Reconstruction Techniques and Vascular Approach After Laparoscopic Left Hemicolectomy and Rectum Low Anterior Resection

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Reconstruction Techniques and Vascular Approach After Laparoscopic Left Hemicolectomy and Laparoscopic Low Anterior Resection for Rectal Cancer: a Randomized Clinical Trial

Conditions
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Colorectal Cancer, Rectal Tumors

Intervention / Treatment
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* Procedure: Initially dissection of inferior mesenteric vein
* Procedure: Initially dissection of inferior mesenteric artery
* Procedure: Latero-terminal colorectal anastomosis
* Procedure: Termino-terminal colorectal anastomosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: group 1A<br>the surgical technique initially dissects the inferior mesenteric vein (IMV). | Procedure: Initially dissection of inferior mesenteric vein<br>* 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)<br>|
| Other: group 1B<br>the surgical technique initially dissects the inferior mesenteric artery (IMA). | Procedure: Initially dissection of inferior mesenteric artery<br>* 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.<br>|
| Other: group 2A<br>the patients will have a latero-terminal colorectal anastomosis | Procedure: Initially dissection of inferior mesenteric vein<br>* 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)<br>Procedure: Latero-terminal colorectal anastomosis<br>* 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.<br>|
| Other: group 2B<br>the patients will have a termino-terminal colorectal anastomosis. | Procedure: Initially dissection of inferior mesenteric artery<br>* 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.<br>Procedure: Termino-terminal colorectal anastomosis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of resected lymph nodes | 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 | 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 | 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 | Study 1: to compare the duration of surgery measured in minutes between the two arms (1A and 1B). | 1 day | 
| Intraoperative outcomes: surgical bleeding | Study 1: to compare the surgical bleeding measured in ml between the two arms (1A and 1B). | 1 day | 
| Intraoperative outcomes: surgical conversion | Study 1: to compare the incidence of surgical conversion to laparotomy between the two arms (1A and 1B). | 1 day | 
| Postoperative complications | Study 1 and 2: Postoperative complications within 90 days after surgery (Clavien-Dindo classification). | 90 days | 
| Survival | Study 1: 5-year survival rate after surgery | 5 years | 
| Quality of life-SF questionnaire | 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 | 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 | 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 | 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 | Study 1: To compare distance to surgical margins measured in mm between the group 1A and 1B | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Colorectal surgery