Trial Outcomes & Findings for Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients (NCT NCT00971750)

NCT ID: NCT00971750

Last Updated: 2012-07-11

Results Overview

Number of patients with cholelithiasis.

• Recruitment status: COMPLETED
• Target enrollment: 253 participants
• Primary outcome timeframe: transabdominal measurements within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively
• Results posted on: 2012-07-11

Participant Flow

Participant milestones

Measure	Ultrasound Study Group Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
Overall Study STARTED	253
Overall Study COMPLETED	253
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients

Baseline characteristics by cohort

Measure	Ultrasound Study Group n=253 Participants Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	251 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age Continuous	43.5 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	192 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants
Region of Enrollment United States	253 participants n=5 Participants

PRIMARY outcome

Timeframe: transabdominal measurements within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively

Number of patients with cholelithiasis.

Outcome measures

Measure	Transabdominal Ultrasound n=253 Participants Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.	Laparoscopic Ultrasound n=253 Participants Laparoscopic ultrasound is performed intraoperatively at the time of gastric bypass.
Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound.	61 participants	60 participants

PRIMARY outcome

Timeframe: 6 years

Number of patients with polyps.

Outcome measures

Measure	Transabdominal Ultrasound n=253 Participants Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.	Laparoscopic Ultrasound n=253 Participants Laparoscopic ultrasound is performed intraoperatively at the time of gastric bypass.
Polyps on Transabdominal and Laparoscopic Ultrasound	6 participants	41 participants

SECONDARY outcome

Timeframe: transabdominal measurements will be done within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively

Mean CBD diameter.

Outcome measures

Measure	Transabdominal Ultrasound n=253 Participants Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.	Laparoscopic Ultrasound n=253 Participants Laparoscopic ultrasound is performed intraoperatively at the time of gastric bypass.
Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound.	4.0 millimeters Standard Deviation 1.28	3.7 millimeters Standard Deviation 1.37

Adverse Events

Ultrasound Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shanu Kothari

Gundersen Lutheran Health System

Phone: 608-775-2331

Email: snkothar@gundluth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place