NCT03083951

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Sep 2017

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

First Submitted

Initial submission to the registry

March 2, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

March 2, 2017

Last Update Submit

September 28, 2023

Conditions

Colorectal CancerSigmoid Cancer

Keywords

Complete mesocolon excisionSigmoid cancerColorectal cancer

Outcome Measures

Primary Outcomes (1)

  • Total number of lymph nodes and lymph node ratio.

    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.

    30 days

Secondary Outcomes (2)

  • Local recurrence

    5 years

  • Survival

    5 years

Other Outcomes (7)

  • Postoperative complications

    90 days

  • Anastomotic leakage

    90 days

  • Intraoperative outcomes: duration of surgery

    1 day

  • +4 more other outcomes

Study Arms (2)

Complete Mesocolon Excision

EXPERIMENTAL

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.

Procedure: Complete mesocolon excision

Conventional Locoregional Lymphadenectomy

ACTIVE COMPARATOR

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.

Procedure: Conventional locoregional lymphadenectomy

Interventions

Complete mesocolon excisionPROCEDURE

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)

Complete Mesocolon Excision
Conventional locoregional lymphadenectomyPROCEDURE

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.

Conventional Locoregional Lymphadenectomy

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

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 (2)

  • Planellas P, Marinello F, Elorza G, Golda T, Farres R, Espin-Basany E, Enriquez-Navascues JM, Kreisler E, Cornejo L, Codina-Cazador A. Impact on defecatory, urinary and sexual function after high-tie sigmoidectomy: a post-hoc analysis of a multicenter randomized controlled trial comparing extended versus standard complete mesocolon excision. Langenbecks Arch Surg. 2023 Aug 1;408(1):293. doi: 10.1007/s00423-023-03026-9.

    PMID: 37526748DERIVED

  • Planellas P, Marinello F, Elorza G, Golda T, Farres R, Espin-Basany E, Enriquez-Navascues JM, Kreisler E, Cornejo L, Codina-Cazador A. Extended Versus Standard Complete Mesocolon Excision in Sigmoid Colon Cancer: A Multicenter Randomized Controlled Trial. Ann Surg. 2022 Feb 1;275(2):271-280. doi: 10.1097/SLA.0000000000005161.

    PMID: 34417367DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsSigmoid Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patient does not know the group to which it has been assigned.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 20, 2017

Study Start

September 1, 2017

Primary Completion

June 1, 2019

Study Completion

January 1, 2023

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)