An interventional study of Traditional Closure and "Cross" closure in Rectal Cancer and Anal Canal Cancer, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-11-09.
Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Not applicable, Interventional, and Treatment
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 346 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 211 studies on the registry; 110 are open to participants now.
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Exclusion Criteria:
(7)Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease; (8)Expectation of lateral lymph node dissection preoperatively
Patients receive primary closure discontinuously for reconstruction of APR perineal wound
Procedure: Traditional Closure
Patients receive "cross" closure for reconstruction of APR perineal wound
Procedure: "Cross" closure
Primary closure discontinuously the perineal wound of APR
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.
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
Time frame: Within 30 days after operation
Primary wound healing rate
the Primary wound healing rate within 30 days after operation
Time frame: 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
Time frame: 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
Time frame: Within 30 days after surgery
The rate of reoperation
The rate of reoperation within 30 days after surgery
Time frame: Within 30 days after surgery
The volumes of presacral drainage
The volumes of presacral drainage within 3, 5, 7 days after surgery
Time frame: 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
Time frame: 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
Time frame: Within 3, 5, 7 days after surgery
Removal time of presacral drainage tube
Removal time of presacral drainage tube within 30 days after surgery
Time frame: 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
Time frame: Within 30 days after surgery
Hospital stay after surgery
Hospital stay after surgery within 30 days after surgery
Time frame: Within 30 days after surgery
The operation time
The operation time
Time frame: Intraoperatively
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Sixth Affiliated Hospital, Sun Yat-sen University