Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 75 of 1002 for:    colon cancer AND resection

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02746224
Recruitment Status : Recruiting
First Posted : April 21, 2016
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
Pere Planellas Giné, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

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 Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : April 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2022

Arm Intervention/treatment
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)

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.

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.

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.




Primary Outcome Measures :
  1. Total number of resected lymph nodes [ Time Frame: 1 month ]
    Study 1:To compare the total number of resected lymph nodes between the two arms (1A and 1B).

  2. Anorectal functional outcome at 12 months assessed by COREFO questionnaire [ Time Frame: 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)

  3. Anorectal functional outcome at 12 months assessed by LARS scale [ Time Frame: 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 :
  1. Intraoperative outcomes: duration of surgery [ Time Frame: 1 day ]
    Study 1: to compare the duration of surgery measured in minutes between the two arms (1A and 1B).

  2. Intraoperative outcomes: surgical bleeding [ Time Frame: 1 day ]
    Study 1: to compare the surgical bleeding measured in ml between the two arms (1A and 1B).

  3. Intraoperative outcomes: surgical conversion [ Time Frame: 1 day ]
    Study 1: to compare the incidence of surgical conversion to laparotomy between the two arms (1A and 1B).

  4. Postoperative complications [ Time Frame: 90 days ]
    Study 1 and 2: Postoperative complications within 90 days after surgery (Clavien-Dindo classification).

  5. Survival [ Time Frame: 5 years ]
    Study 1: 5-year survival rate after surgery

  6. Quality of life [ Time Frame: 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.

  7. Anorectal functional outcome assessed by COREFO questionnaire [ Time Frame: 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).

  8. Postoperative complications and anastomotic leakage [ Time Frame: 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.

  9. Anorectal functional outcome assessed by LARS scale [ Time Frame: 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).

  10. Distance to surgical margins [ Time Frame: 1 month ]
    Study 1: To compare distance to surgical margins measured in mm between the group 1A and 1B



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02746224


Contacts
Layout table for location contacts
Contact: Pere Planellas Giné, MD-PhD 0034 972940200 ext 2260 pereplanellas@hotmail.com

Locations
Layout table for location information
Spain
University Hospital Dr. Josep Trueta of Girona Recruiting
Girona, Spain, 17007
Contact: Pere Planellas Giné, MD-PhD       pereplanellas@hotmail.com   
Principal Investigator: Pere Planellas Giné, MD-PhD         
Principal Investigator: Helena Salvador Rosés, MD         
Sponsors and Collaborators
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Investigators
Layout table for investigator information
Principal Investigator: Pere Planellas Giné, MD-PhD Colorectal Surgery Unit. Department of General and Digestive Surgery. University Hospital Dr. Josep Trueta of Girona

Layout table for additonal information
Responsible Party: Pere Planellas Giné, MD-PhD, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
ClinicalTrials.gov Identifier: NCT02746224     History of Changes
Other Study ID Numbers: 34502
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pere Planellas Giné, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta:
Colorectal cancer
Colorectal surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases