MedTrace Logo

Watchful Waiting Versus Repair of Oligosymptomatic Incisional Hernias

NCT01349400 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 636

Last updated 2024-02-13

No results posted yet for this study

Summary

Watchful waiting is non-inferior to surgical repair of asymptomatic and oligosymptomatic incisional hernias in terms of pain and discomfort during normal activities.

Conditions

  • Incisional Hernia

Interventions

OTHER

Watchful waiting

Watchful waiting means the observation of the hernia. The patient is informed about signs of deterioration or incarceration. The hernia is controlled clinically on defined follow-up visits.

PROCEDURE

Hernia repair

Open or laparoscopic hernia repair with mesh (non-absorbable or partly-absorbable alloplastic material) or with direct suture repair. For hernias measuring ≥ 3 cm mesh repair is recommended. A wide overlap of the mesh over the fascia margin on each side has to be provided. These are all standard techniques in incisional hernia repair.

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Johannes C Lauscher, M. D. · Charité Campus Benjamin Franklin, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01349400 on ClinicalTrials.gov