Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT04889456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-05-17
First Post:
2021-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Standardizing Right Hemicolectomy for Colon Cancer
Sponsor:
Amsterdam UMC, location VUmc
Organization:
Study Overview
Official Title:
Implementation of Optimized and Standardized Surgical Technique for Right Sided Colon Cancer: a Prospective Interventional Sequential Cohort Study With a Transition Period
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Right
Brief Summary:
A surgical intervention might be highly variable amongst surgeons and centers. This variability has a potential relevance concerning clinical outcomes.
For right-sided colon cancer, the laparoscopic right hemicolectomy (LRHC) knows substantial variation. Especially since the surgical technique has been evolving during the latest decade with the introduction of intracorporeal anastomosis, a dissection technique within the correct embryological planes (complete mesocolic excision) and central vascular ligation of the segmental branches at its origin, resulting in an optimal lymph node dissection.
Given the insights from recent studies showing the association between quality of surgery and relevant clinical outcomes, there is a great need for a formative quality assessment of LRHC. 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.
The main objective of this study is to improve surgical outcomes for patient with right-sided colon cancer by a prospective sequential interventional cohort study that aims to standardize the surgical technique with subsequent controlled implementation after standardized review of the current practice in a nationwide multicenter setting. The primary endpoint is the 30-day morbidity according to the Clavien-Dindo classification system.
For right-sided colon cancer, the laparoscopic right hemicolectomy (LRHC) knows substantial variation. Especially since the surgical technique has been evolving during the latest decade with the introduction of intracorporeal anastomosis, a dissection technique within the correct embryological planes (complete mesocolic excision) and central vascular ligation of the segmental branches at its origin, resulting in an optimal lymph node dissection.
Given the insights from recent studies showing the association between quality of surgery and relevant clinical outcomes, there is a great need for a formative quality assessment of LRHC. 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.
The main objective of this study is to improve surgical outcomes for patient with right-sided colon cancer by a prospective sequential interventional cohort study that aims to standardize the surgical technique with subsequent controlled implementation after standardized review of the current practice in a nationwide multicenter setting. The primary endpoint is the 30-day morbidity according to the Clavien-Dindo classification system.
Detailed Description:
1. Prospective mapping of current practice with surgical variations in laparoscopic right hemicolectomy (total duration of inclusion 3 months) N= 40 centers N = 310 videos
1. METC approval for the use of anonymized videos of a laparoscopic procedure and collection of corresponding clinical outcomes.
2. Approaching hospitals for participation (high volume centers (50+ colon cancers).
3. Prospective inclusion of consecutive patients undergoing laparoscopic right hemicolectomy in the participating hospitals in three months.
2. Development of Standard Laparoscopic Right Hemicolectomy: an (inter)national Delphi study
1. Approaching specialists to participate in the Delphi method (from participating hospitals in step 1).
2. Identification of crucial steps and measures according to literature and expert's opinion (Delphi method).
3. Documentation of steps and the order in which they need to be performed, development of a competency assessment tool (CAT).
3. Skills center training facility
a. Training the participating surgeons in the method of the standardized laparoscopic right hemicolectomy, as consented in the Delphi method.
4. Implementation of the standardized laparoscopic right hemicolectomy with proctoring during another period with prospective inclusion of consecutive patients with collection of surgical videos in all participating hospitals (N=40 centers, total 310 videos)
1. Rating videos.
2. Comparing with pre-implementation performance based on outcome measures reflecting oncological quality of surgery, and 30-day clinical outcomes.
3. Comparing with pre-implementation performance based on the long-term outcomes. (3-year DFS and 5-year OS).
5. Implementing standardised lap right hemicolectomy (after learning curve without proctoring)
1. Consecutive inclusion of patients (n=310)
2. CT imaging
3. Video analysis
4. Competency analysis
5. Variation analysis
6. Clinico pathological data
1. METC approval for the use of anonymized videos of a laparoscopic procedure and collection of corresponding clinical outcomes.
2. Approaching hospitals for participation (high volume centers (50+ colon cancers).
3. Prospective inclusion of consecutive patients undergoing laparoscopic right hemicolectomy in the participating hospitals in three months.
2. Development of Standard Laparoscopic Right Hemicolectomy: an (inter)national Delphi study
1. Approaching specialists to participate in the Delphi method (from participating hospitals in step 1).
2. Identification of crucial steps and measures according to literature and expert's opinion (Delphi method).
3. Documentation of steps and the order in which they need to be performed, development of a competency assessment tool (CAT).
3. Skills center training facility
a. Training the participating surgeons in the method of the standardized laparoscopic right hemicolectomy, as consented in the Delphi method.
4. Implementation of the standardized laparoscopic right hemicolectomy with proctoring during another period with prospective inclusion of consecutive patients with collection of surgical videos in all participating hospitals (N=40 centers, total 310 videos)
1. Rating videos.
2. Comparing with pre-implementation performance based on outcome measures reflecting oncological quality of surgery, and 30-day clinical outcomes.
3. Comparing with pre-implementation performance based on the long-term outcomes. (3-year DFS and 5-year OS).
5. Implementing standardised lap right hemicolectomy (after learning curve without proctoring)
1. Consecutive inclusion of patients (n=310)
2. CT imaging
3. Video analysis
4. Competency analysis
5. Variation analysis
6. Clinico pathological data
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: