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NCT Number: NCT01461525

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

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.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hallym University College of Medicine, Anyang-si, Gyeonggi-do, South Korea

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About this study

This prospective study was designed to compare the quality of life after sphincter saving surgery and abdominoperineal resection. Because of ethical issues, it is difficult to conduct as a randomized trial. On the basis of tumor location, extent, and preoperative anal function, patient will be attributed to two different operative method groups. On the assumption that 10% of the patients are lost to follow-up at 1 year, at least 74 patients undergoing APR and 220 patients undergoing SPS will be recruited. The study will be continued until the target sample size will be achieved.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Abdominoperineal resection

Procedure

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

Other names: APR, Miles' operation

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

Other names: SPS

Primary outcomes

  1. Quality of life outcome

    Time frame: 3 years

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

Secondary outcomes

  1. Oncologic outcomes

    Time frame: 5 years

    Oncologic outcomes (recurrence, survival)

  2. Bladder function

    Time frame: 3 years

    Measured by IPSS questionnaire at preoperative(baseline)and postoperative(12,24,36 months).

  3. Sexual function

    Time frame: 3 years

    Measured by FSFI,IIEF-5 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).

  4. Anal function

    Time frame: 3 years

    Only patients with sphincter preservation surgery, measured by manometry and MSKCC questionnaire at preoperative(baseline)and after ileostomy repair (12,24,36 months).

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

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

Registry information

Official study title

Comparison of Sphincter Preservation Surgery Versus Abdominoperineal Resection for Low Rectal Cancer: Prospective Clinical Trial

Acronym: ASPIRE

Important dates

Study start
2011
Primary completion
2019
Study completion
2020
First posted
Oct 28, 2011
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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