Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-02-09 @ 11:42 AM
Study NCT ID:
NCT04837950
Status:
UNKNOWN
Last Update Posted:
2021-04-13
First Post:
2020-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Pleural Cavity Volume and Surgical Exposure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Volume of saline in pleural cavity and surgical field overview before and after pulling traction suture'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'During video-assisted thoracoscopic surgery a diaphragmatic traction-suture is placed posteriorly at the border between the central tendinous part and the peripheral muscular part. Body temperate saline solution is then poured into the pleural cavity until the cavity is filled up to the soft-tissue retractor in the utility port. The volume of saline in the pleural cavity is then measured and registered before and after distal contraction of the diaphragmatic traction suture through the camera port. Subsequently the surgeon will be asked to evaluate and rate the surgical field visual overview, before and after contraction of the suture. Furthermore, anonymized video recordings focusing on the pleural cavity visual overview before and after distal contraction of the suture, will be presented to specialist thoracic surgeons for a blinded evaluation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-08', 'studyFirstSubmitDate': '2020-11-09', 'studyFirstSubmitQcDate': '2021-04-07', 'lastUpdatePostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pleural cavity volume before', 'timeFrame': '1 minute after applying the traction suture', 'description': 'Pleural cavity volume (ml) before distal retraction of the diaphragmatic traction suture.'}, {'measure': 'Pleural cavity volume after', 'timeFrame': '2 minute after applying the traction suture', 'description': 'Pleural cavity volume (ml) after distal retraction of the diaphragmatic traction suture.'}], 'secondaryOutcomes': [{'measure': 'Visual overview', 'timeFrame': '1 minute after applying the traction suture', 'description': "The surgeon's evaluation of the surgical field visual overview before and after distal retraction of the diaphragmatic traction suture using a numeric rating scale (1-10)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thoracic Cancer']}, 'referencesModule': {'references': [{'pmid': '34586461', 'type': 'DERIVED', 'citation': 'Dittberner FA, Ladegaard L, Licht PB. A Diaphragmic Traction Suture Increases Pleural Cavity Volume and Surgical Field Overview During Video-Assisted Thoracoscopic Surgery. World J Surg. 2022 Jan;46(1):259-264. doi: 10.1007/s00268-021-06329-4. Epub 2021 Sep 29.'}]}, 'descriptionModule': {'briefSummary': 'The investigators want to investigate if a diaphragmatic traction-suture affects the pleural cavity volume, as well as improves visual overview of a surgical field during minimally invasive thoracic surgery.', 'detailedDescription': 'A visually good surgical field is essential in performing safe and optimal dissection of anatomical structures during Video Assisted Thoracoscopic Surgery (VATS). A number of patients referred to VATS-surgery appear with an elevated diaphragm, reducing visibility and complicating safe surgical techniques, thus entailing conversion from VATS into an open Thoracotomy. Some surgeons handle the decreased visibility due to an elevated diaphragm by increasing the amount of ports during VATS. Others have benefited from attaching a traction suture on the diaphragmatic posterior tendinous part, thus flatting the diaphragmatic dome when the suture is tightly retracted through the camera-port. It turns out that most thoracic surgery clinics are not familiar with this technique. There are also no articles regarding this topic in medical literature. We want to investigate if the diaphragmatic traction-suture affects the pleural cavity volume, as well as improves visual overview of a surgical field during minimally invasive thoracic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* known or suspected lung cancer\n* scheduled for VATS-surgery\n* perioperative finding of elevated diaphragma\n\nExclusion Criteria:\n\n* not willing to give informed consent.\n* perioperative finding of pleural adherences\n* perioperative finding without an elevated diaphragma'}, 'identificationModule': {'nctId': 'NCT04837950', 'briefTitle': 'Changes in Pleural Cavity Volume and Surgical Exposure', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Changes in Pleural Cavity Volume and Surgical Exposure Through Suture Retraction of the Diaphragm During VATS Procedures', 'orgStudyIdInfo': {'id': '20/44867'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Before pulling diaphragmatic suture', 'description': 'Measurement of pleural cavity volume and visual overview before pulling diaphragmatic suture', 'interventionNames': ['Procedure: Diaphragmatic traction-suture']}, {'type': 'EXPERIMENTAL', 'label': 'After pulling diaphragmatic suture', 'description': 'Measurement of pleural cavity volume and visual overview after pulling diaphragmatic suture', 'interventionNames': ['Procedure: Diaphragmatic traction-suture']}], 'interventions': [{'name': 'Diaphragmatic traction-suture', 'type': 'PROCEDURE', 'description': 'Measurement of pleural cavity volume before pulling the diaphragmatic traction-suture Measurement of pleural cavity volume after pulling the diaphragmatic traction-suture', 'armGroupLabels': ['After pulling diaphragmatic suture', 'Before pulling diaphragmatic suture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Peter B Licht, MD PhD', 'role': 'CONTACT', 'email': 'peter.licht@rsyd.dk', 'phone': '+45 65411831'}, {'name': 'Peter B Licht, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Finn Dittberner', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Dept Cardiothorcic Surgery, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Professor', 'investigatorFullName': 'Peter B Licht', 'investigatorAffiliation': 'Odense University Hospital'}}}}