Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
Study NCT ID:
NCT06737068
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-17
First Post:
2024-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Pressure Pneumoperitoneum Using AirSeal® for Reduction in Postoperative Shoulder Pain Following Robot Assisted Hiatal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006551', 'term': 'Hernia, Hiatal'}, {'id': 'D011027', 'term': 'Pneumoperitoneum'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D020069', 'term': 'Shoulder Pain'}], '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'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2024-11-19', 'studyFirstSubmitQcDate': '2024-12-11', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in post-operative shoulder pain', 'timeFrame': '1 week (on average)', 'description': 'Percentage reduction in post-operative shoulder pain from POD#0 to \\~1 week post-operative telephone appointment'}], 'secondaryOutcomes': [{'measure': 'Severity of postoperative shoulder pain on POD #0', 'timeFrame': '6 hours (on average)', 'description': 'Severity of postoperative shoulder pain on POD #0 (recorded at nursing shift change \\~7PM)'}, {'measure': 'Severity of postoperative shoulder pain on POD #1', 'timeFrame': '18 hours (on average)', 'description': 'Severity of postoperative shoulder pain on POD #1 (when surgical team rounds \\~6-8AM)'}, {'measure': 'Severity of postoperative shoulder pain at ~1 week', 'timeFrame': '1 week (on average)', 'description': 'Severity of postoperative shoulder pain at \\~1 week post-operative telephone appointment'}, {'measure': 'Severity of postoperative shoulder pain at ~2 weeks post-op', 'timeFrame': '2 weeks (on average)', 'description': 'Severity of postoperative shoulder pain at \\~2 week postoperative clinic visit measured by numeric pain rating scale and morphine milligram equivalents'}, {'measure': 'length of hospital stay', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'length of hospital stay'}, {'measure': 'readmission rates for shoulder pain', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'readmission rates for chief complaint of shoulder pain'}, {'measure': 'number of postoperative clinic visits related to shoulder pain management', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'number of postoperative clinic visits related to shoulder pain management'}, {'measure': 'discharge disposition', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'discharge disposition (home, SNF, rehab, etc)'}, {'measure': 'standard vs extended narcotic regimen', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'standard vs extended (requiring refill) narcotic regimen'}, {'measure': 'quality of life', 'timeFrame': '1 week (on average)', 'description': 'quality of life assessed via EQ-5D-5L and EQ-VAS questionnaires'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hernia, Hiatal', 'Pneumoperitoneum', 'Postoperative Pain', 'Shoulder Pain']}, 'referencesModule': {'references': [{'pmid': '32767145', 'type': 'BACKGROUND', 'citation': 'Luketina R, Luketina TLH, Antoniou SA, Kohler G, Konneker S, Manzenreiter L, Wundsam H, Koch OO, Knauer M, Emmanuel K. Prospective randomized controlled trial on comparison of standard CO2 pressure pneumoperitoneum insufflator versus AirSeal(R). Surg Endosc. 2021 Jul;35(7):3670-3678. doi: 10.1007/s00464-020-07846-4. Epub 2020 Aug 7.'}, {'pmid': '35327010', 'type': 'BACKGROUND', 'citation': 'Buda A, Di Martino G, Borghese M, Restaino S, Surace A, Puppo A, Paracchini S, Ferrari D, Perotto S, Novelli A, De Ponti E, Borghi C, Fanfani F, Fruscio R. Low-Pressure Laparoscopy Using the AirSeal System versus Standard Insufflation in Early-Stage Endometrial Cancer: A Multicenter, Retrospective Study (ARIEL Study). Healthcare (Basel). 2022 Mar 14;10(3):531. doi: 10.3390/healthcare10030531.'}, {'pmid': '22385527', 'type': 'BACKGROUND', 'citation': 'Yasir M, Mehta KS, Banday VH, Aiman A, Masood I, Iqbal B. Evaluation of post operative shoulder tip pain in low pressure versus standard pressure pneumoperitoneum during laparoscopic cholecystectomy. Surgeon. 2012 Apr;10(2):71-4. doi: 10.1016/j.surge.2011.02.003. Epub 2011 Mar 21.'}, {'pmid': '9112891', 'type': 'BACKGROUND', 'citation': "Wallace DH, Serpell MG, Baxter JN, O'Dwyer PJ. Randomized trial of different insufflation pressures for laparoscopic cholecystectomy. Br J Surg. 1997 Apr;84(4):455-8."}, {'pmid': '25265495', 'type': 'BACKGROUND', 'citation': 'Topcu HO, Cavkaytar S, Kokanali K, Guzel AI, Islimye M, Doganay M. A prospective randomized trial of postoperative pain following different insufflation pressures during gynecologic laparoscopy. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:81-5. doi: 10.1016/j.ejogrb.2014.09.003. Epub 2014 Sep 16.'}, {'pmid': '28403972', 'type': 'BACKGROUND', 'citation': 'Sroussi J, Elies A, Rigouzzo A, Louvet N, Mezzadri M, Fazel A, Benifla JL. Low pressure gynecological laparoscopy (7mmHg) with AirSeal(R) System versus a standard insufflation (15mmHg): A pilot study in 60 patients. J Gynecol Obstet Hum Reprod. 2017 Feb;46(2):155-158. doi: 10.1016/j.jogoh.2016.09.003. Epub 2017 Jan 30.'}, {'pmid': '35442815', 'type': 'BACKGROUND', 'citation': 'Saway JP, McCaul M, Mulekar MS, McMahon DP, Richards WO. Review of Outcomes of Low Verses Standard Pressure Pneumoperitoneum in Laparoscopic Surgery. Am Surg. 2022 Aug;88(8):1832-1837. doi: 10.1177/00031348221084956. Epub 2022 Apr 20.'}, {'pmid': '10971421', 'type': 'BACKGROUND', 'citation': 'Sarli L, Costi R, Sansebastiano G, Trivelli M, Roncoroni L. Prospective randomized trial of low-pressure pneumoperitoneum for reduction of shoulder-tip pain following laparoscopy. Br J Surg. 2000 Sep;87(9):1161-5. doi: 10.1046/j.1365-2168.2000.01507.x.'}, {'pmid': '19542853', 'type': 'BACKGROUND', 'citation': 'Joshipura VP, Haribhakti SP, Patel NR, Naik RP, Soni HN, Patel B, Bhavsar MS, Narwaria MB, Thakker R. A prospective randomized, controlled study comparing low pressure versus high pressure pneumoperitoneum during laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2009 Jun;19(3):234-40. doi: 10.1097/SLE.0b013e3181a97012.'}, {'pmid': '24503370', 'type': 'BACKGROUND', 'citation': 'Hua J, Gong J, Yao L, Zhou B, Song Z. Low-pressure versus standard-pressure pneumoperitoneum for laparoscopic cholecystectomy: a systematic review and meta-analysis. Am J Surg. 2014 Jul;208(1):143-50. doi: 10.1016/j.amjsurg.2013.09.027. Epub 2014 Jan 16.'}, {'pmid': '24639018', 'type': 'BACKGROUND', 'citation': 'Gurusamy KS, Vaughan J, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 18;2014(3):CD006930. doi: 10.1002/14651858.CD006930.pub3.'}, {'pmid': '32572753', 'type': 'BACKGROUND', 'citation': 'Foley CE, Ryan E, Huang JQ. Less is more: clinical impact of decreasing pneumoperitoneum pressures during robotic surgery. J Robot Surg. 2021 Apr;15(2):299-307. doi: 10.1007/s11701-020-01104-4. Epub 2020 Jun 22.'}, {'pmid': '32809844', 'type': 'BACKGROUND', 'citation': "O'Connor SC, Mallard M, Desai SS, Couto F, Gottlieb M, Ewing A, Cobb WS, Carbonell AM, Warren JA. Robotic Versus Laparoscopic Approach to Hiatal Hernia Repair: Results After 7 Years of Robotic Experience. Am Surg. 2020 Sep;86(9):1083-1087. doi: 10.1177/0003134820943547. Epub 2020 Aug 18."}], 'seeAlsoLinks': [{'url': 'https://www.conmed.com/en-us/products/airseal-and-insufflation', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the incidence and severity of post-operative shoulder pain following elective robot-assisted hiatal hernia repair in hopes of reducing pain and associated costs as well as clinic and emergency department visits due to this pain. You will undergo standard robot-assisted hiatal hernia repair with the standard postoperative care. The only difference is that you may be selected for the group where lower pressures used to fill your abdomen with carbon dioxide will be used, and you will be asked to fill out logs regarding your pain postoperatively. You will have postoperative appointments that are standard following this procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing elective robot assisted hiatal hernia repair\n\nExclusion Criteria:\n\n* patients less than 18 years of age\n* conversion to open surgery\n* BMI \\> 40\n* history of abdominoplasty\n* history of chronic pain and/or opioid dependence\n* history of COPD and/or supplemental oxygen use\n* pregnant patients\n* incarcerated patients\n* patient refusal'}, 'identificationModule': {'nctId': 'NCT06737068', 'briefTitle': 'Low Pressure Pneumoperitoneum Using AirSeal® for Reduction in Postoperative Shoulder Pain Following Robot Assisted Hiatal Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Riverside University Health System Medical Center'}, 'officialTitle': 'Low Pressure Pneumoperitoneum Using AirSeal® for Reduction in Postoperative Shoulder Pain Following Robot Assisted Hiatal Hernia Repair: a Prospective Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '2068123-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Pressure Pneumoperitoneum (8-10 mmHg)', 'description': 'Elective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 8-10 mmHg throughout the case', 'interventionNames': ['Procedure: Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device']}, {'type': 'OTHER', 'label': 'Standard Pressure Pneumoperitoneum (13-15 mmHg)', 'description': 'Elective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 13-15 mmHg throughout the case', 'interventionNames': ['Procedure: Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device']}], 'interventions': [{'name': 'Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device', 'type': 'PROCEDURE', 'otherNames': ['low pressure'], 'description': 'Elective robot assisted hiatal hernia repair with low pressure pneumoperitoneum (8-10mmHg) with AirSeal device', 'armGroupLabels': ['Low Pressure Pneumoperitoneum (8-10 mmHg)']}, {'name': 'Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device', 'type': 'PROCEDURE', 'otherNames': ['standard pressure'], 'description': 'Elective robot assisted hiatal hernia repair with standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device', 'armGroupLabels': ['Standard Pressure Pneumoperitoneum (13-15 mmHg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92555', 'city': 'Moreno Valley', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Institutional Review Board Manager', 'role': 'CONTACT', 'email': 'G.Moulton@RUHealth.org', 'phone': '951-486-4452'}, {'name': 'Marcos Michelotti, MD', 'role': 'CONTACT'}, {'name': 'Lan-Anh A Nguyen, MD', 'role': 'CONTACT'}], 'facility': 'Riverside University Health System', 'geoPoint': {'lat': 33.93752, 'lon': -117.23059}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riverside University Health System Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}