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Robotic Versus Laparoscopic Ventral Hernia Repair

Primary Purpose

Hernia, Ventral

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Robotic Repair

Laparoscopic Repair

About this trial

This is an interventional treatment trial for Hernia, Ventral focused on measuring Ventral Hernia, Hernia Repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-All patients undergoing elective ventral hernia repair deemed appropriate for minimally invasive repair.

Exclusion Criteria:

Patients unlikely to survive beyond 2 years based upon surgeon judgment (e.g. advanced cirrhosis or metastatic cancer)
Patients unlikely to follow-up (e.g. lives out of state or no phone)
Advanced COPD or CHF
History of open abdomen or extensive lysis of adhesions for bowel obstruction
Ascites due to cirrhosis or malignancy
Active infection such as infected mesh
Ventral hernia size greater than 12 cm

Sites / Locations

UT Health-Memorial Hermann
UTHealth-Lyndon B. Johnson (LBJ) Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Laparoscopic Repair

Robotic Repair

Arm Description

The abdomen will be entered and insufflated utilizing a 5 mm optical port. Only 5 mm ports will be utilized laterally to take down all anterior abdominal wall adhesions. A mid-density polypropylene mesh with a one-sided adhesion barrier that provides at least 5 cm of overlap in all directions will be inserted through a 11 or 12 mm port placed through the defect. Excision of hernia sac and preperitoneal fat and defect closure will be performed per current practice. The mesh will be secured in four points with 0-PDS sutures and/or tacked with a double crown of tacks per our current practice.

Three lateral ports will be placed including a 12 port for the camera. Adhesions will be taken down from the anterior abdominal wall. Hernia sac and preperitoneal fat will be excised per current practice and defect will be closed using a running locking barbed suture. A mid-density polypropylene mesh with a one-sided adhesion barrier that provides at least 5 cm of overlap in all directions will be inserted through the 12 mm port. The mesh will be secured circumferentially with a running barbed suture.

Outcomes

Primary Outcome Measures

Total number of days in the hospital

Total number of days spent in the hospital. This will be calculated by adding the hospital length of stay for initial surgery, length of stay for any additional readmission resulting from the surgery, and emergency room visits resulting from the surgery. This information will be collected up to 90 days after the surgery.

Secondary Outcome Measures

Surgical Site Infection (SSI)

CDC definition

Surgical Site Occurrence (SSO)

Hematoma, seroma, dehiscence, necrosis, non-healing wound found on abdominal exam.

Hernia Reoccurence

A hernia that was repaired in the past but has returned

Patient centered outcomes

Collected using HerQLes

Patient centered outcomes

Collected using EQ5D

Cost from a healthcare perspective

Looking at differences in what is spent for robotic repair and laparoscopic repair of ventral hernias

Full Information

NCT ID

NCT03490266

First Posted

March 21, 2018

Last Updated

May 23, 2022

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT03490266

Brief Title

Robotic Versus Laparoscopic Ventral Hernia Repair

Official Title

Robotic Versus Laparoscopic Ventral Hernia Repair: A Multicenter Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

April 3, 2018 (Actual)

Primary Completion Date

April 9, 2020 (Actual)

Study Completion Date

May 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Ventral hernias are a common disease and one half of all individuals are born with or will acquire a ventral hernia in their lifetime. Repair of ventral hernias may be associated with significant morbidity, including surgical site infection, hernia recurrence and reoperation. Minimally invasive ventral hernia repair decreases rates of surgical site infection and hospital length of stay, without affecting recurrence, however the laparoscopic approach to ventral hernia repair accounts for only about 1/3 of all total hernia repairs performed in the US. Recent large database studies have suggested that robotic ventral hernia repair may be associated with decreased hospital length of stay. However, this study is affected by common biases of database studies and randomized controlled trials are needed to assess the true impact of robotics for ventral hernia repair.

Detailed Description

Ventral hernias are a common disease and one-half of all individuals are born with or will acquire a ventral hernia in their lifetime. Repair of ventral hernias are associated with substantial morbidity including surgical site infection, hernia recurrence, and reoperation. Randomized controlled trials and nationwide databases have shown that minimally invasive ventral hernia repair (i.e. laparoscopic ventral hernia repair) as opposed to open ventral hernia repair is associated with decreased rates of surgical site infection and hospital length of stay with no impact on long-term outcomes of hernia recurrence. Recent large database studies have suggested that robotic ventral hernia repair may be associated with decreased hospital length of stay. However, this study is affected by common biases of database studies and randomized controlled trials are needed to assess the true impact of robotics for ventral hernia repair. The growth of the robotic platform in surgery is growing exponentially. Despite this, the evidence supporting robotics remains limited. Studies demonstrating benefit such as improved outcomes or decreased hospital length of stay, are largely cohort studies subject to substantial bias. Among randomized controlled trials, none have demonstrated benefit with robotic surgery. Recently, the America's Hernia Society (AHS) has endorsed robotic ventral hernia surgery. A series of studies published under the AHS Quality Collaborative (AHSQC) database have demonstrated improved outcomes with robotic ventral hernia repair when compared to open and laparoscopic surgery. However, the results of these studies remain hypothesis generating and randomized controlled trials are needed. This study would represent among the first randomized controlled trials assessing the effect of robotic versus laparoscopic ventral hernia repair.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hernia, Ventral

Keywords

Ventral Hernia, Hernia Repair

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Laparoscopic Repair

Arm Type

Active Comparator

Arm Description

Arm Title

Robotic Repair

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Robotic Repair

Other Intervention Name(s)

da Vinci Si Surgical System, Endoscopic Instrument Control System, Model IS3000

Intervention Description

The surgeon will be utilizing a robotic system to repair the hernia.

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic Repair

Intervention Description

The surgeon will be repairing the hernia laparoscopically.

Primary Outcome Measure Information:

Title

Total number of days in the hospital

Description

Time Frame

90 days post-operative

Secondary Outcome Measure Information:

Title

Surgical Site Infection (SSI)

Description

CDC definition

Time Frame