Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-01-04 @ 8:43 PM
Study NCT ID:
NCT01720966
Status:
COMPLETED
Last Update Posted:
2015-11-10
First Post:
2012-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adhesions After Open Versus Laparoscopic Resection of Colorectal Malignancies Detected During Liver Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000267', 'term': 'Tissue Adhesions'}], 'ancestors': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006498', 'term': 'Hepatectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-09', 'studyFirstSubmitDate': '2012-10-24', 'studyFirstSubmitQcDate': '2012-11-01', 'lastUpdatePostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Small bowel obstruction in history', 'timeFrame': 'in history (up to 5 years preceeding second operation)', 'description': 'Patient has episode of small bowel obstruction in medical history'}], 'primaryOutcomes': [{'measure': 'Incidence of adhesion to ventral abdominal wall', 'timeFrame': 'peroperative (1 day)', 'description': 'To compare the incidence of adhesions to the ventral abdominal wall in patients undergoing laparotomy or laparoscopy for intended liver resection for colorectal metastases after open versus laparoscopic resection of the primary tumour.'}], 'secondaryOutcomes': [{'measure': 'Incidence of adhesions', 'timeFrame': 'peroperative (1 day)', 'description': 'Total incidence of adhesions'}, {'measure': 'Extent of adhesions', 'timeFrame': 'peroperative (1 day)', 'description': 'Extent of adhesions'}, {'measure': 'Adhesion Score', 'timeFrame': 'peroperative (1 day)', 'description': 'Adhesion score according to Zühlke'}, {'measure': 'Adhesiolysis', 'timeFrame': 'peroperative (1 day)', 'description': 'need to perform adhesiolysis'}, {'measure': 'Duration of adhesiolysis', 'timeFrame': 'peroperative (1 day)', 'description': 'Duration of adhesiolysis in minutes'}, {'measure': 'Inadvertent bowel injury', 'timeFrame': 'peroperative (1 day)', 'description': 'Inadvertent bowel injury made during operation'}, {'measure': 'Postoperative mobidity', 'timeFrame': '30 days', 'description': 'Incidence of predetermined postoperative complications:\n\n* mortality\n* incisional wound infection\n* abdominal sepsis\n* pneumonia\n* urinary tract infection'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adhesions', 'laparoscopy', 'laparotomy', 'liver resection', 'colorectal malignancy'], 'conditions': ['Adhesions']}, 'referencesModule': {'references': [{'pmid': '23013804', 'type': 'BACKGROUND', 'citation': 'ten Broek RP, Strik C, Issa Y, Bleichrodt RP, van Goor H. Adhesiolysis-related morbidity in abdominal surgery. Ann Surg. 2013 Jul;258(1):98-106. doi: 10.1097/SLA.0b013e31826f4969.'}]}, 'descriptionModule': {'briefSummary': "Rationale: Adhesion formation is a frequent complication after abdominal surgery. Adhesion formation might be reduced by laparoscopic surgery, however sound evidence is lacking. Colorectal surgery would be a good clinical model to investigate adhesion formation between open and laparoscopic surgery because of the adhesion formation propensity of colorectal surgery. However, a randomized controlled study to provide direct evidence is unlikely because of large numbers of patients needed for such a trial and the difficulty to check for adhesion formation at second surgery. Therefore we investigate adhesion formation after laparoscopic and open colorectal surgery for malignancy at liver surgery for metastases.\n\nObjective: The aim of our study is to compare the incidence of adhesions after laparoscopic versus open surgery for colorectal malignancies during liver resection for colorectal metastases.\n\nStudy design: The study is designed as a prospective observational cohort study.\n\nStudy population: All consecutive, adult patients undergoing laparotomy or laparoscopy for intended liver resection or radio frequency ablation for liver metastases of a colorectal malignancy in whom inspection of the middle and lower abdomen is possible to map adhesions.\n\nMain study parameters/endpoints:\n\n* Primary endpoint is incidence of adhesions to the ventral abdominal wall around the site of the original incision.\n* Secondary endpoints are episodes of bowel obstruction between index surgery and liver surgery; total incidence of adhesions; extent of adhesions; Zühlke classification of adhesions; performance of adhesiolysis; duration of adhesiolysis; peroperative complications: enterotomy, seromuscular injury, inadvertent organ injury during adhesiolysis; postoperative complications: delayed diagnosed perforation, SAE's.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: This study is an observational study. The existence of adhesions will be assessed during laparotomy or laparoscopy for the treatment of liver metastases. The laparotomy is indicated for medical treatment and should not be enlarged solely for the assessment of adhesions nor will the operating time be influenced for this purpose.\n\nAdhesions and peroperative complications have to be scored by the operating surgeon during or directly after surgery. The postoperative complications have to be scored during the postoperative course by the doctors on the ward. These assessments do not interfere with the treatment of the patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients undergoing laparotomy or laparoscopy for intended liver resection or radio frequency ablation for colorectal metastases in the before mentioned centers will be assessed for eligibility. The planned number of patients will be recruited in approximately 1 year.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* laparotomy or laparoscopy for intended liver resection or radio frequency ablation for colorectal metastases\n* laparoscopy or laparotomy for colorectal malignancy in history\n* age ≥18 years\n\nExclusion Criteria:\n\n* a history of abdominal surgery with a high risk of adhesions either before resection of the primary tumour or during the interval between resection of the primary tumour and liver resection. These high risk surgeries are:\n\n * Colorectal surgery\n * Ovarian surgery\n * Abdominal wall surgery\n* mental incompetence'}, 'identificationModule': {'nctId': 'NCT01720966', 'acronym': 'ALIVE', 'briefTitle': 'Adhesions After Open Versus Laparoscopic Resection of Colorectal Malignancies Detected During Liver Resection', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Adhesions After Open Versus Laparoscopic Resection of Colorectal Malignancies Detected During Liver Resection', 'orgStudyIdInfo': {'id': 'RU-RTB-0004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Laparoscopy', 'description': 'Patients who will undergo liver resection who have a laparoscopically performed colorectal resection in history. Assignment to cohort is on intention to treat of the primary operation.', 'interventionNames': ['Procedure: Liver resection']}, {'label': 'Laparotomy', 'description': 'Patients who will undergo liver resection who have an open colorectal resection in history. Assignment to cohort is on intention to treat of the primary operation.', 'interventionNames': ['Procedure: Liver resection']}], 'interventions': [{'name': 'Liver resection', 'type': 'PROCEDURE', 'description': 'Liver resection performed for metastatic disease from colorectal carcinoma', 'armGroupLabels': ['Laparoscopy', 'Laparotomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboud University Nijmegen Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Apeldoorn', 'country': 'Netherlands', 'facility': 'Gelre Ziekenhuis', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'city': 'Ede', 'country': 'Netherlands', 'facility': 'Ziekenhuis Gelderse Vallei', 'geoPoint': {'lat': 52.03333, 'lon': 5.65833}}, {'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Daniel de hoed kliniek', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Veldhoven', 'country': 'Netherlands', 'facility': 'Maxima Medisch Centrum', 'geoPoint': {'lat': 51.41833, 'lon': 5.40278}}], 'overallOfficials': [{'name': 'Harry P van Goor, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}