Colon CancerNCT03826446
Laparoscopic Versus Open Complete Mesocolic Excision With Central Vascular Ligation in Right Colon Cancer
A study testing Surgery in people with Colon Cancer, run by Menoufia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jan 2016to 31 Dec 2018
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1- All cases with perforation or obstruction. 2- Metastatic colon cancer. 3- Patients undergoing colectomy including another part of the colon than right colon.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Colorectal cancer incidence and mortality rates vary markedly around the world. Globally, colorectal cancer is the third most commonly diagnosed cancer in males and the second in females, with 1.65 million new cases and almost 835,000 deaths in 2015. Rates are substantially higher in males than in females.
The right colon has a large caliber, a thin wall, and its contents are liquid; thus, obstruction is a late event. Bleeding is usually occult. Fatigue and weakness caused by severe anemia may be the only complaints. Tumors sometimes grow large enough to be palpable through the abdominal wall before other symptoms appear.
Curative treatment for right colon cancer includes resection of the tumor-bearing bowel segment. There are standard types of operations, depending on the location of the tumor. The types of standard resections are based on the knowledge of lymphatic drainage and lymph node anatomy.
Right sided hemicolectomy is the standard type of operation for cancers in the caecum, the ascending colon. In 2009, Hohenberger, a German scholar, proposed the term of complete mesocolic excision (CME), whose basic theory is mainly composed of two concepts in fetal anatomy and surgical oncology: sharp dissection of the mesocolic plane and the parietal plane. CME helps to keep the colonic mesentery intact, clarify the dissected area from central lymph nodes, emphasize the importance of transecting colon-feeding blood at the root, and increase the range of longitudinal enterotomy. Thus, CME provides a standardization of surgeries for colon cancer.
Traditionally, approach to right colon cancer is through open exploration but this approach has more blood loss, prolonged postoperative hospital stay, sever postoperative pain and delayed recovery..
Laparoscopic right colectomy (LRC) for colon cancer became a well-established technique in the surgical armamentarium of colorectal operations. It has well proved advantages: reduction in postoperative pain, time to return of bowel function, and length of hospital stay.
The purpose of the present study was to compare between laparoscopic and open complete mesocolic excision with central vascular ligation in right colon cancer as regards technical feasibility, advantages and disadvantages of both procedures.
This was prospective randomized study and was carried out on 60 patients diagnosed as operable right sided colon cancer and the patients will be divided into two groups:
Group I: Open right hemicolectomy with complete mesocolic excision with central vascular ligation.
Group II: Laparoscopic right hemicolectomy with complete mesocolic excision with central vascular ligation.
All patients were subjected to preoperative assessment in the form of:
- Full history.
- Clinical evaluation and body weight.
- Laboratory investigation (Complete blood picture, liver function tests, blood sugar, blood urea, serum creatinine, prothrombin time, serum albumin and tumour markers(.
- Imaging (chest X-ray, US abdomen, CT abdomen and pelvis).
- Histopathology diagnosis (endoscopic biopsy, tissue diagnosis).
Operative technique
In patients of group I:
- A standard mechanical bowel preparation will be performed 24 hours before operation.
- The patient will be placed in the supine position and the operation will be carried out in a standard manner.
- A midline incision of about 15 to 20 cm will be made.
- The right-sided colon will be mobilized before mesenteric division and the same vessels will be dissected frequently.
- Ileotransverse end-to-end hand anastomosis is operated and the mesenteric defect will be closed.
In patients of group II:
- A standard mechanical bowel preparation will be performed 24 hours before the operation.
- A high-definition laparoscope will be used.
- Under general anaesthesia the operation is carried out in standard manner, with the patient in a modified lithotomy position.
- After achieving pneumoperitoneum (12 mm Hg), a 12-mm trocar will be placed through an incision just above the umbilicus, and a 30-degree laparoscope will be inserted through the 12-mm trocar. The second 10-mm trocar will be inserted at the upper left quadrant of the abdomen for the major acting port. The third 5-mm trocar will be inserted at the lower left quadrant for the second major active port. The fourth and fifth 5-mm trocars will be inserted at the upper right and lower right quadrants.
- According to laparoscopic procedure, the position, composition, and spatial relationships of the surgery planes needed for laparoscopic complete mesocolic excision for right sided colic cancer cases are identified.
Intraoperatively, all patients will be assessed for:
- Time of the procedure.
- Amount of blood loss.
Postoperative follow up:
Patients will be followed up by the standardized follow up protocol. They will be examined by the outpatient setting after:
- 2 weeks (post-operative) for: wound infection, leakage, pathological outcome (The tumor node metastasis (TNM) stage, histologic grade of differentiation, number of harvested lymph nodes, lymphovascular invasion, estimation of resection margins).
- Every 3 months for 1-2 years by: history taking, physical examination, carcinoembryonic antigen measurement,
- Every 6 months for 1-2 years by: chest, abdomen-pelvic computed tomography for detection of local or systemic recurrence.
- Conditions
- Colon Cancer
- Being tested
- Surgery
- Keywords
- Right colon cancer, 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.
SurgeryProcedure or surgery
laparoscopic and open complete mesocolic excision with central vascular ligation in right colon cancer.
| Study group | Role | What they receive |
|---|---|---|
| Open Surgery | Other | Patients diagnosed as operable right sided colon cancer were enrolled in this study and did open complete mesocolic excision procedures Receives: 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 Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start13 Jan 2016
- Primary completion17 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Mohamed Shady, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826446
- Sponsor's protocol ID
- Faculty of medicine-MenoufiaU
- Status last verified
- Jan 2019
- First submitted
- 27 Jan 2019
- Last updated
- 1 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Open Complete Mesocolic Excision With Central Vascular Ligation in Right Colon Cancer
- ClinicalTrials.gov ID
- NCT03826446
- Acronym / sponsor ID
- Faculty of medicine-MenoufiaU
- Conditions
- Colon Cancer
- Keywords
- Right colon cancer, Mesocolic excision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 13 Jan 2016 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 1 Feb 2019 (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.
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.
Detailed description
Colorectal cancer incidence and mortality rates vary markedly around the world. Globally, colorectal cancer is the third most commonly diagnosed cancer in males and the second in females, with 1.65 million new cases and almost 835,000 deaths in 2015. Rates are substantially higher in males than in females.
The right colon has a large caliber, a thin wall, and its contents are liquid; thus, obstruction is a late event. Bleeding is usually occult. Fatigue and weakness caused by severe anemia may be the only complaints. Tumors sometimes grow large enough to be palpable through the abdominal wall before other symptoms appear.
Curative treatment for right colon cancer includes resection of the tumor-bearing bowel segment. There are standard types of operations, depending on the location of the tumor. The types of standard resections are based on the knowledge of lymphatic drainage and lymph node anatomy.
Right sided hemicolectomy is the standard type of operation for cancers in the caecum, the ascending colon. In 2009, Hohenberger, a German scholar, proposed the term of complete mesocolic excision (CME), whose basic theory is mainly composed of two concepts in fetal anatomy and surgical oncology: sharp dissection of the mesocolic plane and the parietal plane. CME helps to keep the colonic mesentery intact, clarify the dissected area from central lymph nodes, emphasize the importance of transecting colon-feeding blood at the root, and increase the range of longitudinal enterotomy. Thus, CME provides a standardization of surgeries for colon cancer.
Traditionally, approach to right colon cancer is through open exploration but this approach has more blood loss, prolonged postoperative hospital stay, sever postoperative pain and delayed recovery..
Laparoscopic right colectomy (LRC) for colon cancer became a well-established technique in the surgical armamentarium of colorectal operations. It has well proved advantages: reduction in postoperative pain, time to return of bowel function, and length of hospital stay.
The purpose of the present study was to compare between laparoscopic and open complete mesocolic excision with central vascular ligation in right colon cancer as regards technical feasibility, advantages and disadvantages of both procedures.
This was prospective randomized study and was carried out on 60 patients diagnosed as operable right sided colon cancer and the patients will be divided into two groups:
Group I: Open right hemicolectomy with complete mesocolic excision with central vascular ligation.
Group II: Laparoscopic right hemicolectomy with complete mesocolic excision with central vascular ligation.
All patients were subjected to preoperative assessment in the form of:
- Full history.
- Clinical evaluation and body weight.
- Laboratory investigation (Complete blood picture, liver function tests, blood sugar, blood urea, serum creatinine, prothrombin time, serum albumin and tumour markers(.
- Imaging (chest X-ray, US abdomen, CT abdomen and pelvis).
- Histopathology diagnosis (endoscopic biopsy, tissue diagnosis).
Operative technique
In patients of group I:
- A standard mechanical bowel preparation will be performed 24 hours before operation.
- The patient will be placed in the supine position and the operation will be carried out in a standard manner.
- A midline incision of about 15 to 20 cm will be made.
- The right-sided colon will be mobilized before mesenteric division and the same vessels will be dissected frequently.
- Ileotransverse end-to-end hand anastomosis is operated and the mesenteric defect will be closed.
In patients of group II:
- A standard mechanical bowel preparation will be performed 24 hours before the operation.
- A high-definition laparoscope will be used.
- Under general anaesthesia the operation is carried out in standard manner, with the patient in a modified lithotomy position.
- After achieving pneumoperitoneum (12 mm Hg), a 12-mm trocar will be placed through an incision just above the umbilicus, and a 30-degree laparoscope will be inserted through the 12-mm trocar. The second 10-mm trocar will be inserted at the upper left quadrant of the abdomen for the major acting port. The third 5-mm trocar will be inserted at the lower left quadrant for the second major active port. The fourth and fifth 5-mm trocars will be inserted at the upper right and lower right quadrants.
- According to laparoscopic procedure, the position, composition, and spatial relationships of the surgery planes needed for laparoscopic complete mesocolic excision for right sided colic cancer cases are identified.
Intraoperatively, all patients will be assessed for:
- Time of the procedure.
- Amount of blood loss.
Postoperative follow up:
Patients will be followed up by the standardized follow up protocol. They will be examined by the outpatient setting after:
- 2 weeks (post-operative) for: wound infection, leakage, pathological outcome (The tumor node metastasis (TNM) stage, histologic grade of differentiation, number of harvested lymph nodes, lymphovascular invasion, estimation of resection margins).
- Every 3 months for 1-2 years by: history taking, physical examination, carcinoembryonic antigen measurement,
- Every 6 months for 1-2 years by: chest, abdomen-pelvic computed tomography for detection of local or systemic recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Surgery | Other | Procedure: SurgeryPatients diagnosed as operable right sided colon cancer were enrolled in this study and did open complete mesocolic excision procedures |
| Laparoscopic Surgery | Other | Procedure: SurgeryPatients diagnosed as operable right sided colon cancer were enrolled in this study and did laparoscopic complete mesocolic excision procedures |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Only operable cases of right colon cancer by (CT scan criteria) which include:
Key exclusion criteria (1 listed)
- 1- All cases with perforation or obstruction. 2- Metastatic colon cancer. 3- Patients undergoing colectomy including another part of the colon than right colon.
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 |
|---|---|---|
| Surgerylaparoscopic and open complete mesocolic excision with central vascular ligation in right colon cancer. | Procedure or surgery | Laparoscopic Surgery, Open Surgery |
Primary outcome
Operative time in open and laparoscopic complete mesocolic excision groups in right cancer colon
Time frame: 1-3 years
Comparing the operative time between laparoscopic and open complete mesocolic excision with central artery ligation groups
Incision length in open and laparoscopic complete mesocolic excision groups in right cancer colon
Time frame: 1-3 years
Comparing the incision length between laparoscopic and open complete mesocolic excision with central artery ligation groups
Hospital stay duration in open and laparoscopic complete mesocolic excision groups in right cancer colon
Time frame: 1-3
Comparing the hospital stay duration between laparoscopic and open complete mesocolic excision with central artery ligation groups
Histopathological findings in open and laparoscopic complete mesocolic excision groups in right cancer colon
Time frame: 1-3 years
Comparing the histopathological findings between laparoscopic and open complete mesocolic excision with central artery ligation groups
Post-operative complications in open and laparoscopic complete mesocolic excision groups in right cancer colon
Time frame: 1-3 years
Comparing the post-operative complications between laparoscopic and open complete mesocolic excision with central artery ligation groups
Recurrence rate in open and laparoscopic complete mesocolic excision groups in right cancer colon
Time frame: 1-3 years
Comparing the recurrence rate between laparoscopic and open complete mesocolic excision with central artery ligation groups
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 1 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery in people with Colon Cancer, run by Menoufia 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 5 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 1 Feb 2019. 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?
Operative time in open and laparoscopic complete mesocolic excision groups in right cancer colon (time frame: 1-3 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2019.