Rectal CancerNCT04481659
Completely Abdominal Approach Laparoscopic Partial Intersphincteric Resection for Rectal Cancer
A study testing Lap partial ISR and NCRT+Lap partial ISR in people with Rectal Cancer, run by Zhongnan Hospital at 1 site in China.
Trial summary
The conventional intersphincteric resection (ISR) for low rectal cancer requires a combined abdominal and perineal approach, and followed with a handsewn coloanal anastomosis, which is time consuming and difficult to accomplish. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Lap partial ISR and NCRT+Lap partial ISR
- 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
- 19 Jul 2020to 19 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Biopsy-proven moderate or well differentiated adenocarcinoma
- Rullier classification of low rectal cancer (types Ⅱ: juxta-anal tumor)
- Clinical staging: initially staged as T1 -2 or down staged to T1-2 after neoadjuvant chemoradiotherapy;
Who cannot join
- Without signing informed consent, poor compliance
- Unfit for laparoscopy
- Other serious diseases not suitable for participating in this clinical trial
- A degree of preoperative fecal incontinence
- After preoperative neoadjuvant chemoradiotherapy, the sphincter function, sexual function and others involved in this trail are seriously affected
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongnan Hospital, Wuhan University
Wuhan, Hubei, 430071
Qun Qian, M.D., (+86)13517110773, wb002554@whu.edu.cn
About this study
Official title: Completely Abdominal Approach Laparoscopic Partial Intersphincteric Resection for Rectal Cancer: A Non-randomized, Prospective, Single-center Study
The conventional intersphincteric resection (ISR) for low rectal cancer requires a combined abdominal and perineal approach, and followed with a handsewn coloanal anastomosis, which is time consuming and difficult to accomplish. A complete laparoscopic abdominal approach partial intersphincteric resection has been proved to be a safe and feasible alternative for low rectal cancer treatment, with the advantages of technical convenience and avoiding a permanent ostomy. But there are few reports concerning differences in clinical outcomes between patients with or without neoadjuvant chemoradiotherapy undergoing partial ISR surgery. Therefore, it is necessary to compare the functional outcomes (including anal and sexual function, and postoperative quality of life [QOL]) and oncologic outcomes of patients who underwent completely abdominal approach laparoscopic partial ISR surgery after neoadjuvant chemoradiotherapy, with those who received ISR surgery directly. Furthermore, the operation difficulty between the above two groups is also worthy of intensive study.
Read the detailed description
Patients with cT1 to cT2 low rectal cancer are directly operated through completely abdominal approach laparoscopic partial ISR surgery. Patients with cT3 low rectal cancer are firstly treated with standard neoadjuvant chemoradiotherapy until down staged to ycT1 to ycT2. The postoperatively functional outcomes and oncologic outcomes between the two groups are compared, including anal and sexual function, QOL and local recurrence rate. The operation difficulty between the above two groups is also investigated, including operation time, the intraoperative and postoperative complications, mesorectum integrity, time for mobilizing the intersphincteric plane, the intactness of the fascia of the levator ani muscle, pubis coccygeus, puborectalis, and external sphincter.
- Conditions
- Rectal Cancer
- Being tested
- Lap partial ISR, NCRT+Lap partial ISR
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lap partial ISRProcedure or surgery
A direct laparoscopic surgery with completely abdominal approach laparoscopic partial intersphincteric resection
NCRT+Lap partial ISRCombination product
Preoperative radiation and chemotherapy + laparoscopic completely abdominal approach laparoscopic partial intersphincteric resection
| Study group | Role | What they receive |
|---|---|---|
| A group | Experimental | Patients who are initially staged as T1-2, according to MRI and intraluminal ultrasound, are assigned to the direct surgery group (determined by the multidisciplnary team [MDT] group) Receives: Procedure: Lap partial ISR |
| B group | Experimental | Patients who are initially staged as T3M0, according to MRI and intraluminal ultrasound, should undertake preoperative chemoradiotherapy (determined by the MDT group). The operation was performed 8-12 weeks after the end of the chemoradiotherapy. Receives: Combination Product: NCRT+Lap partial ISR |
What is being measured
The primary outcome is the main question the study is designed to answer.
The damage degree of anal function
The value of this index in group A was defined as the preoperative anal function score minus the postoperative anal score. The value of this index in group B was defined as the anal function score which the patients have completed the standard neoadjuvant therapy minus the postoperative anal function score.
Measured: 5 years
Secondary outcomes (5)
Time for mobilizing the intersphincteric space
Time for mobilizing the intersphincteric space
Measured: 5 years
The intactness of levator anus muscle fascia
The intactness of levator anus muscle fascia
Measured: 5 years
he quality of specimen pathology: total mesorectal excision (TME) quality, the involvement of distal margin and circumferential margin
The quality of specimen pathology: total mesorectal excision (TME) quality, the involvement of distal margin and circumferential margin
Measured: 5 years
Intraoperative and postoperative complications
Intraoperative and postoperative complications
Measured: 5 years
Local recurrence
Local recurrence
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start19 Jul 2020 (estimated)
- Primary completion19 Jul 2025 (estimated)
- Study completion19 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481659
- Sponsor's protocol ID
- ZhongnanH1
- Status last verified
- Jul 2020
- First submitted
- 19 Jul 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Completely Abdominal Approach Laparoscopic Partial Intersphincteric Resection for Rectal Cancer: A Non-randomized, Prospective, Single-center Study
- ClinicalTrials.gov ID
- NCT04481659
- Acronym / sponsor ID
- ZhongnanH1
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 19 Jul 2020 (estimated)
- Primary completion
- 19 Jul 2025 (estimated)
- Study completion
- 19 Jul 2025 (estimated)
- First posted
- 22 Jul 2020 (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 conventional intersphincteric resection (ISR) for low rectal cancer requires a combined abdominal and perineal approach, and followed with a handsewn coloanal anastomosis, which is time consuming and difficult to accomplish. A complete laparoscopic abdominal approach partial intersphincteric resection has been proved to be a safe and feasible alternative for low rectal cancer treatment, with the advantages of technical convenience and avoiding a permanent ostomy. But there are few reports concerning differences in clinical outcomes between patients with or without neoadjuvant chemoradiotherapy undergoing partial ISR surgery. Therefore, it is necessary to compare the functional outcomes (including anal and sexual function, and postoperative quality of life [QOL]) and oncologic outcomes of patients who underwent completely abdominal approach laparoscopic partial ISR surgery after neoadjuvant chemoradiotherapy, with those who received ISR surgery directly. Furthermore, the operation difficulty between the above two groups is also worthy of intensive study.
Detailed description
Patients with cT1 to cT2 low rectal cancer are directly operated through completely abdominal approach laparoscopic partial ISR surgery. Patients with cT3 low rectal cancer are firstly treated with standard neoadjuvant chemoradiotherapy until down staged to ycT1 to ycT2. The postoperatively functional outcomes and oncologic outcomes between the two groups are compared, including anal and sexual function, QOL and local recurrence rate. The operation difficulty between the above two groups is also investigated, including operation time, the intraoperative and postoperative complications, mesorectum integrity, time for mobilizing the intersphincteric plane, the intactness of the fascia of the levator ani muscle, pubis coccygeus, puborectalis, and external sphincter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | Experimental | Procedure: Lap partial ISRPatients who are initially staged as T1-2, according to MRI and intraluminal ultrasound, are assigned to the direct surgery group (determined by the multidisciplnary team [MDT] group) |
| B group | Experimental | Combination Product: NCRT+Lap partial ISRPatients who are initially staged as T3M0, according to MRI and intraluminal ultrasound, should undertake preoperative chemoradiotherapy (determined by the MDT group). The operation was performed 8-12 weeks after the end of the chemoradiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Biopsy-proven moderate or well differentiated adenocarcinoma
- Rullier classification of low rectal cancer (types Ⅱ: juxta-anal tumor)
- Clinical staging: initially staged as T1 -2 or down staged to T1-2 after neoadjuvant chemoradiotherapy;
Key exclusion criteria (5 listed)
- Without signing informed consent, poor compliance
- Unfit for laparoscopy
- Other serious diseases not suitable for participating in this clinical trial
- A degree of preoperative fecal incontinence
- After preoperative neoadjuvant chemoradiotherapy, the sphincter function, sexual function and others involved in this trail are seriously affected
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 |
|---|---|---|
| Lap partial ISRA direct laparoscopic surgery with completely abdominal approach laparoscopic partial intersphincteric resection | Procedure or surgery | A group |
| NCRT+Lap partial ISRPreoperative radiation and chemotherapy + laparoscopic completely abdominal approach laparoscopic partial intersphincteric resection | Combination product | B group |
Primary outcome
The damage degree of anal function
Time frame: 5 years
The value of this index in group A was defined as the preoperative anal function score minus the postoperative anal score. The value of this index in group B was defined as the anal function score which the patients have completed the standard neoadjuvant therapy minus the postoperative anal function score.
5 secondary outcomes
Time for mobilizing the intersphincteric space
Time frame: 5 years
The intactness of levator anus muscle fascia
Time frame: 5 years
he quality of specimen pathology: total mesorectal excision (TME) quality, the involvement of distal margin and circumferential margin
Time frame: 5 years
Intraoperative and postoperative complications
Time frame: 5 years
Local recurrence
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lap partial ISR and NCRT+Lap partial ISR in people with Rectal Cancer, run by Zhongnan Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 22 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qun Qian, M.D. ((+86)13517110773, wb002554@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The damage degree of anal function (time frame: 5 years). 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 22 Jul 2020.