[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547845":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":50,"responsibleParty":71,"collaborators":44,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":44,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":53,"whyStopped":44,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"All India Institute of Medical Sciences, Bhubaneswar","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"USG-guided Veress needle insertion","EXPERIMENTAL","Ultrasonography-guided Veress needle will be inserted, and a real-time pneumoperitoneum will be created as the first step of a laparoscopic bariatric surgical procedure. The bariatric procedures include laparoscopic sleeve gastrectomy and gastric bypass procedures. The ultrasound's high-frequency (10-13Hz) linear probe will be used peri-operatively to identify the planes of the abdominal wall. Once the Veress needle is successfully inserted into the peritoneal cavity in real-time visualisation and pneumoperitoneum created, thereafter the bariatric procedures will be continued as routinely done.",[13],"Procedure: Ultrasonography guided Veress needle insertion for creating pneumoperitoneum",{"label":15,"type":16,"description":17,"interventionNames":18},"Blind Veress needle insertion","ACTIVE_COMPARATOR","The Veress needle is inserted blindly, as regularly done in any other laparoscopic surgery, and the successful pneumoperitoneum is confirmed by aspiration of the needle, saline drop test and percussion on the abdomen.",[19],"Procedure: Veress needle will be inserted blindly as a closed technique for creating pneumoperitoneum",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Ultrasonography guided Veress needle insertion for creating pneumoperitoneum","A real-time visualisation of the path of the Veress needle entry by the use of high frequency (13-6 MHz) probe ultrasonography.",[9],[27],"Sonosite Edge II Portable Ultrasound machine",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Veress needle will be inserted blindly as a closed technique for creating pneumoperitoneum","The Veress needle is inserted blindly and guided by the resistance of tissues and the click sounds of layers of abdominal wall.",[15],[33],"Stainless steel spring loaded reusable hollow needle of 2mm in diameter and 15-18cm long",[35],{"name":36,"affiliation":37,"role":38},"Prof. Prakash K. Sasmal, MS, FACS","Professor of General Surgery, All India Institute of Medical Sciences, Bhubaneswar, India","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Dr Prakash K. Sasmal, MS, FACS","CONTACT","+919438884255",null,"drpksasmal@gmail.com",{"name":47,"role":42,"phone":48,"phoneExt":44,"email":49},"Dr Pradeep K. Singh, MS, FACS","+919438884254","surg_pradeep@aiimsbhubaneswar.edu.in",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"All India Institute of Medical Sciences","RECRUITING","Bhubaneswar","Odisha","751019","India","IN",{"type":60,"coordinates":61},"Point",[62,63],85.83385,20.27241,{"lat":63,"lon":62},[66,67,68],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},{"name":47,"role":42,"phone":48,"phoneExt":44,"email":49},{"name":69,"role":70,"phone":44,"phoneExt":44,"email":44},"Dr Tara P Tripathy, MD","SUB_INVESTIGATOR",{"type":38,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Dr. Prakash Kumar Sasmal","Professor of General Surgery","100547845","ultrasonography-guided-pneumoperitoneum-for-laparoscopic-surgery-in-morbidly-obese-patients-100547845",false,"NCT06413264","Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients","Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients: A Single-blinded Randomized Control Study (USP TRIAL)","USP","Inclusion Criteria:\n\n* All patients in the age group of 18 -65 years undergoing laparoscopic bariatric surgery with weight \\>100 kg\n* Subcutaneous fat thickness of more than 5 cm as determined by pre-operative ultrasonography\n* BMI \\> 40 kg\u002Fm2\n\nExclusion Criteria:\n\n* Patients who don't give consent and do not understand the nature of the study\n* Patients undergoing a re-do surgery","ALL","18 Years","65 Years",{"count":86,"type":87},40,"ESTIMATED","INTERVENTIONAL",[90],"NA","Bariatric Surgery for morbid obesity is indicated when BMI \\> 40 kg\u002Fm2 without comorbidities or BMI \\> 35 kg\u002Fm2 with co-morbidities. Different surgeries performed for obesity are classified as restrictive, malabsorptive, and hybrid procedures.\n\nBecause laparoscopic surgery has increased the interest and growth of bariatric surgery, soaring demand for laparoscopic bariatric surgery from patients has boosted the boom in bariatric surgery worldwide.\n\nAchieving pneumoperitoneum is the initial and one of the most crucial steps in any laparoscopic surgery, giving the surgeon working space to operate on a particular organ\u002Forgan system. Usually, pneumoperitoneum is achieved either by a closed technique with a veress needle or an open technique with many variations like finger assisted or the conventional open technique.\n\nGiven the excess amount of subcutaneous fat in morbidly obese patients, putting a veress needle to achieve pneumoperitoneum successfully is particularly challenging which takes a toll on the operating surgeon when he\u002Fshe is trying to locate the midline one can either overshoot to cause omental emphysema or undershoot getting lost in the subcutaneous fat. It is usually done in the supra umbilical area. Sometimes, due to previous surgical scars other sites are preferred.\n\nSonography is routinely used by radiologists with negligible radiation exposure. Anesthesiologists in the operating room have used it for many assisted procedures like central line insertion \u002F giving nerve blocks. It can also be used in obese patients undergoing metabolic surgery to assist in creating pneumoperitoneum by a veress needle.\n\nAdvantages of Intraoperative ultrasonography in this particular study :\n\n1. To quantify the thickness of subcutaneous fat\n2. To visualise the linea alba and guide the veress needle safely into the peritoneal cavity\n3. Real-time visualisation of the pneumoperitoneum created\n4. Avoid complications like omental emphysema, bowel or vascular injury",[93,94,95],"Pneumoperitoneum","Morbid Obesity","Bariatric Surgery Candidate",[97,98,99,100,101,102,103,104],"pneumoperitoneum","closed technique","Veress needle","ultrasonography-guided","morbidly obese","bariatric surgery","metabolic surgery","access-related injury","2024-07-29",{"date":107,"type":108},"2024-07-30","ACTUAL",{"date":110,"type":108},"2024-07-01",{"date":112,"type":87},"2026-06-30",{"name":5,"class":6},1]