Watchful Waiting Versus Repair of Oligosymptomatic Incisional Hernias

NCT01349400 | Completed DMC

• 1 other identifier: KS6-233
• Study Type: interventional
• Target: 636
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

asymptomatic; minimally symptomatic

Outcome Measures

Primary Outcomes (1)

• Pain/ discomfort during normal activities

  Pain/ discomfort during normal activities as a result of the hernia or hernia operation 2 years after enrolment measured by the hernia-specific Surgical Pain Scale (SPS) on a 150 mm-scale ranging from "no pain sensation" to "most intense pain imaginable".

  24 months

Secondary Outcomes (5)

• Patient satisfaction with care (5 point Likert scale)

  24 months

• Pain/discomfort at rest /pain during sports /maximal pain

  24 months

• Pain Disability Index

  24 months

• Quality of Life (SF-36)

  24 months

• Frequency of acute incarcerations

  24 months

Study Arms (2)

watchful waiting

EXPERIMENTAL

After informed consent and randomization into the watchful waiting group patients will receive standardized verbal information and written instructions on symptoms of acute incarceration. In case of acute symptoms they will be told to visit a physician immediately. On follow-up visits at 1 month, 12 months and 24 months the hernia size will be determined by physical examination, and the pain/ discomfort and the functional status will be monitored. Control intervention/ reference test: 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. Divergent types of repair are permitted but have to be documented.

Other: Watchful waiting

Hernia repair

ACTIVE COMPARATOR

Intervention: 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. Divergent types of repair are permitted but have to be documented.

Procedure: Hernia repair

Interventions

Watchful waiting OTHER

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.

watchful waiting

Hernia repair PROCEDURE

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.

Hernia repair

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years
• asymptomatic/ oligosymptomatic incisional hernia

You may not qualify if:

• no hernia detectable by physical examination
• acute incarcerated hernia
• emergency hernia repair
• pain or discomfort associated with the hernia during normal activities
• local or systemic infection
• ASA score \>3
• inability to complete or comprehend the preoperative questionnaire
• repair with biologic prothesis

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• German Research Foundation: collaborator

Study Sites (1)

Charité Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Related Publications (1)

• Lauscher JC, Martus P, Stroux A, Neudecker J, Behrens U, Hammerich R, Buhr HJ, Ritz JP. Development of a clinical trial to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia: study protocol for a randomized controlled trial. Trials. 2012 Feb 7;13:14. doi: 10.1186/1745-6215-13-14.

  PMID: 22314130 DERIVED

MeSH Terms

Conditions

Incisional Hernia

Interventions

Watchful Waiting; Herniorrhaphy

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Johannes C Lauscher, M. D.

  Charité Campus Benjamin Franklin, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Watchful waiting vs. surgical repair

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: May 6, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

DE (1)