ISOperistaltic Versus ANTIperistaltic Anastomosis After Laparoscopic Right Colectomy for Cancer

Primary Malignant Neoplasm of Ascending Colon Clinical Trial

— ISOVANTI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309931
• Other study ID #: CCR-HCUVA-2014-01
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: November 1, 2017

Study information

• Verified date: March 2023
• Source: Hospital Universitario Virgen de la Arrixaca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Primary Malignant Neoplasm of Ascending Colon

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de La Arrixaca	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative complications	Number of patients with postoperative complications and grade of Clavien-Dindo	within the first 30 days up to one year after surgery
Secondary	Operating time		During surgery
Secondary	Anastomosis time		From the enteromy to its closure.
Secondary	Hospital length of say		participants will be followed for the duration of hospital stay, an expected average of 4 days
Secondary	first tolerance day	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
Secondary	first flatus day		participants will be followed for the duration of hospital stay, an expected average of 4 days
Secondary	first faeces day		participants will be followed for the duration of hospital stay, an expected average of 4 days
Secondary	Orocecal transit	Using hydrogen breath test curves. preoperative, at day 2 postoperative, 1 month, 6 months and 1 year.	up to one year
Secondary	Gastrointestinal life quality	Using gastrointestinal quality life index questionnaire. preoperative, 1 month, 6 months and 1 year.	up to one year