NCT01174069

Brief Summary

Hypothesis: Natural orifice transgastric cholecystectomy with laparoscopic assist will be feasible and have comparable complication rates as standard lap cholecystectomy. Patient benefits will include less pain and scaring.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2010

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

8.4 years

First QC Date

July 30, 2010

Last Update Submit

August 29, 2019

Conditions

Cholecystitis

Keywords

NOTEScholecystectomyendoscopic

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record.

    30 days

Secondary Outcomes (1)

  • Perception of surgical outcome

    30 days post operatively

Study Arms (1)

NOTES cholecystectomy

EXPERIMENTAL
Procedure: NOTES assisted laparoscopic cholecystectomy

Interventions

NOTES assisted laparoscopic cholecystectomyPROCEDURE

Surgical removal of the gallbladder using endoscopic instruments.

Also known as: NOTES Cholecystectomy
NOTES cholecystectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to undergo general anesthesia
  • Age \> 18 years of age and \< 80 years of age
  • Ability to give informed consent

You may not qualify if:

  • Acute cholecystitis
  • Body Mass Index (BMI) \> 40
  • Contraindicated for esophagogastroduodenoscopy (EGD)
  • Gallstones \> 2.5cm in diameter
  • Gall bladder more than 15cm in length on U/S
  • Presence of common duct stones
  • Presence of esophageal stricture
  • Altered gastric anatomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Legacy health System

Portland, Oregon, 97210, United States

Location

MeSH Terms

Conditions

Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Christy M Dunst, MD

    The Oregon Clinic

    PRINCIPAL INVESTIGATOR

  • Angi B Gill, RN

    The Oregon Clinic

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 30, 2010

First Posted

August 3, 2010

Study Start

May 1, 2007

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

September 3, 2019

Record last verified: 2019-08

Locations

US(1)