Assessment of Quality of life (QOL) in colorectal cancer patients with colostomy
Ontology highlight
ABSTRACT:
DISEASE(S): Malignant Neoplasm Of Colon, Unspecified
PROVIDER: 2592526 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Revision of bowel segment, stoma placement, vascular anomalies - will be recorded intraoperativelyTimepoint: Anastomotic leak at 30 days from the day of surgery.
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Project description: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.
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Project description:Background:Development of a parastomal hernia is common following abdominoperineal excision (APE). The true incidence is difficult to assess fully owing to differing lengths of follow-up and techniques used to assess herniation; radiological or clinical. The primary aim of this study was to evaluate colostomy diameter by studying the rate of change of axial and sagittal trephine diameters, trephine area, and the ratio of the trephine over time. A secondary aim was to investigate variation in trephine area and variables affecting parasternal hernia over time. Methods:Serial CT scans performed after APE from January 2006 to December 2014 were reviewed. Variables analysed included age, sex, trephine position relative to rectus abdominis muscle (RAM), type of incision for stoma creation, and axial and sagittal trephine diameters measured on follow-up CT. A Bayesian hierarchical modelling framework was used to examine the relationship of trephine diameters, area and ratio over time. Results:Of 112 patients undergoing APE, 103 were eligible for analysis; this included 91 colostomies (88·3 per cent) through the RAM and 12 (11·7 per cent) lateral to the RAM. Median age of the patients was 68 years. Sixty patients (58·3 per cent) had a circular and 43 (41·7 per cent) a cruciate incision for stoma creation. The sagittal trephine diameter increased by 0·22 (95 per cent credible interval 0·12 to 0·32) mm/month for both sexes. Women reported a significant increase in axial trephine diameters; the male : female ratio difference was -0·17 (-0·30 to -0·03) mm/month and for trephine areas -6·21 (0·96 to 13·7) mm2/month. Patient age, colostomy trephine location and shape of incision were not statistically significant variables for parasternal hernia. Conclusion:Female sex was the only variable affecting the rate of increase in axial trephine diameter and trephine area over time.
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