Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-18 @ 12:52 AM
Study NCT ID:
NCT02667860
Status:
COMPLETED
Last Update Posted:
2019-01-14
First Post:
2016-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-corporeal vs Extra-corporeal Anastomosis in Laparoscopically Assisted Right Hemicolectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-11', 'studyFirstSubmitDate': '2016-01-13', 'studyFirstSubmitQcDate': '2016-01-26', 'lastUpdatePostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': '1 month', 'description': 'is identified when the patient has tolerated diet and has had bowel movements and is discharged from the hospital'}], 'secondaryOutcomes': [{'measure': 'Return to normal peristalsis', 'timeFrame': '1 week', 'description': 'Physiological parameter'}, {'measure': 'Size of the surgical wound', 'timeFrame': '1 month', 'description': 'we measure the wound in cm'}, {'measure': 'Rate of Surgical Site Infection', 'timeFrame': '1 month', 'description': 'clinical wound infection or positive culture'}, {'measure': 'Rate of Incisional Hernia', 'timeFrame': '1 year after discharge', 'description': 'Physical exploration and CT scan (performed during the follow up)'}, {'measure': 'Aesthetic result', 'timeFrame': '1 month after discharge', 'description': 'Questionnaire'}, {'measure': 'Postoperative pain', 'timeFrame': '1 month after discharge', 'description': 'Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intracorporeal anastomosis', 'laparoscopic colectomy', 'outcomes', 'length of stay', 'analgesia', 'aesthetic', 'extracorporeal anastomosis', 'laparoscopic'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '31846067', 'type': 'DERIVED', 'citation': 'Bollo J, Turrado V, Rabal A, Carrillo E, Gich I, Martinez MC, Hernandez P, Targarona E. Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial). Br J Surg. 2020 Mar;107(4):364-372. doi: 10.1002/bjs.11389. Epub 2019 Dec 17.'}, {'pmid': '30191370', 'type': 'DERIVED', 'citation': 'Bollo J, Salas P, Martinez MC, Hernandez P, Rabal A, Carrillo E, Targarona E. Intracorporeal versus extracorporeal anastomosis in right hemicolectomy assisted by laparoscopy: study protocol for a randomized controlled trial. Int J Colorectal Dis. 2018 Nov;33(11):1635-1641. doi: 10.1007/s00384-018-3157-9. Epub 2018 Sep 6.'}]}, 'descriptionModule': {'briefSummary': 'The creation of an intracorporeal anastomosis during right hemicolectomy is regarded as superior than the extracorporeal anastomosis in terms of recovery of peristalsis, aesthetic results, analgesia requirements and length of hospital stay. The objective of this study is to compare the postoperative results of intracorporeal versus extracorporeal anastomosis in patients undergoing laparoscopic right hemicolectomy.', 'detailedDescription': 'Laparoscopic surgery has entailed a great technical revolution in colorectal surgery, providing a better and quicker return to normal functions of the patients, associating a lower morbidity and better aesthetic results compared with traditional open surgery. This study wants to find the difference between intracorporeal and extracorporeal anastomosis.\n\nThe creation of an intracorporeal anastomosis in right hemicolectomy seems superior to extracorporeal anastomosis in terms of recovery of the normal bowel function, wound size, aesthetic results and analgesia requirements. This will entail a shorter hospital stay. Several studies have demonstrated this but all of them are retrospective non randomised.\n\nIn terms of postoperative pain, the most accepted theory is that it depends on the traction of the porto-mesenteric axis. When the intracorporeal anastomosis is performed there is no traction of this mesenteric axis while in the extracorporeal anastomosis this traction is more important in obese patients.\n\nThis traction of the mesentery, as well as being one of the main factors related with postoperative pain, is responsible of the postoperative adynamic ileus, that should have a higher incidence when the manipulation is higher.\n\nIn the patients undergoing an intracorporeal anastomosis, the assistance incision will be a suprapubic Pfannenstiel. In the patients undergoing an extracorporeal anastomosis the assistance incision will be a transverse in the right upper quadrant. It is well known that the Pfannenstiel incision has a lower incidence of superficial surgical wound infection, a lower rate of incisional hernia, a lower need of analgesics, and better aesthetic results, when compared with the incision in the right upper quadrant.\n\nAll this factors should entail a lower hospital stay in patients undergoing an intracorporeal anastomosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgical procedure with curative purpose.\n* American Society of Anaesthesiologists Physical Status (ASA) I, II and III.\n* Elective surgery.\n* Informed consent.\n\nExclusion Criteria:\n\n* Denial of informed consent.\n* Advanced neoplasia.\n* Urgent surgery.\n* ASA IV.'}, 'identificationModule': {'nctId': 'NCT02667860', 'briefTitle': 'Intra-corporeal vs Extra-corporeal Anastomosis in Laparoscopically Assisted Right Hemicolectomy', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Intra-corporeal vs Extra-corporeal Anastomosis in Laparoscopically Assisted Right Hemicolectomy', 'orgStudyIdInfo': {'id': 'IIBSP-AIE-2015-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intracorporeal anastomosis', 'description': 'Iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Echelon Endopatch and closure of the defect with running suture or another firing of Echelon Endopatch. The surgical specimen will be retrieved through a Pfannenstiel incision.', 'interventionNames': ['Procedure: Intracorporeal anastomosis.', 'Device: Echelon Endopatch']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Extracorporeal anastomosis', 'description': 'A transverse incision in the right upper quadrant will be performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Rel Stapler', 'interventionNames': ['Procedure: Extracorporeal anastomosis', 'Device: Proximate Linear Cutter']}], 'interventions': [{'name': 'Intracorporeal anastomosis.', 'type': 'PROCEDURE', 'description': 'Iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Echelon Endopatch and closure of the defect with running suture or another firing of Echelon Endopatch. The surgical specimen will be retrieved through a Pfannenstiel incision.', 'armGroupLabels': ['Intracorporeal anastomosis']}, {'name': 'Extracorporeal anastomosis', 'type': 'PROCEDURE', 'description': 'A transverse incision in the right upper quadrant will be performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Stapler.', 'armGroupLabels': ['Extracorporeal anastomosis']}, {'name': 'Echelon Endopatch', 'type': 'DEVICE', 'description': 'Use of an Echelon Endopatch Powered Device to perform an ileocolonic side-to-side anastomosis.', 'armGroupLabels': ['Intracorporeal anastomosis']}, {'name': 'Proximate Linear Cutter', 'type': 'DEVICE', 'description': 'Use of a Proximate Linear Cutter device to perform a side-to-side ileo-colonic anastomosis.Use of a Proximate stapler to the closure of the defect associated with the creation of the side-to-side ileo-colonic anastomosis.', 'armGroupLabels': ['Extracorporeal anastomosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Jesus Bollo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'All the time', 'ipdSharing': 'YES', 'description': 'Raw data will be available upon request to the main researcher.', 'accessCriteria': 'without'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}