- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03731754
"Cross" Closure for Reconstructing the Perineal Wound of Abdominoperineal Resection (CCRPWAR)
"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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lei Wang, MD, PhD
- Phone Number: 86-20-38254052
- Email: leiwangyinhu@126.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Traditional Closure
Patients receive primary closure discontinuously for reconstruction of APR perineal wound
|
Primary closure discontinuously the perineal wound of APR
|
EXPERIMENTAL: "Cross" Closure
Patients receive "cross" closure for reconstruction of APR perineal wound
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Within 30 days after operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary wound healing rate
Time Frame: Within 30 days after operation
|
the Primary wound healing rate within 30 days after operation
|
Within 30 days after operation
|
CTCAE grade for complications of perineal wound
Time Frame: Within 30 days after surgery
|
the CTCAE grade for complications of perineal wound within 30 days after surgery
|
Within 30 days after surgery
|
The incidence of each complication of perineal wound
Time Frame: Within 30 days after surgery
|
The incidence of each complication of perineal wound within 30 days after surgery
|
Within 30 days after surgery
|
The rate of reoperation
Time Frame: Within 30 days after surgery
|
The rate of reoperation within 30 days after surgery
|
Within 30 days after surgery
|
The volumes of presacral drainage
Time Frame: Within 3, 5, 7 days after surgery
|
The volumes of presacral drainage within 3, 5, 7 days after surgery
|
Within 3, 5, 7 days after surgery
|
The volumes of presacral residual cavity hydrops
Time Frame: 3 and 7 days postoperatively
|
The volumes of presacral residual cavity hydrops within 3 and 7 days postoperatively
|
3 and 7 days postoperatively
|
The times of dressing change of perineal wound
Time Frame: Within 3, 5, 7 days after surgery
|
The times of dressing change of perineal wound within 3, 5, 7 days after surgery
|
Within 3, 5, 7 days after surgery
|
Removal time of presacral drainage tube
Time Frame: Within 30 days after surgery
|
Removal time of presacral drainage tube within 30 days after surgery
|
Within 30 days after surgery
|
Scar scores for perineal wound and evaluation of patients' overall satisfaction
Time Frame: Within 30 days after surgery
|
Scar scores for perineal wound and evaluation of patients' overall satisfaction within 30 days after surgery
|
Within 30 days after surgery
|
Hospital stay after surgery
Time Frame: Within 30 days after surgery
|
Hospital stay after surgery within 30 days after surgery
|
Within 30 days after surgery
|
The operation time
Time Frame: Intraoperatively
|
The operation time
|
Intraoperatively
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lei Wang, MD, PhD, Sixth Affiliated Hospital, Sun Yat-sen University
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCRPWAR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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