Clinical trial NCT02746224: Reconstruction Techniques and Vascular Approach After Laparoscopic Left Hemicolectomy and Rectum Low Anterior Resection
Official title: Reconstruction Techniques and Vascular Approach After Laparoscopic Left Hemicolectomy and Laparoscopic Low Anterior Resection for Rectal Cancer: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Rectal Tumors
Keywords: Colorectal cancer
Colorectal surgery
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility 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

Primary outcomes:
measure: Total number of resected lymph nodes
timeFrame: 1 month
measure: Anorectal functional outcome at 12 months assessed by COREFO questionnaire
timeFrame: 12 months
measure: Anorectal functional outcome at 12 months assessed by LARS scale
timeFrame: 12 months
Secondary outcomes:
measure: Intraoperative outcomes: duration of surgery
timeFrame: 1 day
measure: Intraoperative outcomes: surgical bleeding
timeFrame: 1 day
measure: Intraoperative outcomes: surgical conversion
timeFrame: 1 day
measure: Postoperative complications
timeFrame: 90 days
measure: Survival
timeFrame: 5 years
measure: Quality of life-SF questionnaire
timeFrame: 6, 12, 18 and 24 months after surgery
measure: Anorectal functional outcome assessed by COREFO questionnaire
timeFrame: 6,18 and 24 months after surgery
measure: Postoperative complications and anastomotic leakage
timeFrame: 90 days after surgery
measure: Anorectal functional outcome assessed by LARS scale
timeFrame: 6,18 and 24 months after surgery
measure: Distance to surgical margins
timeFrame: 1 month
Other outcomes:
Locations:
city: Girona
country: Spain
facility: University Hospital Dr. Josep Trueta of Girona
Study officials:
affiliation: Colorectal Surgery Unit. Department of General and Digestive Surgery. University Hospital Dr. Josep Trueta of Girona
name: Pere Planellas Giné, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.