The main objective of this study is to improve surgical and oncological outcomes for patients with right-sided colon cancer by conducting a prospective sequential interventional cohort study that aims to evaluate national implementation of the LRHC…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the 90-day morbidity with Clavien-Dindo classification.
Secondary outcome
• Intraoperative complications (i.e. vascular injury, injury to other organs);
• 90-day mortality;
• Conversion;
• Operative time;
• Blood loss;
• Validated assessment of plane of dissection;
• Validated assessment of level of vascular ligation;
• Grading of the resection specimen according to Benz et al. [17];
• Total lymph node count;
• Number of resected positive lymph nodes;
• Resection margins;
• Completeness of mesocolic excision based on postoperative CT imaging;
• Locoregional recurrence;
• Distant metastasis;
• 3-year disease free survival (DFS);
• 5-year overall survival (OS);
• Long-term morbidity: incisional hernia, adhesion related small bowel
obstruction, readmissions, reinterventions, anastomotic leakage.
Background summary
Surgical procedures for gastrointestinal oncology intervention are inevitably
variable amongst surgeons and centers. Although this variation is acceptable to
a certain degree, a substantial proportion of this variability has a potential
relevance for both short term clinical outcomes and long term oncological
survival. For patients with right-sided colon cancer, a laparoscopic right
hemicolectomy (LRHC) is the surgical procedure of choice to remove the cancer
and locoregional lymph nodes. This surgical technique has evolved during the
last decade with the introduction of the intracorporeal anastomosis, the
Pfannenstiel extraction and the complete mesocolic excision (CME). The latter
is a dissection technique in embryological planes with a central vascular
ligation of the segmental branches at its origin, resulting in an optimal
lymphadenectomy. Given the insights from recent studies showing a positive
association between the quality of surgery and relevant clinical outcomes,
there is a great need to reduce the interinstitutional and intersurgeon
variability and to implement an optimized and standardized surgical technique
for right-sided colon cancer in the Netherlands to improve short- and long-term
clinical and oncological outcomes. Currently, within the LRHC, there is
variation in the way the procedure is performed and the majority of surgeons in
the Netherlands have not implemented one or more elements of the right
hemicolectomy as is recommended by the recent Dutch and international
guidelines. This implicates potential to improve clinical outcomes by
implementing all recommended steps of LRHC. This kind of implementation needs a
consensus of the national society of colorectal surgeons for the key elements
of the procedure to be incorporated in an uniform procedure to be trained,
implemented and to allow formative quality assessment. Detailed objective
assessment of the LRHC is currently not performed in clinical practice nor in
surgical training. Quality assessment of LRHC has great potential to improve
surgical training and furthermore, implementation of a standardized technique
will ultimately lead to better quality of care for patients suffering from
right-sided colon cancer.
Study objective
The main objective of this study is to improve surgical and oncological
outcomes for patients with right-sided colon cancer by conducting a prospective
sequential interventional cohort study that aims to evaluate national
implementation of the LRHC as a standardized surgical technique (determined in
a completed Delphi study, based on best evidence and existing guidelines) into
current practice in a nationwide multicenter setting.
Study design
A prospective interventional sequential cohort study with a transition period.
Intervention
Implementation of the standardized right hemicolectomy with proctoring during a
subsequent period with prospective inclusion of consecutive patients and the
collection of surgical videos in all participating hospitals. The standardized
right hemicolectomy consists of preoperatively properly assessing the
(vascular) anatomy on the CT scan, applying pneumoperitoneum of 8-12mmHg,
performing a complete mesocolic excision (CME) with central vascular ligation
(CVL) which has been described in detail within the Delphi study, performing an
intracorporeal anastomosis and extracting the specimen through the Pfannenstiel
incision using a wound protector.
Study burden and risks
The combination of moderate harm and a low probability results in a risk
classification of negligible risk. The likelihood of complications is very low
since the standardized technique does not differ significantly or very little
for most surgeons, and this technique is implemented in a very safe manner
(comprehensive training and proctoring). Additionally, it's worth noting that
this technique is already described in the guidelines in this way.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
1) Planned laparoscopic or robot-assisted (extended) right hemicolectomy for
colon cancer of
the caecum, ascending colon, hepatic flexure or proximal transverse colon
2) Age above 18 years
3) Signed informed consent
Exclusion criteria
1) cT4b/multivisceral resection
2) cTNM stage 4 (M1)
3) ASA 4
4) Immune modulating medication
5) Prior midline or transverse laparotomy larger than 10 cm (not including
Pfannenstiel and McBurney's incision)
6) Perforated disease/peritumoral abscess/fistula
7) Acute obstruction
8) Emergency surgery
9) Neuroendocrine neoplasm (NEN)
10) Other malignancies treated within 5 years from diagnosis of colon cancer,
except for curatively treated prostate, breast, skin and cervical cancer
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04889456 |
| CCMO | NL81212.029.22 |