Anal Canal Cancer, Rectal Cancer
Conditions
Keywords
Traditional closure, Cross closure, Rectal cancer, Anal canal cancer, Abdominoperineal resection
Brief 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 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.
Interventions
PROCEDURETraditional Closure
Primary closure discontinuously the perineal wound of APR
PROCEDURECross closure
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.
Sponsors
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
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-75 years old; 2. ECOG performance status: 0-2; 3. Histologically confirmed rectal cancer or anal canal cancer; 4. Completely resected the primary tumor; 5. No evidence of distant metastasis; 6. Tolerable general anesthesia; 7. Total radiation dose of 45-50 Gy needed if the patient needs to receive routine segmental radiotherapy; 8. Provision of written informed consent.
Exclusion criteria
1. Emergency surgery required when the patients combined with acute ileus, perforation and hemorrhage; 2. Extralevator abdominoperineal resection needed; 3. American Society of Anesthesiologists (ASA) IV or V; 4. Combined with other tumors; 5. Severe mental illness; (7)Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease; (8)Expectation of lateral lymph node dissection preoperatively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate of perineal wound | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CTCAE grade for complications of perineal wound | Within 30 days after surgery | the CTCAE grade for complications of perineal wound within 30 days after surgery |
| The incidence of each complication of perineal wound | Within 30 days after surgery | The incidence of each complication of perineal wound within 30 days after surgery |
| The rate of reoperation | Within 30 days after surgery | The rate of reoperation within 30 days after surgery |
| The volumes of presacral drainage | Within 3, 5, 7 days after surgery | The volumes of presacral drainage within 3, 5, 7 days after surgery |
| The volumes of presacral residual cavity hydrops | 3 and 7 days postoperatively | The volumes of presacral residual cavity hydrops within 3 and 7 days postoperatively |
| Primary wound healing rate | Within 30 days after operation | the Primary wound healing rate within 30 days after operation |
| Removal time of presacral drainage tube | Within 30 days after surgery | Removal time of presacral drainage tube within 30 days after surgery |
| Scar scores for perineal wound and evaluation of patients' overall satisfaction | Within 30 days after surgery | Scar scores for perineal wound and evaluation of patients' overall satisfaction within 30 days after surgery |
| Hospital stay after surgery | Within 30 days after surgery | Hospital stay after surgery within 30 days after surgery |
| The operation time | Intraoperatively | The operation time |
| The times of dressing change of perineal wound | Within 3, 5, 7 days after surgery | The times of dressing change of perineal wound within 3, 5, 7 days after surgery |
Contacts
Primary ContactLei Wang, MD, PhD
Outcome results
None listed