Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT06986902
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2025-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Analysis of Postoperative Manometry Outcomes in Nissen vs Toupet Fundoplication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-04-06', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Distal Contractile Integral (DCI)', 'timeFrame': '6 Weeks Postoperative', 'description': 'Postoperative peristaltic vigor will be quantified as DCI on HRM at 6 weeks. Unit of measurement : mm Hg·s·cm'}, {'measure': 'Integrated Relaxation Pressure over 4 seconds (IRP-4s)', 'timeFrame': '6 Weeks Postoperative', 'description': 'IRP-4s will be measured on HRM tracings 6 weeks postoperatively to assess adequacy of LES relaxation during swallowing.\n\nUnit of Measurment : mm Hg'}, {'measure': 'Distal Latency', 'timeFrame': '6 Weeks Postoperative', 'description': 'Time from swallow onset to distal contractile deceleration point will be recorded on HRM 6 weeks post-surgery.\n\nUnit of Measurment : seconds'}, {'measure': 'Percentage of Normal Esophageal Contractions', 'timeFrame': '6 Weeks Postoperative', 'description': 'Proportion of swallows exhibiting normal peristaltic patterns on HRM 6 weeks after surgery.\n\nunit of measurement : %'}, {'measure': 'Percentage of Fragmented Esophageal Contractions', 'timeFrame': '6 Weeks Postoperative', 'description': 'Proportion of swallows showing fragmented peristalsis on HRM 6 weeks post-operation.\n\nunit of measurement : %'}], 'primaryOutcomes': [{'measure': 'Lower Esophageal Sphincter (LES) Resting Pressure', 'timeFrame': '6 Weeks Postoperative', 'description': 'LES resting pressure will be recorded using high-resolution manometry (HRM) at 6 weeks after surgery to quantify baseline LES tone restoration.\n\nUnit of Measurment : mm Hg'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['GERD - Gastro-Esophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial investigates the effects of laparoscopic Nissen and Toupet fundoplication on postoperative esophageal manometry findings in patients with gastroesophageal reflux disease (GERD). The study, conducted at Ain Shams University Hospitals, involved 20 adult patients randomly assigned to undergo either procedure. Preoperative and postoperative high-resolution manometry (HRM) was used to assess lower esophageal sphincter (LES) pressure and esophageal motility.', 'detailedDescription': "Preoperative Setting:\n\nBefore surgery, all patients underwent a thorough clinical assessment to evaluate the severity of their GERD symptoms, history of medication use, and the presence of extra-esophageal manifestations such as chronic cough or aspiration. A comprehensive diagnostic workup was conducted, including upper gastrointestinal endoscopy to assess mucosal integrity, rule out Barrett's esophagus, and evaluate the presence of a hiatal hernia. A barium swallow study was performed to assess esophageal motility, reflux severity, and anatomical abnormalities. The cornerstone of preoperative evaluation was high-resolution manometry (HRM), which provided precise measurements of lower esophageal sphincter (LES) pressure, esophageal peristalsis, and overall esophagogastric junction function.\n\nPatients were deemed eligible for the study if they were between 18 and 65 years old and had documented low LES pressure on HRM. Those with persistent GERD symptoms despite at least 12 weeks of maximal medical therapy, intolerance to medication, or a desire to avoid lifelong proton pump inhibitor (PPI) therapy were considered suitable candidates. To ensure adequate postoperative esophageal motility, only patients with at least 30% esophageal peristalsis were included. Patients with esophageal motility disorders (such as achalasia), morbid obesity (BMI \\>35 kg/m²), a history of upper abdominal surgery, or a severely shortened esophagus were excluded. Patients classified as ASA III, IV, or V were also excluded due to the increased surgical risks associated with poor general health.\n\nPatients were required to fast for at least 6-8 hours before surgery to minimize aspiration risk. Routine preoperative laboratory investigations, including a complete blood count (CBC), coagulation profile, and liver and kidney function tests, were performed. All patients underwent a pre-anesthesia assessment to determine their fitness for general anesthesia. On the day of surgery, prophylactic intravenous antibiotics were administered.\n\nIntraoperative Setting:\n\nThe surgery was performed laparoscopically under general anesthesia. Patients were positioned in the modified lithotomy position with a reverse Trendelenburg tilt (head-up) to improve surgical exposure of the esophagogastric junction. The abdominal area was sterilized using antiseptic solution, and a CO₂ pneumoperitoneum was established (typically 12-15 mmHg) to facilitate laparoscopic access. A total of five to six laparoscopic ports were placed, with a 10-mm umbilical port for the camera and 5-mm ports for instruments and liver retraction.\n\nFor Nissen fundoplication, the procedure included circumferential dissection of the esophagus (ensuring 2-3 cm intra-abdominal length), crural closure with non-absorbable sutures, and mobilization of the gastric fundus (with division of short gastric vessels as needed). A 360° wrap was constructed and secured with four to five interrupted sutures. A 60F esophageal bougie was introduced intraoperatively to prevent a tight wrap.\n\nFor Toupet fundoplication, esophageal mobilization and crural closure were performed similarly. A 270° posterior wrap was constructed by positioning the gastric fundus posteriorly around the esophagus. It was secured with two to three sutures anchoring it to the right crura, two to three sutures attaching it to the esophagus, and two sutures securing it to the left crura. No esophageal bougie was used.\n\nAfter the wrap, the surgeon ensured adequate tension, confirmed hemostasis, inspected for injury, and closed the abdominal incisions. Patients were extubated once fully recovered from anesthesia.\n\nPostoperative Setting:\n\nFollowing surgery, patients were monitored in the post-anesthesia care unit (PACU). Pain was managed with intravenous analgesics (e.g., paracetamol, NSAIDs, or opioids). Antiemetics such as ondansetron or metoclopramide were administered. Early ambulation was encouraged to reduce risks of deep vein thrombosis (DVT) and pulmonary complications.\n\nPostoperative dietary advancement was structured to support healing. On the first postoperative day, patients were started on clear liquids. Over the next week, they progressed to a full liquid diet, then to soft/puréed foods by weeks 2-4, and finally to solids after four weeks while avoiding carbonated or hard foods.\n\nAll patients underwent high-resolution manometry (HRM) at six weeks postoperatively to assess LES pressure and esophageal motility. Data were collected and prepared for later analysis in accordance with study protocols."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients between 18 and 65 years of age\n* Patients with pre-operable low LES pressure proven by High resolution manometry.\n* Patients refractory to medical therapy: Persistent symptoms after 12 weeks of maximal medical therapies, recurrence upon cessation of medications.\n* Patients who are non-compliance with medical therapies or inability to tolerate medical therapies .\n* Patients with esophageal motility more than 30%\n\nExclusion Criteria:\n\n* Patients with esophageal motility less than 30%.\n* Patent with morbidly obese (BMI more than 35 kg/m2),\n* Patients with recent upper abdominal surgery or severely shortened esophagus\n* Extremes of age less than 18 and more than 65.\n* Patients who are unfit for general anesthesia (ASAIII,IV or V)..'}, 'identificationModule': {'nctId': 'NCT06986902', 'briefTitle': 'Comparative Analysis of Postoperative Manometry Outcomes in Nissen vs Toupet Fundoplication', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Comparative Study Between the Effect of Nissen Fundoplication and Toupet Fundoplication on Post Operative Manometry Findings A Randomized Control Trial Study', 'orgStudyIdInfo': {'id': 'No. IRB00006379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'N GROUP', 'description': 'Patients undergoing laparoscopic Nissen fundoplication (LNF), which involves a 360° total wrap of the gastric fundus around the esophagus.', 'interventionNames': ['Procedure: Laparoscopic Nissen Fundoplication']}, {'type': 'EXPERIMENTAL', 'label': 'T group', 'description': 'Patients undergoing laparoscopic Toupet fundoplication (LTF), which involves a 270° posterior partial wrap of the gastric fundus around the esophagus.', 'interventionNames': ['Procedure: Laparoscopic Toupet fundoplication']}], 'interventions': [{'name': 'Laparoscopic Nissen Fundoplication', 'type': 'PROCEDURE', 'description': 'a 360° total wrap of the gastric fundus around the esophagus.', 'armGroupLabels': ['N GROUP']}, {'name': 'Laparoscopic Toupet fundoplication', 'type': 'PROCEDURE', 'description': 'a 270° posterior partial wrap of the gastric fundus around the esophagus.', 'armGroupLabels': ['T group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11111', 'city': 'Cairo', 'state': 'Egypt', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Edward A Gadalla, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant lecturer in General surgery Department , Ain shams University Hospitals'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'all data will be shared once study is completed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}