NCT07756749

Brief Summary

Evaluation of the perioperative and patient reported outcomes of a new surgical technique: single-port robotic suprapubic inguinal hernia repair (SPIN procedure).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
37mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress1%
Aug 2026Aug 2029

Study Start

First participant enrolled

August 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

August 7, 2026

Last Update Submit

August 7, 2026

Conditions

Inguinal Hernia Repair

Keywords

Inguinal hernia repairda Vinci SP Surgical SystemSuprapubic inguinal hernia repair

Outcome Measures

Primary Outcomes (3)

  • Operative time

    Total operative time from skin incision to skin closure

    During surgery

  • Technical errors with the robotic system

    Number and type of technical errors or device-related issues encountered during the procedure.

    During surgery

  • Complication Rate

    Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification

    From surgery until 1 month postoperatively

Secondary Outcomes (3)

  • EuraHS Quality of Life score

    Preoperatively, 1 month and 1 year postoperatively

  • Body Image Questionnaire Score

    Preoperatively, 1 month , and 1 year postoperatively

  • hernia recurrence

    1 year postoperatively

Study Arms (1)

single-port robotic suprapubic inguinal hernia repair

EXPERIMENTAL
Procedure: single-port robotic suprapubic inguinal hernia repair

Interventions

single-port robotic suprapubic inguinal hernia repairPROCEDURE

single-port robotic suprapubic inguinal hernia repair

single-port robotic suprapubic inguinal hernia repair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with a primary inguinal hernia, either unilateral or bilateral

You may not qualify if:

  • Recurrent inguinal hernia after preperitoneal repair
  • Irreducible scrotal hernia
  • Post-prostatectomy
  • Laparotomy in the lower abdomen
  • Pregnancy
  • Contra-indication for general anaesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Maria Middelares

Ghent, East-Flanders, 9000, Belgium

Location

Central Study Contacts

Filip Muysoms, MD, PhD

CONTACT

+32477325710filip.muysoms@gmail.com

Jolien Lansens, Study coordinator

CONTACT

+3292461854Jolien.Lansens@mijnziekenhuis.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Surgery Department

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 11, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2029

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)