Overall SurvivalNCT03364478
Comparative Study of Medial-to-Lateral Approach vs Dorsal and Medial Hybrid Approach in Laparoscopic Right Hemicolectomy
A study testing DML group and MLA group in people with Overall Survival and Postoperative Complications, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
Trial summary
To standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether dorsal and medial hybrid approach could improve disease-free survival in patients with right colon cancer, compared with traditional medial-to-lateral approach in laparoscopic righ hemicolectomy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Overall Survival, Postoperative Complications
- What is being tested?
- DML group and MLA group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jan 2022
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged more then 18 years old;
- Diagnosed as right hemi colonic cancer with colonoscopic biopsy;
- Without metastasis;
- No Invasion of surrounding tissues;
- Limited operation;
- Underwent laparoscopic radical right hemicolectomy (L-right hemicolectomy);
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- BMI 18~30kg/m2;
- Without multiple primary tumors;
- Sign on the Medical informed Consent.
Who cannot join
- Simultaneous or simultaneous multiple primary colorectal cancer;
- Preoperative imaging examination results show:
- Tumor involves the surrounding organs and combined organ resection need to be done;
- Distant metastasis;
- Unable to perform R0 resection;
- History of any other malignant tumor in recent 5 years;
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- Patients need emergency operation;
- Not suitable for laparoscopic surgery;
- Women during Pregnancy or breast feeding period;
- Informed consent refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial: Comparative Study of Medial-to-Lateral Approach vs Dorsal and Medial Hybrid Approach in Laparoscopic Right Hemicolectomy
To standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether dorsal and medial hybrid approach could improve disease-free survival in patients with right colon cancer, compared with traditional medial-to-lateral approach in laparoscopic righ hemicolectomy.
- Conditions
- Overall Survival, Postoperative Complications
- Being tested
- DML group, MLA group
- Keywords
- Surgical approach, Laparoscopic right hemicolectomy
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DML groupProcedure or surgery
The group underwent laparoscopic right hemicolectomy with dorsal and medial hybrid approach.
MLA groupProcedure or surgery
The group underwent laparoscopic right hemicolectomy with traditional medial-to-lateral approach.
| Study group | Role | What they receive |
|---|---|---|
| DML group | Experimental | The group underwent laparoscopic right hemicolectomy with dorsal and medial hybrid approach. In DML group, the dissecting based on CME is performed with dorsal approach and medial approach hybridized. Receives: Procedure: DML group |
| MLA group | Active comparator | The group underwent laparoscopic right hemicolectomy with traditional medial-to-lateral approach. In MLA group,the dissecting based on CME is performed with meidial-to-lateral approach. Receives: Procedure: MLA group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: 3 years
Secondary outcomes (3)
The rate of postoperative complication
Measured: 30 days
3 years overall survival
Measured: 3 years
The rate of local and distant recurrence
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Overall SurvivalStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minhua Zheng, PhD, Study director, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364478
- Sponsor's protocol ID
- ShanghaiMISC-RHC
- Status last verified
- Nov 2017
- First submitted
- 1 Dec 2017
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fujita J, Uyama I, Sugioka A, Komori Y, Matsui H, Hasumi A. Laparoscopic right hemicolectomy with radical lymph node dissection using the no-touch isolation technique for advanced colon cancer. Surg Today. 2001;31(1):93-6. doi: 10.1007/s005950170230.
PubMed 11213054Matsuda T, Iwasaki T, Mitsutsuji M, Hirata K, Maekawa Y, Tanaka T, Shimada E, Kakeji Y. Cranial-to-caudal approach for radical lymph node dissection along the surgical trunk in laparoscopic right hemicolectomy. Surg Endosc. 2015 Apr;29(4):1001. doi: 10.1007/s00464-014-3761-x. Epub 2014 Aug 19.
PubMed 25135445Li H, He Y, Lin Z, Xiong W, Diao D, Wang W, Wan J, Zou L. Laparoscopic caudal-to-cranial approach for radical lymph node dissection in right hemicolectomy. Langenbecks Arch Surg. 2016 Aug;401(5):741-6. doi: 10.1007/s00423-016-1465-5. Epub 2016 Jun 18.
PubMed 27318491Zou L, Xiong W, Mo D, He Y, Li H, Tan P, Wang W, Wan J. Laparoscopic Radical Extended Right Hemicolectomy Using a Caudal-to-Cranial Approach. Ann Surg Oncol. 2016 Aug;23(8):2562-3. doi: 10.1245/s10434-016-5215-2. Epub 2016 Apr 12.
PubMed 27072997Lotti M, Capponi MG, Campanati L, Bertoli P, Palamara F, Coccolini F, Ansaloni L. Laparoscopic right colectomy: Miles away or just around the corner? J Minim Access Surg. 2016 Jan-Mar;12(1):41-6. doi: 10.4103/0972-9941.158960.
PubMed 26917918Zheng B, Wang N, Wu T, Qiao Q, Zhou S, Zhang B, Yang Y, Xie S, Wang K, He X. [Comparison of cranial-to-caudal medial versus traditional medial approach in laparoscopic right hemicolectomy: a case-control study]. Zhonghua Wei Chang Wai Ke Za Zhi. 2015 Aug;18(8):812-6. Chinese.
PubMed 26303693Honaker M, Scouten S, Sacksner J, Ziegler M, Wasvary H. A medial to lateral approach offers a superior lymph node harvest for laparoscopic right colectomy. Int J Colorectal Dis. 2016 Mar;31(3):631-4. doi: 10.1007/s00384-015-2499-9. Epub 2016 Jan 22.
PubMed 26801787
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial: Comparative Study of Medial-to-Lateral Approach vs Dorsal and Medial Hybrid Approach in Laparoscopic Right Hemicolectomy
- ClinicalTrials.gov ID
- NCT03364478
- Acronym / sponsor ID
- ShanghaiMISC-RHC
- Conditions
- Overall Survival, Postoperative Complications
- Keywords
- Surgical approach, Laparoscopic right hemicolectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 6 Dec 2017 (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.
To standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether dorsal and medial hybrid approach could improve disease-free survival in patients with right colon cancer, compared with traditional medial-to-lateral approach in laparoscopic righ hemicolectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DML group | Experimental | Procedure: DML groupThe group underwent laparoscopic right hemicolectomy with dorsal and medial hybrid approach. In DML group, the dissecting based on CME is performed with dorsal approach and medial approach hybridized. |
| MLA group | Active comparator | Procedure: MLA groupThe group underwent laparoscopic right hemicolectomy with traditional medial-to-lateral approach. In MLA group,the dissecting based on CME is performed with meidial-to-lateral approach. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged more then 18 years old;
- Diagnosed as right hemi colonic cancer with colonoscopic biopsy;
- Without metastasis;
- No Invasion of surrounding tissues;
- Limited operation;
Key exclusion criteria (10 listed)
- Simultaneous or simultaneous multiple primary colorectal cancer;
- Preoperative imaging examination results show:
- History of any other malignant tumor in recent 5 years;
- Patients need emergency operation;
- Not suitable for laparoscopic surgery;
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 |
|---|---|---|
| DML groupThe group underwent laparoscopic right hemicolectomy with dorsal and medial hybrid approach. | Procedure or surgery | DML group |
| MLA groupThe group underwent laparoscopic right hemicolectomy with traditional medial-to-lateral approach. | Procedure or surgery | MLA group |
Primary outcome
Disease-free survival
Time frame: 3 years
3 secondary outcomes
The rate of postoperative complication
Time frame: 30 days
3 years overall survival
Time frame: 3 years
The rate of local and distant recurrence
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
- Results publication: PubMed 11213054Fujita J, Uyama I, Sugioka A, Komori Y, Matsui H, Hasumi A. Laparoscopic right hemicolectomy with radical lymph node dissection using the no-touch isolation technique for advanced colon cancer. Surg Today. 2001;31(1):93-6. doi: 10.1007/s005950170230.
- Results publication: PubMed 25135445Matsuda T, Iwasaki T, Mitsutsuji M, Hirata K, Maekawa Y, Tanaka T, Shimada E, Kakeji Y. Cranial-to-caudal approach for radical lymph node dissection along the surgical trunk in laparoscopic right hemicolectomy. Surg Endosc. 2015 Apr;29(4):1001. doi: 10.1007/s00464-014-3761-x. Epub 2014 Aug 19.
- Results publication: PubMed 27318491Li H, He Y, Lin Z, Xiong W, Diao D, Wang W, Wan J, Zou L. Laparoscopic caudal-to-cranial approach for radical lymph node dissection in right hemicolectomy. Langenbecks Arch Surg. 2016 Aug;401(5):741-6. doi: 10.1007/s00423-016-1465-5. Epub 2016 Jun 18.
- Results publication: PubMed 27072997Zou L, Xiong W, Mo D, He Y, Li H, Tan P, Wang W, Wan J. Laparoscopic Radical Extended Right Hemicolectomy Using a Caudal-to-Cranial Approach. Ann Surg Oncol. 2016 Aug;23(8):2562-3. doi: 10.1245/s10434-016-5215-2. Epub 2016 Apr 12.
- Results publication: PubMed 26917918Lotti M, Capponi MG, Campanati L, Bertoli P, Palamara F, Coccolini F, Ansaloni L. Laparoscopic right colectomy: Miles away or just around the corner? J Minim Access Surg. 2016 Jan-Mar;12(1):41-6. doi: 10.4103/0972-9941.158960.
- Results publication: PubMed 26303693Zheng B, Wang N, Wu T, Qiao Q, Zhou S, Zhang B, Yang Y, Xie S, Wang K, He X. [Comparison of cranial-to-caudal medial versus traditional medial approach in laparoscopic right hemicolectomy: a case-control study]. Zhonghua Wei Chang Wai Ke Za Zhi. 2015 Aug;18(8):812-6. Chinese.
- Results publication: PubMed 26801787Honaker M, Scouten S, Sacksner J, Ziegler M, Wasvary H. A medial to lateral approach offers a superior lymph node harvest for laparoscopic right colectomy. Int J Colorectal Dis. 2016 Mar;31(3):631-4. doi: 10.1007/s00384-015-2499-9. Epub 2016 Jan 22.
- Individual participant dataSharing planned: No
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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.
Minhua Zheng, PhD study director
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DML group and MLA group in people with Overall Survival and Postoperative Complications, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 14 Dec 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minhua Zheng, PhD (+86-13564119545, zmhtiger@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 3 years). 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 NCT03364478, which also lists 7 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 14 Dec 2017.