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Impact of the non-muscle cutting periumbilical transverse incision on the risk of incisional hernia compared to the midline incision during laparoscopic colorectal cancer surgery: A randomized controlled multi-center trial

ABSTRACT: Interventions: Procedure/Surgery : Incision for removal or anastomosis of colon tissue is performed by extending the laparoscopic incision horizontally. A transverse incision is made in the anterior fascia of the rectus muscle. The abdominal rectus muscle is not incised, but the muscles are lateralized out to find the posterior fascia and peritoneum and incise horizontally. Primary outcome(s): Incisional hernia incidence rate of 1 year (12 months) from the date of surgery Primary Purpose : Other(To demonstrate that transverse incision after laparoscopic colorectal cancer surgery reduces the incidence of incisional hernia compared to vertical incision around the umbilicus), Intervention Model : Parallel, Blinding/Masking : , Blinding Target : , Allocation : RCT

DISEASE(S): Neoplasms

PROVIDER: 2513939 | 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

Dataset Information

Impact of the non-muscle cutting periumbilical transverse incision on the risk of incisional hernia compared to the midline incision during laparoscopic colorectal cancer surgery: A randomized controlled multi-center trial

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