Colorectal Neoplasms Clinical Trial
— LONGCROSSOfficial title:
Parastomal Hernia Prevention: Longitudinal Incision Versus Cruciate Incision in the Construction of an End Colostomy. LONG CROSS Trial
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
".
DESIGN:
Randomized, open and parallel clinical trial so patients will be assigned to the cruciate
incision group or longitudinal incision with a 1: 1 allocation ratio.
POPULATION:
Patients undergoing colorectal cancer surgery a definitive end colostomy.
OBJECTIVES:
The main objective is to compare the parastomal hernia rate diagnosed by imaging at 2 years
after surgery.
Secondary objectives are:
1. Clinically relevant parastomal hernia rate by physical examination 2 years after
surgery.
2. Incidence of postoperative complications related to the stoma (dehiscence, retraction,
stenosis, necrosis, surgical revision, prolapse and special needs of care of the stoma
in the immediate or late postoperative period); 3) Incidence of postoperative
complications assessed according to the Comprehensive Complication Index (CCI) scale.
4) Ease / difficulty in the management of stomatherapy devices by patients using VAS (Visual
Analogue Scale).
DESCRIPTION OF THE INTERVENTION:
An end colostomy without placement of a prophylactic mesh will be performed in all patients.
In the group 1A, a longitudinal incision will be made in the anterior rectus fascia and in
the posterior fascia, with two Prolene sutures at the ends of the incision of the anterior
aponeurosis. In patients of group 1B, a cruciate incision will be made in the anterior rectus
fascia, as well as in the posterior fascia.
DURATION OF THE STUDY:
The expected duration of the study is 3 years.
PATIENT FOLLOW UP TIME:
The planned follow-up time is 2 years.
EXPECTED RECRUITMENT TIME:
12 months.
Status | Recruiting |
Enrollment | 42 |
Est. completion date | April 15, 2022 |
Est. primary completion date | October 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Jose Maria Enriquez Navascues | Donostia San Sebastian | |
Spain | Jose Maria Enriquez Navascues | Donostia San Sebastian |
Lead Sponsor | Collaborator |
---|---|
Hospital Donostia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | parastomal hernia rate by imaging | parastomal hernia by CT | 2 years | |
Secondary | Clinically relevant parastomal hernia rate | by physical examination | 2 years after surgery | |
Secondary | Incidence of postoperative complications related to the stoma (dehiscence, retraction, stenosis, necrosis, surgical revision, prolapse and special needs | Physical examination | 2 years | |
Secondary | Ease / difficulty in the management of stomatherapy devices | using VAS scale (Visual Analogue Scale). Visual analogue scales (VAS) is psychometric measuring instrument designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control, measuring from 0 (unhappy) 10 (very happy). | 2 years |
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