ISOperistaltic Versus ANTIperistaltic Anastomosis After Laparoscopic Right Colectomy for Cancer

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.

Full Title of Study: “Randomized Clinical Trial Comparing Isoperistaltic Versus Antiperistaltic Side to Side Anastomosis After Right Laparoscopic Hemicolectomy for Cancer.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: November 1, 2016

Interventions

  • Procedure: antiperistaltic side-to-side ileocecal anastomosis
    • Right laparoscopic hemicolectomy + antiperistaltic side-to-side ileocecal anastomosis
  • Procedure: isoperistaltic side-to-side ileocecal anastomosis
    • Right laparoscopic hemicolectomy+isoperistaltic side-to-side ileocecal anastomosis

Arms, Groups and Cohorts

  • Active Comparator: Isoperistaltic anastomosis
    • Patients with right colon cancer who undergo a right laparoscopic hemicolectomy and a 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
    • 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
  • 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
    • Time Frame: up to one year
    • Using hydrogen breath test curves. preoperative, at day 2 postoperative, 1 month, 6 months and 1 year.
  • Gastrointestinal life quality
    • Time Frame: up to one year
    • Using gastrointestinal quality life index questionnaire. preoperative, 1 month, 6 months and 1 year.

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Hospital Universitario Virgen de la Arrixaca
    • Provider of Information About this Clinical Study
      • Principal Investigator: Jesus Abrisqueta Carrion, Ph D – Hospital Universitario Virgen de la Arrixaca
    • Overall Official(s)
      • Juan Lujan, Ph D, Study Director, Hospital Universitario Virgen de la Arrixaca

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