| Objective: |
The objective of this study is to prospectively evaluate the postoperative recovery, hospital stay, wound complications, severe complications, and mid-term results (Hernia, recurrence…) of right colectomy, comparing intracorporeal vs extracorporeal anastomosis and comparing laparoscopic vs robotic techniques. |
| Aim: |
Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and the associated regional fat and lymph nodes, and is the accepted treatment for malignant neoplasms of the right colon.
A minimally invasive approach is commonly used for right colectomy, with studies reporting reduced complications, blood loss, and hospital stay when compared to an open approach.[2]
However, there remains controversy regarding whether robotic assistance is advantageous for this technique and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is best.
In 2012, Park et al. [3] published the only available randomized controlled trial comparing robotic and laparoscopic right colectomy, with 35 patients in each arm. The only statistically significant differences found were a longer operative time and a higher cost in the robotic group; however, the groups were not equal in the use of ICA, with 30 robotic vs. only 7 laparoscopic patients receiving an ICA.
A database study utilizing the NSQIP by Miller et al. [4] reported shorter hospital stays and longer operative times with robotic right colectomy when compared to a laparoscopic approach; however, this study did not track anastomosis type and even though it was a database study, the robotic arm included only 109 patients as compared to 2,740 patients in the laparoscopic study arm.
Two recent systematic reviews by Xu et al. [5] and Trastulli et al [6] reported significantly less blood loss, lower postoperative complications and a faster recovery of bowel movements with robotic colon surgery when compared with a laparoscopic approach. The review by Trastulli et al. also reported significantly fewer conversions to open surgery specifically for robotic right colon surgery.
These studies suggest that robotic right colectomy is associated with a better and shorter postoperative recovery when compared with a laparoscopic approach.
Studies comparing anastomotic techniques include the first study to compare laparoscopic intracorporeal anastomosis (ICA) with laparoscopic extracorporeal anastomosis (ECA) in right colectomy by Hellan et al. [7]. In that study, the authors found no differences between anastomotic techniques. However, a recent systematic review and meta-analysis of 12 studies comparing laparoscopic ICA and ECA that included 1492 patients, reported that ICA decreased the length of hospital stay and reduced short-term morbidity, including significantly reducing the rate of surgical site infection [8]. Another study by Shapiro et al. [9] reported decreased rates of incisional hernias and re-interventions with ICA.
A second systematic review and meta-analysis of 15 papers and 4 conference abstracts that included 1957 patients, reported improved cosmesis as measured by a smaller incision length, significant less blood loss, shorter time to first defecation, shorter time to liquid diet, and shorter length of hospital stay with laparoscopic ICA vs. ECA [10].
These studies suggest that intracorporeal anastomosis after minimally invasive right colectomy has several advantages, and robotic assistance could enhance the ability of the surgeon to perform an intracorporeal anastomosis, reducing the conversion rate and improving the quality of the suturing with the EndoWristed® instruments.
Many of the above-mentioned results relied on retrospective non-randomized comparison trials that compared robotic to laparoscopy without controlling for anastomosis technique, or compared ICA to ECA without testing for a possible benefit of robotic assistance. Therefore, prospective, multicenter studies simultaneously comparing both variables (surgical approach and anastomotic technique) are needed to provide further scientific evidence on the best technique for minimally invasive right colectomy.
|
| Methods: |
This study is a prospective, international, multi-center, 4-parallel-cohorts study. Sites or surgeons will select a cohort of the study for which they are qualified.
Four cohorts will be the subject of study:
1. Robotic Right Colectomy with ICA
2. Robotic Right Colectomy with ECA
3. Laparoscopic Right Colectomy with ICA
4. Laparoscopic Right Colectomy with ECA
It is not feasible to randomize patients to compare these techniques as doing so would limit the number of centers that could participate. Not all centers in Europe have access to robotic systems and not all surgeons in Europe are trained in intracorporeal anastomosis.
All patient assessments will be done according to the sites standard of care. Parameters routinely recorded during right colectomy surgery will be collected prospectively. Enrolled subjects will undergo assessments at the following intervals: pre-operative, operative, discharge, 30 days, 3 months, 1 year and 2 years post–surgery. A description of the study visits and required study procedures is included in the protocol. Patient assessments will be done according to standard of care.
|
| Reason for International Trial: |
Participating Centers/investigators are qualified colorectal or general surgeons experienced with surgical management of patients with colon lesions that have a patient population fitting the study requirements. All surgeons considered for participation must be experienced in the relevant technique for minimally invasive right colectomy procedures. For the intracorporeal anastomosis cohorts, Pfannenstiel incision will be the chosen wound for specimen extraction. It is desirable that participating centers have an implemented ERAS protocol.
A surgeon must select which procedure he/she will contribute to and consecutively maintain this technique on all eligible patients during the enrollment phase. Different surgeons from the same institution may select different techniques. Surgeons will have completed their learning curve for the procedure selected. To ensure this, surgeons must have done more than or at least 30 minimally invasive right colectomy procedures for a colon tumor to be eligible.
|
