ISOperistaltic Versus ANTIperistaltic Anastomosis After Laparoscopic Right Colectomy for Cancer

Hospital Universitario Virgen de la Arrixaca108 enrolled

Overview

The study will provide a precise control compared to the two interventions (iso vs antiperistaltic anastomoses) with thorough measurements of the postoperative variables and complications to improve the evaluation of the surgical technique. It will also enable an evaluation of the quality of life after the procedures.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

108

Conditions

Primary Malignant Neoplasm of Ascending Colon

Interventions

antiperistaltic side-to-side ileocecal anastomosisPROCEDURE

Right laparoscopic hemicolectomy + antiperistaltic side-to-side ileocecal anastomosis

isoperistaltic side-to-side ileocecal anastomosisPROCEDURE

Right laparoscopic hemicolectomy+isoperistaltic side-to-side ileocecal anastomosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient has given informed consent to participate * No surgery contraindications * Elective surgery * No pregnancy or nursery during the study * Older than 18 years * Complete preoperative cancer staging * Tumour characteristics: * Cecum, ascending, hepatic angle or transverse colon tumour confirmed by endoscopic biopsy * Radiologically resectable tumours * Absence of vascular, nervous or bone infiltration * T4 stages with near organ infiltration * Absence of peritoneal carcinomatosis * Absence of respiratory pathology that prevents for doing hydrogen breath test Exclusion Criteria: * Pregnancy * Intestinal bowel disease like Crohn's disease or ulcerative colitis. * Metastatic bone illness * Previous abdominal surgery with bowel resection * Malabsorption syndromes

Locations (1)

Hospital Universitario Virgen de La Arrixaca

Murcia, Spain

Outcomes

Primary Outcomes

postoperative complications

Number of patients with postoperative complications and grade of Clavien-Dindo

Time frame: within the first 30 days up to one year after surgery

Secondary Outcomes

Operating time

Time frame: During surgery

Anastomosis time

Time frame: From the enteromy to its closure.

Hospital length of say

Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days

first tolerance day

First day taking liquids without vomits or abdominal distension

Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days

first flatus day

Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days

first faeces day

Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days

Orocecal transit

Using hydrogen breath test curves. preoperative, at day 2 postoperative, 1 month, 6 months and 1 year.

Time frame: up to one year

Gastrointestinal life quality

Using gastrointestinal quality life index questionnaire. preoperative, 1 month, 6 months and 1 year.

Time frame: up to one year

Data from ClinicalTrials.gov

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