NCT01932216

Brief Summary

Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy

Trial Health

90
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
2 countries

8 active sites

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

First Submitted

Initial submission to the registry

August 27, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

October 16, 2017

Status Verified

October 1, 2017

Enrollment Period

3.3 years

First QC Date

August 27, 2013

Last Update Submit

October 12, 2017

Conditions

Symptomatic Gallbladder Disease

Keywords

robotic single-site cholecystectomylaparoscopic cholecystectomycosmesisquality of life

Outcome Measures

Primary Outcomes (1)

  • Cosmesis

    The primary objective of this study is to evaluate cosmesis, patient satisfaction and quality of life after robotic- assisted single incision cholecystectomy procedure using da Vinci Single- Site Instruments™ in comparison to a multiport laparoscopic approach.

    up to 3 months after surgery

Study Arms (2)

Single-site robotic cholecystectomy

ACTIVE COMPARATOR

Single-site cholecystectomy using da Vinci robotic assisted surgery

Procedure: Cholecystectomy

Multi-port laparoscopic cholecystectomy

ACTIVE COMPARATOR

Multi-port cholecystectomy using laparoscopic surgery

Procedure: Cholecystectomy

Interventions

CholecystectomyPROCEDURE

Gallbladder removal

Multi-port laparoscopic cholecystectomySingle-site robotic cholecystectomy

Eligibility Criteria

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

You may qualify if:

  • Patient between ages of 18- 80 year
  • Patient with symptomatic gallbladder disease
  • Patient willing to participate in this study and able to provide informed consent

You may not qualify if:

  • Patient pregnancy
  • Emergency patient
  • Patient with acute cholecystitis
  • Patient with upper midline visible abdominal scars or keloid
  • Presence of umbilical hernia , or prior umbilical hernia repair
  • Inability of patients to tolerate Trendelenberg position or pneumoperitoneum
  • Patient with cirrhosis
  • Patients with mental impairment that preclude giving informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Huntington Memorial Hospital

Pasadena, California, 91105, United States

Location

JFK Medical center

Lake Worth, Florida, 33462, United States

Location

Baptist Health South Florida

Miami, Florida, 33173, United States

Location

West Suburban Hospital

Elmwood Park, Illinois, 60707, United States

Location

Dr. Omar Kudsi

Brockton, Massachusetts, 02301, United States

Location

Hillcrest Medical Center

Tulsa, Oklahoma, 74104, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

Athens Medical center

Marousi, Athens, 15125, Greece

Location

Related Publications (1)

  • Kudsi OY, Castellanos A, Kaza S, McCarty J, Dickens E, Martin D, Tiesenga FM, Konstantinidis K, Hirides P, Mehendale S, Gonzalez A. Cosmesis, patient satisfaction, and quality of life after da Vinci Single-Site cholecystectomy and multiport laparoscopic cholecystectomy: short-term results from a prospective, multicenter, randomized, controlled trial. Surg Endosc. 2017 Aug;31(8):3242-3250. doi: 10.1007/s00464-016-5353-4. Epub 2016 Nov 18.

    PMID: 27864724DERIVED

MeSH Terms

Interventions

Cholecystectomy

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2013

First Posted

August 30, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

October 16, 2017

Record last verified: 2017-10

Locations

GR(1)US(7)