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OpenTrials
Completed

NCT Number: NCT03490266

Robotic Versus Laparoscopic Ventral Hernia Repair

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Health-Memorial Hermann, Houston, Texas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

robotic repair

Procedure

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

Other names: da Vinci Si Surgical System, Endoscopic Instrument Control System, Model IS3000

Laparoscopic repair

Procedure

The surgeon will be repairing the hernia laparoscopically.

Primary outcomes

  1. Total number of days in the hospital

    Time frame: 90 days post-operative

    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 outcomes

  1. Surgical Site Infection (SSI)

    Time frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years

    CDC definition

  2. Surgical Site Occurrence (SSO)

    Time frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years

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

  3. Hernia Reoccurence

    Time frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years

    A hernia that was repaired in the past but has returned

  4. Patient centered outcomes

    Time frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years

    Collected using HerQLes

  5. Patient centered outcomes

    Time frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years

    Collected using EQ5D

  6. Cost from a healthcare perspective

    Time frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years

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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Apr 6, 2018
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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