Rectal NeoplasmsNCT05943444
Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer
A study testing Parks technique and Bacon technique in people with Rectal Neoplasms and Low Anterior Resection Syndrome, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Neoplasms, Low Anterior Resection Syndrome, Anastomotic Leak
- What is being tested?
- Parks technique and Bacon technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2023to 8 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital, Sun Yatsen University
Guangzhou, Guangdong
Jun Huang, 13926451242, huangj97@mail.sysu.edu.cn
About this study
Official title: Comparison of Postoperative Anal Function Between Different Anastomosis Techniques(Parks Versus Bacon) in Low Rectal Cancer: A Prospective, Multicentric and Randomized Controlled Study
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
- Being tested
- Parks technique, Bacon technique
- Keywords
- anal function, Parks technique, Bacon technique
- Medical subject headings
- Rectal Neoplasms, Low Anterior Resection Syndrome, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parks techniqueProcedure or surgery
compare different operational styles of low rectal cancer
Bacon techniqueProcedure or surgery
Bacon technique
| Study group | Role | What they receive |
|---|---|---|
| Parks technique | Active comparator | patients receive coloanal anastomosis operation Receives: Procedure: Parks technique |
| Bacon technique | Experimental | patients receive coloanal pull-out anastomosis operation Receives: Procedure: Bacon technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year after surgery
Secondary outcomes (4)
LARS score at 3 months after surgery
to score bowel dysfunction after LAR
Measured: 3 months after surgery
LARS score at 6 months after surgery
to score bowel dysfunction after LAR
Measured: 6 months after surgery
Postoperative Quality of Life Score
using a score system to access the quality of life after surgery
Measured: 3, 6, and 12 months after operation
The incidence of postoperative anastomotic complications
the corresponding complications after surgery
Measured: 3, 6, and 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start8 Aug 2023
- Primary completion8 Aug 2027 (estimated)
- Study completion8 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Huang, MD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943444
- Sponsor's protocol ID
- E2023072
- Status last verified
- Dec 2025
- First submitted
- 28 Jun 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Anal Function Between Different Anastomosis Techniques(Parks Versus Bacon) in Low Rectal Cancer: A Prospective, Multicentric and Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05943444
- Acronym / sponsor ID
- E2023072
- Keywords
- anal function, Parks technique, Bacon technique
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 8 Aug 2027 (estimated)
- Study completion
- 8 Aug 2027 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parks technique | Active comparator | Procedure: Parks techniquepatients receive coloanal anastomosis operation |
| Bacon technique | Experimental | Procedure: Bacon techniquepatients receive coloanal pull-out anastomosis operation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parks techniquecompare different operational styles of low rectal cancer | Procedure or surgery | Parks technique |
| Bacon techniqueBacon technique | Procedure or surgery | Bacon technique |
Primary outcome
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
4 secondary outcomes
LARS score at 3 months after surgery
Time frame: 3 months after surgery
LARS score at 6 months after surgery
Time frame: 6 months after surgery
Postoperative Quality of Life Score
Time frame: 3, 6, and 12 months after operation
The incidence of postoperative anastomotic complications
Time frame: 3, 6, and 12 months after operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Huang, MD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parks technique and Bacon technique in people with Rectal Neoplasms and Low Anterior Resection Syndrome, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Huang, MD (13926451242, huangj97@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Anterior Resection Syndrome (LARS) score 1 year after surgery (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.