Long-term Results in Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy

October 28, 2022 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Long-term Clinical Results and Direct Economic Implication Within the Randomized Clinical Trial Comparing Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy

Advantages of laparoscopic right colectomy with intracorporeal anastomosis (IA) compared to extracorporeal anastomosis (EA) are widely studied. Nowadays we can conclude, with a high level of scientific evidence, that there are a number of short-term clinical advantages of laparoscopic right colectomy with intracorporeal anastomosis (IA).

However, there is currently no randomized studies describing long-term clinical and oncological outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

Little evidence has been published demonstrating the advantages of IA versus EA.

Recent publications show the superiority of IA in terms of early functional digestive recovery, a shorter surgical incision, a lower need for analgesia, lower blood loss, and lower postoperative Clavien-Dindo grade. These results are similar to other further published studies, including multicenter randomized clinical trials and meta-analyses.

Methods:

This is a a long-term clinical follow-up study of 140 patients included preaviously in the single-blind single-center randomized prospective clinical trial conducted at the Hospital de la Santa Creu i Sant Pau (HSCSP) between 2015-2018; in which 30-day clinical outcomes after laparoscopic right colectomy for colon cancer with IA vs EA anastomosis were compared.

In this new trial, prospective clinical follow-up of the included 140 patients, randomized in two groups IA and EA, will be carried out, with a minimum time of 3 years.

The main objective of the study will be:

-Comparing long-term oncological outcomes of IA vs. EA anastomosis in laparoscopic right colectomy for malignant neoplasm.

The secondary objectives will be:

  • Analyzing the appearance of abdominal wall hernias and episodes of occlusion.
  • Describing the direct costs of both techniques retrospectively, through the financial records of the HSCSP institution.

The main hypothesis will be:

-IA is not inferior compared to EA in terms of oncological and clinical results, with a lower rate of abdominal postoperative hernias and occlusive/subocclusive episodes.

A regular prospective clinical follow-up through periodic medical visits and complementary tests established by the criteria of the Colorectal Cancer management protocol (document agreed by the HSCSP Colorectal Tumors Committee) will be conducted.

For the economic evaluation, all direct in-hospital costs that were registered by the HSCSP management will be analysed.

Extensive written information and an informed consent about the study will be provided to the patient.

The study does not entail any risk for the patient as it does not interfere with the usual follow-up or require extraordinary complementary studies.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Neoplasms settled in the cecum, right colon, hepatic flexure or proximal transverse colon
  • Surgical procedure with curative purpose.
  • American Society of Anaesthesiologists Physical Status (ASA) I, II and III.
  • Elective surgery.
  • Signed Informed Consent.

Exclusion Criteria:

  • Denial of informed consent.
  • Advanced neoplasia (Stage IV)
  • Urgent surgery.
  • ASA IV.
  • Bening colonic disease, such Ulcerative Colitis or Crohn Disease
  • Multivisceral procedures performed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intracorporeal anastomosis (IA)
Experimental: Intracorporeal anastomosis Iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Echelon Endopatch and closure of the defect with running suture or another firing of Echelon Endopatch. The surgical specimen is retrieved through a Pfannenstiel incision.
Procedure: Intracorporeal anastomosis

Iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Echelon Endopatch and closure of the defect with running suture or another firing of Echelon Endopatch. The surgical specimen will be retrieved through a Pfannenstiel incision.

Device:

Use of an Echelon Endopatch Powered Device to perform an ileocolonic side-to-side anastomosis.
Active Comparator: Extracorporeal anastomosis (EA)
A transverse incision in the right upper quadrant is performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Rel Stapler
Procedure: Extracorporeal anastomosis

A transverse incision in the right upper quadrant will be performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Stapler.

Device:

Use of a Proximate Linear Cutter device to perform a side-to-side ileo-colonic anastomosis.Use of a Proximate stapler to the closure of the defect associated with the creation of the side-to-side ileo-colonic anastomosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years
Percentage of patients alive after a 3-years follow-up-period since the laparoscopic right colectomy is performed
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 3 years
Percentage of patients alive without any type of recurrence (local or distant) after a 3-years follow-up-period since the laparoscopic right colectomy is performed
3 years
Local recurrence
Time Frame: 3 years
Percentage of patients that experiment disease recurrence which is placed in the previously operated area
3 years
Distant recurrence
Time Frame: 3 years
Percentage of patients that experiment disease recurrence which is placed in a different area from the previously operated region (intraperitoneal, liver, lung metastases, etc)
3 years
Incisional hernia
Time Frame: 3 years
Percentage of patients that present an abdominal hernia settled on any of the incisions performed during the laparoscopic right colectomy
3 years
Intestinal obstruction
Time Frame: 3 years
Percentage of patients that experiment mechanical impairment or complete arrest of the passage of contents through the intestine due to pathology that causes blockage of the bowel.
3 years
Cost of surgical material
Time Frame: Intraoperative time
Price (in euro) of the material used in the operating room in each procedure
Intraoperative time
Cost of operative room
Time Frame: Intraoperative time
Price (in euro) of the total amount of hours of surgical time per each procedure
Intraoperative time
Cost per global hospitalization
Time Frame: Time from the first day of operation until the day that the patient is discharged from the hospital
Price (in euro) of the total amount of days of hospitalization per each group
Time from the first day of operation until the day that the patient is discharged from the hospital
Cost per ICU hospitalization
Time Frame: Time from the first day of entry into ICU until the day that the patient is transfered to Surgery Department
Price (in euro) of the total amount of days of hospitalization in Intensive Care Unit per each group
Time from the first day of entry into ICU until the day that the patient is transfered to Surgery Department
Cost of tests during hospitalization
Time Frame: Time from the first day of operation until the day that the patient is discharged from the hospital
Price (in euro) of the total amount of costs related to laboratory and diagnosis during the hospitalization period, per each group
Time from the first day of operation until the day that the patient is discharged from the hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2022

Primary Completion (Anticipated)

December 28, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

May 23, 2022

First Submitted That Met QC Criteria

July 5, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Actual)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-ANA-2021-16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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