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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| First Affiliated Hospital of Jinan University | OTHER |
| The First Affiliated Hospital of Guangzhou Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Closure | Active Comparator | Patients receive primary closure discontinuously for reconstruction of APR perineal wound |
|
| "Cross" Closure | Experimental | Patients receive "cross" closure for reconstruction of APR perineal wound |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Closure | Procedure | Primary closure discontinuously the perineal wound of APR |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 30 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Primary wound healing rate | the Primary wound healing rate within 30 days after operation | 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 |
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Inclusion Criteria:
Exclusion Criteria:
(7)Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease; (8)Expectation of lateral lymph node dissection preoperatively
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Wang, MD, PhD | Contact | 86-20-38254052 | leiwangyinhu@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Lei Wang, MD, PhD | Sixth Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| C563020 | Anal Canal Carcinoma |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Second Affiliated Hospital of Guangzhou Medical University | OTHER |
| Southern Medical University, China | OTHER |
| Guangdong Provincial Hospital of Traditional Chinese Medicine | OTHER |
| Guangzhou First People's Hospital | OTHER |
| Affiliated Hospital of Guangdong Medical University | OTHER |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Meizhou People's Hospital | OTHER |
| Jieyang People's Hospital | OTHER |
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| "Cross" closure | Procedure | 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. |
|
| 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 | Within 30 days after surgery |
| The rate of reoperation | The rate of reoperation within 30 days after surgery | Within 30 days after surgery |
| The volumes of presacral drainage | 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 | 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 | 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 | 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 | 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 | Hospital stay after surgery within 30 days after surgery | Within 30 days after surgery |
| The operation time | The operation time | Intraoperatively |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |