Clinical trial NCT03918369: Study of the Intracorporeal Versus Extracorporeal Anastomosis in Right Hemicolectomy: HEMI-D-TREND-study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Keywords: Right Colon Cancer,
Right hemicolectomy
Laparoscopic right hemicolectomy
Intracorporeal anastomosis
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Mireia Pascua-Solé
name: Laura Mora-Lopez
name: Anna Pallisera-Lloveras
name: Sheila Serra-Pla
name: Ricard Sales
name: Beatriz Espina
name: Luis Romangolo
name: Anna Serracant
name: Cristina Ruiz
name: Mº José Mañas Gomez
name: Angels Montserrat-Marti
name: Mireia Merichal
name: Carlos Cerdán-Santacruz
name: Antonio Sanchez
name: Helena Vallverdú
First posted: 2019-04-17
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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 study, 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). 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

Detailed description: Study Design: TREND-study design (Transparent Reporting of Evaluations with Non-randomized Designs-TREND):

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.

Study procedure

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 Extracorporeal anastomosis group according to the usual technique in each center.

Expected duration of subject participation; what is done and when: Duration of the study two years.

Population

Patients diagnosed with adenocarcinoma of the right colon up to the hepatic angle after complete colonoscopy, biopsy, and chest, abdominal and pelvic CT, and chest radiography, of the participating hospitals.

Recruitment Plan

Centers intracorporeal group: Parc Taulí University Hospital, Spain. Hospital Universitario Joan XXIII de Tarragona, Spain. Hospital de Cancer de Barretos. Brazil

Centers extracorporeal group: Consorcio Hospitalario de Terrassa (Barcelona), Spain. Hospital de Universitario de Vich (Barcelona), Spain. Hospital Universitario Arnau de Vilanova de Lleida, Spain. Hospital Santa Tecla de Tarragona, Spain. Hospital Universitario Sant Joan de Reus (Tarragona), Spain.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with right colon neoplasia non-metastatic.
* 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.
* Patients who undergone a 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

Primary outcomes:
measure: Percentage of anastomotic leak (AL)
timeFrame: 30 days
measure: Rate of global morbidity
timeFrame: 30 days
measure: Rate of Surgical site infection
timeFrame: 30 days
measure: Rate of Re-interventions
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Universitario Parc Tauli de Sabadell
state: Barcelona
Study officials:
affiliation: Corporacio Parc Tauli. Parc Tauli University Hospital
name: Xavier Serra-Aracil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frasson M, Granero-Castro P, Ramos Rodriguez JL, Flor-Lorente B, Braithwaite M, Marti Martinez E, Alvarez Perez JA, Codina Cazador A, Espi A, Garcia-Granero E; ANACO Study Group. Risk factors for anastomotic leak and postoperative morbidity and mortality after elective right colectomy for cancer: results from a prospective, multicentric study of 1102 patients. Int J Colorectal Dis. 2016 Jan;31(1):105-14. doi: 10.1007/s00384-015-2376-6. Epub 2015 Aug 28.
citation: Frasson M, Flor-Lorente B, Rodriguez JL, Granero-Castro P, Hervas D, Alvarez Rico MA, Brao MJ, Sanchez Gonzalez JM, Garcia-Granero E; ANACO Study Group. Risk Factors for Anastomotic Leak After Colon Resection for Cancer: Multivariate Analysis and Nomogram From a Multicentric, Prospective, National Study With 3193 Patients. Ann Surg. 2015 Aug;262(2):321-30. doi: 10.1097/SLA.0000000000000973.