides a chance to optimise the patients' medical condition, perform a complete pre-operative screening of the patient's health status and examine possible concomitant illnesses. Besides nutritional status, also the functional capacity of the patient seems to be an important factor in postoperative mortality and morbidity. Studies, in elective colorectal surgery, show promising results after improving the functional capacity of patients (prehabilitation) on the recovery after colorectal surgery. However, this third option of bridge to surgery also has some disadvantages. Preoptimization leads to an prolonged duration of stay prior to surgery in a semi acute setting, with a central venous line and potentially insufficient decompression.
This study aims to determine whether implementation of bridge to surgery protocols is feasible and reduces mortality- and morbidity (stoma rates, major- and minor complications) rates in potentially curable patients presenting with acute obstructing CRC. By prospectively collecting the data, the feasibility of the protocols will be reported and the decrease in mortality and morbidity rates can be evaluated.
Conditions
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Colonic Neoplasms Malignant
Keywords
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Right-sided
Bridge-to-surgery
Obstructive
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Nasogastric tube
Patients with right sided obstructive colon cancer will receive non-surgical decompression with a nasogastric probe. Prior to the definitive oncological resection, patients undergo preoperative optimisation which involves the engagement of a dietician and physiotherapist. Patients eligible for elective resection will have their resection 7-10 days after initial decompression.
No interventions assigned to this group
Ileostomy
Patients with right sided obstructive colon cancer will receive a ileostomy. Prior to the definitive oncological resection, patients undergo preoperative optimisation which involves the engagement of a dietician and physiotherapist. Patients eligible for elective resection will be operated at least 7 days after initial decompression and no later than 4 weeks after initial presentation.
No interventions assigned to this group
Right-sided stent
Patients with right sided obstructive colon cancer will receive a right-sided stent. Prior to the definitive oncological resection, patients undergo preoperative optimisation which involves the engagement of a dietician and physiotherapist. Patients eligible for elective resection will be operated at least 7 days after initial decompression and no later than 4 weeks after initial presentation.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients age is 18 years or older
* Patients presenting with symptoms of obstruction (including cecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon) caused by (high suspicion or histologically proven) colonic cancer.
* Patient presenting with symptoms of partial obstruction (abdominal pain, nausea, vomiting, diarrhoea) confirmed by the presence of a dilated colon or ileum with a computed tomography (CT-scan).
* Treatment with curative intent.
* Patients presenting with symptoms of obstruction (including cecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon) caused by (high suspicion or histologically proven) colonic cancer.
* Patient presenting with symptoms of partial obstruction (abdominal pain, nausea, vomiting, diarrhoea) confirmed by the presence of a dilated colon or ileum with a computed tomography (CT-scan).
* Treatment with curative intent.
Exclusion Criteria
* Obstruction of the colon pathologically caused by benign disease.
* Obstruction of the colon caused by an extra-colonic malignancy.
* Suspicion of emergency complications caused by peritonitis due to perforation (tumour or blow out) or sepsis.
* Patients with advanced disease who will undergo a palliative trajectory.
* Rectal cancer
* Obstruction of the colon caused by an extra-colonic malignancy.
* Suspicion of emergency complications caused by peritonitis due to perforation (tumour or blow out) or sepsis.
* Patients with advanced disease who will undergo a palliative trajectory.
* Rectal cancer
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Amphia Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jennifer Schreinemakers, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Amphia Hospital Breda, The Netherlands
Locations
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Amphia Hospital
Breda, North Brabant, Netherlands
Site Status
RECRUITING
Countries
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Netherlands
Central Contacts
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Facility Contacts
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Elze Lockhorst, Drs.
Role: primary
References
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Boeding JRE, Cuperus IE, Rijken AM, Crolla RMPH, Verhoef C, Gobardhan PD, Schreinemakers JMJ. Postponing surgery to optimise patients with acute right-sided obstructing colon cancer - A pilot study. Eur J Surg Oncol. 2023 Sep;49(9):106906. doi: 10.1016/j.ejso.2023.04.005. Epub 2023 Apr 9.
Reference Type
BACKGROUND
Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
Reference Type
BACKGROUND
van Rooijen SJ, Molenaar CJL, Schep G, van Lieshout RHMA, Beijer S, Dubbers R, Rademakers N, Papen-Botterhuis NE, van Kempen S, Carli F, Roumen RMH, Slooter GD. Making Patients Fit for Surgery: Introducing a Four Pillar Multimodal Prehabilitation Program in Colorectal Cancer. Am J Phys Med Rehabil. 2019 Oct;98(10):888-896. doi: 10.1097/PHM.0000000000001221.
Reference Type
BACKGROUND
Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.
Reference Type
BACKGROUND
Nishiyama VKG, Albertini SM, Moraes CMZG, Godoy MF, Netinho JG. MALNUTRITION AND CLINICAL OUTCOMES IN SURGICAL PATIENTS WITH COLORECTAL DISEASE. Arq Gastroenterol. 2018 Oct-Dec;55(4):397-402. doi: 10.1590/S0004-2803.201800000-85.
Reference Type
BACKGROUND
Barao K, Abe Vicente Cavagnari M, Silva Fucuta P, Manoukian Forones N. Association Between Nutrition Status and Survival in Elderly Patients With Colorectal Cancer. Nutr Clin Pract. 2017 Oct;32(5):658-663. doi: 10.1177/0884533617706894. Epub 2017 May 23.
Reference Type
BACKGROUND
Schwegler I, von Holzen A, Gutzwiller JP, Schlumpf R, Muhlebach S, Stanga Z. Nutritional risk is a clinical predictor of postoperative mortality and morbidity in surgery for colorectal cancer. Br J Surg. 2010 Jan;97(1):92-7. doi: 10.1002/bjs.6805.
Reference Type
BACKGROUND
Li CY, Guo SB, Wang NF. Decompression of acute left-sided malignant colorectal obstruction: comparing transanal drainage tube with metallic stent. J Clin Gastroenterol. 2014 May-Jun;48(5):e37-42. doi: 10.1097/MCG.0b013e31829f30ca.
Reference Type
BACKGROUND
Shigeta K, Baba H, Yamafuji K, Kaneda H, Katsura H, Kubochi K. Outcomes for patients with obstructing colorectal cancers treated with one-stage surgery using transanal drainage tubes. J Gastrointest Surg. 2014 Aug;18(8):1507-13. doi: 10.1007/s11605-014-2541-1. Epub 2014 May 29.
Reference Type
BACKGROUND
Amelung FJ, Borstlap WAA, Consten ECJ, Veld JV, van Halsema EE, Bemelman WA, Siersema PD, Ter Borg F, van Hooft JE, Tanis PJ; Dutch Snapshot Research Group. Propensity score-matched analysis of oncological outcome between stent as bridge to surgery and emergency resection in patients with malignant left-sided colonic obstruction. Br J Surg. 2019 Jul;106(8):1075-1086. doi: 10.1002/bjs.11172. Epub 2019 May 10.
Reference Type
BACKGROUND
van den Berg MW, Sloothaak DA, Dijkgraaf MG, van der Zaag ES, Bemelman WA, Tanis PJ, Bosker RJ, Fockens P, ter Borg F, van Hooft JE. Bridge-to-surgery stent placement versus emergency surgery for acute malignant colonic obstruction. Br J Surg. 2014 Jun;101(7):867-73. doi: 10.1002/bjs.9521. Epub 2014 Apr 16.
Reference Type
BACKGROUND
Tan CJ, Dasari BV, Gardiner K. Systematic review and meta-analysis of randomized clinical trials of self-expanding metallic stents as a bridge to surgery versus emergency surgery for malignant left-sided large bowel obstruction. Br J Surg. 2012 Apr;99(4):469-76. doi: 10.1002/bjs.8689. Epub 2012 Jan 19.
Reference Type
BACKGROUND
Zhang Y, Shi J, Shi B, Song CY, Xie WF, Chen YX. Self-expanding metallic stent as a bridge to surgery versus emergency surgery for obstructive colorectal cancer: a meta-analysis. Surg Endosc. 2012 Jan;26(1):110-9. doi: 10.1007/s00464-011-1835-6. Epub 2011 Jul 26.
Reference Type
BACKGROUND
Alcantara M, Serra-Aracil X, Falco J, Mora L, Bombardo J, Navarro S. Prospective, controlled, randomized study of intraoperative colonic lavage versus stent placement in obstructive left-sided colonic cancer. World J Surg. 2011 Aug;35(8):1904-10. doi: 10.1007/s00268-011-1139-y.
Reference Type
BACKGROUND
van Hooft JE, Fockens P, Marinelli AW, Bossuyt PM, Bemelman WA; Dutch Stent-In study group. Premature closure of the Dutch Stent-in I study. Lancet. 2006 Nov 4;368(9547):1573-4. doi: 10.1016/S0140-6736(06)69660-8. No abstract available.
Reference Type
BACKGROUND
Sloothaak DA, van den Berg MW, Dijkgraaf MG, Fockens P, Tanis PJ, van Hooft JE, Bemelman WA; collaborative Dutch Stent-In study group. Oncological outcome of malignant colonic obstruction in the Dutch Stent-In 2 trial. Br J Surg. 2014 Dec;101(13):1751-7. doi: 10.1002/bjs.9645. Epub 2014 Oct 9.
Reference Type
BACKGROUND
van Hooft JE, Bemelman WA, Oldenburg B, Marinelli AW, Lutke Holzik MF, Grubben MJ, Sprangers MA, Dijkgraaf MG, Fockens P; collaborative Dutch Stent-In study group. Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: a multicentre randomised trial. Lancet Oncol. 2011 Apr;12(4):344-52. doi: 10.1016/S1470-2045(11)70035-3.
Reference Type
BACKGROUND
Pirlet IA, Slim K, Kwiatkowski F, Michot F, Millat BL. Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial. Surg Endosc. 2011 Jun;25(6):1814-21. doi: 10.1007/s00464-010-1471-6. Epub 2010 Dec 18.
Reference Type
BACKGROUND
Frago R, Biondo S, Millan M, Kreisler E, Golda T, Fraccalvieri D, Miguel B, Jaurrieta E. Differences between proximal and distal obstructing colonic cancer after curative surgery. Colorectal Dis. 2011 Jun;13(6):e116-22. doi: 10.1111/j.1463-1318.2010.02549.x.
Reference Type
BACKGROUND
Kube R, Mroczkowski P, Granowski D, Benedix F, Sahm M, Schmidt U, Gastinger I, Lippert H; Study group Qualitatssicherung Kolon/Rektum-Karzinome (Primartumor) (Quality assurance in primary colorectal carcinoma). Anastomotic leakage after colon cancer surgery: a predictor of significant morbidity and hospital mortality, and diminished tumour-free survival. Eur J Surg Oncol. 2010 Feb;36(2):120-4. doi: 10.1016/j.ejso.2009.08.011. Epub 2009 Sep 22.
Reference Type
BACKGROUND
Gessler B, Eriksson O, Angenete E. Diagnosis, treatment, and consequences of anastomotic leakage in colorectal surgery. Int J Colorectal Dis. 2017 Apr;32(4):549-556. doi: 10.1007/s00384-016-2744-x. Epub 2017 Jan 9.
Reference Type
BACKGROUND
Ramphal W, Boeding JRE, Gobardhan PD, Rutten HJT, de Winter LJMB, Crolla RMPH, Schreinemakers JMJ. Oncologic outcome and recurrence rate following anastomotic leakage after curative resection for colorectal cancer. Surg Oncol. 2018 Dec;27(4):730-736. doi: 10.1016/j.suronc.2018.10.003. Epub 2018 Oct 10.
Reference Type
BACKGROUND
van de Wall BJ, Draaisma WA, Schouten ES, Broeders IA, Consten EC. Conventional and laparoscopic reversal of the Hartmann procedure: a review of literature. J Gastrointest Surg. 2010 Apr;14(4):743-52. doi: 10.1007/s11605-009-1084-3.
Reference Type
BACKGROUND
Pisano M, Zorcolo L, Merli C, Cimbanassi S, Poiasina E, Ceresoli M, Agresta F, Allievi N, Bellanova G, Coccolini F, Coy C, Fugazzola P, Martinez CA, Montori G, Paolillo C, Penachim TJ, Pereira B, Reis T, Restivo A, Rezende-Neto J, Sartelli M, Valentino M, Abu-Zidan FM, Ashkenazi I, Bala M, Chiara O, De' Angelis N, Deidda S, De Simone B, Di Saverio S, Finotti E, Kenji I, Moore E, Wexner S, Biffl W, Coimbra R, Guttadauro A, Leppaniemi A, Maier R, Magnone S, Mefire AC, Peitzmann A, Sakakushev B, Sugrue M, Viale P, Weber D, Kashuk J, Fraga GP, Kluger I, Catena F, Ansaloni L. 2017 WSES guidelines on colon and rectal cancer emergencies: obstruction and perforation. World J Emerg Surg. 2018 Aug 13;13:36. doi: 10.1186/s13017-018-0192-3. eCollection 2018.
Reference Type
BACKGROUND
Amelung FJ, Consten ECJ, Siersema PD, Tanis PJ. A Population-Based Analysis of Three Treatment Modalities for Malignant Obstruction of the Proximal Colon: Acute Resection Versus Stent or Stoma as a Bridge to Surgery. Ann Surg Oncol. 2016 Oct;23(11):3660-3668. doi: 10.1245/s10434-016-5247-7. Epub 2016 May 24.
Reference Type
BACKGROUND
Tan KK, Sim R. Surgery for obstructed colorectal malignancy in an Asian population: predictors of morbidity and comparison between left- and right-sided cancers. J Gastrointest Surg. 2010 Feb;14(2):295-302. doi: 10.1007/s11605-009-1074-5. Epub 2009 Nov 6.
Reference Type
BACKGROUND
Kolfschoten NE, Wouters MW, Gooiker GA, Eddes EH, Kievit J, Tollenaar RA, Marang-van de Mheen PJ; Dutch Surgical Colorectal Audit group. Nonelective colon cancer resections in elderly patients: results from the dutch surgical colorectal audit. Dig Surg. 2012;29(5):412-9. doi: 10.1159/000345614. Epub 2012 Dec 13.
Reference Type
BACKGROUND
Tanis PJ, Paulino Pereira NR, van Hooft JE, Consten EC, Bemelman WA; Dutch Surgical Colorectal Audit. Resection of Obstructive Left-Sided Colon Cancer at a National Level: A Prospective Analysis of Short-Term Outcomes in 1,816 Patients. Dig Surg. 2015;32(5):317-24. doi: 10.1159/000433561. Epub 2015 Jul 4.
Reference Type
BACKGROUND
Aslar AK, Ozdemir S, Mahmoudi H, Kuzu MA. Analysis of 230 cases of emergent surgery for obstructing colon cancer--lessons learned. J Gastrointest Surg. 2011 Jan;15(1):110-9. doi: 10.1007/s11605-010-1360-2. Epub 2010 Oct 26.
Reference Type
BACKGROUND
Ho KS, Quah HM, Lim JF, Tang CL, Eu KW. Endoscopic stenting and elective surgery versus emergency surgery for left-sided malignant colonic obstruction: a prospective randomized trial. Int J Colorectal Dis. 2012 Mar;27(3):355-62. doi: 10.1007/s00384-011-1331-4. Epub 2011 Oct 28.
Reference Type
BACKGROUND
Panis Y, Maggiori L, Caranhac G, Bretagnol F, Vicaut E. Mortality after colorectal cancer surgery: a French survey of more than 84,000 patients. Ann Surg. 2011 Nov;254(5):738-43; discussion 743-4. doi: 10.1097/SLA.0b013e31823604ac.
Reference Type
BACKGROUND
Bakker IS, Snijders HS, Grossmann I, Karsten TM, Havenga K, Wiggers T. High mortality rates after nonelective colon cancer resection: results of a national audit. Colorectal Dis. 2016 Jun;18(6):612-21. doi: 10.1111/codi.13262.
Reference Type
BACKGROUND
Boeding JRE, Ramphal W, Crolla RMPH, Boonman-de Winter LJM, Gobardhan PD, Schreinemakers JMJ. Ileus caused by obstructing colorectal cancer-impact on long-term survival. Int J Colorectal Dis. 2018 Oct;33(10):1393-1400. doi: 10.1007/s00384-018-3132-5. Epub 2018 Jul 25.
Reference Type
BACKGROUND
Jullumstro E, Wibe A, Lydersen S, Edna TH. Colon cancer incidence, presentation, treatment and outcomes over 25 years. Colorectal Dis. 2011 May;13(5):512-8. doi: 10.1111/j.1463-1318.2010.02191.x.
Reference Type
BACKGROUND
Van Leersum NJ, Snijders HS, Henneman D, Kolfschoten NE, Gooiker GA, ten Berge MG, Eddes EH, Wouters MW, Tollenaar RA; Dutch Surgical Colorectal Cancer Audit Group; Bemelman WA, van Dam RM, Elferink MA, Karsten TM, van Krieken JH, Lemmens VE, Rutten HJ, Manusama ER, van de Velde CJ, Meijerink WJ, Wiggers T, van der Harst E, Dekker JW, Boerma D. The Dutch surgical colorectal audit. Eur J Surg Oncol. 2013 Oct;39(10):1063-70. doi: 10.1016/j.ejso.2013.05.008. Epub 2013 Jul 18.
Reference Type
BACKGROUND
Other Identifiers
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AW23.050, W19.249
Identifier Type: -
Identifier Source: org_study_id