Minimally Invasive Trocar Placement in Obesity Surgery

This study has been completed.
Sponsor:
Collaborators:
Stryker SA
Natural Orifice Surgery Consortium for Assessment and Research
Information provided by (Responsible Party):
Jeffrey Hazey, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00610025
First received: December 26, 2007
Last updated: February 11, 2013
Last verified: February 2013

December 26, 2007
February 11, 2013
July 2007
October 2009   (final data collection date for primary outcome measure)
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. [ Time Frame: At surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00610025 on ClinicalTrials.gov Archive Site
Bacterial contamination analysis; results compared to previous study. [ Time Frame: Surgery ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Minimally Invasive Trocar Placement in Obesity Surgery
Transgastric Peritoneoscopy for Evaluation of the Abdominal Wall to Direct Laparoscopic Trocar Placement

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

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Obesity
Procedure: Transgastric access to the abdomen
Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.
  • Active Comparator: 1
    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)
    Intervention: Procedure: Transgastric access to the abdomen
  • Active Comparator: 2
    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)
    Intervention: Procedure: Transgastric access to the abdomen
  • Active Comparator: 3
    10 patients with no previous history of abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)
    Intervention: Procedure: Transgastric access to the abdomen
  • Active Comparator: 4
    10 patients with history of previous abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)
    Intervention: Procedure: Transgastric access to the abdomen
  • Active Comparator: 5
    10 patients, all with no previous mid to upper abdominal surgeries, no Veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)
    Intervention: Procedure: Transgastric access to the abdomen
  • Active Comparator: 6
    10 patients, all with previous mid-to-upper abdominal surgeries, no Veress needle pre-insufflation, endoscopic take-down of intra-abdominal adhesions (if identified)
    Intervention: Procedure: Transgastric access to the abdomen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00610025
NOTES Trocar Study, Project 60009927, Award GRT00006515, IRB 2007H0045
No
Jeffrey Hazey, The Ohio State University
Jeffrey Hazey
  • Stryker SA
  • Natural Orifice Surgery Consortium for Assessment and Research
Principal Investigator: Jeffrey W Hazey, MD The Ohio State University Medical Center/Center for Minimally Invasive Surgery
Ohio State University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP