Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:52 PM
Study NCT ID:
NCT04700956
Status:
COMPLETED
Last Update Posted:
2022-08-17
First Post:
2020-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Does the Use of Prophylactic Mesh Reduce Incisional Hernia?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069290', 'term': 'Incisional Hernia'}], 'ancestors': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013537', 'term': 'Sutures'}], 'ancestors': [{'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2020-12-19', 'studyFirstSubmitQcDate': '2021-01-07', 'lastUpdatePostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'primary outcome', 'timeFrame': 'up to one year', 'description': 'incisional hernia rate'}], 'secondaryOutcomes': [{'measure': 'secondary outcome', 'timeFrame': 'up to one months', 'description': 'seroma rate'}, {'measure': 'secondary outcome', 'timeFrame': 'up to one months', 'description': 'hematoma rate'}, {'measure': 'secondary outcome', 'timeFrame': 'up to ten days', 'description': 'burst abdomen rate'}, {'measure': 'secondary outcome', 'timeFrame': 'up to one months', 'description': 'deep vein thymbosis rate'}, {'measure': 'secondary outcome', 'timeFrame': 'up to one months', 'description': 'pulmonary and cardiac complication rate'}, {'measure': 'secondary outcome', 'timeFrame': 'up to one hundred twenty minutes', 'description': 'mean operation time (minute)'}, {'measure': 'secondary outcome', 'timeFrame': 'up to twenty days', 'description': 'mean hospital stay time (day)'}, {'measure': 'secondary outcome', 'timeFrame': 'up to one year', 'description': 'chronic pain rate (visual analog scale, VAS)'}, {'measure': 'secondary outcome', 'timeFrame': 'up to one year', 'description': 'quality of life measures (0-100 points) - It will be measured using the EQ-5D test.'}, {'measure': 'secondary outcome', 'timeFrame': 'up to one year', 'description': 're-operation rate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['incisional hernia', 'prophylactic', 'mesh', 'emergency surgery'], 'conditions': ['Incisional Hernia']}, 'referencesModule': {'references': [{'pmid': '32057193', 'type': 'RESULT', 'citation': 'Jairam AP, Lopez-Cano M, Garcia-Alamino JM, Pereira JA, Timmermans L, Jeekel J, Lange J, Muysoms F. Prevention of incisional hernia after midline laparotomy with prophylactic mesh reinforcement: a meta-analysis and trial sequential analysis. BJS Open. 2020 Jun;4(3):357-368. doi: 10.1002/bjs5.50261. Epub 2020 Feb 14.'}, {'pmid': '28400141', 'type': 'RESULT', 'citation': 'Argudo N, Iskra MP, Pera M, Sancho JJ, Grande L, Lopez-Cano M, Pereira JA. The use of an algorithm for prophylactic mesh use in high risk patients reduces the incidence of incisional hernia following laparotomy for colorectal cancer resection. Cir Esp. 2017 Apr;95(4):222-228. doi: 10.1016/j.ciresp.2017.03.010. Epub 2017 Apr 8. English, Spanish.'}, {'pmid': '23712289', 'type': 'RESULT', 'citation': 'Bhangu A, Fitzgerald JE, Singh P, Battersby N, Marriott P, Pinkney T. Systematic review and meta-analysis of prophylactic mesh placement for prevention of incisional hernia following midline laparotomy. Hernia. 2013 Aug;17(4):445-55. doi: 10.1007/s10029-013-1119-2. Epub 2013 May 28.'}, {'pmid': '26189071', 'type': 'RESULT', 'citation': 'Fischer JP, Basta MN, Wink JD, Krishnan NM, Kovach SJ. Cost-utility analysis of the use of prophylactic mesh augmentation compared with primary fascial suture repair in patients at high risk for incisional hernia. Surgery. 2015 Sep;158(3):700-11. doi: 10.1016/j.surg.2015.02.030. Epub 2015 Jul 15.'}, {'pmid': '23568247', 'type': 'RESULT', 'citation': 'Kurmann A, Barnetta C, Candinas D, Beldi G. Implantation of prophylactic nonabsorbable intraperitoneal mesh in patients with peritonitis is safe and feasible. World J Surg. 2013 Jul;37(7):1656-60. doi: 10.1007/s00268-013-2019-4.'}, {'pmid': '21547421', 'type': 'RESULT', 'citation': 'Llaguna OH, Avgerinos DV, Nagda P, Elfant D, Leitman IM, Goodman E. Does prophylactic biologic mesh placement protect against the development of incisional hernia in high-risk patients? World J Surg. 2011 Jul;35(7):1651-5. doi: 10.1007/s00268-011-1131-6.'}, {'pmid': '28864937', 'type': 'RESULT', 'citation': 'Payne R, Aldwinckle J, Ward S. Meta-analysis of randomised trials comparing the use of prophylactic mesh to standard midline closure in the reduction of incisional herniae. Hernia. 2017 Dec;21(6):843-853. doi: 10.1007/s10029-017-1653-4. Epub 2017 Sep 1.'}, {'pmid': '30288617', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '25575254', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Incisional hernia is a common condition after abdominal surgery. Because linea alba has less vascularity, incisional hernia more common in midline incisions. It is seen in the general population between 11-20%. In some high-risk situations, this rate increases up to 40-69% (abdominal aortic aneurysm, morbid obesity, colorectal surgery).It is known that incisional hernia that occurs in the postoperative period can lead to emergency surgical causes such as incarceration-strangulation, has a significant share in health expenses and seriously impairs the quality of life in patients.One of the methods tried to reduce incisional hernia is the use of mesh. But this abdominal closure technique is not used routinely in our country and the other countries. This study will be important of the studies in Turkey and world for patient selection in prophylactic mesh use, techniques to be applied and early / late results.\n\nThe aim of the study is to compare the classical abdominal closure technique with use of mesh in order to minimize the incisional hernia and associated complications after midline laparotomy.', 'detailedDescription': 'Background\n\nThere are patient and surgical procedure-related risk factors that increase the risk of postoperative incisional hernia. Patient-related risk factors: male gender, previous laparotomy, over 50 years of age, malignant disease, COPD, hypoalbuminemia, sepsis, obesity (BMI\\> 30 kg / m2), anemia, DM, used to steroid, smoking, chemoterapi, cardiovascular disease, RT to the abdominal wall and to be postoperative abdominal wall defects. In studies conducted in many centers around the world, it has been shown that the use of prophylactic mesh reduces the incidence of incisional hernia, especially in high-risk patients. When the literature was reviewed, reviews and meta-analyzes about the use of prophylactic mesh showed a significant decrease in incisional hernia incidence. However, routine practice has not yet been recommended, as long-term follow-up results and secondary results (complications, cost analysis, quality of life) are not clearly explained. However, it has been reported that higher quality studies are needed.\n\nThis abdominal closure technique is not used routinely in our country. This study will be one of the first studies in Turkey for patient selection in prophylactic mesh use, techniques to be applied and early / late results.\n\nThe aim of the study is to compare the classical abdominal closure technique with use of mesh in order to minimize the incisional hernia and associated complications after midline laparotomy.\n\nMethod\n\nPatients aged 18 years and over who were scheduled to undergo emergency abdominal surgery with midline laparotomy will be randomly assigned (1: 1) to primary abdominal closure or mesh group via a computer-generated randomization sequence.\n\nDetailed information was given to all patients before they were included in the study, and their informed consent forms were recorded.\n\nThe method in the primary suture group: The linea alba will be closed to a ratio of 5mm / 5mm. Only the fascia will be sutured ; fat or muscle tissue will be avoided. Subcutaneous tissue will be closed with polyglactin 3/0 suture. The skin will be closed with a stapler.\n\nMethod in the mesh group: After the fascia was closed with the same method, 5 cm of subcutaneous tissue will be dissected around the incision. The mesh will be placed in the supra-aponeurotic area (onlay) to a distance of laterally and cranial-caudally 5 cm from the fascia margins. The mesh used will be partially absorbable, light and large porous. After this procedure, the borders of the mesh will be fixed circumferentially on the abdominal wall using polypropylene suture to prevent the intestines from herniating on the mesh. Two subcutaneous drainage catheters will be placed in all patients with mesh.\n\nAntithrombotic prophylaxis with low molecular weight heparin, antibiotic prophylaxis with cefazolin and metronidazole will be applied to all patients according to the hospital protocol.\n\nPower analysis; To provide sufficient statistical power, sample size calculation was made. Incisional hernia rates were estimated between 5% and 25% between the two groups. It was calculated that 49 patients per group with 80% test power in the 95% confidence interval would be needed. In the follow-up period, it was planned to include 52 patients in each group, with the prediction that 5% of the patients would be excluded from the study.\n\nData Entry and Statistical Analysis; Kolmogorov-Smirnov and Shapiro-Wilk normality tests will be carried out before starting the statistical analysis. If normality cannot be achieved even in one of the groups, non-parametric test methods will be selected. Next, the Mann-Whitney U test will be used to compare the variables obtained by the measurement between the two groups.\n\nChi-square and Fisher Final tests will be used to analyze the relationships or differences between groups in terms of categorical variables.\n\nUnivariate logistic regression analysis will be performed to determine the factors thought to cause an incisional hernia. Then, multivariate logistic regression analysis will be done for variables with'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being older than 18 years of age,\n* laparotomy with the midline incision of the abdomen,\n* all emergency surgery indications,\n* having at least two of the risk factors.\n\nExclusion Criteria:\n\n* Patients under 18 years of age,\n* elective surgeries,\n* off-midline incisions,\n* concurrent hernia,\n* laparoscopic surgery,\n* history of metastatic cancer,\n* life expectancy less than 2 years,\n* pregnancy.'}, 'identificationModule': {'nctId': 'NCT04700956', 'briefTitle': 'Does the Use of Prophylactic Mesh Reduce Incisional Hernia?', 'organization': {'class': 'OTHER', 'fullName': 'Konya City Hospital'}, 'officialTitle': 'Does Prophylactic Mesh Placement in Emergency Midline Laparotomy Reduce the Incidence of Incisional Hernia? A Prospective Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '20202020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'the primary suture group', 'description': 'The linea alba will be closed to a ratio of 5mm / 5mm. Only the fascia will be sutured ; fat or muscle tissue will be avoided. Subcutaneous tissue will be closed with polyglactin 3/0 suture. The skin will be closed with a stapler.', 'interventionNames': ['Procedure: primary abdominal closure']}, {'type': 'EXPERIMENTAL', 'label': 'mesh group', 'description': 'After the fascia was closed with the same method, 5 cm of subcutaneous tissue will be dissected around the incision. The mesh will be placed in the supra-aponeurotic area (onlay) to a distance of laterally and cranial-caudally 5 cm from the fascia margins. The mesh used will be partially absorbable, light and large porous. After this procedure, the borders of the mesh will be fixed circumferentially on the abdominal wall using polypropylene suture to prevent the intestines from herniating on the mesh. Two subcutaneous drainage catheters will be placed in all patients with mesh.', 'interventionNames': ['Device: abdominal closure with prophylactic mesh']}], 'interventions': [{'name': 'primary abdominal closure', 'type': 'PROCEDURE', 'otherNames': ['primary abdominal closure with suture'], 'description': 'The linea alba will be closed to a ratio of 5mm / 5mm. Only the fascia will be sutured ; fat or muscle tissue will be avoided. Subcutaneous tissue will be closed with polyglactin 3/0 suture. The skin will be closed with a stapler.', 'armGroupLabels': ['the primary suture group']}, {'name': 'abdominal closure with prophylactic mesh', 'type': 'DEVICE', 'description': 'After the fascia was closed with the same method, 5 cm of subcutaneous tissue will be dissected around the incision. The mesh will be placed in the supra-aponeurotic area (onlay) to a distance of laterally and cranial-caudally 5 cm from the fascia margins. The mesh used will be partially absorbable, light and large porous. After this procedure, the borders of the mesh will be fixed circumferentially on the abdominal wall using polypropylene suture to prevent the intestines from herniating on the mesh. Two subcutaneous drainage catheters will be placed in all patients with mesh.', 'armGroupLabels': ['mesh group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Health Science University Konya City Hospital General Surgery Department', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konya City Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant', 'investigatorFullName': 'Mehmet Eşref Ulutaş', 'investigatorAffiliation': 'Konya City Hospital'}}}}