Comparative Study of Medial-to-Lateral Approach vs Dorsal and Medial Hybrid Approach in Laparoscopic Right Hemicolectomy

NCT03364478 | Unknown

• 1 other identifier: ShanghaiMISC-RHC
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overall Survival; Postoperative Complications

Keywords

Surgical approach; Laparoscopic right hemicolectomy

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  3 years

Secondary Outcomes (3)

• The rate of postoperative complication

  30 days

• 3 years overall survival

  3 years

• The rate of local and distant recurrence

  3 years

Study Arms (2)

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.

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.

Procedure: MLA group

Interventions

DML group PROCEDURE

The group underwent laparoscopic right hemicolectomy with dorsal and medial hybrid approach.

DML group

MLA group PROCEDURE

The group underwent laparoscopic right hemicolectomy with traditional medial-to-lateral approach.

MLA group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• BMI 18\~30kg/m2;
• Without multiple primary tumors;
• Sign on the Medical informed Consent.

You may not qualify if:

• 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;
• Patients need emergency operation;
• Not suitable for laparoscopic surgery;
• Women during Pregnancy or breast feeding period;
• Informed consent refusal

Sponsors & Collaborators

• Shanghai Minimally Invasive Surgery Center: lead

Study Sites (1)

Shanghai Ruijin Hospttal

Shanghai, Sahgnhai, 200000, China

Location

Related Publications (7)

• 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.

  PMID: 11213054 RESULT

• Matsuda 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.

  PMID: 25135445 RESULT

• Li 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.

  PMID: 27318491 RESULT

• Zou 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.

  PMID: 27072997 RESULT

• Lotti 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.

  PMID: 26917918 RESULT

• Zheng 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.

  PMID: 26303693 RESULT

• Honaker 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.

  PMID: 26801787 RESULT

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Minhua Zheng, PhD

  Ruijin Hospital

  STUDY DIRECTOR

Central Study Contacts

Minhua Zheng, PhD

CONTACT

+86-13564119545; zmhtiger@yeah.net

Hiju Hong, PhD Student

CONTACT

+86-13564119545; jing12722@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 6, 2017
• Study Start: January 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: December 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)