Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2026-02-19 @ 4:34 PM
Study NCT ID:
NCT02669992
Status:
RECRUITING
Last Update Posted:
2023-01-26
First Post:
2015-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Loop Ileostomy Closure:Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009074', 'term': 'Melanocyte-Stimulating Hormones'}], 'ancestors': [{'id': 'D053486', 'term': 'Melanocortins'}, {'id': 'D011333', 'term': 'Pro-Opiomelanocortin'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-25', 'studyFirstSubmitDate': '2015-12-08', 'studyFirstSubmitQcDate': '2016-01-27', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with postoperative bowel obstruction', 'timeFrame': '30 days', 'description': 'Postoperative bowel obstruction within 30 Days, detected clinically or by the use of x-ray'}, {'measure': 'Number of participants with postoperative stoma site hernia', 'timeFrame': '2 year', 'description': 'Herni postoperatively on the site of previous stoma detected within 2 years'}], 'secondaryOutcomes': [{'measure': 'Number of participants with postoperative complications', 'timeFrame': '30 days'}, {'measure': 'Postoperative Hospital stay', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ileostomy'], 'conditions': ['Rectal Neoplasm']}, 'referencesModule': {'references': [{'pmid': '21845418', 'type': 'BACKGROUND', 'citation': 'Gustavsson K, Gunnarsson U, Jestin P. Postoperative complications after closure of a diverting ileostoma--differences according to closure technique. Int J Colorectal Dis. 2012 Jan;27(1):55-8. doi: 10.1007/s00384-011-1287-4. Epub 2011 Aug 16.'}, {'pmid': '24033921', 'type': 'BACKGROUND', 'citation': 'Gong J, Guo Z, Li Y, Gu L, Zhu W, Li J, Li N. Stapled vs hand suture closure of loop ileostomy: a meta-analysis. Colorectal Dis. 2013;15(10):e561-8. doi: 10.1111/codi.12388.'}, {'pmid': '25276286', 'type': 'BACKGROUND', 'citation': 'Rubio-Perez I, Leon M, Pastor D, Diaz Dominguez J, Cantero R. Increased postoperative complications after protective ileostomy closure delay: An institutional study. World J Gastrointest Surg. 2014 Sep 27;6(9):169-74. doi: 10.4240/wjgs.v6.i9.169.'}, {'pmid': '20372898', 'type': 'BACKGROUND', 'citation': 'Akiyoshi T, Fujimoto Y, Konishi T, Kuroyanagi H, Ueno M, Oya M, Yamaguchi T. Complications of loop ileostomy closure in patients with rectal tumor. World J Surg. 2010 Aug;34(8):1937-42. doi: 10.1007/s00268-010-0547-8.'}, {'pmid': '19102343', 'type': 'BACKGROUND', 'citation': 'Chude GG, Rayate NV, Patris V, Koshariya M, Jagad R, Kawamoto J, Lygidakis NJ. Defunctioning loop ileostomy with low anterior resection for distal rectal cancer: should we make an ileostomy as a routine procedure? A prospective randomized study. Hepatogastroenterology. 2008 Sep-Oct;55(86-87):1562-7.'}, {'pmid': '23095628', 'type': 'BACKGROUND', 'citation': 'Loffler T, Rossion I, Bruckner T, Diener MK, Koch M, von Frankenberg M, Pochhammer J, Thomusch O, Kijak T, Simon T, Mihaljevic AL, Kruger M, Stein E, Prechtl G, Hodina R, Michal W, Strunk R, Henkel K, Bunse J, Jaschke G, Politt D, Heistermann HP, Fusser M, Lange C, Stamm A, Vosschulte A, Holzer R, Partecke LI, Burdzik E, Hug HM, Luntz SP, Kieser M, Buchler MW, Weitz J; HASTA Trial Group. HAnd Suture Versus STApling for Closure of Loop Ileostomy (HASTA Trial): results of a multicenter randomized trial (DRKS00000040). Ann Surg. 2012 Nov;256(5):828-35; discussion 835-6. doi: 10.1097/SLA.0b013e318272df97.'}]}, 'descriptionModule': {'briefSummary': 'There are severel problems associated with the closing of a temporary loop-ileostomy after surgery for rectal cancer. The purpose of this study is to answer two questions:\n\n1. The choice of anastomotic method - does it influence the postoperative course?\n2. The use of a prophylactic mesh when closing the stoma site - will there be less hernias?', 'detailedDescription': 'Postoperative complications after closure of a temporary loop ileostomy after rectal cancer surgery are common. In this study the investigators propose the hypothesis that a stapled anastomotic technique will decrease postoperative small bowel obstruction and a mesh closure of the stoma site in the abdominal wall will decrease hernia formation.\n\nAll patients will be randomized to stapled or hand-sewn anastomosis. The randomization to mesh or suture closure of the abdominal wall is optional.\n\nThe stapled anastomotic technique is performed by the use of a linear staple device and the hand-sewn technique with a running seromuscular monofilament suture.\n\nThe stoma site has two options and will be closed either by the use of mesh (lightweight), positioned under the muscle (retromuscular), or just by long-lasting suture. The anterior fascia of the rectus as well as the skin are closed by the use of running monofilament longlasting sutures, the latter in a pursestring procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* loop ileostomy after rectal cancer surgery\n* loop ileostomy closure is permitted and possible according to clinical practice\n\nExclusion Criteria:\n\n* patient unable to understand written or oral information'}, 'identificationModule': {'nctId': 'NCT02669992', 'acronym': 'LISTO', 'briefTitle': 'Loop Ileostomy Closure:Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site?', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Loop Ileostomy Closure.Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site in the Abdominal Wall. A Prospective Randomised Multicenter Trial.', 'orgStudyIdInfo': {'id': '2015/321-31/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stapled anastomosis', 'description': 'Stapled anastomosis by the use of commercially available linear stapler device', 'interventionNames': ['Procedure: Stapled or Hand-sewn anastomosis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hand-sewn anastomosis', 'description': 'Hand-sewn by the use of a resorbable monofilament suture', 'interventionNames': ['Procedure: Stapled or Hand-sewn anastomosis']}, {'type': 'EXPERIMENTAL', 'label': 'Abdominal wall mesh closure', 'description': 'Closure by the use of a mesh low-weight net device', 'interventionNames': ['Procedure: Mesh or suture stoma site closure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Abdominal wall suture closure', 'description': 'Closure by the use of slowly absorbing monofilament suture', 'interventionNames': ['Procedure: Mesh or suture stoma site closure']}], 'interventions': [{'name': 'Stapled or Hand-sewn anastomosis', 'type': 'PROCEDURE', 'description': 'Randomization between stapled or hand-sewn anastomosis', 'armGroupLabels': ['Hand-sewn anastomosis', 'Stapled anastomosis']}, {'name': 'Mesh or suture stoma site closure', 'type': 'PROCEDURE', 'description': 'Randomization between suture or Mesh closure of the stoma site', 'armGroupLabels': ['Abdominal wall mesh closure', 'Abdominal wall suture closure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Petra wieveg, MD', 'role': 'CONTACT'}], 'facility': 'Sahlgrenska Universitetssjukhuset, Östra sjukhuset', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Karlstad', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Claes Erixon', 'role': 'CONTACT'}], 'facility': 'Centralsjukhuset Karlstad', 'geoPoint': {'lat': 59.3793, 'lon': 13.50357}}, {'city': 'Luleå', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Christoffer Odensten', 'role': 'CONTACT'}], 'facility': 'Sunderby Sjukhus', 'geoPoint': {'lat': 65.58415, 'lon': 22.15465}}, {'city': 'Lycksele', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Lycksele lasarett', 'geoPoint': {'lat': 64.59537, 'lon': 18.67351}}, {'city': 'Norrtälje', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Rebecka Zacharias', 'role': 'CONTACT'}], 'facility': 'Norrtälje sjukhus', 'geoPoint': {'lat': 59.75799, 'lon': 18.70496}}, {'city': 'Östersund', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Pär Nordin', 'role': 'CONTACT'}], 'facility': 'Östersunds sjukhus', 'geoPoint': {'lat': 63.1792, 'lon': 14.63566}}, {'city': 'Skellefteå', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Mats Hjortborg', 'role': 'CONTACT'}], 'facility': 'Skellefteå lasarett', 'geoPoint': {'lat': 64.75067, 'lon': 20.95279}}, {'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Ylva Falken, MD', 'role': 'CONTACT'}], 'facility': 'Danderyds sjukhus', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Ulrik Lindforss', 'role': 'CONTACT'}], 'facility': 'Karolinska universitetssjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Umeå', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Ulf Gunnarsson, prof', 'role': 'CONTACT'}], 'facility': 'Norrlands Universitets Sjukhus', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'zip': '62149', 'city': 'Visby', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Pontus Gustafsson, MD', 'role': 'CONTACT', 'email': 'pontus.gustafsson@gotland.se', 'phone': '+46703272152'}], 'facility': 'Region Gotland', 'geoPoint': {'lat': 57.64089, 'lon': 18.29602}}], 'centralContacts': [{'name': 'Pontus Gustafsson, MD', 'role': 'CONTACT', 'email': 'pontus.gustafsson@gotland.se', 'phone': '+46703272152'}], 'overallOfficials': [{'name': 'Ulrik Lindforss, A.P', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Ulrik Lindforss', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}