Low Rectal CancerNCT07849023
Application of Precision Partial Intersphincteric Resection (PPISR)
A study testing Precision Partial Intersphincteric Resection (PPISR) and Traditional Intersphincteric Resection in people with Low Rectal Cancer and Rectal Cancer Patients, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The goal of this study is to establish a standardized operating procedure for Precision Partial Intersphincteric Resection (PPISR), and to evaluate its surgical safety, functional benefits, and oncological efficacy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Rectal Cancer, Rectal Cancer Patients
- What is being tested?
- Precision Partial Intersphincteric Resection (PPISR) and Traditional Intersphincteric Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2026to Jun 2030
- 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
- Patients aged 18-75 years old
- Pathology suggestive of moderately to highly differentiated rectal adenocarcinoma
- Tumor lower margin ≤ 5 cm from the anal verge
- Pre-operative tumor (T) staging of T1-T3 and T1-T2 below the level of the anal raphe muscle
- No distant metastasis such as lung, liver and other organs
Who cannot join
- Preoperative patients with severe underlying diseases (such as severe liver and kidney function, cardiopulmonary function, coagulation dysfunction, etc.)
- Patients with malignant tumors in other parts of the body
- Patients who underwent emergency surgery due to acute perforation, obstruction, etc.
- Patients with tumor infiltration of peripheral organs during the operation, which required combined resection or palliative resection
- Patients who had a mid-opening laparoscopic operation for various reasons -during the operation
- Patients with poor anal function before operation, which is not suitable for anus preservation surgery.
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
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
chunwu zhang, 86+0577-55578055
About this study
Official title: Application of Precision Partial Intersphincteric Resection (PPISR) in Patients With Ultra-low Rectal Cancer
The goal of this study is to establish a standardized operating procedure for Precision Partial Intersphincteric Resection (PPISR), and to evaluate its surgical safety, functional benefits, and oncological efficacy.
- Conditions
- Low Rectal Cancer, Rectal Cancer Patients
- Being tested
- Precision Partial Intersphincteric Resection (PPISR), Traditional Intersphincteric Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision Partial Intersphincteric Resection (PPISR)Procedure or surgery
The experimental group underwent the PPISR procedure. The surgical process was as follows:
- The abdominal team performed the TME procedure, completely resecting the mesorectum at the level of the mesorectum termination line within the levator hiatus.
- The transanal team completed routine preoperative preparation and disinfection, and located the distal and lateral resection margins of the tumor (with a margin distance ≥5 mm from the tumor boundary), thereby preserving part of the internal anal sphincter and normal intestinal wall tissue.
- A "U"-shaped dissection was performed cranially along the marking line within the intersphincteric space, meeting the abdominal team at the level of the levator hiatus, as shown in Figure 1.
- The specimen was removed either transanally or transabdominally.
- The proximal intestinal segment was trimmed, intestinal anastomosis was performed manually, and the procedure was concluded.
Traditional Intersphincteric ResectionProcedure or surgery
The control group underwent the traditional ISR procedure. The surgical process was as follows:
- The abdominal team entered the abdominal cavity and mobilized the sigmoid colon and rectum according to the principle of total mesorectal excision (TME). The vessels were ligated at a high position, and the rectum was dissected downward along the presacral space to the level of the levator ani muscle (pelvic floor), fully exposing the distal rectum and the levator ani muscle.
- The transanal team made a full-thickness circumferential incision in the rectal mucosa slightly above the dentate line (approximately ≥1 cm), entering the intersphincteric groove. A sharp circumferential dissection was performed along this groove to "pull" the rectum (along with its internal sphincter) out from within the external anal sphincter. During this dissection, care was taken to avoid damaging the external sphincter complex and its innervation.
- When the perineal dissection plane reached the level of
| Study group | Role | What they receive |
|---|---|---|
| PPISR | Experimental | The experimental group underwent the PPISR procedure. Receives: Procedure: Precision Partial Intersphincteric Resection (PPISR) |
| Traditional ISR | Active comparator | The control group underwent the traditional ISR procedure Receives: Procedure: Traditional Intersphincteric Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative anal function as assessed by Wexner Score
Scale Title: Wexner Fecal Incontinence Score. The minimum values:0. The maximum values:20. Higher scores mean a worse outcome.
Measured: At 3 and 6 months postoperatively
Postoperative quality of life as assessed by EORTC QLQ-C30
Scale Title: European Organization for Research and Treatment of cancer Quality of Life Questionnaire. The minimum values:0. The maximum values:100. Higher scores mean a worse outcome.
Measured: At 1 year postoperatively
3-year local recurrence rate as assessed by abdominal contrast-enhanced MRI
Participants have an MRI every 3 months postoperatively
Measured: 3 years postoperatively
Secondary outcomes (4)
Circumferential resection margin negative rate
Measured: Immediately after the pathology results come out
intraoperative blood loss
Measured: Immediately after the surgery
Postoperative-related complication incidence
Complications include postoperative bleeding, abdominal cavity infection, thoracic cavity infection, urinary tract infection, etc.
Measured: From the end of surgery to 3 months postoperatively
Postoperative hospital stay duration
Measured: From the end of surgery to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start8 Feb 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Rectal CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849023
- Sponsor's protocol ID
- KY2025-246
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Precision Partial Intersphincteric Resection (PPISR) in Patients With Ultra-low Rectal Cancer
- ClinicalTrials.gov ID
- NCT07849023
- Acronym / sponsor ID
- KY2025-246
- Conditions
- Low Rectal Cancer, Rectal Cancer Patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 8 Feb 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 30 Sep 2026 (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 establish a standardized operating procedure for Precision Partial Intersphincteric Resection (PPISR), and to evaluate its surgical safety, functional benefits, and oncological efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPISR | Experimental | Procedure: Precision Partial Intersphincteric Resection (PPISR)The experimental group underwent the PPISR procedure. |
| Traditional ISR | Active comparator | Procedure: Traditional Intersphincteric ResectionThe control group underwent the traditional ISR procedure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18-75 years old
- Pathology suggestive of moderately to highly differentiated rectal adenocarcinoma
- Tumor lower margin ≤ 5 cm from the anal verge
- Pre-operative tumor (T) staging of T1-T3 and T1-T2 below the level of the anal raphe muscle
- No distant metastasis such as lung, liver and other organs
Key exclusion criteria (6 listed)
- Preoperative patients with severe underlying diseases (such as severe liver and kidney function, cardiopulmonary function, coagulation dysfunction, etc.)
- Patients with malignant tumors in other parts of the body
- Patients who underwent emergency surgery due to acute perforation, obstruction, etc.
- Patients with tumor infiltration of peripheral organs during the operation, which required combined resection or palliative resection
- Patients who had a mid-opening laparoscopic operation for various reasons -during the operation
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 |
|---|---|---|
| Precision Partial Intersphincteric Resection (PPISR)The experimental group underwent the PPISR procedure. The surgical process was as follows: 1. The abdominal team performed the TME procedure, completely resecting the mesorectum at the level of the mesorectum termination line within the levator hiatus. 2. The transanal team completed routine preoperative preparation and disinfection, and located the distal and lateral resection margins of the tumor (with a margin distance ≥5 mm from the tumor boundary), thereby preserving part of the internal anal sphincter and normal intestinal wall tissue. 3. A "U"-shaped dissection was performed cranially along the marking line within the intersphincteric space, meeting the abdominal team at the level of the levator hiatus, as shown in Figure 1. 4. The specimen was removed either transanally or transabdominally. 5. The proximal intestinal segment was trimmed, intestinal anastomosis was performed manually, and the procedure was concluded. | Procedure or surgery | PPISR |
| Traditional Intersphincteric ResectionThe control group underwent the traditional ISR procedure. The surgical process was as follows: 1. The abdominal team entered the abdominal cavity and mobilized the sigmoid colon and rectum according to the principle of total mesorectal excision (TME). The vessels were ligated at a high position, and the rectum was dissected downward along the presacral space to the level of the levator ani muscle (pelvic floor), fully exposing the distal rectum and the levator ani muscle. 2. The transanal team made a full-thickness circumferential incision in the rectal mucosa slightly above the dentate line (approximately ≥1 cm), entering the intersphincteric groove. A sharp circumferential dissection was performed along this groove to "pull" the rectum (along with its internal sphincter) out from within the external anal sphincter. During this dissection, care was taken to avoid damaging the external sphincter complex and its innervation. 3. When the perineal dissection plane reached the level of | Procedure or surgery | Traditional ISR |
Primary outcome
Postoperative anal function as assessed by Wexner Score
Time frame: At 3 and 6 months postoperatively
Scale Title: Wexner Fecal Incontinence Score. The minimum values:0. The maximum values:20. Higher scores mean a worse outcome.
Postoperative quality of life as assessed by EORTC QLQ-C30
Time frame: At 1 year postoperatively
Scale Title: European Organization for Research and Treatment of cancer Quality of Life Questionnaire. The minimum values:0. The maximum values:100. Higher scores mean a worse outcome.
3-year local recurrence rate as assessed by abdominal contrast-enhanced MRI
Time frame: 3 years postoperatively
Participants have an MRI every 3 months postoperatively
4 secondary outcomes
Circumferential resection margin negative rate
Time frame: Immediately after the pathology results come out
intraoperative blood loss
Time frame: Immediately after the surgery
Postoperative-related complication incidence
Time frame: From the end of surgery to 3 months postoperatively
Postoperative hospital stay duration
Time frame: From the end of surgery to discharge
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 30 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision Partial Intersphincteric Resection (PPISR) and Traditional Intersphincteric Resection in people with Low Rectal Cancer and Rectal Cancer Patients, run by First Affiliated Hospital of Wenzhou Medical 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 5 inclusion and 6 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 30 Sep 2026. 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 shaotang li (86+18815039766, lishaotang163@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative anal function as assessed by Wexner Score (time frame: At 3 and 6 months postoperatively). The study lists 3 primary outcomes in all. 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 30 Sep 2026.