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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03731754
Other study ID # CCRPWAR
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 20, 2018
Est. completion date December 20, 2020

Study information

Verified date October 2018
Source Sixth Affiliated Hospital, Sun Yat-sen University
Contact Lei Wang, MD, PhD
Phone 86-20-38254052
Email leiwangyinhu@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 346
Est. completion date December 20, 2020
Est. primary completion date November 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Intervention

Procedure:
Traditional Closure
Primary closure discontinuously the perineal wound of APR
"Cross" 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.

Locations

Country Name City State
n/a

Sponsors (13)

Lead Sponsor Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University Cancer Institute and Hospital, Chinese Academy of Medical Sciences, First Affiliated Hospital of Jinan University, First Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou First People's Hospital, Jieyang People's Hospital, Meizhou People's Hospital, Second Affiliated Hospital of Guangzhou Medical University, Southern Medical University, China, The Affiliated Hospital of Guangdong Medical College, The First Affiliated Hospital of Guangzhou Medical University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Primary wound healing rate the Primary wound healing rate within 30 days after operation Within 30 days after operation
Secondary 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
Secondary 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
Secondary The rate of reoperation The rate of reoperation within 30 days after surgery Within 30 days after surgery
Secondary The volumes of presacral drainage The volumes of presacral drainage within 3, 5, 7 days after surgery Within 3, 5, 7 days after surgery
Secondary 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
Secondary 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
Secondary Removal time of presacral drainage tube Removal time of presacral drainage tube within 30 days after surgery Within 30 days after surgery
Secondary 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
Secondary Hospital stay after surgery Hospital stay after surgery within 30 days after surgery Within 30 days after surgery
Secondary The operation time The operation time Intraoperatively
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