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NCT Number: NCT05943444

Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer

The goal of this study is to compare the postoperative anal function of patients with ultra-low rectal cancer after Parks operation (colon anal anastomosis) and Bacon operation (colon anal pull-out anastomosis), which may provide clinical evidence for the improvement of anal function and quality of life.

The main questions it aims to answer are: the difference of anal function 1 year after surgery type of study: clinical trial participant population: patients with low rectal cancer Participants will receive Parks operation of Bacon operation If there is a comparison group: Researchers will compare Parks and Bacon operation to see if the anal function 1 year after surgery is different.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Sixth Affiliated Hospital, Sun Yatsen University

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Jun Huang

CONTACT

[email protected]

13926451242

About this study

objective: To compare the postoperative anal function of patients with ultra-low rectal cancer after Parks operation (colon anal anastomosis) and Bacon operation (colon anal pull-out anastomosis), which may provide clinical evidence for the improvement of anal function and quality of life.

primary outcome: Low Anterior Resection Syndrome (LARS) score 1 year after surgery secondary outcomes: 1. LARS score at 3 months after surgery 2. LARS score at 6 months after surgery 3. Postoperative Quality of Life Score 4. The incidence of postoperative anastomotic complications

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men or women, aged between 18 and 75 years;
  • Pathological diagnosis of rectal cancer before operation, with the distance from the lower edge of the tumor to the dentate line ≤ 3cm by MR imaging;
  • No local complications (including complete/ incomplete obstruction, active bleeding, local invasion of sphincter or levator ani, etc.) before operation;
  • Suitable for anal preservation surgery discussed by MDT;
  • Adequate bone marrow, liver, renal and cardiac function meeting the requirements of surgery and anesthesia;
  • R0 resection is expected technically;
  • Provision of written informed consent.

Exclusion criteria

  • Previous history of malignant colorectal tumors;
  • Complications such as obstruction and gastrointestinal bleeding that need an emergency operation;
  • Unachievable R0 resection due to invasion of adjacent organs by primary tumor;
  • Multiple primary tumors;
  • History of other malignancy;
  • Participation in other clinical trials within the previous 4 weeks of enrollment;
  • ASA physical status score ≥ IV level and/or ECOG performance status ≥ 2;
  • Intolerance of surgery due to liver, renal, cardiopulmonary or coagulation dysfunction, or underlying diseases;
  • History of serious mental disorders;
  • Women in pregnancy or lactation period;
  • Uncontrolled infection before operation;
  • Unsuitable to be included due to other clinical and laboratory conditions by the judgement of investigators.

Treatment and study plan

Parks technique

Procedure

compare different operational styles of low rectal cancer

Bacon technique

Procedure

Bacon technique

Primary outcomes

  1. Low Anterior Resection Syndrome (LARS) score 1 year after surgery

    Time frame: 1 year after surgery

    use a scoring system for bowel dysfunction after LAR for rectal cancer on the basis of symptoms and impact on quality of life

Secondary outcomes

  1. LARS score at 3 months after surgery

    Time frame: 3 months after surgery

    to score bowel dysfunction after LAR

  2. LARS score at 6 months after surgery

    Time frame: 6 months after surgery

    to score bowel dysfunction after LAR

  3. Postoperative Quality of Life Score

    Time frame: 3, 6, and 12 months after operation

    using a score system to access the quality of life after surgery

  4. The incidence of postoperative anastomotic complications

    Time frame: 3, 6, and 12 months after operation

    the corresponding complications after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Huang, MD

CONTACT

[email protected]

13926451242

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

Comparison of Postoperative Anal Function Between Different Anastomosis Techniques(Parks Versus Bacon) in Low Rectal Cancer: A Prospective, Multicentric and Randomized Controlled Study

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 13, 2023
Registry last updated
Dec 18, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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