A Comparison of Single Port and Four Port Laparoscopic Gallbladder Removal

NCT01489436 | Completed DMC

• 1 other identifier: 11-001162
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

New minimally invasive surgical treatments are often outpatient procedures with low complication rates, promising fast recovery. The traditional physician-reported outcomes such as complication rates, blood loss, and hospital stay are not useful to guide treatment recommendations for one or the other minimally invasive procedure. This study aims to apply patient-reported outcomes developed within the NIH framework for cancer research and chronic disease treatment to the comparative effectiveness research in minimally invasive procedures for benign disease.

Conditions

CHOLELITHIASIS

Keywords

gallstone disease; cholecystectomy; minimally invasive; surgical; laparoscopic; single port; cytokine

Outcome Measures

Primary Outcomes (1)

• Pain Scores on the Visual Analog Scale

  The investigators will utilize the Patient-Reported Outcomes from the VAS to measure changes from Baseline to day 1 post OP. A 15-mm difference on a 100-mm visual analog scale with a standard deviation of 25 mm at any time point will constitute a clinically relevant difference.

  Baseline to Post Operative day 1

Secondary Outcomes (3)

• Quality of Life (QOL)

  up to 7 days

• Heart Rate Variability (HRV) Data

  During surgery from incision to closure

• Cytokine levels in blood

  Baseline, during surgery form incision to closure, 1 hour post OP and 4 hour post OP

Study Arms (2)

Single port cholecystectomy

ACTIVE COMPARATOR

In brief, a flexible, multi-sleeve 15-mm trocar designed specifically for single-port cholecystectomy will be inserted at the umbilicus via a 15-mm single incision. An additional 2-mm grasping device may be introduced in the right upper quadrant for retraction if necessary; this device is placed percutaneously without the need for a trocar. A 5-mm laparoscopic clip applier will be introduced through the periumbilical trocar to ligate the cystic artery and the cystic duct. The gallbladder will be removed through the umbilical port, adequate hemostasis is ensured, the umbilical trocar removed, and the single operative site will be closed and sterile dressings applied (four Band-Aids).

Procedure: Single-port cholecystectomy

Four-port laparoscopic cholecystectomy

ACTIVE COMPARATOR

The control procedure for the research practicum is a four-trocar laparoscopic cholecystectomy, the current gold-standard operation. This approach utilizes a 10-mm trocar placed at the umbilicus via a 15-mm incision and three separate subcostal 5-mm trocars placed via separate 5-mm incisions. The gallbladder will be removed through the umbilical trocar site. On occasion, this incision needs to be enlarged to accommodate removal of the gallbladder. Trocar sites will be closed and sterile dressings applied (four Band-Aids).

Procedure: Four-port laparoscopic cholecystectomy

Interventions

Single-port cholecystectomy PROCEDURE

In brief, a flexible, multi-sleeve 15-mm trocar designed specifically for single-port cholecystectomy will be inserted at the umbilicus via a 15-mm single incision. This trocar permits simultaneous introduction of multiple instruments, including a 5-mm flexible-tip laparoscope. Standard 5-mm instruments will be used for retraction and dissection. An additional 2-mm grasping device may be introduced in the right upper quadrant for retraction if necessary. A 5-mm laparoscopic clip applier will be introduced through the periumbilical trocar to ligate the cystic artery and the cystic duct. The gallbladder will be removed through the umbilical port.

Also known as: Minimally invasive surgery

Single port cholecystectomy

Four-port laparoscopic cholecystectomy PROCEDURE

The control procedure for the research practicum is a four-trocar laparoscopic cholecystectomy, the current gold-standard operation. This approach utilizes a 10-mm trocar placed at the umbilicus via a 15-mm incision and three separate subcostal 5-mm trocars placed via separate 5-mm incisions. The gallbladder will be removed through the umbilical trocar site. On occasion, this incision needs to be enlarged to accommodate removal of the gallbladder.

Also known as: Minimally invasive surgery

Four-port laparoscopic cholecystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) patients undergoing cholecystectomy in an elective setting for symptomatic gallstone disease.

You may not qualify if:

• Patients \<18 years of age
• Pregnant patients
• Patients with ASA-class \>3
• Patients undergoing treatment for chronic pain with opiates
• Patients with biopsy proven gallbladder cancer
• Patients who cannot provide consent for the study
• Patients not willing to participate in the study
• Prisoners/Institutionalized individuals

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Bingener J, Skaran P, McConico A, Novotny P, Wettstein P, Sletten DM, Park M, Low P, Sloan J. A Double-Blinded Randomized Trial to Compare the Effectiveness of Minimally Invasive Procedures Using Patient-Reported Outcomes. J Am Coll Surg. 2015 Jul;221(1):111-21. doi: 10.1016/j.jamcollsurg.2015.02.022. Epub 2015 Mar 3.

  PMID: 26095558 RESULT

Related Links

• A Double-Blinded Randomized Trial to Compare the Effectiveness of Minimally Invasive Procedures Using Patient-Reported Outcomes.

MeSH Terms

Conditions

Cholelithiasis

Interventions

Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Juliane Bingener-Casey, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: December 9, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

US (1)