Minimally Invasive Trocar Placement in Obesity Surgery

Study Overview
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Brief Summary
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During surgery for obesity, minimally invasive endoscopy can be performed and can assist the surgeon in determining surgical incision sites.

Detailed Description
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Transgastric endoscopic access, without laparoscopic guidance, to the peritoneal cavity can be performed safely and guide trocar placement in morbidly obese patients undergoing Roux-en-y gastric bypass.

Official Title
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Transgastric Peritoneoscopy for Evaluation of the Abdominal Wall to Direct Laparoscopic Trocar Placement

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Transgastric access to the abdomen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery Exclusion Criteria: Lack of consent History of previous gastric surgery Contraindication to upper endoscopy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>10 patients with no previous abdominal surgeries, pre-insufflation of the abdomen using a veress needle (standard procedure for insufflating the abdomen for laparoscopic surgery) | Procedure: Transgastric access to the abdomen<br>* Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.<br>|
| Active Comparator: 2<br>10 patients with history of previous abdominal surgeries, pre-insufflation of the abdomen using veress needle (standard procedure for insufflating the abdomen for laparoscopic surgery) | Procedure: Transgastric access to the abdomen<br>* Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.<br>|
| Active Comparator: 3<br>10 patients with no previous history of abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically) | Procedure: Transgastric access to the abdomen<br>* Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.<br>|
| Active Comparator: 4<br>10 patients with history of previous abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically) | Procedure: Transgastric access to the abdomen<br>* Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.<br>|
| Active Comparator: 5<br>10 patients, all with no previous mid to upper abdominal surgeries, no Veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically) | Procedure: Transgastric access to the abdomen<br>* Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.<br>|
| Active Comparator: 6<br>10 patients, all with previous mid-to-upper abdominal surgeries, no Veress needle pre-insufflation, endoscopic take-down of intra-abdominal adhesions (if identified) | Procedure: Transgastric access to the abdomen<br>* Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The achievement of safe transgastric access to the abdomen; the ability to visualize the abdominal wall to assist in safe trocar placement in the morbidly obese patient. |  | At surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial contamination analysis; results compared to previous study. |  | Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NOTES, transgastric endoscopy, obesity surgery, Roux-en-Y surgery