ISOperistaltic Versus ANTIperistaltic Anastomosis After Laparoscopic Right Colectomy for Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Malignant Neoplasm of Ascending Colon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Isoperistaltic anastomosis

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

Group Type ACTIVE_COMPARATOR

isoperistaltic side-to-side ileocecal anastomosis

Intervention Type PROCEDURE

Right laparoscopic hemicolectomy+isoperistaltic side-to-side ileocecal anastomosis

Antiperistaltic anastomosis

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

Group Type ACTIVE_COMPARATOR

antiperistaltic side-to-side ileocecal anastomosis

Intervention Type PROCEDURE

Right laparoscopic hemicolectomy + antiperistaltic side-to-side ileocecal anastomosis

Interventions

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antiperistaltic side-to-side ileocecal anastomosis

Right laparoscopic hemicolectomy + antiperistaltic side-to-side ileocecal anastomosis

Intervention Type PROCEDURE

isoperistaltic side-to-side ileocecal anastomosis

Right laparoscopic hemicolectomy+isoperistaltic side-to-side ileocecal anastomosis

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No