Clinical trial NCT03731754: "Cross" Closure for Reconstructing the Perineal Wound of Abdominoperineal Resection
Official title: "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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Anal Canal Cancer
Keywords: Traditional closure
"Cross" closure
Rectal cancer
Anal canal cancer
Abdominoperineal resection
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: First Affiliated Hospital of Jinan University
name: The First Affiliated Hospital of Guangzhou Medical University
name: Second Affiliated Hospital of Guangzhou Medical University
name: Southern Medical University, China
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Guangzhou First People's Hospital
name: Affiliated Hospital of Guangdong Medical University
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Meizhou People's Hospital
name: Jieyang People's Hospital
First posted: 2018-11-06
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complication rate of perineal wound
timeFrame: Within 30 days after operation
Secondary outcomes:
measure: Primary wound healing rate
timeFrame: Within 30 days after operation
measure: CTCAE grade for complications of perineal wound
timeFrame: Within 30 days after surgery
measure: The incidence of each complication of perineal wound
timeFrame: Within 30 days after surgery
measure: The rate of reoperation
timeFrame: Within 30 days after surgery
measure: The volumes of presacral drainage
timeFrame: Within 3, 5, 7 days after surgery
measure: The volumes of presacral residual cavity hydrops
timeFrame: 3 and 7 days postoperatively
measure: The times of dressing change of perineal wound
timeFrame: Within 3, 5, 7 days after surgery
measure: Removal time of presacral drainage tube
timeFrame: Within 30 days after surgery
measure: Scar scores for perineal wound and evaluation of patients' overall satisfaction
timeFrame: Within 30 days after surgery
measure: Hospital stay after surgery
timeFrame: Within 30 days after surgery
measure: The operation time
timeFrame: Intraoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: Lei Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: