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Status unknownNCT00949273Updated Nov 28, 2013

Safety and Efficacy Study of Cylindrical Abdominoperineal Resection to Treat Rectal Cancer

An observational study in Rectal Cancer, Treatment and Postoperative Complications, sponsored by Beijing Chao Yang Hospital. Status unknown at 7 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-11-28.

Sponsored by Beijing Chao Yang Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether cylindrical abdominoperineal resection is effective in the treatment of advanced very low rectal cancer

Read the detailed description

Abdominoperineal resection (APR) is still a common operation in patients with tumours less than 6 cm from the anal verge. The perineal phase of APR is a difficult part of the operation, often done with the patient in the supine position.The risk of inadvertent bowel perforation is high, the resulting specimen frequently has a waist at the lower border of the mesorectum, and the circumferential resection margin (CRM) is often close to the rectal muscle tube. The cylindrical APR may be performed via an extended posterior perineal approach, that aims to create a more cylindrical specimen without a waist. The potential benefit of this technique is a reduction in the risk of bowel perforation and tumour involvement of the CRM, and thus in the risk of local recurrence.

Perineal wounds in patients following APR are at considerable risk for infection, dehiscence and delayed healing when closed primarily. This can be further increased in patients who have received neoadjuvant chemoradiation therapy. The adoption of extended resection, such as the cylindrical APR, may cause additional risks. The use of acellular biomaterials, including human acellular dermal matrix (HADM) has drawn great interest for the complex abdominal wall reconstruction.

The purpose of this study is to determine whether cylindrical abdominoperineal resection is effective in the treatment of advanced very low rectal cancer, and to determine the initial results of pelvic reconstruction using human acellular dermal matrix after cylindrical abdominoperineal resection.

02

Conditions studied

  • Rectal Cancer
  • Treatment
  • Postoperative Complications
  • Neoplasm Recurrence, Local
  • Survival Rate

Keywords

  • cylindrical abdominoperineal resection
  • rectal cancer
  • acellular dermal matrix
  • pelvic reconstruction
  • circumferential resection margin
  • overall survival
03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's planned enrollment of 300 is above the median of 160 across 413 observational studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Beijing Chao Yang Hospital is the lead sponsor of 135 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

hospitalized patients with rectal cancer

Inclusion criteria

  • Tumor within 6 cm of the anal verge, or with very narrow pelvis
  • T3-T4 as determined by preoperative MRI or endorectal ultrasonography examination, or a low tumor is fixed or tethered at rectal examination
  • Absence of distant metastases
  • Absence of intestinal obstruction

Exclusion criteria

Exclusion Criteria:

  • T1-T2 as determined by preoperative MRI or endorectal ultrasonography examination
  • with distant metastases
  • with intestinal obstruction
  • pregnancy or lactation
  • allergic constitution to heterogeneous protein
  • with operation contraindication
  • with mental disorder
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
300 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • cylindrical abdominoperineal resection

    patients underwent cylindrical abdominoperineal resection for advanced very low rectal cancer

    Procedure: cylindrical abdominoperineal resection

  • abdominoperineal resection

    patients underwent conventional abdominoperineal resection for advanced very low rectal cancer

Interventions

  • Procedurecylindrical abdominoperineal resection

    Extended abdominoperineal resection with human acellular dermal matrix reconstruction of the pelvic floor for rectal cancer

    Also known as: Ruinuo

06

What researchers measure

Primary outcomes

  1. postoperative complications

    Time frame: 08/01/2011

Secondary outcomes

  1. 3-years overall survival

    Time frame: 08/01/2013

07

Study locations

7 of 7 sites recruiting
  • Beijing Luhe Hospital
    Beijing, Beijing 100000, China
    Recruiting
  • General Surgery, Beijing Chao Yang Hospital
    Beijing, Beijing 100020, China
    • Jia Gang Han, M.D. · Contact · hjg512@yahoo.com.cn · 86-013522867841
    • Zhen Jun Wang, M.D. · Principal investigator
    • Jia Gang Han, M.D. · Sub investigator
    • Hua Chong Ma, M.D. · Sub investigator
    • Yan Fu Du, M.D. · Sub investigator
    • Min Zhe Li, M.D. · Sub investigator
    Recruiting
  • The first Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan 450003, China
    • Wei Tang Yuan, M.D. · Contact · 86-013673384555
    • Wei Tang Yuan, M.D. · Principal investigator
    Recruiting
  • Zhongnan Hospital, Wuhan University
    Wuhan, Hubei 430077, China
    • Qun Qian, M.D. · Contact · 86-013517110773
    • Qun Qian, M.D. · Principal investigator
    Recruiting
  • Shenyang Anorectal Hospital
    Shenyang, Liaoning 110002, China
    Recruiting
  • General Surgery, Shandong Provincial Hospital
    Jinan, Shandong 250022, China
    • Yong Dai, M.D. · Contact · 86-013708933989
    • Yong Dai, M.D. · Principal investigator
    Recruiting
  • Shandong Cancer Hospital and Institute
    Jinan, Shandong 250117, China
    • Heng Ma, M.D. · Contact · 86-013954191086
    • Heng Ma, M.D. · Principal investigator
    Recruiting
08

References and documents

Publications

  • Holm T, Ljung A, Haggmark T, Jurell G, Lagergren J. Extended abdominoperineal resection with gluteus maximus flap reconstruction of the pelvic floor for rectal cancer. Br J Surg. 2007 Feb;94(2):232-8. doi: 10.1002/bjs.5489. PubMed 17143848 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00949273
Lead sponsor
Beijing Chao Yang Hospital
Collaborators
Shandong Provincial Hospital, Shandong Cancer Hospital and Institute, The First Affiliated Hospital of Zhengzhou University, Wuhan University, Shenyang Anorectal Hospital, Beijing Luhe Hospital
Responsible party
Zhen Jun Wang (Professor and Head of General Surgery, Beijing Chao Yang Hospital) — Principal investigator
First posted
Jul 30, 2009
Start date
Jul 2009
Primary completion
Nov 2013 (estimated)
Completion
Nov 2013 (estimated)
Last update
Nov 28, 2013

Study contacts

Zhen Jun Wang, M.D.
Contact
wang3zj@sohu.com
86-013601393711
Jia Gang Han, M.D.
Contact
wzhj611@163.com
86-013522867841
Zhen Jun Wang, M.D.
study chair · Beijing Chao Yang Hospital
Yong Dai, M.D.
principal investigator · Shandong Provincial Hospital
Heng Ma, M.D.
principal investigator · Shandong Cancer Hospital and Institute
Qun Qian, M.D.
principal investigator · Zhong Nan Hospital, Wuhan University
Xian Dong Zeng, M.D.
principal investigator · Shenyang Anorectal Hospital
Jian Hua Cai, M.D.
principal investigator · Beijing Luhe Hospital
Wei Tang Yuan, M.D.
principal investigator · The First Affiliated Hospital of Zhengzhou University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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