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RecruitingNCT05943444Updated Dec 18, 2025

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

An interventional study of Parks technique and Bacon technique in Rectal Neoplasms, Low Anterior Resection Syndrome and Anastomotic Leak, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-18.

Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
256
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Rectal Neoplasms
  • Low Anterior Resection Syndrome
  • Anastomotic Leak
  • Quality of Life

Keywords

  • anal function
  • Parks technique
  • Bacon technique
03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 517 are open to participants now.

This study's planned enrollment of 256 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 211 studies on the registry; 110 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Men or women, aged between 18 and 75 years;
  2. 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;
  3. No local complications (including complete/ incomplete obstruction, active bleeding, local invasion of sphincter or levator ani, etc.) before operation;
  4. Suitable for anal preservation surgery discussed by MDT;
  5. Adequate bone marrow, liver, renal and cardiac function meeting the requirements of surgery and anesthesia;
  6. R0 resection is expected technically;
  7. Provision of written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Previous history of malignant colorectal tumors;
  2. Complications such as obstruction and gastrointestinal bleeding that need an emergency operation;
  3. Unachievable R0 resection due to invasion of adjacent organs by primary tumor;
  4. Multiple primary tumors;
  5. History of other malignancy;
  6. Participation in other clinical trials within the previous 4 weeks of enrollment;
  7. ASA physical status score ≥ IV level and/or ECOG performance status ≥ 2;
  8. Intolerance of surgery due to liver, renal, cardiopulmonary or coagulation dysfunction, or underlying diseases;
  9. History of serious mental disorders;
  10. Women in pregnancy or lactation period;
  11. Uncontrolled infection before operation;
  12. Unsuitable to be included due to other clinical and laboratory conditions by the judgement of investigators.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
256 participants (estimated)

Study arms

  • Active comparator
    Parks technique

    patients receive coloanal anastomosis operation

    Procedure: Parks technique

  • Experimental
    Bacon technique

    patients receive coloanal pull-out anastomosis operation

    Procedure: Bacon technique

Interventions

  • ProcedureParks technique

    compare different operational styles of low rectal cancer

  • ProcedureBacon technique

    Bacon technique

06

What researchers measure

Primary outcomes

  1. Low Anterior Resection Syndrome (LARS) score 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

    Time frame: 1 year after surgery

Secondary outcomes

  1. LARS score at 3 months after surgery

    to score bowel dysfunction after LAR

    Time frame: 3 months after surgery

  2. LARS score at 6 months after surgery

    to score bowel dysfunction after LAR

    Time frame: 6 months after surgery

  3. Postoperative Quality of Life Score

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

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

  4. The incidence of postoperative anastomotic complications

    the corresponding complications after surgery

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

07

Study locations

1 of 1 sites recruiting
  • The Sixth Affiliated Hospital, Sun Yatsen University
    Guangzhou, Guangdong, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05943444
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Responsible party
Sponsor
First posted
Jul 13, 2023
Start date
Aug 8, 2023
Primary completion
Aug 8, 2027 (estimated)
Completion
Aug 8, 2027 (estimated)
Last update
Dec 18, 2025

Study contacts

Jun Huang, MD
Contact
huangj97@mail.sysu.edu.cn
13926451242
Jun Huang, MD
principal investigator · Sixth Affiliated Hospital, Sun Yat-sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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