Clinical trial NCT05446558: Long-term Results in Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy
Official title: Long-term Clinical Results and Direct Economic Implication Within the Randomized Clinical Trial Comparing Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Colon Neoplasm
Malignant Neoplasm
Colon Neoplasia
Colon Neoplasm, Malignant
Keywords: anastomosis
laparoscopic right colectomy
intracorporeal
extracorporeal
intracorporeal anastomosis
extracorporeal anastomosis
randomized controlled trial
oncological outcomes
long-term follow-up
colectomy
minimally invasive surgery
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was a parallel group trial with a 1:1 allocation ratio.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Disease-free survival
timeFrame: 3 years
measure: Local recurrence
timeFrame: 3 years
measure: Distant recurrence
timeFrame: 3 years
measure: Incisional hernia
timeFrame: 3 years
measure: Intestinal obstruction
timeFrame: 3 years
measure: Cost of surgical material
timeFrame: Intraoperative time
measure: Cost of operative room
timeFrame: Intraoperative time
measure: Cost per global hospitalization
timeFrame: Time from the first day of operation until the day that the patient is discharged from the hospital
measure: Cost per ICU hospitalization
timeFrame: Time from the first day of entry into ICU until the day that the patient is transfered to Surgery Department
measure: Cost of tests during hospitalization
timeFrame: Time from the first day of operation until the day that the patient is discharged from the hospital
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
citation: Bollo J, Salas P, Martinez MC, Hernandez P, Rabal A, Carrillo E, Targarona E. Intracorporeal versus extracorporeal anastomosis in right hemicolectomy assisted by laparoscopy: study protocol for a randomized controlled trial. Int J Colorectal Dis. 2018 Nov;33(11):1635-1641. doi: 10.1007/s00384-018-3157-9. Epub 2018 Sep 6.
citation: Bollo J, Turrado V, Rabal A, Carrillo E, Gich I, Martinez MC, Hernandez P, Targarona E. Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial). Br J Surg. 2020 Mar;107(4):364-372. doi: 10.1002/bjs.11389. Epub 2019 Dec 17.