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NOTES-Assisted Laparoscopic Cholecystectomy Surgery

Assisted Laparoscopic Cholecystectomy Surgery

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00486655
Enrollment
25
Registered
2007-06-14
Start date
2007-05-31
Completion date
2007-06-30
Last updated
2012-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystitis, Cholelithiasis

Keywords

Cholecystectomy, NOTES, Transgastric

Brief summary

This study proposes to evaluate the ability to reduce the size and number of laparoscopic incisions required to perform gall bladder removal by using flexible endoscopic instruments introduced through the mouth, into the stomach and through the stomach wall.

Detailed description

A typical laparoscopic gall bladder removal procedure requires placement of a rigid laparoscope through a 1.5-2.5 cm incision in the umbilicus and then 2-3 additional 0.5 cm incisions for additional instrumentation. While post-operative complication rates for this procedure are small, wound infection, particularly of the large incision, is one of the most common post-operative complications. There is also a risk of a post-operative hernia at these incision sites. A less invasive surgical technique that reduces the size or number of laparoscopic incisions offers the potential clinical benefits of eliminating wound infections, hernias and decreasing post-operative pain following laparoscopic gall bladder removal.

Interventions

PROCEDURENOTES-Assisted Cholecystectomy

Sponsors

USGI Medical
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Ability to undergo general anesthesia * Age \>= 18 yrs. of age and \<= 85 yrs. of age * Ability to give informed consent

Exclusion criteria

* Acute cholecystitis * BMI \>= 40 * Contraindicated for EGD * Presence of common duct stones * Presence of esophageal stricture * Altered gastric anatomy

Design outcomes

Primary

MeasureTime frame
Quality of Life2 weeks

Secondary

MeasureTime frame
Incidence of complications2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026