Right Hemicolectomy
ProcedureIt is the resection of the right colon by a tumor and the reconstruction by an ileocolic anastomosis: intracorporeal or extracorporeal
NCT Number: NCT03990714
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
It is the resection of the right colon by a tumor and the reconstruction by an ileocolic anastomosis: intracorporeal or extracorporeal
Time frame: 24 months
To compare perioperative morbidity between laparoscopic right hemicolectomy with intracorporeal anastomosis versus extracorporeal anastomosis within 30 days after surgery.
Time frame: 4 hours
o evaluate the difference in surgical time between right hemicolectomy with intracorporeal versus extracorporeal anastomosis.
Time frame: 24 hour
Quantify, 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.
Time frame: 30 days
To evaluate and compare the rate of anastomotic dehiscence in both groups of anastomoses up to 30 days after surgery.
Time frame: 30 days
To evaluate the infection rate of the surgical site in both groups up to 30 days after surgery.
Time frame: 180 days
o compare the difference of days of hospital stay in both groups of anastomoses.
Hospital Universitario Torrecárdenas
Other
Intracorporeal Vs Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy: a Multicenter Randomized Clinical Trial (The IVEA-study)
Acronym: IVEA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06168669
Anastomotic Leak, Colorectal Surgery
Orlando, Florida, United States
View Trial DetailsNCT05264467
Anastomotic Leak, Colorectal Surgery
Concepción, Chile
View Trial DetailsNCT07464600
Anastomotic Leak, CRP Point-of-care Testing Trajectory
Amiens, France
View Trial DetailsNCT06522061
Anastomotic Leak, Artificial Intelligence
Vancouver, British Columbia, Canada
View Trial Details