NCT05528107

Brief Summary

The survey will compare primary and secondary outcomes of laparoscopic intraperitoneal onlay mesh (IPOM plus) and extended totally extraperitoneal (eTEP) repair for incisional hernia. The research hypothesis is the following: patients who underwent eTEP repair may experience 30% less pain, assessed on the NRS-11 scale by the end of postoperative day 1, compared with IPOM plus procedure

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 30, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 14, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

August 30, 2022

Last Update Submit

March 14, 2023

Conditions

Incisional Hernia of Midline of Abdomen

Keywords

incisional ventral herniaIPOMeTEPpain

Outcome Measures

Primary Outcomes (1)

  • pain on postoperative day 1

    Pain score will be assessed using the Numeric Pain Rating Scale. The mean pain score is calculated between pain values at rest and on coughing. Participants verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)". 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.

    postoperative day 1

Secondary Outcomes (6)

  • pain on postoperative days 7 and 30

    postoperative 7 (±1) and 30 (±3) days

  • number of participants with chronic pain

    postoperative day 100 (±5 days)

  • length of stay

    30 days after surgery

  • postoperative complications

    30 days after surgery

  • analgetic consumption

    48 hours after surgery

  • +1 more secondary outcomes

Study Arms (2)

Laparoscopic Intraperitoneal Onlay Mesh plus ventral hernia repair

ACTIVE COMPARATOR

Laparoscopic Intraperitoneal Onlay Mesh plus repair will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement and suturing hernia defect.

Procedure: Lap IPOM plus

Extended-view totally extraperitoneal ventral hernia repair

ACTIVE COMPARATOR

Extended-view totally extraperitoneal ventral hernia repair will be used to perform minimally invasive ventral hernia repair with retrorectus mesh placement

Procedure: eTEP

Interventions

Lap IPOM plusPROCEDURE

Participants will undergo Lap IPOM plus repair according to the assigned treatment arm.

Also known as: Laparoscopic Intraperitoneal Onlay Mesh plus ventral hernia repair
Laparoscopic Intraperitoneal Onlay Mesh plus ventral hernia repair
eTEPPROCEDURE

Participants will undergo eTEP repair according to the assigned treatment arm.

Also known as: Extended-view totally extraperitoneal ventral hernia repair
Extended-view totally extraperitoneal ventral hernia repair

Eligibility Criteria

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

You may qualify if:

  • midline incisional hernia
  • defect width 2-6 cm
  • ASA I-II class
  • Elective hernia repair
  • Considered eligible for minimally invasive ventral hernia repair
  • Able to give informed consent
  • Able to tolerate general anesthesia

You may not qualify if:

  • primary ventral herna
  • lateral hernia with/without midline
  • defect width more than 6 cm
  • refuse to give informed consent
  • prior mesh placement in the retrorectus space

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical City Hospital #1 named after N.I. Pirogov

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Alexander Sazhin, professor

CONTACT

+79163904180sazhin-av@yandex.ru

Georgy Ivakhov, PhD

CONTACT

+79262844224ivakhovsurg@yandex.ru

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
SPONSOR

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 6, 2022

Study Start

February 14, 2023

Primary Completion

December 1, 2023

Study Completion

March 1, 2024

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)