Study of a New Laparoscopic Technique for Parastomal Hernia Repair With Mesh

NCT00138957 | Withdrawn

• 1 other identifier: KA05102m
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to evaluate a new laparoscopic technique for parastomal hernia repair using an intraperitoneally placed Proceed mesh, looking at postoperative complications, recurrence rate and postoperative pain and quality of life.

Conditions

Hernia; Abdominal Hernia

Keywords

Laparoscopic parastomal hernia repair; Intraperitoneally; Mesh; Quality of life; Postoperative pain; Recurrence

Outcome Measures

Primary Outcomes (8)

• Recurrence of parastomal hernia after 6 months (ultrasound and clinical)

• Postoperative pain (Visual Analog Scale, VAS 0-100, Verbal Rating Scale, VRS 0-3)

• Stricture of stoma (Bougie, mm)

• Quality of life (SF-36 and Ostomy Adjustment Scale (OAS))

• General well-being (VAS 0-100)

• Postoperative ileus/paralysis > 24 hours

• Patient's satisfaction (VAS 0-100)

• Bandage problems (VRS 0-3)

Secondary Outcomes (1)

• Medical and surgical complications

Interventions

Laparoscopic parastomal hernia repair with mesh PROCEDURE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 80 years
• Indication for laparoscopic parastomal hernia repair in general anaesthesia.
• Danish speaking
• ASA group I-III
• No remaining malignancy after former primary radical operation for colorectal cancer

You may not qualify if:

• Former operation (open/lap) for parastomal hernia with insertion of mesh, or other mesh operation in the area of herniation
• Incarcerated hernia (acute operation)
• History of abuse or permanent morphine use
• Expected bad compliance
• Current systemic steroid use or other immuno-suppressive treatment
• HIV-positive, pregnant or breast feeding
• Medical conditions contraindicating general anaesthesia
• Simultaneous operation for other ventral, inguinal or umbilical hernia
• Epidural or spinal anaesthesia
• Conversion to open procedure

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• Ethicon, Inc.: collaborator

MeSH Terms

Conditions

Hernia; Hernia, Abdominal; Pain, Postoperative; Recurrence

Interventions

Melanocyte-Stimulating Hormones

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Jacob Rosenberg, Prof, MD

  Gentofte University Hospital, Dept. of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 30, 2005
• Study Start: September 1, 2005
• Study Completion: December 1, 2007
• Last Updated: July 11, 2008

Record last verified: 2008-07