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Longitudinal Incision Versus Cruciate Incision in the Construction of an End Colostomy

ABSTRACT: 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.

DISEASE(S): Hernia,Surgical Wound,Colostomy Stoma,Colorectal Neoplasms,Parastomal Hernia

PROVIDER: 2339952 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Intervention1: Rectus sheath block: A USG machine with linear array probe (5-12MHz) with an imaging depth of 4-6cm will be used for performing the block. The ultrasound probe will be placed transverse on abdomen, immediately lateral (3 cm) to umbilicus. A 20-gauge needle will be inserted in-plane in a medial to lateral orientation, through the subcutaneous tissue, to pierce through the anterior rectus sheath. Upon identification of the rectus muscle and hyperechoic twin lines deep to it (posterior rectus sheath and fascia transversalis) in the ultrasound image the needle tip will be advanced to the desired position, posterior to the rectus muscle and above the underlying posterior rectus sheath under direct vision. Following conï¬?rmation of the correct position of the needle tip with hydro dissection of the rectus muscle away from the posterior rectus by administration of 0.51ml of normal saline; 20ml of 0.25% bupivacaine will be administered for block performance. The procedure will be repeated on the opposite side. Intervention2: oblique subcostal Transversus abdominis plane block: A USG linear array probe with high- or an intermediate-frequency linear probe of 35 to 40 mm will provide adequate imaging. A needle of up to 15 to 20 cm in length , bend into a slight curve will be required , decribed by Hebbard et al .15 The operator will stand on the left side of the patient in the supine position, and both sides are blocked from this position, with the right hand holding the needle and the left hand holding the probe. To perform the block, the rectus abdominis and underlying transversus abdominis muscles will be identified near the costal margin and xyphoid. Local anesthetic is injected incrementally in the TAP (hydrodissection) by a needle passing along the obliq Primary outcome(s): â?¢To assess the analgesic efficacy of rectus sheath block. â?¢To assess the analgesic efficacy of oblique subcostal TAP block. â?¢To compare the analgesic efficacy of both blocks. Timepoint: 24 hrs Study Design: Randomized, Parallel Group Trial Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant and Investigator Blinded

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Longitudinal Incision Versus Cruciate Incision in the Construction of an End Colostomy

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