NCT00678873

Brief Summary

The investigators aim to investigate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy. The investigators hypothesize that Single Incision Laparoscopic Cholecystectomy is safe and feasible.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2008

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

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 15, 2009

Status Verified

August 1, 2008

Enrollment Period

1.8 years

First QC Date

May 14, 2008

Last Update Submit

December 14, 2009

Conditions

Cholelithiasis

Keywords

Single IncisionSingle AccessSurgeryCholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Safety and feasibility

    12 months

Secondary Outcomes (1)

  • Short-term clinical outcomes

    12 months

Study Arms (1)

Surgical group

EXPERIMENTAL

Patients with ultrasound proven symptomatic cholelithiasis (gallstones).

Procedure: Single Incision Laparoscopic Cholecystectomy

Interventions

Single Incision Laparoscopic CholecystectomyPROCEDURE

A single trans-umbilical incision laparoscopic cholecystectomy will be performed by standard fashion and under general anesthesia.

Also known as: Single incision surgery, Single access surgery, Single incision laparoscopy, Single access laparoscopy, Laparoscopic cholecystectomy, Single access laparoscopic cholecystectomy, Cholecystectomy
Surgical group

Eligibility Criteria

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

You may qualify if:

  • Adults male and female(\>18 years old)
  • Capable of giving informed consent
  • Ultrasound proven cholelithiasis
  • Symptomatic cholelithiasis
  • Elective cholecystectomy

You may not qualify if:

  • Pregnancy
  • Contraindications for general anesthesia
  • Morbid obesity
  • Multiple previous abdominal surgeries
  • Uncontrolled medical conditions
  • Acute cholecystitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Cholelithiasis

Interventions

Cholecystectomy, LaparoscopicCholecystectomy

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Homero Rivas, MD

    UTSouthwestern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 14, 2008

First Posted

May 16, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 15, 2009

Record last verified: 2008-08

Locations

US(1)