- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02746224
Reconstruction Techniques and Vascular Approach After Laparoscopic Left Hemicolectomy and Rectum Low Anterior Resection (TAHR)
Reconstruction Techniques and Vascular Approach After Laparoscopic Left Hemicolectomy and Laparoscopic Low Anterior Resection for Rectal Cancer: a Randomized Clinical Trial
This is an interventional, controlled and randomized single-center clinical trial with patients diagnosed with colorectal cancer that will undergo laparoscopic left hemicolectomy or laparoscopic low anterior resection for rectal cancer.
All patients included in the study (study 1) are randomized into two groups (group 1A and group 1B): in the group 1A the surgical technique initially dissects the inferior mesenteric vein (IMV) and in the group 1B the surgical technique initially dissects the inferior mesenteric artery.
The patients who will undergo a colorectal anastomosis will be included in the study 2 and will be randomized to group 2A and group 2B: in group 2A the patients will have a latero-terminal colorectal anastomosis and in group 2B a termino-terminal colorectal anastomosis.
Study hypothesis:
Study 1: the surgical technique that initially dissects the IMV presents a greater number of total resected lymph nodes compared to the technique that initially dissects the IMA.
Study 2: latero-terminal anorectal anastomosis has a better anorectal functional outcome than termino-terminal anorectal anastomosis.
Primary outcome measures:
- Study 1:To compare the total number of resected lymph nodes and the distance to the surgical margins between the two arms (1A and 1B).
- Study 2: to compare the anorectal functional outcome at 12 months after surgery or ileostomy closure between the two arms (2A and 2B). The anorectal function will be assessed by the scores of the validated Colorectal Functional Outcome Questionnaire (COREFO) and the validated scale LARS (Syndrome anterior resection of the rectum).
Secondary outcome measures:
- Study 1: to compare the duration of surgery, bleeding and need for surgical conversion between the two arms (1A and 1B). Another objectives are to compare the incidence of postoperative complications (measured by the Clavien-Dindo classification) and survival.
- Study 2: to compare the quality of life and anorectal functional outcomes at : 6, 12, 18 and 24 months after intervention (or ileostomy closure) between the two arms (2A and 2B). The anorectal function will be assessed by the validated COREFO questionnaire and the LARS scale. The quality of life will be assessed by the validated questionnaire of quality of life: SF-36. Another objective is to compare the incidence of postoperative complications assessed by the Clavien-Dindo classification and the incidence of anastomotic leakage.
Study Overview
Status
Conditions
Detailed Description
This is an interventional, controlled and randomized single-center clinical trial with patients diagnosed with colorectal cancer that will undergo laparoscopic left hemicolectomy or laparoscopic low anterior resection for rectal cancer.
Methods:
All patients included in the study (study 1) are randomized into two groups (group 1A and group 1B): in the group 1A the surgical technique initially dissects the inferior mesenteric vein (IMV) and in the group 1B the surgical technique initially dissects the inferior mesenteric artery.
The patients who will undergo a colorectal anastomosis will be included in the study 2 and will be randomized to group 2A and group 2B: in group 2A the patients will have a latero-terminal colorectal anastomosis and in group 2B a termino-terminal colorectal anastomosis.
Study hypothesis:
Study 1: the surgical technique that initially dissects the IMV presents a greater number of total resected lymph nodes compared to the technique that initially dissects the IMA.
Study 2: latero-terminal anorectal anastomosis has a better anorectal functional outcome than termino-terminal anorectal anastomosis.
Primary outcome measures:
- Study 1:To compare the total number of resected lymph nodes and the distance to the surgical margins between the two arms (1A and 1B).
- Study 2: to compare the anorectal functional outcome at 12 months after surgery or ileostomy closure between the two arms (2A and 2B). The anorectal function will be assessed by the scores of the validated Colorectal Functional Outcome Questionnaire (COREFO) and the validated scale LARS (Syndrome anterior resection of the rectum).
Secondary outcome measures:
- Study 1: to compare the duration of surgery, bleeding and need for surgical conversion between the two arms (1A and 1B). Another objectives are to compare the incidence of postoperative complications (measured by the Clavien-Dindo classification) and survival.
- Study 2: to compare the quality of life and anorectal functional outcomes at : 6, 12, 18 and 24 months after intervention (or ileostomy closure) between the two arms (2A and 2B). The anorectal function will be assessed by the validated COREFO questionnaire and the LARS scale. The quality of life will be assessed by the validated questionnaire of quality of life: SF-36. Another objective is to compare the incidence of postoperative complications assessed by the Clavien-Dindo classification and the incidence of anastomotic leakage.
Duration and follow up
Study 1: the expected study duration is 6'5 years.
Study 2: the expected duration of the study is 3'5 years.
The planned duration of follow up in the study 1 is 5 years, in the study 2 is 2 years.
Selection criteria
Inclusion Criteria:
Study 1:
- Patients with colorectal cancer that will undergo laparoscopic left hemicolectomy or laparoscopic low anterior resection for rectal cancer.
- Age ≥ 18 years
- Histology proven adenocarcinoma or adenoma with or without chemotherapy or neoadjuvant radiochemotherapy
- Any T, any N, M or any adenoma
- Attempt to R0 resection
- Signed informed consent by the patient and by the researcher
- Quality of Life Questionnaire completed
Study 2:
- Patients with colorectal cancer that will undergo laparoscopic left hemicolectomy or laparoscopic low anterior resection for rectal cancer with colorectal anastomosis.
- Age ≥ 18 years
- Histology proven adenocarcinoma or adenoma with or without chemotherapy or neoadjuvant radiochemotherapy
- Any T, any N, M or any adenoma
- Attempt to R0 resection
- Signed informed consent by the patient and by the researcher
- Quality of Life Questionnaire completed
Exclusion Criteria:
Study 1:
- Colorectal tumor with different histology to adenocarcinoma or adenoma
- History of colorectal cancer surgery different to the local excision
- Inflammatory bowel disease with pathologic confirmation
- Patients with psychiatric illness, addiction or disorder with inability to understand informed consent
- Inability to read or understand any of the languages of the informed consent and questionnaires (Catalan, spanish)
- Another synchronous malignancy
- Emergency Surgery
- Any patient that medical characteristics present an individual risk raised to be included and complete the study
Study 2:
- Patients who won't undergo colorectal anastomosis
- Colorectal tumor with different histology to adenocarcinoma or adenoma
- History of colorectal cancer surgery different to the local excision
- Inflammatory bowel disease with pathologic confirmation
- Patients with psychiatric illness, addiction or disorder with inability to understand informed consent
- Inability to read or understand any of the languages of the informed consent and questionnaires (Catalan, spanish)
- Another synchronous malignancy
- Emergency Surgery
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Girona, Spain, 17007
- University Hospital Dr. Josep Trueta of Girona
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Study 1:
- Patients with colorectal cancer that will undergo laparoscopic left hemicolectomy or laparoscopic low anterior resection for rectal cancer.
- Age ≥ 18 years
- Histology proven adenocarcinoma or adenoma with or without chemotherapy or neoadjuvant radiochemotherapy
- Any T, any N, M or any adenoma
- Attempt to R0 resection
- Signed informed consent by the patient and by the researcher
- Quality of Life Questionnaire completed
Study 2:
- Patients with colorectal cancer that will undergo laparoscopic left hemicolectomy or laparoscopic low anterior resection for rectal cancer with colorectal anastomosis.
- Age ≥ 18 years
- Histology proven adenocarcinoma or adenoma with or without chemotherapy or neoadjuvant radiochemotherapy
- Any T, any N, M or any adenoma
- Attempt to R0 resection
- Signed informed consent by the patient and by the researcher
- Quality of Life Questionnaire completed
Exclusion Criteria:
Study 1:
- Colorectal tumor with different histology to adenocarcinoma or adenoma
- History of colorectal cancer surgery different to the local excision
- Inflammatory bowel disease with pathologic confirmation
- Patients with psychiatric illness, addiction or disorder with inability to understand informed consent
- Inability to read or understand any of the languages of the informed consent and questionnaires (Catalan, spanish)
- Another synchronous malignancy
- Emergency Surgery
- Any patient that medical characteristics present an individual risk raised to be included and complete the study
Study 2:
- Patients who won't undergo colorectal anastomosis
- Colorectal tumor with different histology to adenocarcinoma or adenoma
- History of colorectal cancer surgery different to the local excision
- Inflammatory bowel disease with pathologic confirmation
- Patients with psychiatric illness, addiction or disorder with inability to understand informed consent
- Inability to read or understand any of the languages of the informed consent and questionnaires (Catalan, spanish)
- Another synchronous malignancy
- Emergency Surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: group 1A
the surgical technique initially dissects the inferior mesenteric vein (IMV).
|
Laparoscopic left hemicolectomy for left colon cancer or laparoscopic low anterior resection for rectal cancer.
In the group 1A the surgical technique initially dissects the inferior mesenteric vein (IMV)
|
Other: group 1B
the surgical technique initially dissects the inferior mesenteric artery (IMA).
|
Laparoscopic left hemicolectomy for left colon cancer or laparoscopic low anterior resection for rectal cancer.
In the group 1B the surgical technique initially dissects the inferior mesenteric artery.
|
Other: group 2A
the patients will have a latero-terminal colorectal anastomosis
|
Laparoscopic left hemicolectomy for left colon cancer or laparoscopic low anterior resection for rectal cancer.
In the group 1A the surgical technique initially dissects the inferior mesenteric vein (IMV)
The patients who will undergo a colorectal anastomosis will be included in the study 2 and will be randomized to group 2A and group 2B: in group 2A the patients will have a latero-terminal colorectal anastomosis and in group 2B a termino-terminal colorectal anastomosis.
|
Other: group 2B
the patients will have a termino-terminal colorectal anastomosis.
|
Laparoscopic left hemicolectomy for left colon cancer or laparoscopic low anterior resection for rectal cancer.
In the group 1B the surgical technique initially dissects the inferior mesenteric artery.
The patients who will undergo a colorectal anastomosis will be included in the study 2 and will be randomized to group 2A and group 2B: in group 2A the patients will have a latero-terminal colorectal anastomosis and in group 2B a termino-terminal colorectal anastomosis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total number of resected lymph nodes
Time Frame: 1 month
|
Study 1:To compare the total number of resected lymph nodes between the two arms (1A and 1B).
|
1 month
|
Anorectal functional outcome at 12 months assessed by COREFO questionnaire
Time Frame: 12 months
|
Study 2: to compare the anorectal functional outcome at 12 months after surgery or ileostomy closure between the two arms (2A and 2B).
Assessed by the validated Colorectal Functional Outcome Questionnaire (COREFO)
|
12 months
|
Anorectal functional outcome at 12 months assessed by LARS scale
Time Frame: 12 months
|
Study 2: to compare the anorectal functional outcome at 12 months after surgery or ileostomy closure between the two arms (2A and 2B).
Assessed by the validated scale LARS (Syndrome anterior resection of the rectum).
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraoperative outcomes: duration of surgery
Time Frame: 1 day
|
Study 1: to compare the duration of surgery measured in minutes between the two arms (1A and 1B).
|
1 day
|
Intraoperative outcomes: surgical bleeding
Time Frame: 1 day
|
Study 1: to compare the surgical bleeding measured in ml between the two arms (1A and 1B).
|
1 day
|
Intraoperative outcomes: surgical conversion
Time Frame: 1 day
|
Study 1: to compare the incidence of surgical conversion to laparotomy between the two arms (1A and 1B).
|
1 day
|
Postoperative complications
Time Frame: 90 days
|
Study 1 and 2: Postoperative complications within 90 days after surgery (Clavien-Dindo classification).
|
90 days
|
Survival
Time Frame: 5 years
|
Study 1: 5-year survival rate after surgery
|
5 years
|
Quality of life-SF questionnaire
Time Frame: 6, 12, 18 and 24 months after surgery
|
Study 2: to compare the quality of life : 6, 12, 18 and 24 months after intervention (or ileostomy closure) between the two arms (2A and 2B).
Assessed by the validated the validated questionnaire of quality of life: SF-36.
|
6, 12, 18 and 24 months after surgery
|
Anorectal functional outcome assessed by COREFO questionnaire
Time Frame: 6,18 and 24 months after surgery
|
Study 2: to compare the anorectal functional outcomes at : 6, 18 and 24 months after intervention (or ileostomy closure) between the two arms (2A and 2B).
Assessed by the validated Colorectal Functional Outcome Questionnaire (COREFO).
|
6,18 and 24 months after surgery
|
Postoperative complications and anastomotic leakage
Time Frame: 90 days after surgery
|
Study 2: to compare the incidence of postoperative complications assessed by the Clavien-Dindo classification and the incidence of anastomotic leakage according to the classification of the International Group for Rectal Cancer Study.
|
90 days after surgery
|
Anorectal functional outcome assessed by LARS scale
Time Frame: 6,18 and 24 months after surgery
|
to compare the anorectal functional outcomes at : 6, 18 and 24 months after intervention (or ileostomy closure) between the two arms (2A and 2B).
Assessed by the validated scale LARS (Syndrome anterior resection of the rectum).
|
6,18 and 24 months after surgery
|
Distance to surgical margins
Time Frame: 1 month
|
Study 1: To compare distance to surgical margins measured in mm between the group 1A and 1B
|
1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pere Planellas Giné, MD-PhD, Colorectal Surgery Unit. Department of General and Digestive Surgery. University Hospital Dr. Josep Trueta of Girona
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 34502
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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