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

University Hospital, Gentofte, Copenhagen

Status

Withdrawn

Conditions

Hernia

Abdominal Hernia

Treatments

Procedure: Laparoscopic parastomal hernia repair with mesh

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00138957

KA05102m

Details and patient eligibility

About

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.

Full description

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

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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