Clinical trial NCT00949273: Safety and Efficacy Study of Cylindrical Abdominoperineal Resection to Treat Rectal Cancer
Official title: A Randomized, Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Cylindrical Abdominoperineal Resection in the Treatment of Advanced Very Low Rectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: 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
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
name: Shandong Cancer Hospital and Institute
name: The First Affiliated Hospital of Zhengzhou University
name: Wuhan University
name: Shenyang Anorectal Hospital
name: Beijing Luhe Hospital
First posted: 2009-07-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hospitalized patients with rectal cancer

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

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: postoperative complications
timeFrame: 08/01/2011
Secondary outcomes:
measure: 3-years overall survival
timeFrame: 08/01/2013
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Luhe Hospital
state: Beijing
city: Beijing
country: China
facility: General Surgery, Beijing Chao Yang Hospital
state: Beijing
city: Zhengzhou
country: China
facility: The first Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Zhongnan Hospital, Wuhan University
state: Hubei
city: Shenyang
country: China
facility: Shenyang Anorectal Hospital
state: Liaoning
city: Jinan
country: China
facility: General Surgery, Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Zhen Jun Wang, M.D.
role: STUDY_CHAIR
affiliation: Shandong Provincial Hospital
name: Yong Dai, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Cancer Hospital and Institute
name: Heng Ma, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhong Nan Hospital, Wuhan University
name: Qun Qian, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenyang Anorectal Hospital
name: Xian Dong Zeng, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Luhe Hospital
name: Jian Hua Cai, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Wei Tang Yuan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.