Cross Closure for Reconstructing the Perineal Wound of Abdominoperineal Resection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Rectal Cancer, Anal Canal Cancer

Intervention / Treatment
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* Procedure: Traditional Closure
* Procedure: Cross closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Closure<br>Patients receive primary closure discontinuously for reconstruction of APR perineal wound | Procedure: Traditional Closure<br>* Primary closure discontinuously the perineal wound of APR<br>|
| Experimental: Cross Closure<br>Patients receive cross closure for reconstruction of APR perineal wound | Procedure: Cross closure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traditional closure, Cross closure, Rectal cancer, Anal canal cancer, Abdominoperineal resection