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Completed

NCT Number: NCT03083951

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Sigmoid Cancer Sigmoid Diseases Sigmoid Neoplasms

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Dr. Josep Trueta of Girona

Girona, 17007, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 impedes 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.

Treatment and study plan

Complete mesocolon excision

Procedure

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)

Conventional locoregional lymphadenectomy

Procedure

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.

Primary outcomes

  1. 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 (defined as ratio of lymph nodes with tumor metastasis to the total lymph nodes resected) between the two arms.

Secondary outcomes

  1. Local recurrence

    Time frame: 5 years

    To compare the tumor local recurrence rate between the two arms.

  2. Survival

    Time frame: 5 years

    To compare the survival rate (deaths from cancer) between the two arms

Other outcomes

  1. Postoperative complications

    Time frame: 90 days

    Postoperative complications within 90 days after surgery (Clavien-Dindo classification).

  2. 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.

  3. Intraoperative outcomes: duration of surgery

    Time frame: 1 day

    To compare the duration of surgery measured in minutes between the two arms

  4. Intraoperative outcomes: surgical bleeding

    Time frame: 1 day

    To compare the surgical bleeding measured in ml between the two arms

  5. Intraoperative outcomes: surgical conversion

    Time frame: 1 day

    To compare the incidence of surgical conversion to laparotomy between the two arms

  6. Genitourinary dysfunction assessed by ICIQ-SF questionnaire

    Time frame: 1 year

    To compare the Genitourinary dysfunction between the two arm measured by ICIQ-SF questionnaire

  7. Defecatory dysfunction assessed 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

Sponsors and collaborators

Lead sponsor

Pere Planellas Giné

Other

Registry information

Acronym: CMELL

Important dates

Study start
2017
Primary completion
2019
Study completion
2023
First posted
Mar 20, 2017
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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