Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:10 AM
Study NCT ID:
NCT06107634
Status:
RECRUITING
Last Update Posted:
2024-12-18
First Post:
2023-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gastropexy in the Repair of Patients with Paraesophageal Hernias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006551', 'term': 'Hernia, Hiatal'}], 'ancestors': [{'id': 'D006548', 'term': 'Hernia, Diaphragmatic'}, {'id': 'D000082122', 'term': 'Internal Hernia'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059485', 'term': 'Gastropexy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The randomization process is initiated after general anesthesia is induced and the group affiliation will be determined by opening of a sealed envelope specifying the group assignment. The information of group allocation is stored in a closed envelope kept in a locked archive until the study is completed.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Conventional paraesophageal hernia repair with the addition of gastropexy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2030-08-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2023-10-24', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of hernia at 1 year after surgery', 'timeFrame': '1 year', 'description': 'Computer tomography of abdomen and thorax'}], 'secondaryOutcomes': [{'measure': 'Recurrence of hernia at 3 years after surgery', 'timeFrame': '3 year', 'description': 'Computer tomography of abdomen and thorax'}, {'measure': 'Complications after surgery', 'timeFrame': '30 days after surgery', 'description': 'Complication classified according to Clavien-Dindo'}, {'measure': 'Length of stay at the hospital after surgery', 'timeFrame': '30 days after surgery', 'description': 'Information from patients journal'}, {'measure': 'Changes in the patients perception of quality of life after surgery', 'timeFrame': '3 months, 12 months, and 36 months', 'description': 'SF-36 (Short Form 36) is a health related quality of life questionnaire. SF-36 is comprised of 36 items that assess eight dimensions of health: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Higher scores mean a better outcome. These can be grouped into mental and physical component summary scores. Scoring is from 0-100. A mean score of 50 has been articulated as normative value.'}, {'measure': 'Changes in the patients perception of gastrointestinal symptoms after surgery', 'timeFrame': '3 months, 12 months, and 36 months', 'description': 'GSRS (The Gastrointestinal Symptom Rating Scale) is a questionnaire, which contains 15 items, and uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one. The questions are grouped in five dimensions. A mean value for the items in each dimension will be calculated:\n\nDiarrhoea syndrome: 11. Increased passage of stools 12. Loose stools 14. Urgent need for defecation\n\nIndigestion syndrome: 6. Borborygmus 7. Abdominal distension 8. Eructation 9. Increased flatus\n\nConstipation syndrome: 10. Decreased passage of stools 13. Hard stools 15. Feeling of incomplete evacuation\n\nAbdominal pain syndrome: 1. Abdominal pain 4. Sucking sensations 5. Nausea and vomiting\n\nReflux syndrome: 2. Heartburn 3. Acid regurgitation.'}, {'measure': 'Changes in the patients perception of dysphagia after surgery', 'timeFrame': '3 months, 12 months, and 36 months', 'description': 'The Dakkak dysphagia score is a questionnaire for assessing benign dysphagia, including nine questions regarding the frequency (always, sometimes, or never) of swallowing difficulties with different food consistencies (liquid, semisolid, and solid foods). The final score ranges from 0 to 45, where 45 represents the most severe dysphagia.'}, {'measure': 'Changes in the patients perception of dysphagia and reflux frequency after surgery', 'timeFrame': '3 months, 12 months, and 36 months', 'description': 'Symptoms of heartburn, reflux, chest pain, dysphagia for liquids and solids, dyspnea, coughing and odynophagia were recorded using a four-graded scale to assess the frequency of symptoms with an arbitrary (empirical) cut off for clinical significance. The same instrument has been used in a previous RCT, from the same institution, comparing different types of anti-reflux procedures.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Paraesophageal Hernia']}, 'descriptionModule': {'briefSummary': 'Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional surgical hernia repair or with the addition of gastropexy.', 'detailedDescription': "Patients scheduled for surgery due to primary paraesophageal herniation are randomized into either the control group or the interventional group.\n\nControl Group: Patients undergo a crural repair combined with a short and floppy Nissen fundoplication.\n\nInterventional Group: In addition to the crural repair and Nissen fundoplication, patients receive a gastropexy. This involves the fixation of the posterior part of the wrap the right crus, the left portion of the wrap to the diaphragm, and the minor curvature of the stomach to the abdominal wall.\n\nFollow-Up Assessments:\n\nImaging: Computed tomography (CT) scans are performed before surgery and at 1 and 3 years postoperatively to evaluate anatomical outcomes.\n\nPatient-Reported Outcomes: The following questionnaires are completed before surgery, as well as at 3 months, 1 year, and 3 years after surgery:\n\nSF-36: A global quality of life instrument. GSRS: The Gastrointestinal Symptoms Rating Scale. Reflux Frequency Questionnaire: A measure reflux disease-related symptoms. Dakkak's Dysphagia Score: An assessment of swallowing difficulties."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients diagnosed with a primary paraesophageal hernia (hiatal hernia types II-IV) who are scheduled for elective or emergency surgical repair at participating centers\n\nExclusion Criteria:\n\n* Previous major upper gastrointestinal (GI) surgery, including prior hiatal hernia repair.\n* Diagnosis of achalasia or any other significant esophageal motility disorder.\n* Inability to understand the purpose of the study and/or inability or unwillingness to provide informed consent.\n* Severe comorbidities, defined by an American Society of Anesthesiologists (ASA) physical status score of greater than III.'}, 'identificationModule': {'nctId': 'NCT06107634', 'acronym': 'PEH3', 'briefTitle': 'Gastropexy in the Repair of Patients with Paraesophageal Hernias', 'organization': {'class': 'OTHER', 'fullName': 'Ersta Diakoni'}, 'officialTitle': 'Can Gastropexy Improve the Efficacy of the Crural Repair in Patients with Paraesophageal Hernias? a Double Blind, Randomized, Multicenter Clinical Trial', 'orgStudyIdInfo': {'id': 'Dnr 2023-01956-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard paraesophageal hernia repair', 'description': 'Standard paraesophageal hernia repair (crural suturing and a total (Nissen) fundoplication)', 'interventionNames': ['Procedure: Paraesophageal hernia repair']}, {'type': 'EXPERIMENTAL', 'label': 'Standard paraesophageal hernia repair + gastropexy', 'description': 'Standard paraesophageal hernia repair with the addition of a three point gastropexy (posterior, left anterolateral and anterior gastropexy)', 'interventionNames': ['Procedure: Gastropexy', 'Procedure: Paraesophageal hernia repair']}], 'interventions': [{'name': 'Gastropexy', 'type': 'PROCEDURE', 'description': 'In the intervention group, a three-point gastropexy is added to the repair. First, the right fundus flap is adapted posteriorly to the crural portion of the diaphragm with a 2-3 cm long running non-absorbable suture ("posterior gastropexy"). Second, the left fundus flap is adapted to the diaphragm anterolateral to the hiatus with a 2-3 cm long running non-absorbable suture ("left anterolateral gastropexy"). Finally, the minor curvature of the anterior stomach wall is adapted during reduced intraabdominal pressure to the anterior abdominal wall with a 2-3 cm long running non-absorbable suture ("anterior gastropexy").', 'armGroupLabels': ['Standard paraesophageal hernia repair + gastropexy']}, {'name': 'Paraesophageal hernia repair', 'type': 'PROCEDURE', 'description': "Ultrasonic shears are used for dissection. The herniated viscera are completely reduced into the abdomen and the hernia sac in fully dissected and resected. The esophagus is mobilized intraabdominally until at least 3 cm rests below the hiatus without tension. The anterior and posterior vagal nerves are identified and preserved. A posterior crural closure with running non-absorbable sutures is performed. An additional anterior crural closure may be performed at the surgeon's discretion. The fundus is mobilized to allow a floppy fundoplication. A total fundoplication is created by three interrupted non-absorbable sutures. No bougies are used routinely for calibration of the fundoplication.", 'armGroupLabels': ['Standard paraesophageal hernia repair', 'Standard paraesophageal hernia repair + gastropexy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '413 45', 'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Alexandros Tsoposidis', 'role': 'CONTACT', 'email': 'alexandros.tsoposidis@gu.se', 'phone': '+4631-3421000'}], 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '221 85', 'city': 'Lund', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Martin Jeremiasen, PhD', 'role': 'CONTACT', 'email': 'martin.jeremiasen@med.lu.se', 'phone': '+4646-171000'}], 'facility': 'Skåne University Hospital Lund', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '611 85', 'city': 'Nyköping', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Apostolos Analatos, PhD', 'role': 'CONTACT', 'email': 'apanalat@gmail.com', 'phone': '+46155-245000'}], 'facility': 'Nyköping Hospital', 'geoPoint': {'lat': 58.753, 'lon': 17.00788}}, {'zip': '11691', 'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Michaela Breistrand', 'role': 'CONTACT', 'email': 'michaela.breistrand@erstadiakoni.se', 'phone': '087146500'}], 'facility': 'Ersta Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '856 43', 'city': 'Sundsvall', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Yücel Cengiz, Associate professor', 'role': 'CONTACT', 'email': 'yucel.cengiz@rvn.se', 'phone': '+4660181000'}, {'name': 'Johan Blixt Dackhammar, PhD Student', 'role': 'CONTACT', 'email': 'johan.blixt.dackhammar@rvn.se', 'phone': '+4660181000'}], 'facility': 'Sundsvall County Hospital', 'geoPoint': {'lat': 62.39129, 'lon': 17.3063}}, {'zip': '751 85', 'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Gustav Linder, PhD', 'role': 'CONTACT', 'email': 'gustav.linder@uu.se', 'phone': '+4618-6110000'}], 'facility': 'Uppsala Academic Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Marcus Reuterwall Hansson, PhD', 'role': 'CONTACT', 'email': 'marcus.reuterwall.hansson@ki.se', 'phone': '+466147500'}], 'overallOfficials': [{'name': 'Anders Thorell, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ersta Diakoni'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ersta Diakoni', 'class': 'OTHER'}, 'collaborators': [{'name': 'Göteborg University', 'class': 'OTHER'}, {'name': 'Sundsvall Hospital', 'class': 'OTHER'}, {'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, senior consultant surgeon', 'investigatorFullName': 'Marcus Reuterwall Hansson', 'investigatorAffiliation': 'Ersta Diakoni'}}}}