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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02830633

Enrollment

Registered

2016-07-13

Start date

2016-07-31

Completion date

2020-07-31

Last updated

2016-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

laparoscopy, rectal cancer, pelvic autonomic nerve

Brief 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.

Interventions

PROCEDURELNTME

Patients in this group received laparoscopy-assisted nerve-preserved TME for treatment of rectal cancer

PROCEDUREOTME

Patients in this group received traditional open TME for treatment of rectal cancer

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Postoperative complications including bleeding, anastomotic leakage, postoperative infection, organ dysfunctions.	postoperative 30 days
The postoperative sexual function assessed by IIEF questionnaire	postoperative one year
The postoperative voiding function assessed by IPSS questionnaire.	postoperative one year

Secondary

Measure	Time frame	Description
Operative time	an expected average of 180 minutes	—
C-reactive protein	postoperative 7 days	serum C-reactive protein level after operation
Postoperative deaths	postoperative 30 days	—
The length postoperative hospital stay	an expected average 8 days	—

Contacts

Primary ContactHan-Hui HH YAO, M.D.

ruoyubaba@163.com+86-18956087855

Backup ContactLiu L LIU, PhD

liuwkjy@126.com+86-15056017712

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026