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

Colorectal Cancer Clinical Trial

— TAHR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02746224
• Other study ID #: 34502
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: September 2, 2021

Study information

• Verified date: September 2021
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2, 2021
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Rectal Neoplasms
• Rectal Tumors

Intervention

Procedure:
• Initially dissection of inferior mesenteric vein
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)
• Initially dissection of inferior mesenteric artery
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
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
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.

Locations

Country	Name	City	State
Spain	University Hospital Dr. Josep Trueta of Girona	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Intraoperative outcomes: surgical bleeding	Study 1: to compare the surgical bleeding measured in ml between the two arms (1A and 1B).	1 day
Secondary	Intraoperative outcomes: surgical conversion	Study 1: to compare the incidence of surgical conversion to laparotomy between the two arms (1A and 1B).	1 day
Secondary	Postoperative complications	Study 1 and 2: Postoperative complications within 90 days after surgery (Clavien-Dindo classification).	90 days
Secondary	Survival	Study 1: 5-year survival rate after surgery	5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Distance to surgical margins	Study 1: To compare distance to surgical margins measured in mm between the group 1A and 1B	1 month