Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-25 @ 11:53 AM
Study NCT ID:
NCT06732661
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-13
First Post:
2024-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preserving the Pre-cardial Fat Pad During Sleeve Gastrectomy on Postoperative Gastroesophageal Reflux
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2024-12-10', 'studyFirstSubmitQcDate': '2024-12-10', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of gastroesophageal reflux disease', 'timeFrame': '1 year', 'description': 'The rate of gastroesophageal reflux disease following sleeve gastrectomy at 1 year'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': '30 days postoperatively', 'description': 'Complications within 30 days postoperatively'}, {'measure': 'Operating time', 'timeFrame': 'During the operation', 'description': 'Time from opeing of the operation to the end of the operation'}, {'measure': 'excessive weight loss', 'timeFrame': '3 months, 6 months, 1 year postoperativel', 'description': 'Percentage of excess weight loss (EWL) at any time postoperative was calculated as the amount of weight loss divided by the amount of excess weight times 100%.'}, {'measure': 'total weight loss', 'timeFrame': '3 months, 6 months, 1 year postoperatively', 'description': 'total weight loss compared with preoperative weight'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleeve gastrectomy', 'pre-cardial fat pad', 'Gastroesophageal Reflux Disease', 'Weight Loss'], 'conditions': ['Sleeve Gastrectomy', 'Pre-cardial Fat Pad', 'Excessive Weight Loss', 'Total Weight Loss', 'Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': "Gastroesophageal reflux disease (GERD) is one of the most common chronic conditions that can affect one's quality of life. Laparoscopic sleeve gastrectomy (LSG) has become a popular technique and currently is the most frequently practiced surgical operation to treat obesity today. However, the prevalence of GERD following SG can be fairly high. Several studies have noted an incidence between 6% and 47%.\n\nThe angle of His is important for the maintenance of esophageal anti-reflux ability, and prevent GERD. Most SG operating consensus recommends surgeons should stay at least 1 cm away from the angle of His. However, on consensus was reached about the pre-cardial fat pad should be routinely dissected or not to avoid leaving behind a large fundus consensus.\n\nThe investigators propose to perform a prospective randomized controlled study to dissect the pre-cardial fat pad or not in obese patients followig sleeve gastrectomy to prevent GERD.", 'detailedDescription': "Gastroesophageal reflux disease (GERD) is one of the most common chronic conditions that can affect one's quality of life. Laparoscopic sleeve gastrectomy (LSG) has become a popular technique and currently is the most frequently practiced surgical operation to treat obesity today. However, the prevalence of GERD following SG can be fairly high. Several studies have noted an incidence between 6% and 47%.\n\nThe angle of His is important for the maintenance of esophageal anti-reflux ability, and prevent GERD. Most SG operating consensus recommends surgeons should stay at least 1 cm away from the angle of His. However, on consensus was reached about the pre-cardial fat pad should be routinely dissected or not to avoid leaving behind a large fundus consensus.\n\nThe dissection of pre-cardial fat pad is helpful to fully expose the gastric fundus, to accurately judge the distance between the incision line and the esophagus, and to help the suture embedding of the incision line. However, the disadvantages might increase the rate of GERD. While retaining the pre-cardial fat pad may contribute to the reduction of GERD rate. However, it might not be conducive to the judgment of cutting distance to the esophagus and the procedure of suture embedding. Futhermore, there may be gastric fundus residue during SG.\n\nThe investigators propose to perform a prospective randomized controlled study to dissect the pre-cardial fat pad or not in obese patients followig sleeve gastrectomy to prevent GERD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI ≥ 32.5 kg/m2 with or without T2DM;\n* 27.5 kg/ m2 \\< BMI \\< 32.5 kg/m2 with T2DM but failed conservative treatment and combined with at least two metabolic diseases or comorbidities;\n* Duration of T2DM ≤15 years with fasting Cpeptide ≥ 50% of normal lower limit\n* Waist circumference: male ≥ 90 cm, female ≥ 85 cm\n* Age within 16\\~65 years old\n\nExclusion Criteria:\n\n* GERD preoperatively\n* Hiatus hernia approved by gastroscopy preoperatively\n* Pregnancy;\n* A history of mental illness and neurological disease;\n* The patient refuses surgery;\n* Combined with pituitary tumor;\n* Long-term use of antidepressant drugs;\n* Long-term use of immunosuppressants;\n* Situations in which the investigator or other examiner considers from the enrolled study that there are good reasons for nonconformity: if there are potential inconsistencies with the clinical protocol'}, 'identificationModule': {'nctId': 'NCT06732661', 'acronym': 'Pad and SG', 'briefTitle': 'Preserving the Pre-cardial Fat Pad During Sleeve Gastrectomy on Postoperative Gastroesophageal Reflux', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'A Prospective Randomized Controlled Study on the Impact of Preserving the Pre-cardial Fat Pad During Sleeve Gastrectomy on Postoperative Gastroesophageal Reflux', 'orgStudyIdInfo': {'id': 'Fat pad-SG'}, 'secondaryIdInfos': [{'id': '82070685', 'type': 'OTHER_GRANT', 'domain': 'National Natural Science Foundation of China (General Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Preserve pre-cardial fat pad', 'description': 'For this group, a sleeve was fashioned starting 4 cm proximal to the pylorus using serial applications of an 60 stapler over a 36Fr oro-gastric bougie. A security distance of 10 mm lateral to the esophagus is respected without dissection of pre-cardial fat pad.'}, {'type': 'EXPERIMENTAL', 'label': 'Dissect pre-cardial fat pad', 'description': 'For this group, a sleeve was fashioned starting 4 cm proximal to the pylorus using serial applications of an 60 stapler over a 36Fr oro-gastric bougie. Dissect the pre-cardial fat pad, and a security distance of 10 mm lateral to the esophagus is respected.', 'interventionNames': ['Procedure: Preserve pre-cardial fat pad', 'Procedure: Dissect pre-cardial fat pad']}], 'interventions': [{'name': 'Preserve pre-cardial fat pad', 'type': 'PROCEDURE', 'description': 'For this group, a sleeve was fashioned starting 4 cm proximal to the pylorus using serial applications of an 60 stapler over a 36Fr oro-gastric bougie. A security distance of 10 mm lateral to the esophagus is respected without dissection of pre-cardial fat pad.', 'armGroupLabels': ['Dissect pre-cardial fat pad']}, {'name': 'Dissect pre-cardial fat pad', 'type': 'PROCEDURE', 'description': 'For this group, a sleeve was fashioned starting 4 cm proximal to the pylorus using serial applications of an 60 stapler over a 36Fr oro-gastric bougie. Dissect the pre-cardial fat pad, and a security distance of 10 mm lateral to the esophagus is respected.', 'armGroupLabels': ['Dissect pre-cardial fat pad']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Chaoyang Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}