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| Name | Class |
|---|---|
| Ethicon, Inc. | INDUSTRY |
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In this retrospective longitudinal observational study we compare the incidence of fascial dehiscence and incisional hernia in patients operated via abdominal wall incision, comparing the barbed suture Stratafix Symmetric to other types of suture during closure of the abdominal wall. In addition, we plan to analize the impact of other risk factors, patient related and patient unrelated, on the incidence of fascial dehiscence.
In this retrospective longitudinal observational study we primarily aim to compare the influence of the applied suture type (Stratafix Symmetric versus other suture types) for primary fascial closure in abdominal surgery on the incidence of fascial dehiscence.
Secondary outcomes such as will also be analized. Primary outcomeis the incidence of abdominal wall dehiscence. Secondary outcomes are the impact of the occurrence of abdominal wall dehiscence on mortality and hospital stay, the influence of other risk factors on the occurrence of abdominal wall dehiscence, the influence of the suture type and other risk factors on the incidence of incisional hernia after 12 months of follow-up and a speciality subgroup analysis.
The diagnoses of each patient and the procedures performed are coded according to ICD 9 or ICD 10. For primary cause diagnoses and secondary diagnoses, external causes and procedures, ICD9/ICD10 codes are also used. Following the AHQR definition, cases of laparotomy dehiscence will be defined as those whose ICD 9/ICD 10 codes conform to "New closure of postoperative abdominal wall disruption", as well as those identified secondarily after crossing the databases as reoperated for this reason with another coding.
Statistical analysis will be performed using statistical techniques appropriate to the variables under study. A descriptive analysis of the population will be performed, frequency results will be expressed in absolute terms, such as percentages and confidence intervals. The percentage of subjects with dehiscence will be calculated by the group. A two-sided 95% confidence interval (CI) for the difference in percentages (Stratafix - Control) will be estimated using the Wald method. If the upper limit of the confidence interval for the difference in percentages (Stratafix-Control) is below 0, then it will be concluded that the true dehiscence rate for Stratafix is lower than that for the control. In addition, two-sided 95% CIs within each group will be estimated for the dehiscence rate using the Clopper-Pearson method.
Continuous variables will be expressed as mean (SD) and median (range) according to the normality test (Kolmogorov Smirnov test). For the study of the relationship between the different variables, Chi-square or Analysis of Variance will be used if they are parametric. And if they do not follow a normal distribution, nonparametric tests will be used (Mann-Whitney U or Kruskal Wallis, as appropriate). Biochemical recurrence-free survival (BCR-free survival) will be estimated using Kaplan-Meier curves. SPSS. 21 (SPSS Inc. Chicago, IL, USA) will be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stratafix | All patients in which Stratafix symmetric was used for the primary closure of the abdominal wall incision |
| |
| Control | All patients in which other, conventional suture types were used for primary closure of the abdominal wall incision |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stratafix Symmetric | Device | Use of Stratafix Symmetric for primary fascial closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal Wall Dehiscence | Disruption of all layers of the abdominal wall with exposure of abdominal viscera within 30 days after primary surgery | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incisional hernia | Any defect of the abdominal wall in the area of the primary incision, palpable or visible in ultrasound, CT- or MR-Scan, with or without protrusion of intraabdominal content | 1 year |
| PROMs - Postoperative Pain |
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Inclusion Criteria:
Exclusion Criteria:
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All adults over 18 years of age operated via laparotomy or laparoscopy with extraction site incision in the 4 participating Hospitals between 01/01/2018 and 21/11/23
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hector Gauadalajara Labajo, PHD | Contact | 0034649429243 | h.guadalajara@quironsalud.es | |
| Marius Kaser, Dr. | Contact | 0034652174951 |
| Name | Affiliation | Role |
|---|---|---|
| Hector Gauadalajara Labajo, PHD | Quironsalud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital universitario General de Villalba | Recruiting | Collado Villalba | Madrid | 28400 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34537149 | Background | Zolin SJ, Rosen MJ. Failure of Abdominal Wall Closure: Prevention and Management. Surg Clin North Am. 2021 Oct;101(5):875-888. doi: 10.1016/j.suc.2021.07.001. | |
| 16420934 | Background | Rodriguez-Hermosa JI, Codina-Cazador A, Ruiz B, Roig J, Girones J, Pujadas M, Pont J, Aldeguer X, Acero D. [Risk factors for acute abdominal wall dehiscence after laparotomy in adults]. Cir Esp. 2005 May;77(5):280-6. doi: 10.1016/s0009-739x(05)70854-x. Spanish. |
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One question about pain - 4 answers
| 1 year |
| PROMs - Mental and emotional health | Two questions - 4 answers for each question | 1 year |
| PROMs - Work an social life performance | Two questions - 4 answers for each question | 1 year |
| PROMs - Fatigue | Two questions - 4 answers for each question | 1 year |
| PROMs - Funcionality | One question - 4 answers for each question | 1 year |
| PROMs - Sexuality | One question - 4 answers for each question | 1 year |
| PROMs - Body image | One question - 4 answers for each question | 1 year |
| Hospital Universitario Infanta Elena | Recruiting | Valdemoro | Madrid | 28342 | Spain |
|
| Hospital Universitario Fundación Jiménez Díaz | Recruiting | Madrid | 28040 | Spain |
|
| Hospital Universitario Rey Juan Carlos | Recruiting | Madrid | 28933 | Spain |
|
| 25956459 | Background | Gili-Ortiz E, Gonzalez-Guerrero R, Bejar-Prado L, Ramirez-Ramirez G, Lopez-Mendez J. [Postoperative dehiscence of the abdominal wound and its impact on excess mortality, hospital stay and costs]. Cir Esp. 2015 Aug-Sep;93(7):444-9. doi: 10.1016/j.ciresp.2015.02.005. Epub 2015 May 6. Spanish. |
| 33394254 | Background | Jensen KK, Oma E, van Ramshorst GH, Nordholm-Carstensen A, Krarup PM. Abdominal wound dehiscence is dangerous: a nationwide study of 14,169 patients undergoing elective open resection for colonic cancer. Hernia. 2022 Feb;26(1):75-86. doi: 10.1007/s10029-020-02350-z. Epub 2021 Jan 4. |
| 21328764 | Background | Farquhar M. AHRQ Quality Indicators. In: Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Apr. Chapter 45. Available from http://www.ncbi.nlm.nih.gov/books/NBK2664/ |
| 30286645 | Background | Zucker BE, Simillis C, Tekkis P, Kontovounisios C. Suture choice to reduce occurrence of surgical site infection, hernia, wound dehiscence and sinus/fistula: a network meta-analysis. Ann R Coll Surg Engl. 2019 Mar;101(3):150-161. doi: 10.1308/rcsann.2018.0170. Epub 2018 Oct 5. |
| 137024 | Background | Jenkins TP. The burst abdominal wound: a mechanical approach. Br J Surg. 1976 Nov;63(11):873-6. doi: 10.1002/bjs.1800631110. |
| 29322212 | Background | 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. |
| 29099149 | Background | Patel SV, Paskar DD, Nelson RL, Vedula SS, Steele SR. Closure methods for laparotomy incisions for preventing incisional hernias and other wound complications. Cochrane Database Syst Rev. 2017 Nov 3;11(11):CD005661. doi: 10.1002/14651858.CD005661.pub2. |
| 11231844 | Background | Cengiz Y, Blomquist P, Israelsson LA. Small tissue bites and wound strength: an experimental study. Arch Surg. 2001 Mar;136(3):272-5. doi: 10.1001/archsurg.136.3.272. |
| 29876355 | Background | Fortelny RH. Abdominal Wall Closure in Elective Midline Laparotomy: The Current Recommendations. Front Surg. 2018 May 23;5:34. doi: 10.3389/fsurg.2018.00034. eCollection 2018. |
| 25618025 | Background | Muysoms FE, Antoniou SA, Bury K, Campanelli G, Conze J, Cuccurullo D, de Beaux AC, Deerenberg EB, East B, Fortelny RH, Gillion JF, Henriksen NA, Israelsson L, Jairam A, Janes A, Jeekel J, Lopez-Cano M, Miserez M, Morales-Conde S, Sanders DL, Simons MP, Smietanski M, Venclauskas L, Berrevoet F; European Hernia Society. European Hernia Society guidelines on the closure of abdominal wall incisions. Hernia. 2015 Feb;19(1):1-24. doi: 10.1007/s10029-014-1342-5. Epub 2015 Jan 25. |
| 28267697 | Background | Tolstrup MB, Watt SK, Gogenur I. Reduced Rate of Dehiscence After Implementation of a Standardized Fascial Closure Technique in Patients Undergoing Emergency Laparotomy. Ann Surg. 2017 Apr;265(4):821-826. doi: 10.1097/SLA.0000000000001762. |
| 32897452 | Background | Denys A, Monbailliu T, Allaeys M, Berrevoet F, van Ramshorst GH. Management of abdominal wound dehiscence: update of the literature and meta-analysis. Hernia. 2021 Apr;25(2):449-462. doi: 10.1007/s10029-020-02294-4. Epub 2020 Sep 8. |
| 33455821 | Background | Pereira Rodriguez JA, Amador-Gil S, Bravo-Salva A, Montcusi-Ventura B, Sancho-Insenser JJ, Pera-Roman M, Lopez-Cano M. Small bites technique for midline laparotomy closure: From theory to practice: Still a long way to go. Surgery. 2021 Jul;170(1):140-145. doi: 10.1016/j.surg.2020.12.007. Epub 2021 Jan 15. |
| ID | Term |
|---|---|
| D013529 | Surgical Wound Dehiscence |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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