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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:
Secondary outcome measures:
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:
Secondary outcome measures:
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:
Study 2:
Exclusion Criteria:
Study 1:
Study 2:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1A | Other | the surgical technique initially dissects the inferior mesenteric vein (IMV). |
|
| group 1B | Other | the surgical technique initially dissects the inferior mesenteric artery (IMA). |
|
| group 2A | Other | the patients will have a latero-terminal colorectal anastomosis |
|
| group 2B | Other | the patients will have a termino-terminal colorectal anastomosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Initially dissection of inferior mesenteric vein | Procedure | 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Study 1:
Study 2:
Exclusion Criteria:
Study 1:
Study 2:
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| Name | Affiliation | Role |
|---|---|---|
| Pere Planellas Giné, MD-PhD | Colorectal Surgery Unit. Department of General and Digestive Surgery. University Hospital Dr. Josep Trueta of Girona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Dr. Josep Trueta of Girona | Girona | 17007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33038521 | Derived | Planellas P, Farres R, Cornejo L, Rodriguez-Hermosa JI, Pigem A, Timoteo A, Ortega N, Codina-Cazador A. Randomized clinical trial comparing side to end vs end to end techniques for colorectal anastomosis. Int J Surg. 2020 Nov;83:220-229. doi: 10.1016/j.ijsu.2020.09.039. Epub 2020 Oct 7. |
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| Initially dissection of inferior mesenteric artery | Procedure | 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. |
|
| Latero-terminal colorectal anastomosis | Procedure | 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. |
|
| Termino-terminal colorectal anastomosis | Procedure | 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 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 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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