ISOperistaltic Versus ANTIperistaltic Anastomosis After Laparoscopic Right Colectomy for Cancer

Not Applicable

Completed

• Conditions: Primary Malignant Neoplasm of Ascending Colon
• Interventions: Procedure: isoperistaltic side-to-side ileocecal anastomosis; Procedure: antiperistaltic side-to-side ileocecal anastomosis

• Registration Number: NCT02309931
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-11-28
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-05
• Primary Completion: 2016-11-01
• Study Completion: 2017-11-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isoperistaltic anastomosis	isoperistaltic side-to-side ileocecal anastomosis	Patients with right colon cancer who undergo a right laparoscopic hemicolectomy and a isoperistaltic side-to-side ileocecal anastomosis
Antiperistaltic anastomosis	antiperistaltic side-to-side ileocecal anastomosis	Patients with right colon cancer who undergo a right laparoscopic hemicolectomy and a antiperistaltic side-to-side ileocecal anastomosis

Primary Outcome Measures

Name	Time	Method
postoperative complications	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

Name	Time	Method
Operating time	During surgery
first faeces day	participants will be followed for the duration of hospital stay, an expected average of 4 days
Gastrointestinal life quality	up to one year	Using gastrointestinal quality life index questionnaire. preoperative, 1 month, 6 months and 1 year.
Anastomosis time	From the enteromy to its closure.
first flatus day	participants will be followed for the duration of hospital stay, an expected average of 4 days
Hospital length of say	participants will be followed for the duration of hospital stay, an expected average of 4 days
Orocecal transit	up to one year	Using hydrogen breath test curves. preoperative, at day 2 postoperative, 1 month, 6 months and 1 year.
first tolerance day	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

Trial Locations

Locations (1)

Hospital Universitario Virgen de La Arrixaca; 🇪🇸 Murcia, Spain