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

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ClinicalTrials.gov Identifier: NCT02309931
Recruitment Status : Unknown
Verified May 2017 by Jesus Abrisqueta Carrion, Hospital Universitario Virgen de la Arrixaca.
Recruitment status was:  Active, not recruiting
First Posted : December 5, 2014
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Jesus Abrisqueta Carrion, Hospital Universitario Virgen de la Arrixaca

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Malignant Neoplasm of Ascending Colon Procedure: antiperistaltic side-to-side ileocecal anastomosis Procedure: isoperistaltic side-to-side ileocecal anastomosis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing Isoperistaltic Versus Antiperistaltic Side to Side Anastomosis After Right Laparoscopic Hemicolectomy for Cancer.
Actual Study Start Date : June 2014
Actual Primary Completion Date : November 1, 2016
Estimated Study Completion Date : November 1, 2017

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Operating time [ Time Frame: During surgery ]
  2. Anastomosis time [ Time Frame: From the enteromy to its closure. ]
  3. Hospital length of say [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days ]
  4. 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

  5. first flatus day [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days ]
  6. first faeces day [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days ]
  7. 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.

  8. Gastrointestinal life quality [ Time Frame: up to one year ]
    Using gastrointestinal quality life index questionnaire. preoperative, 1 month, 6 months and 1 year.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309931


Locations
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Spain
Hospital Universitario Virgen de La Arrixaca
Murcia, Spain, 30120
Sponsors and Collaborators
Hospital Universitario Virgen de la Arrixaca
Investigators
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Study Director: Juan Lujan, Ph D Hospital Universitario Virgen de la Arrixaca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jesus Abrisqueta Carrion, Ph D, Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier: NCT02309931     History of Changes
Other Study ID Numbers: CCR-HCUVA-2014-01
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Keywords provided by Jesus Abrisqueta Carrion, Hospital Universitario Virgen de la Arrixaca:
Right hemicolectomy
Side-to-side anastomosis
Orocecal time
Antipersitaltic
Isoperistaltic
Laparoscopic colectomy
Right laparoscopic hemicolectomy
Additional relevant MeSH terms:
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Neoplasms
Antidiarrheals
Gastrointestinal Agents