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Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL) (CMELL)

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ClinicalTrials.gov Identifier: NCT03083951
Recruitment Status : Active, not recruiting
First Posted : March 20, 2017
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Pere Planellas Giné, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Tracking Information
First Submitted Date  ICMJE March 2, 2017
First Posted Date  ICMJE March 20, 2017
Last Update Posted Date September 10, 2019
Actual Study Start Date  ICMJE September 1, 2017
Actual Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2017)
Total number of lymph nodes and lymph node ratio. [ Time Frame: 30 days ]
To compare the total number of lymph nodes resected and the lymph node ratio (definded as ratio of lymph nodes with tumor metastasis to the total lymph nodes resected) between the two arms.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03083951 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2017)
  • Local recurrence [ Time Frame: 5 years ]
    To compare the tumor local recurrence rate between the two arms.
  • Survival [ Time Frame: 5 years ]
    To compare the survival rate (deaths from cancer) between the two arms
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 13, 2017)
  • Postoperative complications [ Time Frame: 90 days ]
    Postoperative complications within 90 days after surgery (Clavien-Dindo classification).
  • Anastomotic leakage [ Time Frame: 90 days ]
    To compare the incidence of anastomotic leakage according to the classification of the International Group for Rectal Cancer Study.
  • Intraoperative outcomes: duration of surgery [ Time Frame: 1 day ]
    To compare the duration of surgery measured in minutes between the two arms
  • Intraoperative outcomes: surgical bleeding [ Time Frame: 1 day ]
    To compare the surgical bleeding measured in ml between the two arms
  • Intraoperative outcomes: surgical conversion [ Time Frame: 1 day ]
    To compare the incidence of surgical conversion to laparotomy between the two arms
  • Genitourinary dysfunction assesed by ICIQ-SF questionnaire [ Time Frame: 1 year ]
    To compare the Genitourinary dysfunction between the two arm measured by ICIQ-SF questionnaire
  • Defecatory dysfunction assesed by FSFI and erectile dysfunction questionnaires [ Time Frame: 1 year ]
    To compare the defecatory dysfunction between the two arms measured by FSFI and erectile dysfunction questionnaires
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)
Official Title  ICMJE Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)
Brief Summary A randomized, controlled clinical trial comparing lymphadenectomy with extended inferior mesenteric artery ligation (complete mesocolon excision: which includes lymphoma tissue from the origin of the inferior mesenteric vein) with conventional locoregional lymphadenectomy in patients undergoing laparoscopic sigmoidectomy for sigmoid cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial, single blind (the patient does not know the group to which it has been assigned) of patients undergoing laparoscopic sigmoid colon cancer resection. In all patients a lymphadenectomy with a high ligation of the Lower Mesenteric Artery will be performed. In patients in group 1A, lymphadenectomy will also include the lymphogranular tissue that accompanies the inferior mesenteric vein from its origin (complete mesocolon excision). In patients in group 1B, a conventional lymphadenectomy will be performed only from the origin of the inferior mesenteric artery without including the lymphatic tissue of the origin of the inferior mesenteric vein.
Masking: Single (Participant)
Masking Description:
The patient does not know the group to which it has been assigned.
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Sigmoid Cancer
Intervention  ICMJE
  • Procedure: Complete mesocolon excision
    Laparoscopic sigmoidectomy with lymphadenectomy of the lymphatic tissue that accompanies the inferior mesenteric vein and a high tie ligation of the inferior mesenteric artery (complete mesocolon excision)
  • Procedure: Conventional locoregional lymphadenectomy
    Laparoscopic sigmoidectomy with lymphadenectomy of the lymphatic tissue that accompanies the inferior mesenteric artery and a high tie ligation of the inferior mesenteric artery with or without section of inferior mesenteric vein.
Study Arms  ICMJE
  • Experimental: Complete Mesocolon Excision
    A high tie of the inferior mesenteric artery (IMA) should be attempted. The inferior mesenteric vein section at the Treitz angle should be performed. The lymphatic tissue that accompanies the inferior mesenteric vein should be added.
    Intervention: Procedure: Complete mesocolon excision
  • Active Comparator: Conventional Locoregional Lymphadenectomy
    A high tie of the inferior mesenteric artery (IMA) should be attempted. Lymphadenectomy of the lymphatic tissue that accompanies the IMA will be performed. The inferior mesenteric vein section could be performed at the discretion of the surgeon.
    Intervention: Procedure: Conventional locoregional lymphadenectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2017)
84
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Actual Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing programmed surgery for laparoscopic sigmoid colon cancer.
  • Age ≥ 18 years and <80 years.
  • Histology of adenocarcinoma or adenoma without chemotherapy or neoadjuvant radiotherapy.
  • Any T, any N, M0.
  • Intention of resection R0.
  • Informed consent signed by the patient and the investigator.

Exclusion Criteria:

  • Colorectal tumor with histology other than adenocarcinoma or adenoma.
  • Colon cancer located in the right colon, transverse, splenic or non-sigmoid left colon.
  • Metastatic disease (M1).
  • History of colorectal cancer surgery, different from a local excision.
  • Inflammatory bowel disease with anatomopathological confirmation.
  • Patients with psychiatric illness, addiction or any disorder that pmpedes the understanding of informed consent.
  • Inability to read or understand any of the languages of the informed consent (Catalan, Spanish).
  • Another synchronous malignant disease.
  • Emergency surgery.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03083951
Other Study ID Numbers  ICMJE 13117
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pere Planellas Giné, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Study Sponsor  ICMJE Pere Planellas Giné
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP