Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial

NCT01461525 | Completed DMC

• 1 other identifier: APR-SPS trial
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 6

Brief Summary

Sphincter preservation surgery in low rectal cancer has been increased due to better understanding of tumor biology and advances in surgical technology. Furthermore, a majority of patients prefer sphincter preservation rather than living with permanent colostomy. But it is not clear whether sphincter preservation is directly related with better quality of life. There have been many studies comparing sphincter preservation surgery and abdominoperineal resection in many aspects including oncologic and functional outcomes, and the quality of life. However, the conclusion remains controversial because of the different results between studies.

Conditions

Rectal Cancer

Keywords

Low Rectal Cancer; Sphincter preservation; Abdominoperineal resection; Quality of life; Sexual function; Urinary function; Oncologic outcome

Outcome Measures

Primary Outcomes (1)

• Quality of life outcome

  Measured by EORTC-QLQ C30, CR38 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).

  3 years

Secondary Outcomes (4)

• Oncologic outcomes

  5 years

• Bladder function

  3 years

• Sexual function

  3 years

• Anal function

  3 years

Study Arms (2)

Sphincter preservation surgery

EXPERIMENTAL

Temporary ileostomy with anal sphincter preservation

Procedure: Sphincter preservation surgery

Abdominoperineal Resection

EXPERIMENTAL

Permanent colostomy with total anal sphincter sacrifice

Procedure: Abdominoperineal resection

Interventions

Abdominoperineal resection PROCEDURE

After high ligation of IMA, TME with autonomic nerve preservation, proctectomy with sphincter sacrifice and permanent colostomy.

Also known as: APR, Miles' operation

Abdominoperineal Resection

Sphincter preservation surgery PROCEDURE

After high ligation of IMA, TME with autonomic nerve preservation, sphincter preservation and proctectomy with distal margin of more than 0.5cm in length and temporary ileostomy

Also known as: SPS

Sphincter preservation surgery

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low rectal cancer (5cm from anal verge by surgeon's digital rectal exam / rigid rectoscopy)
• Patient who understands and accepts to sign the informed consent form
• Confirmed preoperative colonoscopic biopsy (adenocarcinoma)
• Proper bone marrow function
• Proper renal function
• Proper liver function
• No severe comorbidity

You may not qualify if:

• Metastatic lesion detected in preoperative assessment
• Previous history of cancer disease. (except patients with skin cancer)
• Severe heart disease, congestive heart disease.
• Severe lung disease, respiratory failure.
• Mental illness.
• Invasion to prostate, bladder and combined resection needed (partial or radical.• Legally prohibited for clinical trial.
• Pregnancy or breast feeding.
• Previous disease or disability expected to influence the assessment of postoperative quality of life.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator
• National Cancer Center, Korea: collaborator
• Seoul National University Boramae Hospital: collaborator
• Hallym University Medical Center: collaborator
• Daehang Hospital: collaborator

Study Sites (6)

Hallym University College of Medicine

Anyang-si, Gyeonggi-do, 431-070, South Korea

Location

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Seoul National University Hospital

Seoul, Jongno-gu, 110-744, South Korea

Location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 156-707, South Korea

Location

Daehang Hospital

Seoul, 481-10, South Korea

Location

Related Publications (1)

• Kang SB, Cho JR, Jeong SY, Oh JH, Ahn S, Choi S, Kim DW, Lee BH, Youk EG, Park SC, Heo SC, Lee DS, Ryoo SB, Park JW, Park HC, Lee SM, Kang SI, Kim MH, Oh HK, Shin R, Kim MJ, Lee KH, Kim YH, Kim JS, Lee KW, Lee HS, Kim HJ, Park YS, Sohn DK, Park KJ; Seoul Colorectal Research Group (SECOG). Quality of life after sphincter preservation surgery or abdominoperineal resection for low rectal cancer (ASPIRE): A long-term prospective, multicentre, cohort study. Lancet Reg Health West Pac. 2020 Dec 28;6:100087. doi: 10.1016/j.lanwpc.2020.100087. eCollection 2021 Jan.

  PMID: 34327411 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Proctectomy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Sung-Bum Kang, Ph. D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Colorectal Cancer Center, Principal Investigator, Professor

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: October 28, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2019
• Study Completion: June 1, 2020
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

KR (6)