Rectal Cancer SurgeryNCT07189780
Comparison of Different Surgical Approaches in Female Rectal Cancer.
A study testing Surgical approach in people with Rectal Cancer Surgery, run by First Affiliated Hospital of Wenzhou Medical University.
Trial summary
Mid-to-low rectal cancer exhibits an extremely high incidence rate in China. Currently, the primary treatment approach for mid-to-low rectal cancer remains surgical intervention, with total mesorectal excision (TME) being the mainstream procedure. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Rectal Cancer Surgery
- What is being tested?
- Surgical approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Aug 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pathologically confirmed rectal adenocarcinoma.
- Female patients scheduled to undergo laparoscopic total mesorectal excision (TME).
- Body mass index (BMI) ≤ 30 kg/m².
- Tumors with the distal margin located ≤ 10 cm from the anal verge.
- Absence of distant metastases (e.g., to the liver, lungs, or other organs).
Who cannot join
- Presence of severe pre-existing comorbidities (e.g., significant hepatic, renal, cardiac, pulmonary, or coagulation dysfunction).
- History of malignancy in other organs.
- Patients requiring emergency surgery due to conditions such as acute perforation or obstruction.
- Intraoperative findings of tumor invasion into adjacent organs necessitating multivisceral resection or palliative resection.
- Previous history of anorectal or rectal surgery. 6Preoperative magnetic resonance imaging (MRI) indicating invasion of the anterior rectal wall.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Two Different Anterior Rectal Wall Mobilization Techniques on Postoperative Outcomes in Female Patients With Mid-low Rectal Cancer: a Multicenter, Prospective, Randomized Controlled Clinical Trial.
Mid-to-low rectal cancer exhibits an extremely high incidence rate in China. Currently, the primary treatment approach for mid-to-low rectal cancer remains surgical intervention, with total mesorectal excision (TME) being the mainstream procedure. In male patients, Heald, Chi Pan , Wei Hongbo , and others have proposed different dissection techniques for the anterior rectal wall. Partial or complete preservation of Denonvilliers Fascia (DVF) during conventional TME (as proposed by Heald) has been shown to significantly reduce intraoperative bleeding and improve postoperative urodynamic function, urinary continence, and sexual function . However, these studies focused exclusively on male patients and did not include female subjects.
In our previous research, we proposed that females do not possess an anatomical structure equivalent to the male DVF. Furthermore, compared to entering the dissection plane by incising the peritoneum 0.5-1 cm above the lowest point of the peritoneal reflection, initiating the peritoneal incision precisely at the lowest point of the peritoneal reflection better ensures the integrity of the mesorectum and vaginal structures, reduces intraoperative bleeding, provides a more favorable operative field, and avoids damage to physiological structures while ensuring complete tumor resection, thereby promoting postoperative recovery. Thus, we concluded that this plane represents the optimal surgical dissection plane for the anterior rectal wall during TME in female patients with mid-to-low rectal cancer without anterior wall invasion.
Since our prior study combined anatomical and clinical retrospective research, we have initiated a prospective multicenter randomized controlled trial to further validate these clinical findings. This study aims to demonstrate that entering the dissection plane at the lowest point of the peritoneal reflection during mid-to-low rectal cancer surgery improves prognosis in female patients, providing high-level evidence-based medical support for the adoption of this technique and establishing the optimal surgical approach for female rectal cancer patients.
- Conditions
- Rectal Cancer Surgery
- Being tested
- Surgical approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical approachProcedure or surgery
Control Group:Incising the peritoneum 0.5-1 cm above the lowest point of the peritoneal reflection to enter the dissection plane.
Experimental Group:Incising the peritoneum precisely at the lowest point of the peritoneal reflection (in the rectovesical or rectouterine pouch) to enter the dissection plane.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental Group:Entering the dissection plane by incising the peritoneum precisely at the lowest point of the peritoneal reflection. Receives: Procedure: Surgical approach |
| Control Group | Active comparator | Control Group:Entering the dissection plane by incising the peritoneum 0.5-1 cm above the lowest point of the peritoneal reflection. Receives: Procedure: Surgical approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Blood Loss
Measured: 2-6hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer SurgeryStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan TongJi Hospital, Zhejiang Cancer Hospital, Fudan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189780
- Sponsor's protocol ID
- KY2025-290
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 24 Sep 2025
- 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 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Two Different Anterior Rectal Wall Mobilization Techniques on Postoperative Outcomes in Female Patients With Mid-low Rectal Cancer: a Multicenter, Prospective, Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07189780
- Acronym / sponsor ID
- KY2025-290
- Conditions
- Rectal Cancer Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Wuhan TongJi Hospital, Zhejiang Cancer Hospital, Fudan University
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 24 Sep 2025 (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.
Mid-to-low rectal cancer exhibits an extremely high incidence rate in China. Currently, the primary treatment approach for mid-to-low rectal cancer remains surgical intervention, with total mesorectal excision (TME) being the mainstream procedure. In male patients, Heald, Chi Pan , Wei Hongbo , and others have proposed different dissection techniques for the anterior rectal wall. Partial or complete preservation of Denonvilliers Fascia (DVF) during conventional TME (as proposed by Heald) has been shown to significantly reduce intraoperative bleeding and improve postoperative urodynamic function, urinary continence, and sexual function . However, these studies focused exclusively on male patients and did not include female subjects.
In our previous research, we proposed that females do not possess an anatomical structure equivalent to the male DVF. Furthermore, compared to entering the dissection plane by incising the peritoneum 0.5-1 cm above the lowest point of the peritoneal reflection, initiating the peritoneal incision precisely at the lowest point of the peritoneal reflection better ensures the integrity of the mesorectum and vaginal structures, reduces intraoperative bleeding, provides a more favorable operative field, and avoids damage to physiological structures while ensuring complete tumor resection, thereby promoting postoperative recovery. Thus, we concluded that this plane represents the optimal surgical dissection plane for the anterior rectal wall during TME in female patients with mid-to-low rectal cancer without anterior wall invasion.
Since our prior study combined anatomical and clinical retrospective research, we have initiated a prospective multicenter randomized controlled trial to further validate these clinical findings. This study aims to demonstrate that entering the dissection plane at the lowest point of the peritoneal reflection during mid-to-low rectal cancer surgery improves prognosis in female patients, providing high-level evidence-based medical support for the adoption of this technique and establishing the optimal surgical approach for female rectal cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Surgical approachExperimental Group:Entering the dissection plane by incising the peritoneum precisely at the lowest point of the peritoneal reflection. |
| Control Group | Active comparator | Procedure: Surgical approachControl Group:Entering the dissection plane by incising the peritoneum 0.5-1 cm above the lowest point of the peritoneal reflection. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologically confirmed rectal adenocarcinoma.
- Female patients scheduled to undergo laparoscopic total mesorectal excision (TME).
- Body mass index (BMI) ≤ 30 kg/m².
- Tumors with the distal margin located ≤ 10 cm from the anal verge.
- Absence of distant metastases (e.g., to the liver, lungs, or other organs).
Key exclusion criteria (5 listed)
- Presence of severe pre-existing comorbidities (e.g., significant hepatic, renal, cardiac, pulmonary, or coagulation dysfunction).
- History of malignancy in other organs.
- Patients requiring emergency surgery due to conditions such as acute perforation or obstruction.
- Intraoperative findings of tumor invasion into adjacent organs necessitating multivisceral resection or palliative resection.
- Previous history of anorectal or rectal surgery. 6Preoperative magnetic resonance imaging (MRI) indicating invasion of the anterior rectal wall.
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 |
|---|---|---|
| Surgical approachControl Group:Incising the peritoneum 0.5-1 cm above the lowest point of the peritoneal reflection to enter the dissection plane. Experimental Group:Incising the peritoneum precisely at the lowest point of the peritoneal reflection (in the rectovesical or rectouterine pouch) to enter the dissection plane. | Procedure or surgery | Control Group, Experimental Group |
Primary outcome
Estimated Blood Loss
Time frame: 2-6hours
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 24 Sep 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical approach in people with Rectal Cancer Surgery, run by First Affiliated Hospital of Wenzhou Medical University.
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 5 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: opening soon, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 (+8618815039766, lishaotang163@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Blood Loss (time frame: 2-6hours). 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 24 Sep 2025.