NCT02746224

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2021

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

3.5 years

First QC Date

April 13, 2016

Last Update Submit

September 6, 2021

Conditions

Colorectal CancerRectal Tumors

Keywords

Colorectal cancerColorectal surgery

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (10)

  • Intraoperative outcomes: duration of surgery

    1 day

  • Intraoperative outcomes: surgical bleeding

    1 day

  • Intraoperative outcomes: surgical conversion

    1 day

  • Postoperative complications

    90 days

  • Survival

    5 years

  • +5 more secondary outcomes

Study Arms (4)

group 1A

OTHER

the surgical technique initially dissects the inferior mesenteric vein (IMV).

Procedure: Initially dissection of inferior mesenteric vein

group 1B

OTHER

the surgical technique initially dissects the inferior mesenteric artery (IMA).

Procedure: Initially dissection of inferior mesenteric artery

group 2A

OTHER

the patients will have a latero-terminal colorectal anastomosis

Procedure: Initially dissection of inferior mesenteric veinProcedure: Latero-terminal colorectal anastomosis

group 2B

OTHER

the patients will have a termino-terminal colorectal anastomosis.

Procedure: Initially dissection of inferior mesenteric arteryProcedure: Termino-terminal colorectal anastomosis

Interventions

Initially dissection of inferior mesenteric veinPROCEDURE

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 1Agroup 2A
Initially dissection of inferior mesenteric arteryPROCEDURE

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 1Bgroup 2B
Latero-terminal colorectal anastomosisPROCEDURE

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 2A
Termino-terminal colorectal anastomosisPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Dr. Josep Trueta of Girona

Girona, 17007, Spain

Location

Related Publications (1)

  • 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.

    PMID: 33038521DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Pere Planellas Giné, MD-PhD

    Colorectal Surgery Unit. Department of General and Digestive Surgery. University Hospital Dr. Josep Trueta of Girona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD-PhD

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 21, 2016

Study Start

April 1, 2016

Primary Completion

September 30, 2019

Study Completion

September 2, 2021

Last Updated

September 13, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)