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

Virgen de la Arrixaca University Clinical Hospital (HCUVA)

Status: Completed

Conditions: Primary Malignant Neoplasm of Ascending Colon

Treatments: Procedure: antiperistaltic side-to-side ileocecal anastomosis; Procedure: isoperistaltic side-to-side ileocecal anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT02309931

CCR-HCUVA-2014-01

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups

Isoperistaltic anastomosis

Active Comparator group

Description:

Patients with right colon cancer who undergo a right laparoscopic hemicolectomy and a isoperistaltic side-to-side ileocecal anastomosis

Treatment:

Procedure: isoperistaltic side-to-side ileocecal anastomosis

Antiperistaltic anastomosis

Active Comparator group

Description:

Patients with right colon cancer who undergo a right laparoscopic hemicolectomy and a antiperistaltic side-to-side ileocecal anastomosis

Treatment:

Procedure: antiperistaltic side-to-side ileocecal anastomosis