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.

Condition	Intervention
Hernia Abdominal Hernia	Procedure: Laparoscopic parastomal hernia repair with mesh

Further Study Details: 

Primary Outcomes: • 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: • Medical and surgical complications
Expected Total Enrollment:  20

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.

The 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.

Looking 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

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00138957

Jens R. Eriksen, MD      +45 39 77 39 77    jravn@dadlnet.dk

Denmark, Hellerup
      Dept. of Surgery, Gentofte University Hospital, Copenhagen,  Hellerup,  2900,  Denmark

Study chairs or principal investigators

Jacob Rosenberg, Prof, MD,  Principal Investigator,  Gentofte University Hospital, Dept. of Surgery   

Study ID Numbers:  KA05102m
Last Updated:  August 29, 2005
Record first received:  August 29, 2005
ClinicalTrials.gov Identifier:  NCT00138957
Health Authority: Denmark: National Board of Health
ClinicalTrials.gov processed this record on 2005-08-30