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Study of the Intracorporeal Versus Extracorporeal Anastomosis in Right Hemicolectomy: HEMI-D-TREND-study (HEMI-D-TREND)

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ClinicalTrials.gov Identifier: NCT03918369
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
Mireia Pascua-Solé
Laura Mora-Lopez
Anna Pallisera-Lloveras
Sheila Serra-Pla
Ricard Sales
Beatriz Espina
Luis Romangolo
Anna Serracant
Cristina Ruiz
Mº José Mañas Gomez
Angels Montserrat-Marti
Mireia Merichal
Charlie Cerdán-Santacruz
Antonio Sanchez
Helena Vallverdu
Andrés Dárdano
Information provided by (Responsible Party):
Xavier Serra-Aracil, Corporacion Parc Tauli

Brief Summary:

INTRODUCTION: Colorectal cancer is the second most frequent cancer in the Western world . Roughly a third of colorectal tumors are located in the right colon , and right hemicolectomy surgery is the treatment of choice in non-disseminated right colon cancer and other benign pathologies. Despite the introduction of laparoscopy and multimodal fast-track perioperative management programs in recent years, postoperative complication rates remain high. The most serious complication is anastomotic leak (AL), which is associated with increased mortality, longer hospital stay, and reduced quality of life due to the presence of ostomies. For a long time, the importance of ileo-colic AL was underestimated. However, the ANACO study1, conducted in 52 hospitals in our environment, reported a rate of AL of 8.4% with a range of 0 to 35%. This wide range is due to the differences in the surgical procedures and anastomoses used (the surgical approach may be open or laparoscopic, and the anastomosis may be manual or mechanical, with all its variations).

The results of intracorporeal laparoscopic anastomosis in the literature vary widely and, are discordant, although those reported so far estimate a DA less than 2%. But the latest publications report low rates of morbidity and of surgical space infection (SSI)5. The main problem with this technique is that it requires a learning curve somewhat greater than the others and its results depend on the skill of the surgeon and his casuistry. For all these reasons, it is necessary to carry out comparative studies that favor the use of this technique as gold standard.

The multicentre, controlled and randomized controlled studies have the disadvantage that randomization in centers not used with one of the techniques does include a learning curve bias. Besides the fact that in a center there is a belief that one of the techniques is superior to the other, it is not ethical to randomize the techniques. This situation has encouraged us to perform a non-randomized TREND-study design (Transparent Reporting of Evaluations with Non-randomized Designs-TREND).

Main objective:

To assess if laparoscopic right hemicolectomy, with anastomosis, obtains better results than laparoscopic with extracorporeal anastomosis and open surgery in terms of global morbidity, surgical space infection, anastomotic leak, re-interventions and hospital stay, in the first 30 postoperative days.

Secondary objectives:

To analyze the rate of anastomotic leak (AL) and organ-cavitary infections in each hospital.

  • Compare the results obtained with those published in the literature.
  • Try to identify the risk factors associated with AL.
  • Analyze the comorbidities associated with the type of incision made for the extraction of the surgical piece, in intra and extracorporeal anastomosis

Condition or disease Intervention/treatment Phase
Colon Cancer Procedure: Laparoscopic right hemicolectomy with intracorporeal anastomosis. Procedure: Laparoscopic right hemicolectomy with extracorporeal anastomosis. Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 456 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A multicenter prospective, non-randomized, controlled study of the intracorporeal mechanical side-to-side isoperistaltic anastomosis versus extracorporeal anastomosis in laparoscopic right hemicolectomy. TREND-study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Controlled Study of the Intracorporeal Mechanical Side-to-side Isoperistaltic Anastomosis Versus Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy: HEMI-D-TREND-study
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : February 1, 2021

Arm Intervention/treatment
Experimental: Laparoscopic Intracorporeal anastomosis
Laparoscopic right hemicolectomy with intracorporeal mechanical side-to-side isoperistaltic anastomosis.
Procedure: Laparoscopic right hemicolectomy with intracorporeal anastomosis.
Intracorporeal anastomosis group The laparoscopic right hemicolectomy with intracorporeal mechanical side-to-side isoperistaltic anastomosis. In this procedure, intracorporeal division of the mesoileum and transverse colon is performed, as shown in the animation. The ileum and transverse colon are divided with the Endopath® Echelon Flex ™ 60 stapler. The specimen is inserted in a plastic bag. Side-to-side isoperistaltic mechanical anastomosis is performed using the same endostapler. A running suture is performed of the mechanical suture orifice, with another reinforcing suture with Monocryl ™ (poliglecaprone 25) or with STRATAFIX ™ Spiral Knotless barbed suture. The specimen is extracted through a Pfannestiel minilaparotomy (3.5-4 cm) Wound Protector

Active Comparator: Laparoscopic extracorporeal anastomosis
Laparoscopic right hemicolectomy with extracorporeal anastomosis.
Procedure: Laparoscopic right hemicolectomy with extracorporeal anastomosis.
Laparoscopic right hemicolectomy with extracorporeal anastomosis with the technical features of each center




Primary Outcome Measures :
  1. Anastomotic leak (AL) [ Time Frame: 30 days ]
    AL was defined in accordance with Peel et al.

  2. Global morbidity [ Time Frame: 30 days ]
    Dindo-Clavien Classification

  3. Surgical site infection [ Time Frame: 30 days ]
    SSI in accordance with the Center for Disease Control (CDC) National Nosocomial Infection Monitoring System

  4. Re-interventions [ Time Frame: 30 days ]
    Re-interventions due to surgical complications



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with right colon neoplasia, not metastatic. With indication of right hemicolectomy and ileo-colic anastomosis. Over 18 years. Scheduled surgery Intervened by the team of surgeons of the Coloproctology Unit of each participating hospital. They have followed the perioperative management program corresponding to the usual practice and technique of each hospital.

Exclusion Criteria:

  • Colon neoplasms from other locations. T4 tumor stage and stage IV of the TNM classification, ASA IV (American Society Anesthesiologists). Non-optimal nutritional status (preoperative albumin ≤3.4 g / dl). Do not sign informed consent, Pregnant patients, Liver cirrhosis, Chronic renal insufficiency in dialysis treatment, BMI <18 and> 35 Kg / m

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918369


Contacts
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Contact: Xavier Serra-Aracil, MD,PhD 34-93-723-1010 ext 21490 jserraa@tauli.cat

Locations
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Spain
Hospital Universitario Parc Tauli de Sabadell Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Xavier Serra-Aracil, MD    34937231010 ext 21490    jserraa@tauli.cat   
Principal Investigator: Xavier Serra-Aracil, MD         
Sponsors and Collaborators
Corporacion Parc Tauli
Mireia Pascua-Solé
Laura Mora-Lopez
Anna Pallisera-Lloveras
Sheila Serra-Pla
Ricard Sales
Beatriz Espina
Luis Romangolo
Anna Serracant
Cristina Ruiz
Mº José Mañas Gomez
Angels Montserrat-Marti
Mireia Merichal
Charlie Cerdán-Santacruz
Antonio Sanchez
Helena Vallverdu
Andrés Dárdano
Investigators
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Principal Investigator: Xavier Serra-Aracil, MD, PhD Corporacio Parc Tauli. Parc Tauli University Hospital

Publications:
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Responsible Party: Xavier Serra-Aracil, MD, PhD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT03918369     History of Changes
Other Study ID Numbers: HEMI-D-TREND-2019
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xavier Serra-Aracil, Corporacion Parc Tauli:
Right Colon Cancer,
Right hemicolectomy
Laparoscopic right hemicolectomy
Intracorporeal anastomosis

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases