NCT05943444

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Aug 2023Aug 2027

First Submitted

Initial submission to the registry

June 28, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

August 8, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2027

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

4 years

First QC Date

June 28, 2023

Last Update Submit

December 11, 2025

Conditions

Rectal NeoplasmsLow Anterior Resection SyndromeAnastomotic LeakQuality of Life

Keywords

anal functionParks techniqueBacon technique

Outcome Measures

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

    1 year after surgery

Secondary Outcomes (4)

  • LARS score at 3 months after surgery

    3 months after surgery

  • LARS score at 6 months after surgery

    6 months after surgery

  • Postoperative Quality of Life Score

    3, 6, and 12 months after operation

  • The incidence of postoperative anastomotic complications

    3, 6, and 12 months after operation

Study Arms (2)

Parks technique

ACTIVE COMPARATOR

patients receive coloanal anastomosis operation

Procedure: Parks technique

Bacon technique

EXPERIMENTAL

patients receive coloanal pull-out anastomosis operation

Procedure: Bacon technique

Interventions

Parks techniquePROCEDURE

compare different operational styles of low rectal cancer

Parks technique
Bacon techniquePROCEDURE

Bacon technique

Bacon technique

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yatsen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Rectal NeoplasmsLow Anterior Resection SyndromeAnastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesColonic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jun Huang, MD

    Sixth Affiliated Hospital, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Huang, MD

CONTACT

13926451242huangj97@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2023

First Posted

July 13, 2023

Study Start

August 8, 2023

Primary Completion (Estimated)

August 8, 2027

Study Completion (Estimated)

August 8, 2027

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations

CN(1)