"Cross" Closure for Reconstructing the Perineal Wound of Abdominoperineal Resection

Not Applicable

• Conditions: Rectal Cancer; Anal Canal Cancer
• Interventions: Procedure: Traditional Closure; Procedure: "Cross" closure

• Registration Number: NCT03731754
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

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.

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2018-11-05
• Study First Posted: 2018-11-06
• Last Update Submitted: 2018-11-07
• Last Update Posted: 2018-11-09
• Study Start: 2018-11-20
• Primary Completion: 2020-11-20
• Study Completion: 2020-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 346

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Closure	Traditional Closure	Patients receive primary closure discontinuously for reconstruction of APR perineal wound
"Cross" Closure	"Cross" closure	Patients receive "cross" closure for reconstruction of APR perineal wound

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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
Hospital stay after surgery	Within 30 days after surgery	Hospital stay after surgery within 30 days after surgery
Primary wound healing rate	Within 30 days after operation	the Primary wound healing rate within 30 days after operation
The rate of reoperation	Within 30 days after surgery	The rate of reoperation within 30 days after surgery
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
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
The operation time	Intraoperatively	The operation time