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

Last updated: April 24, 2018
Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer

Digestive System Neoplasms

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT02165800
CUSTOMER-001
  • Ages 20-60
  • Male

Study Summary

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.

Eligibility Criteria

Inclusion

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 preoperativeevaluation according to the AJCC Cancer Staging Manual Seventh Edition

  • Expected curative resection through both L-PANP-TME and O-PANP-TME; Performance statusof 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale

  • ASA (American Society of Anesthesiology) score class I, II, or III; Written informedconsent

  • Urinary and sexual function normal preoperatively

Exclusion

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 byrectal cancer

  • Rectal cancer invades surrounding tissues

  • Existence of genuine incontinence or severe stress incontinence preoperatively

Study Design

Total Participants: 667
Study Start date:
January 01, 2014
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong 510630
    China

    Active - Recruiting

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