Multicenter Study on Laparoscopic Versus Open PANP-TME for Male Mid-low Rectal Cancer Patients

Sun Yat-sen University

Status: Unknown

Conditions: Rectum Neoplasms

Treatments: Procedure: O-PANP-TME; Procedure: L-PANP-TME

Study type: Interventional

Funder types: Other

Identifiers

NCT02165800

CUSTOMER-001

Details and patient eligibility

About

TME (Total mesorectum excision) is the golden standard of radical resection for mid-low rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle will lead to high incidence of urinary and sexual function disorder. Open PANP (pelvic autonomic nerve preservation) TME surgery played a role in decreasing incidence of urinary and sexual function disorder. However, 32%-44% patients still suffered from urinary and sexual function disorder when underwent Open PANP TME surgery (O-PANP-TME).

Laparoscopy-assisted TME surgery (L-TME) is applied wildly nowadays. In the early stage of work, we performed laparoscopy-assisted PANP TME surgery (L-PANP-TME) to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm our early work, we design a multiple-center randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between L-PANP-TME and O-PANP-TME.

Enrollment: 667 estimated patients

Sex: Male

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from over 20 to under 60 years
• Primary rectal adenocarcinoma confirmed pathologically by endoscopic biopsy
• Mid-low rectal cancer (distance from anal edge≤12cm); cT1-3, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
• Expected curative resection through both L-PANP-TME and O-PANP-TME; Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
• ASA (American Society of Anesthesiology) score class I, II, or III; Written informed consent
• Urinary and sexual function normal preoperatively

Exclusion criteria

• Women during pregnancy or breast-feeding
• Severe mental disorder
• History of previous pelvic surgery
• Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
• History of other malignant disease within past five years
• History of unstable angina or myocardial infarction within past six months
• History of cerebrovascular accident within past six months
• History of continuous systematic administration of corticosteroids within one month
• Contraindication of heart, brain, lung, etc dysfunction
• Requirement of simultaneous surgery for other disease
• Emergency surgery due to complication (bleeding, obstruction or perforation) caused by rectal cancer
• Rectal cancer invades surrounding tissues
• Existence of genuine incontinence or severe stress incontinence preoperatively

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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667 participants in 2 patient groups

O-PANP-TME

Active Comparator group

Description:

Open pelvic autonomic nerve preservation total mesorectum excision for male mid-low rectal cancer patients

Treatment:

Procedure: O-PANP-TME

L-PANP-TME

Experimental group

Description:

Laparoscopy-assisted pelvic autonomic nerve preservation total mesorectum excision for male mid-low rectal cancer patients

Treatment:

Procedure: L-PANP-TME