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Intracorporeal Vs Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy

Intracorporeal Vs Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy: a Multicenter Randomized Clinical Trial (The IVEA-study)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03990714
Acronym
IVEA
Enrollment
168
Registered
2019-06-19
Start date
2016-01-01
Completion date
2018-12-31
Last updated
2019-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak, Colectomy, Colorectal Surgery, Laparoscopy

Keywords

Right hemicolectomy, Intracorporeal anastomosis, Extracorporeal anastomosis, Laparoscopy

Brief summary

Objective. The aim of this study was to evaluate short-term outcomes of performing intracorporeal versus extracorporeal anastomosis in laparoscopic right hemicolectomy for right colon neoplasm. Background. Despite advances in laparoscopic approach in colorectal surgery and the clear benefit of this approach over open surgery, the technical difficulty in performing intracorporeal anastomosis causes certain groups continue performing it extracorporeally in right colon surgery. Methods. This study was a prospective multicenter randomized trial with two parallel groups being done intracorporeal anastomosis (IA) or extracorporeal anastomosis (EA) in laparoscopic right hemicolectomy for right colon neoplasm, carried out between January 2016 and December 2018.

Detailed description

Right hemicolectomy using a minimally invasive technique allows for an earlier recovery, with less postoperative pain and less hospital stay. After right hemicolectomy, the ileocolic anastomosis is not performed naturally as is habitually done in low anterior resections or sigmoidectomies. There is, therefore, no standardization in the reconstruction technique, with two possibilities: intracorporeal and extracorporeal anastomosis. The intracorporeal anastomosis allows proper visualization of it, ensuring adequate conformation (absence of rotation or traction), in addition allowing the closure of the mesos and avoiding the possible appearance of internal hernia, also allowing to choose the location and length of the incision necessary for the extraction of the piece. On the other hand, it is a difficult technique that requires high training in advanced laparoscopy. The extracorporeal anastomosis is performed by extracting both ends (terminal ileum and transverse colon) through the incision through which the piece is obtained, and the anastomosis is performed. It does not require, therefore, an important training in intracorporeal sutures. On the contrary, it forces to make the abdominal incision in the area that allows the extraction of said ends. In obese patients it can be difficult since the mesos are short and do not allow their extraction easilywith ,so sometimes, it forces excessive traction. In addition, intestinal rotations during the anastomosis may go unnoticed. Although there are currently defenders of both techniques, the extracorporeal anastomosis is currently the most performed in our environment and will be used as a reference treatment in the present study. Numerous studies have been published comparing both techniques. A very recent meta-analysis, including 12 non-randomized comparative studies with 1492 patients, concluded that intracorporeal anastomosis is associated with less morbidity and a reduction in hospital stay, suggesting a faster recovery. To date, no well-designed, prospective, randomized and randomized study exists in the literature. We believe it is necessary, therefore, to carry out a project that compares both surgical techniques in the treatment of right colon cancer and assess which is associated with a lower postoperative morbidity.

Interventions

It is the resection of the right colon by a tumor and the reconstruction by an ileocolic anastomosis: intracorporeal or extracorporeal

Sponsors

Sponsor- Investigator MD Ángel Reina Duarte. HUTorrecárdenas
CollaboratorUNKNOWN
Sponsor-Investigator BA Francisco Rubio Gil. HU Torrecárdenas
CollaboratorUNKNOWN
Sponsor-Investigator MD Elisabet Vidaña Márquez. HU Torrecárdenas
CollaboratorUNKNOWN
Sponsor-Investigator MD Juan Manuel García Torrecillas. HU Torrecárdenas
CollaboratorUNKNOWN
Sponsor-Investigator Rocío Torres Fernández. HU Torrecárdenas
CollaboratorUNKNOWN
Sponsor-Investigator MD Almudena Moreno Serrano. Hospital Inmaculada. Huercal-Overa
CollaboratorUNKNOWN
Sponsor-Investigator MD Pedro Moya Forcén. HU Torrecárdenas
CollaboratorUNKNOWN
Sponsor-Investigator MD Jorge Alejandro Benavides Buleje. HU Reina Sofía
CollaboratorUNKNOWN
Hospital Universitario Torrecárdenas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

The IVEA-study is a prospective multicenter randomized trial with two parallel groups being done IA or EA in laparoscopic right hemicolectomy for right colon neoplasia.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients had to be 18 years of age or over, to be programmed for laparoscopic surgery for right colon neoplasm and provide a signed written consent form.

Exclusion criteria

* All patients who do not meet all the inclusion criteria were excluded. The other

Design outcomes

Primary

MeasureTime frameDescription
In patients with right colon cancer, laparoscopic right hemicolectomy with intracorporeal anastomosis presents less perioperative morbidity than extracorporeal anastomosis.24 monthsTo compare perioperative morbidity between laparoscopic right hemicolectomy with intracorporeal anastomosis versus extracorporeal anastomosis within 30 days after surgery.

Secondary

MeasureTime frameDescription
Surgical time4 hourso evaluate the difference in surgical time between right hemicolectomy with intracorporeal versus extracorporeal anastomosis.
VAS24 hourQuantify, by means of the Visual-Analogue Scale (VAS: is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post- surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)), postoperative pain 24 hours after surgery and the day of hospital discharge, and determine which of the two laparoscopic right hemicolectomy techniques produces less pain.
Dehiscence30 daysTo evaluate and compare the rate of anastomotic dehiscence in both groups of anastomoses up to 30 days after surgery.
Infection rate30 daysTo evaluate the infection rate of the surgical site in both groups up to 30 days after surgery.
Days of hospital stay180 dayso compare the difference of days of hospital stay in both groups of anastomoses.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026