Abdominal Wall Closure After Laparotomy in Oncologic Surgery
NCT ID: NCT05041530
Last Updated: 2022-12-27
Study Results
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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UNKNOWN
NA
30 participants
INTERVENTIONAL
2022-06-17
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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REBUILD
Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo oncologic laparotomy per the standard of care. The abdominal wall will be closed with REBUILD Bioabsorbable and suture of the surgeon's choice.
REBUILD Bioabsorbable
REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures.
Interventions
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REBUILD Bioabsorbable
REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures.
Eligibility Criteria
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Inclusion Criteria
2. Patient is scheduled for oncologic, open, elective, intent-to-cure laparotomy
3. Patient is able to provide written informed consent
4. Patient is able and willing to comply with all study requirements
Exclusion Criteria
2. Patient has had previous failed surgical repair of a ventral or incisional hernia
3. Patient has a current infection at the intended surgical site
4. Patient is participating in a concurrent investigational medical device study
5. Patient is pregnant or planning on becoming pregnant during the study period
6. Patient has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to be compliant with post-operative visits.
18 Years
75 Years
ALL
No
Sponsors
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Cogent Technologies Corporation
UNKNOWN
AbSolutions Med Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Luis J Palacios Fuenmayor, MD
Role: PRINCIPAL_INVESTIGATOR
Clinica Las Americas
Locations
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Clinica Medellin
Medellín, Antioquia, Colombia
Clinica Las Americas
Medellín, , Colombia
Countries
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Central Contacts
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Facility Contacts
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Gloria Salazar
Role: primary
Claudia Asela
Role: backup
Luis J Palacios Fuenmayor, MD
Role: primary
Laura Lobo
Role: backup
References
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Kokotovic D, Bisgaard T, Helgstrand F. Long-term Recurrence and Complications Associated With Elective Incisional Hernia Repair. JAMA. 2016 Oct 18;316(15):1575-1582. doi: 10.1001/jama.2016.15217.
Flum DR, Horvath K, Koepsell T. Have outcomes of incisional hernia repair improved with time? A population-based analysis. Ann Surg. 2003 Jan;237(1):129-35. doi: 10.1097/00000658-200301000-00018.
Hawn MT, Snyder CW, Graham LA, Gray SH, Finan KR, Vick CC. Long-term follow-up of technical outcomes for incisional hernia repair. J Am Coll Surg. 2010 May;210(5):648-55, 655-7. doi: 10.1016/j.jamcollsurg.2009.12.038.
Deeken CR, Matthews BD. Characterization of the Mechanical Strength, Resorption Properties, and Histologic Characteristics of a Fully Absorbable Material (Poly-4-hydroxybutyrate-PHASIX Mesh) in a Porcine Model of Hernia Repair. ISRN Surg. 2013 May 28;2013:238067. doi: 10.1155/2013/238067. Print 2013.
Glauser PM, Brosi P, Speich B, Kaser SA, Heigl A, Rosenberg R, Maurer CA. Prophylactic Intraperitoneal Onlay Mesh Following Midline Laparotomy-Long-Term Results of a Randomized Controlled Trial. World J Surg. 2019 Jul;43(7):1669-1675. doi: 10.1007/s00268-019-04964-6.
Kohler A, Lavanchy JL, Lenoir U, Kurmann A, Candinas D, Beldi G. Effectiveness of Prophylactic Intraperitoneal Mesh Implantation for Prevention of Incisional Hernia in Patients Undergoing Open Abdominal Surgery: A Randomized Clinical Trial. JAMA Surg. 2019 Feb 1;154(2):109-115. doi: 10.1001/jamasurg.2018.4221.
San Miguel C, Melero D, Jimenez E, Lopez P, Robin A, Blazquez LA, Lopez-Monclus J, Gonzalez E, Jimenez C, Garcia-Urena MA. Long-term outcomes after prophylactic use of onlay mesh in midline laparotomy. Hernia. 2018 Dec;22(6):1113-1122. doi: 10.1007/s10029-018-1833-x. Epub 2018 Oct 4.
Jairam AP, Timmermans L, Eker HH, Pierik REGJM, van Klaveren D, Steyerberg EW, Timman R, van der Ham AC, Dawson I, Charbon JA, Schuhmacher C, Mihaljevic A, Izbicki JR, Fikatas P, Knebel P, Fortelny RH, Kleinrensink GJ, Lange JF, Jeekel HJ; PRIMA Trialist Group. Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement versus primary suture only in midline laparotomies (PRIMA): 2-year follow-up of a multicentre, double-blind, randomised controlled trial. Lancet. 2017 Aug 5;390(10094):567-576. doi: 10.1016/S0140-6736(17)31332-6. Epub 2017 Jun 20.
Muysoms FE, Detry O, Vierendeels T, Huyghe M, Miserez M, Ruppert M, Tollens T, Defraigne JO, Berrevoet F. Prevention of Incisional Hernias by Prophylactic Mesh-augmented Reinforcement of Midline Laparotomies for Abdominal Aortic Aneurysm Treatment: A Randomized Controlled Trial. Ann Surg. 2016 Apr;263(4):638-45. doi: 10.1097/SLA.0000000000001369.
Bali C, Papakostas J, Georgiou G, Kouvelos G, Avgos S, Arnaoutoglou E, Papadopoulos G, Matsagkas M. A comparative study of sutured versus bovine pericardium mesh abdominal closure after open abdominal aortic aneurysm repair. Hernia. 2015 Apr;19(2):267-71. doi: 10.1007/s10029-014-1262-4. Epub 2014 May 13.
Deerenberg EB, Harlaar JJ, Steyerberg EW, Lont HE, van Doorn HC, Heisterkamp J, Wijnhoven BP, Schouten WR, Cense HA, Stockmann HB, Berends FJ, Dijkhuizen FPH, Dwarkasing RS, Jairam AP, van Ramshorst GH, Kleinrensink GJ, Jeekel J, Lange JF. Small bites versus large bites for closure of abdominal midline incisions (STITCH): a double-blind, multicentre, randomised controlled trial. Lancet. 2015 Sep 26;386(10000):1254-1260. doi: 10.1016/S0140-6736(15)60459-7. Epub 2015 Jul 15.
Garcia-Urena MA, Lopez-Monclus J, Hernando LA, Montes DM, Valle de Lersundi AR, Pavon CC, Ceinos CJ, Quindos PL. Randomized controlled trial of the use of a large-pore polypropylene mesh to prevent incisional hernia in colorectal surgery. Ann Surg. 2015 May;261(5):876-81. doi: 10.1097/SLA.0000000000001116.
Sarr MG, Hutcher NE, Snyder S, Hodde J, Carmody B. A prospective, randomized, multicenter trial of Surgisis Gold, a biologic prosthetic, as a sublay reinforcement of the fascial closure after open bariatric surgery. Surgery. 2014 Oct;156(4):902-8. doi: 10.1016/j.surg.2014.06.022.
Khorgami Z, Shoar S, Laghaie B, Aminian A, Hosseini Araghi N, Soroush A. Prophylactic retention sutures in midline laparotomy in high-risk patients for wound dehiscence: a randomized controlled trial. J Surg Res. 2013 Apr;180(2):238-43. doi: 10.1016/j.jss.2012.05.012. Epub 2012 May 24.
Curro G, Centorrino T, Low V, Sarra G, Navarra G. Long-term outcome with the prophylactic use of polypropylene mesh in morbidly obese patients undergoing biliopancreatic diversion. Obes Surg. 2012 Feb;22(2):279-82. doi: 10.1007/s11695-011-0486-y.
Rasic Z, Schwarz D, Adam VN, Sever M, Lojo N, Rasic D, Matejic T. Efficacy of antimicrobial triclosan-coated polyglactin 910 (Vicryl* Plus) suture for closure of the abdominal wall after colorectal surgery. Coll Antropol. 2011 Jun;35(2):439-43.
Bloemen A, van Dooren P, Huizinga BF, Hoofwijk AG. Randomized clinical trial comparing polypropylene or polydioxanone for midline abdominal wall closure. Br J Surg. 2011 May;98(5):633-9. doi: 10.1002/bjs.7398. Epub 2011 Jan 19.
Bevis PM, Windhaber RA, Lear PA, Poskitt KR, Earnshaw JJ, Mitchell DC. Randomized clinical trial of mesh versus sutured wound closure after open abdominal aortic aneurysm surgery. Br J Surg. 2010 Oct;97(10):1497-502. doi: 10.1002/bjs.7137.
El-Khadrawy OH, Moussa G, Mansour O, Hashish MS. Prophylactic prosthetic reinforcement of midline abdominal incisions in high-risk patients. Hernia. 2009 Jun;13(3):267-74. doi: 10.1007/s10029-009-0484-3. Epub 2009 Mar 5.
Henriksen NA, Deerenberg EB, Venclauskas L, Fortelny RH, Miserez M, Muysoms FE. Meta-analysis on Materials and Techniques for Laparotomy Closure: The MATCH Review. World J Surg. 2018 Jun;42(6):1666-1678. doi: 10.1007/s00268-017-4393-9.
Taylor DA, Merten SL, Sandercoe GD, Gahankari D, Ingram SB, Moncrieff NJ, Ho K, Sellars GD, Magnusson MR. Abdominoplasty Improves Low Back Pain and Urinary Incontinence. Plast Reconstr Surg. 2018 Mar;141(3):637-645. doi: 10.1097/PRS.0000000000004100.
Nenshi R, Bensimon C, Wood T, Wright F, Smith AJ, Brenneman F. Complex abdominal wall hernias as a barrier to quality of life in cancer survivors. Can J Surg. 2019 Mar 22;62(3):1-7. doi: 10.1503/cjs.014917. Online ahead of print.
Burger JW, Lange JF, Halm JA, Kleinrensink GJ, Jeekel H. Incisional hernia: early complication of abdominal surgery. World J Surg. 2005 Dec;29(12):1608-13. doi: 10.1007/s00268-005-7929-3.
Harlaar JJ, Deerenberg EB, Dwarkasing RS, Kamperman AM, Kleinrensink GJ, Jeekel J, Lange JF. Development of incisional herniation after midline laparotomy. BJS Open. 2017 May 10;1(1):18-23. doi: 10.1002/bjs5.3. eCollection 2017 Feb.
Onyekwelu I, Yakkanti R, Protzer L, Pinkston CM, Tucker C, Seligson D. Surgical Wound Classification and Surgical Site Infections in the Orthopaedic Patient. J Am Acad Orthop Surg Glob Res Rev. 2017 Jun 13;1(3):e022. doi: 10.5435/JAAOSGlobal-D-17-00022. eCollection 2017 Jun.
Playforth MJ, Sauven PD, Evans M, Pollock AV. The prediction of incisional hernias by radio-opaque markers. Ann R Coll Surg Engl. 1986 Mar;68(2):82-4.
Pollock AV, Evans M. Early prediction of late incisional hernias. Br J Surg. 1989 Sep;76(9):953-4. doi: 10.1002/bjs.1800760926. No abstract available.
Related Links
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American Society of Anesthesiologists Physical Status Classification System
Other Identifiers
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CTP-0001
Identifier Type: -
Identifier Source: org_study_id