Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2026-01-04 @ 2:45 PM
Study NCT ID:
NCT00138957
Status:
WITHDRAWN
Last Update Posted:
2008-07-11
First Post:
2005-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of a New Laparoscopic Technique for Parastomal Hernia Repair With Mesh
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009074', 'term': 'Melanocyte-Stimulating Hormones'}], 'ancestors': [{'id': 'D053486', 'term': 'Melanocortins'}, {'id': 'D011333', 'term': 'Pro-Opiomelanocortin'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'whyStopped': 'too few patients included', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2007-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-07-09', 'studyFirstSubmitDate': '2005-08-29', 'studyFirstSubmitQcDate': '2005-08-29', 'lastUpdatePostDateStruct': {'date': '2008-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of parastomal hernia after 6 months (ultrasound and clinical)'}, {'measure': 'Postoperative pain (Visual Analog Scale, VAS 0-100, Verbal Rating Scale, VRS 0-3)'}, {'measure': 'Stricture of stoma (Bougie, mm)'}, {'measure': 'Quality of life (SF-36 and Ostomy Adjustment Scale (OAS))'}, {'measure': 'General well-being (VAS 0-100)'}, {'measure': 'Postoperative ileus/paralysis > 24 hours'}, {'measure': "Patient's satisfaction (VAS 0-100)"}, {'measure': 'Bandage problems (VRS 0-3)'}], 'secondaryOutcomes': [{'measure': 'Medical and surgical complications'}]}, 'conditionsModule': {'keywords': ['Laparoscopic parastomal hernia repair', 'Intraperitoneally', 'Mesh', 'Quality of life', 'Postoperative pain', 'Recurrence'], 'conditions': ['Hernia', 'Abdominal Hernia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Parastomal hernia affects up to 50% of all patients following formation of a stoma, most often in patients with a colostomy. About 20% of the patients need surgical correction of their parastomal hernia. Symptoms associated with parastomal hernias goes from mild physical (pain) and cosmetic discomfort to life threatening conditions with obstruction, strangulation and perforation. Parastomal hernias have big socioeconomic consequences and remain a considerable clinical problem.\n\nThe surgical treatment of parastomal hernias is controversial. The best way to treat it is to restore the continuity of the intestine, but in permanent stomas, this is not an option. Many surgical techniques have been described when intervention is required, but the results are unacceptable. The traditional open techniques are local simple suturing of the fascia defect, stoma relocation, or repair with a prosthetic material either intraperitoneally or extraperitoneally (subfascial or onlay). Overall, the results of all methods are poor with high recurrence rates and high morbidity and mortality. Mesh repair has the lowest recurrence rate (0-39%) and stoma relocation and simple suture has reported recurrence rates on 0-76% and 46-100%, respectively. Laparoscopic repair of parastomal hernias with a prosthetic mesh inserted intraperitoneally is a new method described in a few small series. The results so far are encouraging, but the follow-up period is short.\n\nLooking at the disappointing results from the traditional open techniques in the treatment of parastomal hernias together with the enormous success in laparoscopic ventral hernia repair and laparoscopy overall, we believe that laparoscopic parastomal hernia repair with mesh will be an effective treatment option in the future. Therefore, we find it interesting to investigate the technique in a prospective study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - 80 years\n* Indication for laparoscopic parastomal hernia repair in general anaesthesia.\n* Danish speaking\n* ASA group I-III\n* No remaining malignancy after former primary radical operation for colorectal cancer\n\nExclusion Criteria:\n\n* Former operation (open/lap) for parastomal hernia with insertion of mesh, or other mesh operation in the area of herniation\n* Incarcerated hernia (acute operation)\n* History of abuse or permanent morphine use\n* Expected bad compliance\n* Current systemic steroid use or other immuno-suppressive treatment\n* HIV-positive, pregnant or breast feeding\n* Medical conditions contraindicating general anaesthesia\n* Simultaneous operation for other ventral, inguinal or umbilical hernia\n* Epidural or spinal anaesthesia\n* Conversion to open procedure'}, 'identificationModule': {'nctId': 'NCT00138957', 'briefTitle': 'Study of a New Laparoscopic Technique for Parastomal Hernia Repair With Mesh', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'Laparoscopic Parastomal Hernia Repair Using an Innovative Composite Polypropylene Mesh - A Prospective Study', 'orgStudyIdInfo': {'id': 'KA05102m'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Laparoscopic parastomal hernia repair with mesh', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jacob Rosenberg, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gentofte University Hospital, Dept. of Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ethicon, Inc.', 'class': 'INDUSTRY'}]}}}