ISOperistaltic Versus ANTIperistaltic Anastomosis After Laparoscopic Right Colectomy for Cancer (ISOVANTI)

March 6, 2023 updated by: Jesus Abrisqueta Carrion, Hospital Universitario Virgen de la Arrixaca

Randomized Clinical Trial Comparing Isoperistaltic Versus Antiperistaltic Side to Side Anastomosis After Right Laparoscopic Hemicolectomy for Cancer.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30120
        • Hospital Universitario Virgen de la Arrixaca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Isoperistaltic anastomosis
Patients with right colon cancer who undergo a right laparoscopic hemicolectomy and a isoperistaltic side-to-side ileocecal anastomosis
Procedure: isoperistaltic side-to-side ileocecal anastomosis
Right laparoscopic hemicolectomy+isoperistaltic side-to-side ileocecal anastomosis
Active Comparator: Antiperistaltic anastomosis
Patients with right colon cancer who undergo a right laparoscopic hemicolectomy and a antiperistaltic side-to-side ileocecal anastomosis
Procedure: antiperistaltic side-to-side ileocecal anastomosis
Right laparoscopic hemicolectomy + antiperistaltic side-to-side ileocecal anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative complications
Time Frame: within the first 30 days up to one year after surgery
Number of patients with postoperative complications and grade of Clavien-Dindo
within the first 30 days up to one year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating time
Time Frame: During surgery
During surgery
Anastomosis time
Time Frame: From the enteromy to its closure.
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
participants will be followed for the duration of hospital stay, an expected average of 4 days
first tolerance day
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
First day taking liquids without vomits or abdominal distension
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
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
participants will be followed for the duration of hospital stay, an expected average of 4 days
Orocecal transit
Time Frame: up to one year
Using hydrogen breath test curves. preoperative, at day 2 postoperative, 1 month, 6 months and 1 year.
up to one year
Gastrointestinal life quality
Time Frame: up to one year
Using gastrointestinal quality life index questionnaire. preoperative, 1 month, 6 months and 1 year.
up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Virgen de la Arrixaca

Investigators

  • Study Director: Juan Lujan, Ph D, Hospital Universitario Virgen de la Arrixaca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

November 28, 2014

First Submitted That Met QC Criteria

December 3, 2014

First Posted (Estimate)

December 5, 2014

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR-HCUVA-2014-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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