NCT02816658

Brief Summary

Inguinal hernia repair is one of the most commonly performed general surgery operations. However, to date, the ideal surgical approach for inguinal hernia surgery. The investigators therefore, propose a randomized controlled trial comparing laparoscopic inguinal hernia surgery repair to robotic inguinal hernia repair surgery. The investigators hypothesize that the robotic approach to inguinal hernia repair will result in improved post-operative outcomes compared to traditional laparoscopic inguinal hernia repairs. Specific Aim #1: To determine if the robotic approach will result in a significant reduction in postoperative pain and earlier return to full function when compared to a laparoscopic inguinal hernia repair. Specific Aim #2: To perform a cost analysis to determine the financial implications of performing a robotic versus a laparoscopic inguinal hernia repair. Specific Aim #3: To determine the effect of surgeon reported ergonomics when performing laparoscopic versus robotic inguinal hernia repairs. Specific Aim #4: Evaluate the long term hernia recurrence rates associated with laparoscopic versus robotic inguinal hernia repairs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

6 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

Study Start

First participant enrolled

May 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

5.1 years

First QC Date

May 26, 2016

Last Update Submit

January 28, 2022

Conditions

Hernia, Inguinal

Outcome Measures

Primary Outcomes (1)

  • Pain Score

    Differences in postoperative pain between those patients who undergo robotic inguinal hernia repair versus laparoscopic inguinal hernia repair.

    2 Years

Secondary Outcomes (3)

  • Ergonomic Tool

    2 Years

  • Institution cost analysis

    2 Years

  • Long-term recurrence rate differences

    2 Years

Study Arms (2)

Laparoscopic Surgery

ACTIVE COMPARATOR

Laparoscopic Inguinal Hernia Repair through a Transabdominal, Preperitoneal Approach

Other: Laparoscopic Inguinal Hernia Repair

Robotic Surgery

ACTIVE COMPARATOR

Robotic Inguinal Hernia Repair

Other: Robotic Inguinal Hernia Repair

Interventions

Laparoscopic Inguinal Hernia RepairOTHER

Laparoscopic Inguinal Hernia Repair

Laparoscopic Surgery
Robotic Inguinal Hernia RepairOTHER

Robotic Inguinal Hernia Repair

Robotic Surgery

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • No prior open abdominal surgery at or below the umbilicus
  • Primary or recurrent unilateral inguinal hernia repair
  • No previous preperitoneal mesh placement
  • BMI less than or equal to 40kg/m2

You may not qualify if:

  • Need for an open inguinal hernia repair
  • Patients presenting for evaluation of bilateral inguinal hernias
  • Patients requiring surgical repair of a strangulated inguinal hernia
  • Patients with liver disease defined by the presence of ascites
  • Patients with end-stage renal disease requiring dialysis
  • Patients who are unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Washington University

St Louis, Missouri, 63110, United States

Location

Mount Sinai Hospital

New York, New York, 10028, United States

Location

New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Greenville Health System

Greenville, South Carolina, 29681, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • Prabhu AS, Carbonell A, Hope W, Warren J, Higgins R, Jacob B, Blatnik J, Haskins I, Alkhatib H, Tastaldi L, Fafaj A, Tu C, Rosen MJ. Robotic Inguinal vs Transabdominal Laparoscopic Inguinal Hernia Repair: The RIVAL Randomized Clinical Trial. JAMA Surg. 2020 May 1;155(5):380-387. doi: 10.1001/jamasurg.2020.0034.

    PMID: 32186683DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Michael J Rosen, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Cleveland Clinic Comprehensive Hernia Center

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 28, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

February 1, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(6)