Complete Mesocolic Excision With Central Vessel Ligation Compared With Conventional Surgery for Colon Cancer

NCT02526836 | Unknown Phase 2

• 1 other identifier: Complete Mesocolic Excision
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

Brief Summary

The aim of this study is to compare between complete mesocolic excision with central vascular ligation and conventional surgery of colon cancer regarding number of harvested lymph nodes, surgical outcome and complications.

Conditions

Colon Cancer

Keywords

colon cancer mesocolic excision central ligation

Outcome Measures

Primary Outcomes (1)

• Lymph nodes harvest

  Number of retrieved lymph nodes

  Day of surgery

Secondary Outcomes (4)

• Oncologic outcome

  2 years

• Operative outcome

  Day of suregry

• Postoperative outcome

  1 month

• Survival outcome

  3 Years

Study Arms (2)

Comparison group

OTHER

including the number of cases with complete data who underwent surgery using the conventional method. Conventional surgery

Procedure: Conventional Surgery

Intervention group

ACTIVE COMPARATOR

including a convenient sample of about 20 patients which is expected to be recruited, for whom Complete Mesocolic Excision (CME) and Central Vascular Ligation (CVL) will be done. Complete mesocolic excision with central vascular ligation

Procedure: Complete mesocolic excision with central vascular ligation

Interventions

Conventional Surgery PROCEDURE

removal of the tumor with no ligation of the vessel centrally or removal of the whole mesocolon

Comparison group

Complete mesocolic excision with central vascular ligation PROCEDURE

excision of the whole mesocolon plus ligation of the supplying blood vessel centrally

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically proven adenocarcinoma (including mucinous and signet-ring cell) or adenosquamous carcinoma on endoscopic biopsy.
• Tumor localization at the caecum, ascending colon, transverse colon, descending colon, sigmoid colon or rectosigmoid on preoperative endoscopy and radiographic imaging \[barium enema or computed tomography (CT)\] without location of the lower border of the tumor at the rectum.
• No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
• Body mass index ≤ 35.
• Sufficient organ function including cardiovascular system and liver.
• Written informed consent.

You may not qualify if:

• Contraindications to major surgery and American Society of Anesthesiologists (ASA) Physical Status scoring 4 which means extreme systemic disorders which have already become an eminent threat to life regardless of the type of treatment.
• Infectious disease requiring treatment.
• Body temperature ≥ 38 °C.
• Pregnant women.
• History of psychiatric disease.
• Use of systemic steroids.
• History of myocardial infarction or unstable angina pectoris within 6 months.
• Severe pulmonary emphysema or pulmonary fibrosis

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (2)

Oncology Center Mansoura University (OCMU), Egypt

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

National Cancer Institute "Fond. G. Pascale"

Naples, 80131, Italy

RECRUITING

Related Publications (2)

• Hohenberger W, Weber K, Matzel K, Papadopoulos T, Merkel S. Standardized surgery for colonic cancer: complete mesocolic excision and central ligation--technical notes and outcome. Colorectal Dis. 2009 May;11(4):354-64; discussion 364-5. doi: 10.1111/j.1463-1318.2008.01735.x. Epub 2009 Nov 5.

  PMID: 19016817 BACKGROUND

• Bertelsen CA, Neuenschwander AU, Jansen JE, Wilhelmsen M, Kirkegaard-Klitbo A, Tenma JR, Bols B, Ingeholm P, Rasmussen LA, Jepsen LV, Iversen ER, Kristensen B, Gogenur I; Danish Colorectal Cancer Group. Disease-free survival after complete mesocolic excision compared with conventional colon cancer surgery: a retrospective, population-based study. Lancet Oncol. 2015 Feb;16(2):161-8. doi: 10.1016/S1470-2045(14)71168-4. Epub 2014 Dec 31.

  PMID: 25555421 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Mohamed Abdelkhalek, M.Sc

  Oncology Center Mansoura University (OCMU), Egypt

  PRINCIPAL INVESTIGATOR

• Giovanni Romano, MD

  National Cancer Institute "Fond. G. Pascale", Italy

  PRINCIPAL INVESTIGATOR

• Adel Denewer, MD

  Oncology Center Mansoura University (OCMU), Egypt

  STUDY CHAIR

• Tamer F Youssef, MD

  Oncology Center Mansoura University (OCMU), Egypt

  STUDY DIRECTOR

Central Study Contacts

Mohamed Abdelkhalek, M.Sc

CONTACT

+201001850214; mabdelkhalek@mans.edu.eg

Ahmed Setit, MD

CONTACT

asetit@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Surgical Oncology

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 18, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: August 16, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1); IT (1)