Laparoscopic Versus Robot-assisted Inguinal Hernia Repair: A Single Institution Randomized Controlled Trial

Laparoscopic Versus Robot-assisted Inguinal Hernia Repair: The Immediate, Intermediate, and Long Term Outcome Differences. A Single Institution Randomized Controlled Trial

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03133533

Enrollment

Registered

2017-04-28

Start date

2018-05-31

Completion date

2023-06-30

Last updated

2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Inguinal

Keywords

robot-assisted

Brief summary

Randomized trial to compare outcomes of laparoscopic and robot assisted inguinal hernia repair.

Detailed description

Inguinal hernia repair is a very common surgical operation. Both laparoscopic and robot-assisted operations are considered acceptable. However, there is no clear indication for a particular approach. No prospective trial has been conducted so far to establish superiority of one approach over the other. The Investigator believes each approach has unique characteristics and may offer advantages over the other in the right population group. The Investigator will randomly assign patients in two arms according to the surgical approach, whether laparoscopic or robot-assisted. The Investigator will collect preoperative characteristics, intraoperative variables, and postoperative outcomes. The Investigator will compare all variables to establish differences between the two groups.

Interventions

PROCEDURElaparoscopic repair

Surgical inguinal hernia repair using laparoscopic approach.

PROCEDURErobot-assisted repair

Surgical inguinal hernia repair using robot-assisted approach.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Participants will be randomized to receive either laparoscopic or robot-assisted repair of inguinal hernia.

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* surgeon determined need for inguinal hernia repair

Exclusion criteria

* \< 18 years of age * \> 99 years of age * medical indication for open repair

Design outcomes

Primary

Measure	Time frame	Description
Operative time	Immediate perioperative time	Time from start to finish of procedure, procedure start and stop times as recorded by anesthesia.

Secondary

Measure	Time frame	Description
Postoperative pain score	Until 5 year postoperative	Abdominal pain at rest and on moving (recumbent to the upright position), will be assessed using 0-10 Numeric Pain Rating Scale preoperatively (baseline), and at 24 hours, 30 days, one and five years postoperatively.

Other

Measure	Time frame	Description
Complications	From immediately post-operative until year five following surgical inguinal hernia repair.	Postoperative 30 day complication rates will be recorded prospectively. All complications (including multiple occurrences per patient) will be recorded and graded per the Clavien-Dindo classification system.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026