Rectal CancerCCRPWARNCT03731754
"Cross" Closure for Reconstructing the Perineal Wound of Abdominoperineal Resection
A study testing Traditional Closure and "Cross" closure in people with Rectal Cancer and Anal Canal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
How to reduce the complications of perineal wound after abdominoperineal resection (APR) has always been a hot topic in the medical field.To reduce the complications of perineal wound and the primary healing of perineal wound must meet the two principles of "unobstructed drainage" and " reduced tension closure".This… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Anal Canal Cancer
- What is being tested?
- Traditional Closure and "Cross" closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2018to 20 Dec 2020
- 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
- Age: 18-75 years old;
- ECOG performance status: 0-2;
- Histologically confirmed rectal cancer or anal canal cancer;
- Completely resected the primary tumor;
- No evidence of distant metastasis;
- Tolerable general anesthesia;
- Total radiation dose of 45-50 Gy needed if the patient needs to receive routine segmental radiotherapy;
- Provision of written informed consent.
Who cannot join
- Emergency surgery required when the patients combined with acute ileus, perforation and hemorrhage;
- Extralevator abdominoperineal resection needed;
- American Society of Anesthesiologists (ASA) IV or V;
- Combined with other tumors;
- Severe mental illness;
- (7)Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease; (8)Expectation of lateral lymph node dissection preoperatively
Trial locations and contacts
No sites are listed yet.
About this study
Official title: "Cross" Closure for Reconstructing the Perineal Wound of Abdominoperineal Resection in Rectal and Anal Cancer Patients: a Multi-center, Randomized, Open-Label, Positive, Parallel Controlled Clinical Trial
How to reduce the complications of perineal wound after abdominoperineal resection (APR) has always been a hot topic in the medical field.To reduce the complications of perineal wound and the primary healing of perineal wound must meet the two principles of "unobstructed drainage" and " reduced tension closure".This concept is similar to the concepts of closure of enterostomy in rectal cancer patients. It was reported that use of cross-stitch closure can significantly reduce complications of closure of enterostomy. So the investigator ever used the "cross" closure to reconstruct the perineal wound of APR, which was really decrease the complications of perineal wound. However, more clinical trails was needed to confirm the conclusion.
Read the detailed description
Perineal wound problems after abdominoperineal resection (APR) for rectal cancer is reported in up to 25%～66% of patients,if the perineum does not heal primarily, the secondary wound healing may prolong hospital stay, may necessitate surgical reintervention, and often requires intensive wound care for several months. Great efforts have been taken to reduce the complications of perineal wound of APR, but the incidence of the perineal wound complications are not effectively decreased.
It was reported that one of the most important factors to determine the primary healing of perineal wound is whether the anterior sacral drainage and perineal stump drainage are sufficient and effective or not, which is similar to the concept of closure of enterostomy.
Previously, it was reported that "cross" closure is an effective method of skin closure for stoma reversal, which allows increased surgical exposure, reduces suture, smooth drainage, aesthetic healing simplifies wound care, and gives a neat cosmetic result.
Therefore, because of the success use of "cross" closure in stoma reversal to reduce the complications of perineal wound, the investigator used the "cross" closure to reconstruct the perineal wound of APR, and it really can decrease the complications of perineal wound. However, more clinical trails are needed to confirm the conclusion.
- Conditions
- Rectal Cancer, Anal Canal Cancer
- Being tested
- Traditional Closure, "Cross" closure
- Keywords
- Traditional closure, "Cross" closure, Rectal cancer, Anal canal cancer, Abdominoperineal resection
- Medical subject headings
- Rectal Neoplasms, Anal Canal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional ClosureProcedure or surgery
Primary closure discontinuously the perineal wound of APR
"Cross" closureProcedure or surgery
Two triangles of skin in the horizontal direction are excised to enlarge the skin incision, and the tumor resected. Then circumferential subcuticular suture of wound, and with tightening of the circumferential suture, the wound resembles a cross.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Closure | Active comparator | Patients receive primary closure discontinuously for reconstruction of APR perineal wound Receives: Procedure: Traditional Closure |
| "Cross" Closure | Experimental | Patients receive "cross" closure for reconstruction of APR perineal wound Receives: Procedure: "Cross" closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate of perineal wound
the complications of perineal wound are include wound infection, wound effusion, wound liquefaction, wound dehiscence, seroma or hematoma ,delayed wound healing, presacral or perineal abscess, perineal or pelvic floor hernia
Measured: Within 30 days after operation
Secondary outcomes (11)
Primary wound healing rate
the Primary wound healing rate within 30 days after operation
Measured: Within 30 days after operation
CTCAE grade for complications of perineal wound
the CTCAE grade for complications of perineal wound within 30 days after surgery
Measured: Within 30 days after surgery
The incidence of each complication of perineal wound
The incidence of each complication of perineal wound within 30 days after surgery
Measured: Within 30 days after surgery
The rate of reoperation
The rate of reoperation within 30 days after surgery
Measured: Within 30 days after surgery
The volumes of presacral drainage
The volumes of presacral drainage within 3, 5, 7 days after surgery
Measured: Within 3, 5, 7 days after surgery
The volumes of presacral residual cavity hydrops
The volumes of presacral residual cavity hydrops within 3 and 7 days postoperatively
Measured: 3 and 7 days postoperatively
The times of dressing change of perineal wound
The times of dressing change of perineal wound within 3, 5, 7 days after surgery
Measured: Within 3, 5, 7 days after surgery
Removal time of presacral drainage tube
Removal time of presacral drainage tube within 30 days after surgery
Measured: Within 30 days after surgery
Scar scores for perineal wound and evaluation of patients' overall satisfaction
Scar scores for perineal wound and evaluation of patients' overall satisfaction within 30 days after surgery
Measured: Within 30 days after surgery
Hospital stay after surgery
Hospital stay after surgery within 30 days after surgery
Measured: Within 30 days after surgery
The operation time
The operation time
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start20 Nov 2018 (estimated)
- Primary completion20 Nov 2020 (estimated)
- Study completion20 Dec 2020 (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.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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
- 346 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Jinan University, The First Affiliated Hospital of Guangzhou Medical University, Second Affiliated Hospital of Guangzhou Medical University, Southern Medical University, China, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou First People's Hospital, Affiliated Hospital of Guangdong Medical University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Meizhou People's Hospital, Jieyang People's Hospital
- Responsible party
- Sponsor
- Investigators
- Lei Wang, MD, PhD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731754
- Sponsor's protocol ID
- CCRPWAR
- Acronym
- CCRPWAR
- Status last verified
- Oct 2018
- First submitted
- 26 Oct 2018
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Cross" Closure for Reconstructing the Perineal Wound of Abdominoperineal Resection in Rectal and Anal Cancer Patients: a Multi-center, Randomized, Open-Label, Positive, Parallel Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03731754
- Acronym / sponsor ID
- CCRPWAR / CCRPWAR
- Conditions
- Rectal Cancer, Anal Canal Cancer
- Keywords
- Traditional closure, "Cross" closure, Rectal cancer, Anal canal cancer, Abdominoperineal resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Jinan University, The First Affiliated Hospital of Guangzhou Medical University, Second Affiliated Hospital of Guangzhou Medical University, Southern Medical University, China, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou First People's Hospital, Affiliated Hospital of Guangdong Medical University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Meizhou People's Hospital, Jieyang People's Hospital
- Study start
- 20 Nov 2018 (estimated)
- Primary completion
- 20 Nov 2020 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 6 Nov 2018 (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.
How to reduce the complications of perineal wound after abdominoperineal resection (APR) has always been a hot topic in the medical field.To reduce the complications of perineal wound and the primary healing of perineal wound must meet the two principles of "unobstructed drainage" and " reduced tension closure".This concept is similar to the concepts of closure of enterostomy in rectal cancer patients. It was reported that use of cross-stitch closure can significantly reduce complications of closure of enterostomy. So the investigator ever used the "cross" closure to reconstruct the perineal wound of APR, which was really decrease the complications of perineal wound. However, more clinical trails was needed to confirm the conclusion.
Detailed description
Perineal wound problems after abdominoperineal resection (APR) for rectal cancer is reported in up to 25%～66% of patients,if the perineum does not heal primarily, the secondary wound healing may prolong hospital stay, may necessitate surgical reintervention, and often requires intensive wound care for several months. Great efforts have been taken to reduce the complications of perineal wound of APR, but the incidence of the perineal wound complications are not effectively decreased.
It was reported that one of the most important factors to determine the primary healing of perineal wound is whether the anterior sacral drainage and perineal stump drainage are sufficient and effective or not, which is similar to the concept of closure of enterostomy.
Previously, it was reported that "cross" closure is an effective method of skin closure for stoma reversal, which allows increased surgical exposure, reduces suture, smooth drainage, aesthetic healing simplifies wound care, and gives a neat cosmetic result.
Therefore, because of the success use of "cross" closure in stoma reversal to reduce the complications of perineal wound, the investigator used the "cross" closure to reconstruct the perineal wound of APR, and it really can decrease the complications of perineal wound. However, more clinical trails are needed to confirm the conclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Closure | Active comparator | Procedure: Traditional ClosurePatients receive primary closure discontinuously for reconstruction of APR perineal wound |
| "Cross" Closure | Experimental | Procedure: "Cross" closurePatients receive "cross" closure for reconstruction of APR perineal wound |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18-75 years old;
- ECOG performance status: 0-2;
- Histologically confirmed rectal cancer or anal canal cancer;
- Completely resected the primary tumor;
- No evidence of distant metastasis;
Key exclusion criteria (6 listed)
- Emergency surgery required when the patients combined with acute ileus, perforation and hemorrhage;
- Extralevator abdominoperineal resection needed;
- American Society of Anesthesiologists (ASA) IV or V;
- Combined with other tumors;
- Severe mental illness;
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 |
|---|---|---|
| Traditional ClosurePrimary closure discontinuously the perineal wound of APR | Procedure or surgery | Traditional Closure |
| "Cross" closureTwo triangles of skin in the horizontal direction are excised to enlarge the skin incision, and the tumor resected. Then circumferential subcuticular suture of wound, and with tightening of the circumferential suture, the wound resembles a cross. | Procedure or surgery | "Cross" Closure |
Primary outcome
Complication rate of perineal wound
Time frame: Within 30 days after operation
the complications of perineal wound are include wound infection, wound effusion, wound liquefaction, wound dehiscence, seroma or hematoma ,delayed wound healing, presacral or perineal abscess, perineal or pelvic floor hernia
11 secondary outcomes
Primary wound healing rate
Time frame: Within 30 days after operation
CTCAE grade for complications of perineal wound
Time frame: Within 30 days after surgery
The incidence of each complication of perineal wound
Time frame: Within 30 days after surgery
The rate of reoperation
Time frame: Within 30 days after surgery
The volumes of presacral drainage
Time frame: Within 3, 5, 7 days after surgery
The volumes of presacral residual cavity hydrops
Time frame: 3 and 7 days postoperatively
The times of dressing change of perineal wound
Time frame: Within 3, 5, 7 days after surgery
Removal time of presacral drainage tube
Time frame: Within 30 days after surgery
Scar scores for perineal wound and evaluation of patients' overall satisfaction
Time frame: Within 30 days after surgery
Hospital stay after surgery
Time frame: Within 30 days after surgery
The operation time
Time frame: Intraoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
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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.
Lei Wang, MD, PhD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Closure and "Cross" closure in people with Rectal Cancer and Anal Canal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen 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 8 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: status not confirmed, as of the sponsor's last update on 9 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Wang, MD, PhD (86-20-38254052, leiwangyinhu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate of perineal wound (time frame: Within 30 days after operation). 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 9 Nov 2018.