Colonic CancerCMENCT04434508
Open Versus Laparoscopic Right Hemicolectomy for Right Colon Cancer
A study testing laparoscopic right hemicolectomy with CME and central v and Open right hemicolectomy with CME and central v in people with Colonic Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colonic Cancer
- What is being tested?
- laparoscopic right hemicolectomy with CME and central v and Open right hemicolectomy with CME and central v
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 25 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with right colonic cancer
Who cannot join
- Patients with distant metastasis, large tumors with extra-colonic invasion emergency presentation (bowel obstruction or perforation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision and Central Vascular Ligation for Right Colon Cancer. A Randomized Prospective Study.
The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery.
Read the detailed description
The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery.
Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.
The primary outcome was the number of lymph nodes (LNs) harvested among both groups. Secondary outcomes included operative time, blood loss, postoperative complications, and hospital stay.
- Conditions
- Colonic Cancer
- Being tested
- laparoscopic right hemicolectomy with CME and central v, Open right hemicolectomy with CME and central v
- Keywords
- Colonic Cancer, laparoscopic right hemicolectomy, complete mesocolic excision
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic right hemicolectomy with CME and central vProcedure or surgery
Also called LHC with CME
laparoscopic right hemicolectomy with CME and central v
Open right hemicolectomy with CME and central vProcedure or surgery
Also called ORH with CME
Open right hemicolectomy with CME and central v
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic right hemicolectomy with CME and central v | Active comparator | laparoscopic right hemicolectomy with CME and central v Receives: Procedure: laparoscopic right hemicolectomy with CME and central v |
| open right hemicolectomy with CME and central v | Active comparator | open right hemicolectomy with CME and central v Receives: Procedure: Open right hemicolectomy with CME and central v |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of lymph nodes (LNs) harvested among both groups
the number of lymph nodes (LNs) harvested among both groups
Measured: 30 DAYS
Secondary outcomes (3)
operative time
operative time
Measured: INTRAOPERATIVE
blood loss,
blood loss,
Measured: intraoperative
post-operative complications
post-operative complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start1 Jul 2017
- Primary completion1 Jan 2020
- Study completion25 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colonic CancerStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman El Nakeeb, Mansoura University
- Investigators
- Ayman E Nakeeb, Principal investigator, Mansoura University, Gastrointestinal Surgery CenterMohamed E el sorogy, MD, Study director, Mansoura University, Gastrointestinal Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434508
- Sponsor's protocol ID
- laparoscopic hemicolectomy
- Acronym
- CME
- Status last verified
- Jun 2020
- First submitted
- 12 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol
Publications
Cho MS, Baek SJ, Hur H, Soh Min B, Baik SH, Kyu Kim N. Modified complete mesocolic excision with central vascular ligation for the treatment of right-sided colon cancer: long-term outcomes and prognostic factors. Ann Surg. 2015 Apr;261(4):708-15. doi: 10.1097/SLA.0000000000000831.
PubMed 25072438Vajda K, Horti I, Cserni G, Bori R, Sikorszki L. [Laparoscopic and open complete mesocolic excision in right-sided colon cancer compared with open and laparoscopic surgery]. Magy Seb. 2020 Mar;73(1):23-28. doi: 10.1556/1046.73.2020.1.3. Hungarian.
PubMed 32172577Dewulf M, Kalmar A, Vandenberk B, Muysoms F, Defoort B, Claeys D, Pletinckx P. Complete mesocolic excision does not increase short-term complications in laparoscopic left-sided colectomies: a comparative retrospective single-center study. Langenbecks Arch Surg. 2019 Aug;404(5):557-564. doi: 10.1007/s00423-019-01797-8. Epub 2019 Jun 26.
PubMed 31243573Emmanuel A, Haji A. Complete mesocolic excision and extended (D3) lymphadenectomy for colonic cancer: is it worth that extra effort? A review of the literature. Int J Colorectal Dis. 2016 Apr;31(4):797-804. doi: 10.1007/s00384-016-2502-0. Epub 2016 Jan 30.
PubMed 26833471
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision and Central Vascular Ligation for Right Colon Cancer. A Randomized Prospective Study.
- ClinicalTrials.gov ID
- NCT04434508
- Acronym / sponsor ID
- CME / laparoscopic hemicolectomy
- Conditions
- Colonic Cancer
- Keywords
- Colonic Cancer, laparoscopic right hemicolectomy, complete mesocolic excision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 25 Jan 2020 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery.
Detailed description
The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery.
Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.
The primary outcome was the number of lymph nodes (LNs) harvested among both groups. Secondary outcomes included operative time, blood loss, postoperative complications, and hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.
| Arm | Type | Receives |
|---|---|---|
| laparoscopic right hemicolectomy with CME and central v | Active comparator | Procedure: laparoscopic right hemicolectomy with CME and central vlaparoscopic right hemicolectomy with CME and central v |
| open right hemicolectomy with CME and central v | Active comparator | Procedure: Open right hemicolectomy with CME and central vopen right hemicolectomy with CME and central v |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with right colonic cancer
Key exclusion criteria (1 listed)
- Patients with distant metastasis, large tumors with extra-colonic invasion emergency presentation (bowel obstruction or perforation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic right hemicolectomy with CME and central vAlso: LHC with CMElaparoscopic right hemicolectomy with CME and central v | Procedure or surgery | laparoscopic right hemicolectomy with CME and central v |
| Open right hemicolectomy with CME and central vAlso: ORH with CMEOpen right hemicolectomy with CME and central v | Procedure or surgery | open right hemicolectomy with CME and central v |
Primary outcome
the number of lymph nodes (LNs) harvested among both groups
Time frame: 30 DAYS
the number of lymph nodes (LNs) harvested among both groups
3 secondary outcomes
operative time
Time frame: INTRAOPERATIVE
blood loss,
Time frame: intraoperative
post-operative complications
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Background: PubMed 25072438Cho MS, Baek SJ, Hur H, Soh Min B, Baik SH, Kyu Kim N. Modified complete mesocolic excision with central vascular ligation for the treatment of right-sided colon cancer: long-term outcomes and prognostic factors. Ann Surg. 2015 Apr;261(4):708-15. doi: 10.1097/SLA.0000000000000831.
- Results publication: PubMed 32172577Vajda K, Horti I, Cserni G, Bori R, Sikorszki L. [Laparoscopic and open complete mesocolic excision in right-sided colon cancer compared with open and laparoscopic surgery]. Magy Seb. 2020 Mar;73(1):23-28. doi: 10.1556/1046.73.2020.1.3. Hungarian.
- Results publication: PubMed 31243573Dewulf M, Kalmar A, Vandenberk B, Muysoms F, Defoort B, Claeys D, Pletinckx P. Complete mesocolic excision does not increase short-term complications in laparoscopic left-sided colectomies: a comparative retrospective single-center study. Langenbecks Arch Surg. 2019 Aug;404(5):557-564. doi: 10.1007/s00423-019-01797-8. Epub 2019 Jun 26.
- Results publication: PubMed 26833471Emmanuel A, Haji A. Complete mesocolic excision and extended (D3) lymphadenectomy for colonic cancer: is it worth that extra effort? A review of the literature. Int J Colorectal Dis. 2016 Apr;31(4):797-804. doi: 10.1007/s00384-016-2502-0. Epub 2016 Jan 30.
- Mansoura universityLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Study Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman E Nakeeb principal investigator
Mansoura University, Gastrointestinal Surgery Center
Mohamed E el sorogy, MD study director
Mansoura University, Gastrointestinal Surgery Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic right hemicolectomy with CME and central v and Open right hemicolectomy with CME and central v in people with Colonic Cancer, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of lymph nodes (LNs) harvested among both groups (time frame: 30 DAYS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04434508, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.