NCT00848146

Brief Summary

Refinements in laparoscopic surgery, coupled with advancements in therapeutic flexible endoscopy, have set the stage for surgery to move to even less invasive techniques to treat conditions in the GI tract and peritoneal cavity. Natural orifice translumenal endoscopic surgery (NOTES) offers a means of reducing and ultimately eliminating the need for abdominal incisions to gain access to the peritoneal cavity. In NOTES, a flexible endoscope and accessory instruments are inserted through a natural body orifice and passed through the wall of an organ to reach the abdominal cavity. By reducing or eliminating the need for abdominal incisions, NOTES may provide a least invasive surgical option that can reduce pain, recovery time, complications, and systemic inflammatory response when compared to a laparoscopic surgical approach. In this study, we propose to use the NOTES technique to eliminate the need for a 1.5-2.5 cm umbilical incision. Hypothesis 1: We hypothesize that a combined endoscopic and laparoscopic approach will be able to eliminate a 1.5 to 2.5 cm infraumbilical incision when performing a laparoscopic cholecystectomy. Hypothesis 2: Closure of the gastrotomy will be facilitated with the Ethicon TAS system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration 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

February 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 4, 2012

Status Verified

July 1, 2012

Enrollment Period

3.1 years

First QC Date

February 19, 2009

Last Update Submit

July 3, 2012

Conditions

Cholecystectomy, LaparoscopicEndoscopy

Outcome Measures

Primary Outcomes (1)

  • post operative pain

    two weeks

Secondary Outcomes (1)

  • quality of life

    two weeks

Study Arms (1)

NOTES-Assisted Lap Chole

EXPERIMENTAL

These patients will undergo an experimental surgical procedure that uses a combination of laparoscopic instruments (i.e., inserted through the skin into the abdominal cavity) and flexible endoscopic instruments (i.e., inserted through the mouth).

Procedure: Endoscopically assisted Laparoscopic Cholecystectomy Surgery

Interventions

Endoscopically assisted Laparoscopic Cholecystectomy SurgeryPROCEDURE

Using endoscopic instruments a small incision will be made in the gastric wall and the endoscope will be advanced into the insufflated peritoneal cavity. At least one laparoscopic trocars will be placed through the abdominal wall for laparoscopic instrument insertion to manipulate and cut tissue. The flexible endoscope will provide visualization of the surgical field and flexible endoscopic instruments may be used to augment surgical manipulation with the laparoscopic instruments. The gallbladder will be removed through the stomach and out of the mouth. Endoscopic clips, sutures or tissue anchors (TAS)will be used to close the gastrotomy.

Also known as: NOTES, Natural orifice translumenal endoscopic surgery, Transgastric Cholecystectomy
NOTES-Assisted Lap Chole

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Acute cholecystitis
  • BMI \> 40
  • Contraindicated for esophagogastroduodenoscopy (EGD)
  • Presence of common duct stones
  • Presence of esophageal stricture
  • Altered gastric anatomy
  • Gallstone greater than 1.5cm diameter seen on pre-op ultrasound
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Study Officials

  • Eric S Hungness, M.D.

    Northwestern University

    PRINCIPAL INVESTIGATOR

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
Assistant professor of surgery

Study Record Dates

First Submitted

February 19, 2009

First Posted

February 20, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 4, 2012

Record last verified: 2012-07

Locations

US(1)