Trial to Evaluate Laparoscopy-assisted Nerve-preserved Total Mesorectal Excision (LNTME) Versus Open TME for Rectal Cancer

Rectal Cancer Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02830633
• Other study ID #: LNTME-01
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 12, 2016
• Last updated: July 9, 2016
• Start date: July 2016
• Est. completion date: July 2020

Study information

• Verified date: July 2016
• Source: Anhui Medical University
• Contact: Han-Hui HH YAO, M.D.
• Phone: +86-18956087855
• Email: ruoyubaba[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine: (1) whether laparoscopy-assisted nerve-preserved total mesorectal excision (LNTME) is as safe as open TME for rectal cancer, and (2) whether LNTME is more effective for protection of pelvic autonomic nerve function from surgical impairing when comparing to open TME.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 2020
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Male patients

2. From 18 years old to 60 years old

3. Normal sexual function

4. Tumor located in rectum (defined as 5- to 12-cm from the anal verge)

5. Pathological confirmed rectal cancer

6. Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual

7. Tumor size < 5 cm

8. ASA score was I-II

9. Informed consent was written

Exclusion Criteria:

1. Distant cancer metastasis

2. History of abdominal surgery

3. With other type of malignancy

4. Preoperative voiding dysfunction

5. Preoperative sexual dysfunction

6. Refusing to attend this trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• LNTME
Patients in this group received laparoscopy-assisted nerve-preserved TME for treatment of rectal cancer
• OTME
Patients in this group received traditional open TME for treatment of rectal cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications including bleeding, anastomotic leakage, postoperative infection, organ dysfunctions.		postoperative 30 days	No
Primary	The postoperative sexual function assessed by IIEF questionnaire		postoperative one year	No
Primary	The postoperative voiding function assessed by IPSS questionnaire.		postoperative one year	No
Secondary	Operative time		an expected average of 180 minutes	No
Secondary	Postoperative deaths		postoperative 30 days	No
Secondary	The length postoperative hospital stay		an expected average 8 days	No
Secondary	C-reactive protein	serum C-reactive protein level after operation	postoperative 7 days	No