Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 10:32 PM
Study NCT ID:
NCT07475169
Status:
COMPLETED
Last Update Posted:
2026-03-16
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Warm Saline Irrigation Before Omentopexy to Reduce Early Bleeding After Laparoscopic Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019106', 'term': 'Postoperative Hemorrhage'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective, randomized, parallel-group clinical trial. Participants undergoing laparoscopic sleeve gastrectomy are randomly assigned in a 1:1 ratio to receive either warm saline irrigation (37-40°C) of the staple line before omentopexy or standard room-temperature saline irrigation. Outcomes are compared between the two independent groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-03-14', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of early postoperative bleeding (composite outcome)', 'timeFrame': 'Within 48 hours after surgery', 'description': 'Composite endpoint defined as the occurrence of any of the following within 48 hours after surgery:\n\n1. Clinical evidence of bleeding\n2. Hemoglobin drop ≥2 g/dL on postoperative day 1\n3. Drain output \\>150 mL within 24 hours\n4. Need for endoscopic or surgical hemostasis'}], 'secondaryOutcomes': [{'measure': 'Hemostasis-phase duration (minutes)', 'timeFrame': 'During surgery (intraoperative)', 'description': 'Time required to achieve complete staple-line hemostasis after sleeve transection and prior to omentopexy (measured intraoperatively, in minutes).'}, {'measure': 'Additional intraoperative hemostatic maneuvers', 'timeFrame': 'During surgery (intraoperative)', 'description': 'Proportion of participants requiring additional hemostatic maneuvers (e.g., bipolar coagulation and/or clipping) to control staple-line bleeding.'}, {'measure': 'Hemoglobin drop (ΔHb) from baseline to postoperative day 1 (g/dL)', 'timeFrame': 'From preoperative baseline to postoperative day 1', 'description': 'Change in hemoglobin level (g/dL) calculated as preoperative hemoglobin minus postoperative day 1 hemoglobin (continuous outcome).'}, {'measure': 'Drain output volume in the first 24 hours (mL)', 'timeFrame': 'Postoperative 0-24 hours', 'description': 'Total drain output volume (mL) during the first 24 hours after surgery; measured every 8 hours and summed (continuous outcome).'}, {'measure': 'Postoperative pain intensity at 24 hours', 'timeFrame': '24 hours after surgery', 'description': 'Pain intensity assessed at 24 hours after surgery using the Visual Analog Scale (0-10). Higher scores indicate worse pain.'}, {'measure': 'Postoperative nausea and vomiting (PONV) within 48 hours', 'timeFrame': 'Postoperative day 0 to day 2 (within 48 hours)', 'description': 'Occurrence of postoperative nausea and/or vomiting and/or need for antiemetics in the early postoperative period.'}, {'measure': 'Length of hospital stay (days)', 'timeFrame': 'Perioperative', 'description': 'Total duration of index hospitalization measured in days from the date of surgery to the date of hospital discharge. Reported as a continuous outcome (mean number of days).'}, {'measure': '30-day postoperative complications (Clavien-Dindo)', 'timeFrame': 'Within 30 days after surgery', 'description': 'Binary outcome (Yes/No) indicating the occurrence of any postoperative complication within 30 days after surgery, classified according to the Clavien-Dindo system. The outcome is reported as the proportion of participants experiencing at least one complication.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laparoscopic sleeve gastrectomy', 'warm saline irrigation', 'staple line', 'omentopexy', 'postoperative bleeding', 'bariatric surgery', 'randomized clinical trial', 'hemostasis'], 'conditions': ['Postoperative Hemorrhage', 'Obesity']}, 'descriptionModule': {'briefSummary': 'This prospective randomized clinical trial evaluates whether warming saline irrigation (37-40 °C) applied to the gastric staple line before performing omentopexy during laparoscopic sleeve gastrectomy (LSG) can reduce early postoperative bleeding compared with conventional room-temperature saline irrigation.\n\nStaple-line bleeding remains one of the most relevant early complications after LSG and may lead to hemoglobin drop, prolonged drainage, blood transfusion, or re-intervention. Although reinforcement techniques such as oversewing or buttressing materials are commonly used, they may increase operative time and cost. Irrigation of the operative field is routinely performed during LSG to improve visualization; however, the potential effect of irrigation temperature on hemostasis has not been previously evaluated in bariatric surgery.\n\nIn this trial, 200 adult patients undergoing primary LSG were randomized in a 1:1 ratio to receive either warm saline irrigation (37-40 °C) or standard room-temperature saline irrigation (22-24 °C) applied directly to the staple line before omentopexy. All other operative steps were standardized.\n\nThe primary outcome is early postoperative bleeding within 48 hours. Secondary outcomes include hemoglobin drop, drain output, need for additional hemostatic maneuvers, operative efficiency, postoperative pain, length of hospital stay, and 30-day complications.\n\nThis study investigates a simple, low-cost, and easily applicable intraoperative modification that may enhance staple-line hemostasis and improve early recovery following LSG.', 'detailedDescription': 'Study Design and Rationale:\n\nThis study is a prospective, randomized, controlled clinical trial conducted at two high-volume tertiary bariatric centers. The aim is to evaluate whether irrigation of the gastric staple line with physiologically warm saline (37-40 °C) before performing omentopexy improves intraoperative hemostasis and reduces early postoperative bleeding following laparoscopic sleeve gastrectomy (LSG).\n\nIrrigation of the operative field is standard practice during laparoscopic surgery to clear blood and enhance visualization. However, the effect of irrigation temperature on staple-line hemostasis in bariatric surgery has not been previously studied. Warm irrigation has demonstrated hemostatic and recovery benefits in other surgical specialties. This trial compares two clinically relevant strategies: warm saline versus conventional room-temperature saline.\n\nParticipants:\n\nA total of 200 adult patients (18-60 years) undergoing primary LSG were enrolled. Inclusion criteria included BMI ≥ 40 kg/m² or ≥ 35 kg/m² with obesity-related comorbidities. Patients with coagulopathy, recent anticoagulant use, prior major upper abdominal surgery, advanced organ failure, pregnancy, or inability to complete follow-up were excluded.\n\nRandomization and Allocation:\n\nPatients were randomized in a 1:1 ratio using a computer-generated sequence with allocation concealment via sealed opaque envelopes. Surgeons were aware of the irrigation temperature, while postoperative assessors and patients were blinded to group allocation.\n\nIntervention:\n\nAfter completion of gastric transection using a 36-French bougie calibration, patients received:\n\n* Warm Irrigation Group: 400 mL sterile saline at 37-40 °C applied along the staple line.\n* Control Group: 400 mL sterile saline at 22-24 °C applied identically.\n\nAfter irrigation and complete suctioning, the staple line was inspected and any active bleeding was controlled using bipolar cautery or clips. Standardized omentopexy was then performed in all patients using interrupted 2-0 PDS sutures spaced 2 cm apart.\n\nNo buttressing material, sealants, or additional reinforcement techniques were used in either group.\n\nPrimary Outcome:\n\nEarly postoperative bleeding within 48 hours, defined as any of the following:\n\n* Hemoglobin drop ≥ 2 g/dL\n* Drain output ≥ 150 mL sanguineous fluid within 24 hours\n* Clinical signs of bleeding\n* Need for endoscopic or surgical hemostasis\n\nSecondary Outcomes:\n\n* Hemostasis-phase duration\n* Hemoglobin drop (continuous variable)\n* 24-hour drain output\n* Additional intraoperative hemostatic maneuvers\n* Postoperative pain scores\n* Postoperative nausea and vomiting\n* Length of hospital stay\n* 30-day complications (Clavien-Dindo classification)\n* Reoperation or readmission\n\nFollow-up:\n\nPatients were evaluated during hospitalization and followed at 1 week, 1 month, and 3 months postoperatively. All randomized patients completed follow-up and were included in intention-to-treat analysis.\n\nStatistical Considerations:\n\nSample size was calculated to detect reduction in bleeding incidence from 15% to 5% with 80% power. Statistical significance was defined as p \\< 0.05.\n\nThis study evaluates a safe, inexpensive, and easily reproducible intraoperative modification that may improve staple-line hemostasis and early recovery after LSG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 60 years\n* BMI ≥ 40 kg/m², or BMI ≥ 35 kg/m² with at least one obesity-related comorbidity (e.g., type 2 diabetes, hypertension, obstructive sleep apnea)\n* Eligible for primary laparoscopic sleeve gastrectomy\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Previous major upper abdominal surgery with expected adhesions\n* Known bleeding disorders\n* Use of anticoagulant or antiplatelet therapy within 7 days before surgery\n* Advanced hepatic or renal disease\n* Unstable cardiac conditions\n* Pregnancy\n* Immunosuppression\n* Active systemic infection\n* Inability to comply with follow-up schedule'}, 'identificationModule': {'nctId': 'NCT07475169', 'acronym': 'WARM-LSG', 'briefTitle': 'Warm Saline Irrigation Before Omentopexy to Reduce Early Bleeding After Laparoscopic Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Warm Staple-Line Irrigation (37-40 °C) Before Omentopexy Reduces Early Bleeding After Laparoscopic Sleeve Gastrectomy: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'FMASU-REC-49/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Warm Saline Irrigation', 'description': 'Warm saline irrigation (37-40°C) applied to the gastric staple line before omentopexy during laparoscopic sleeve gastrectomy.', 'interventionNames': ['Procedure: Warm Saline Irrigation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Room Temperature Saline', 'description': 'Standard room-temperature saline irrigation applied to the gastric staple line before omentopexy.', 'interventionNames': ['Procedure: Room Temperature Saline Irrigation']}], 'interventions': [{'name': 'Warm Saline Irrigation', 'type': 'PROCEDURE', 'description': 'Irrigation of the gastric staple line using warm saline (37-40°C) prior to omentopexy.', 'armGroupLabels': ['Warm Saline Irrigation']}, {'name': 'Room Temperature Saline Irrigation', 'type': 'PROCEDURE', 'description': 'Irrigation of the gastric staple line using room-temperature saline prior to omentopexy.', 'armGroupLabels': ['Room Temperature Saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}