NCT03826446

Brief Summary

Right sided hemicolectomy is the standard type of operation for cancers in the caecum, the ascending colon.The aim of this study was to compare between laparoscopic and open complete mesocolic excision with central vascular ligation in right colon cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

2.9 years

First QC Date

January 27, 2019

Last Update Submit

January 30, 2019

Conditions

Colon Cancer

Keywords

Right colon cancerMesocolic excision

Outcome Measures

Primary Outcomes (6)

  • Operative time in open and laparoscopic complete mesocolic excision groups in right cancer colon

    Comparing the operative time between laparoscopic and open complete mesocolic excision with central artery ligation groups

    1-3 years

  • Incision length in open and laparoscopic complete mesocolic excision groups in right cancer colon

    Comparing the incision length between laparoscopic and open complete mesocolic excision with central artery ligation groups

    1-3 years

  • Hospital stay duration in open and laparoscopic complete mesocolic excision groups in right cancer colon

    Comparing the hospital stay duration between laparoscopic and open complete mesocolic excision with central artery ligation groups

    1-3

  • Histopathological findings in open and laparoscopic complete mesocolic excision groups in right cancer colon

    Comparing the histopathological findings between laparoscopic and open complete mesocolic excision with central artery ligation groups

    1-3 years

  • Post-operative complications in open and laparoscopic complete mesocolic excision groups in right cancer colon

    Comparing the post-operative complications between laparoscopic and open complete mesocolic excision with central artery ligation groups

    1-3 years

  • Recurrence rate in open and laparoscopic complete mesocolic excision groups in right cancer colon

    Comparing the recurrence rate between laparoscopic and open complete mesocolic excision with central artery ligation groups

    1-3 years

Study Arms (2)

Open Surgery

OTHER

Patients diagnosed as operable right sided colon cancer were enrolled in this study and did open complete mesocolic excision procedures

Procedure: Surgery

Laparoscopic Surgery

OTHER

Patients diagnosed as operable right sided colon cancer were enrolled in this study and did laparoscopic complete mesocolic excision procedures

Procedure: Surgery

Interventions

SurgeryPROCEDURE

laparoscopic and open complete mesocolic excision with central vascular ligation in right colon cancer.

Laparoscopic SurgeryOpen Surgery

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Only operable cases of right colon cancer by (CT scan criteria) which include:
  • No permeation of surrounding fat planes.
  • No encasement of major vascular structures.
  • No extensive local spread.
  • No distant metastases or peritoneal infiltration were included in this study.

You may not qualify if:

  • All cases with perforation or obstruction. 2- Metastatic colon cancer. 3- Patients undergoing colectomy including another part of the colon than right colon.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

ShebinElkom, Menoufia, 32511, Egypt

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
kshady- Principal investigstor

Study Record Dates

First Submitted

January 27, 2019

First Posted

February 1, 2019

Study Start

January 13, 2016

Primary Completion

December 17, 2018

Study Completion

December 31, 2018

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

EG(1)