Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-04-15 @ 7:02 PM
Study NCT ID:
NCT02791633
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2016-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2016-06-02', 'studyFirstSubmitQcDate': '2016-06-02', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disability free survival', 'timeFrame': '1 year', 'description': 'Disability free survival'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of life', 'timeFrame': '1 year', 'description': 'Use of WHODAS-12, WHOQOL-BREF with specific symptom questionnaires'}, {'measure': 'Impact of surgical pathology type on disability free survival', 'timeFrame': '1 year', 'description': 'Impact of surgical pathology type on disability free survival'}, {'measure': 'Impact of pre-operative Charlson Score on disability free survival', 'timeFrame': '1 year', 'description': 'Impact of pre-operative Charlson Score on disability free survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Quality of Life', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': "Observational feasibility study using Patient Reported Outcomes (PRO) to assess quality of life and 'return to normal life' up to 1 year following emergency laparotomy", 'detailedDescription': "Regaining baseline Health Related Quality of Life (HRQoL) and returning to 'normal life' after surgery are of vital importance for patients. Knowledge of the trajectory and degree of long-term functional recovery following emergency laparotomy, including the regaining of optimal HRQoL is limited as most research relating to this field has been done in patients undergoing planned surgery. Furthermore, a comprehensive understanding of the pattern of recovery and restoration of baseline HRQoL is also important to researchers wishing to assess the full impact of interventions in order to improve outcomes following emergency laparotomy. Assessing HRQoL in this surgical population remains a challenge in the absence of a validated instrument. The investigators plan to undertake a feasibility study to assess utilisation of four patient questionnaires, well established within other surgical populations, to describe the quality of early and long-term recovery following emergency laparotomy. The investigators will utilise the QoR-15 to describe short-term (in - hospital) recovery metrics and versions of the WHO-DAS and the WHOQOL-BREF to describe longer term disability free survival and return towards baseline HRQoL. The Post-Operative Morbidity Survey (POMS) will help capture the onset of complications at different points during recovery. The study also aims to test the feasibility of assessing the impact of pre-operative co-morbidities, age, quality of peri-operative and intra-operative care, surgical indication and findings as well as post-operative complications on long-term HRQoL."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients meeting NELA inclusion criteria (National Emergency Laparotomy Audit), undergoing Emergency Laparotomy at Russells Hall Hospital agreeing to participate', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- \\>=18 years NELA Inclusion Criteria\n\nExclusion Criteria:\n\n\\- Not willing to participate NELA Exclusion criteria'}, 'identificationModule': {'nctId': 'NCT02791633', 'acronym': 'REmLap', 'briefTitle': 'Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Dudley Group NHS Foundation Trust'}, 'officialTitle': 'Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study', 'orgStudyIdInfo': {'id': 'REmLap'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'otherNames': ['WHODAS, SF36, QOR15, POMS'], 'description': 'Quality of recovery and quality of recovery follow up questionnaires'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DY1 2HQ', 'city': 'Dudley', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'Russells Hall Hospital', 'geoPoint': {'lat': 52.5, 'lon': -2.08333}}], 'overallOfficials': [{'name': 'Adrian Jennings', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dudley Group NHSFT'}, {'name': 'Rajan Patel', 'role': 'STUDY_DIRECTOR', 'affiliation': 'DGNHSFT'}, {'name': 'Faisal Baig', 'role': 'STUDY_DIRECTOR', 'affiliation': 'DGNHSFT'}, {'name': 'Peter Waterland', 'role': 'STUDY_DIRECTOR', 'affiliation': 'DGNHSFT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dudley Group NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}