Status:
UNKNOWN
Longitudinal Incision Versus Cruciate Incision in the Construction of an End Colostomy
Lead Sponsor:
Hospital Donostia
Conditions:
Colorectal Neoplasms
Parastomal Hernia
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
TITLE: "Incidence of parastomal hernia: Randomized clinical trial comparing the longitudinal fascial incision (" Hepworth hitch ") vs. cruciate incision in the exteriorization of a end colostomy ". ...
Detailed Description
Parastomal hernia is one of the major complications after definitive terminal colostomy in patients with colorectal cancer, which is clinically relevant in up to 50% of the cases but can reach 78% of ...
Eligibility Criteria
Inclusion
- Patients undergoing surgery for colorectal cancer undergoing definitive end colostomy.
- Age ≥ 18 years and \<85 years.
- Any type of tumor, any T, N, M0.
- Consent signed by the patient and by the researcher.
Exclusion
- no colostomy, not end stoma.
- Inflammatory bowel disease with anatomopathological confirmation.
- Patients with previous incisional hernias or carriers of meshes except inguinal hernioplasties.
- Patients with previous stoma.
- Inability to read or understand any of the languages of informed consent.
- Emergency surgery.
- Psychiatric diseases, addictions or any disorder that prevents the compression of informed consent.
- Extraction of the piece by colostomy hole.
- Colostomies not previously marked by specialized stomatherapist.
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04397783
Start Date
April 15 2019
End Date
April 15 2022
Last Update
June 16 2020
Active Locations (2)
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1
Jose Maria Enriquez Navascues
Donostia / San Sebastian, Spain
2
Jose Maria Enriquez Navascues
Donostia / San Sebastian, Spain