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

Sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (Other)

Overall Status

Completed

CT.gov ID

NCT02746224

Collaborator

(none)

Enrollment

Location

Arms

65.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Rectal Tumors	Procedure: Initially dissection of inferior mesenteric vein Procedure: Initially dissection of inferior mesenteric artery Procedure: Latero-terminal colorectal anastomosis Procedure: Termino-terminal colorectal anastomosis	N/A

Detailed Description

Methods:

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 Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Sep 30, 2019

Actual Study Completion Date :

Sep 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: group 1A the surgical technique initially dissects the inferior mesenteric vein (IMV).	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)
Other: group 1B the surgical technique initially dissects the inferior mesenteric artery (IMA).	Procedure: 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.
Other: group 2A the patients will have a latero-terminal colorectal anastomosis	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) Procedure: 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.
Other: group 2B the patients will have a termino-terminal colorectal anastomosis.	Procedure: 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. Procedure: 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.

Outcome Measures

Primary Outcome Measures

Total number of resected lymph nodes [1 month]
Study 1:To compare the total number of resected lymph nodes between the two arms (1A and 1B).
Anorectal functional outcome at 12 months assessed by COREFO questionnaire [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)
Anorectal functional outcome at 12 months assessed by LARS scale [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).

Secondary Outcome Measures

Intraoperative outcomes: duration of surgery [1 day]
Study 1: to compare the duration of surgery measured in minutes between the two arms (1A and 1B).
Intraoperative outcomes: surgical bleeding [1 day]
Study 1: to compare the surgical bleeding measured in ml between the two arms (1A and 1B).
Intraoperative outcomes: surgical conversion [1 day]
Study 1: to compare the incidence of surgical conversion to laparotomy between the two arms (1A and 1B).
Postoperative complications [90 days]
Study 1 and 2: Postoperative complications within 90 days after surgery (Clavien-Dindo classification).
Survival [5 years]
Study 1: 5-year survival rate after surgery
Quality of life-SF questionnaire [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.
Anorectal functional outcome assessed by COREFO questionnaire [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).
Postoperative complications and anastomotic leakage [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.
Anorectal functional outcome assessed by LARS scale [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).
Distance to surgical margins [1 month]
Study 1: To compare distance to surgical margins measured in mm between the group 1A and 1B

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Dr. Josep Trueta of Girona	Girona		Spain	17007

Sponsors and Collaborators

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Investigators

Principal Investigator: Pere Planellas Giné, MD-PhD, Colorectal Surgery Unit. Department of General and Digestive Surgery. University Hospital Dr. Josep Trueta of Girona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pere Planellas Giné, MD-PhD, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

ClinicalTrials.gov Identifier:

NCT02746224

Other Study ID Numbers:

34502

First Posted:

Apr 21, 2016

Last Update Posted:

Sep 13, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Pere Planellas Giné, MD-PhD, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Colorectal cancer

Colorectal surgery

Additional relevant MeSH terms:

Colorectal Neoplasms

Rectal Neoplasms

Study Results

No Results Posted as of Sep 13, 2021