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"Cross" Closure for Reconstructing the Perineal Wound of Abdominoperineal Resection (CCRPWAR)

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ClinicalTrials.gov Identifier: NCT03731754
Recruitment Status : Not yet recruiting
First Posted : November 6, 2018
Last Update Posted : November 9, 2018
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
First Affiliated Hospital of Jinan University
The First Affiliated Hospital of Guangzhou Medical University
Second Affiliated Hospital of Guangzhou Medical University
Southern Medical University, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou First People's Hospital
The Affiliated Hospital of Guangdong Medical College
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Meizhou People's Hospital
Jieyang People's Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Anal Canal Cancer Procedure: Traditional Closure Procedure: "Cross" closure Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 20, 2018
Estimated Primary Completion Date : November 20, 2020
Estimated Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Traditional Closure
Patients receive primary closure discontinuously for reconstruction of APR perineal wound
Procedure: Traditional Closure
Primary closure discontinuously the perineal wound of APR

Experimental: "Cross" Closure
Patients receive "cross" closure for reconstruction of APR perineal wound
Procedure: "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.




Primary Outcome Measures :
  1. Complication rate of perineal wound [ Time Frame: 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 :
  1. Primary wound healing rate [ Time Frame: Within 30 days after operation ]
    the Primary wound healing rate within 30 days after operation

  2. CTCAE grade for complications of perineal wound [ Time Frame: Within 30 days after surgery ]
    the CTCAE grade for complications of perineal wound within 30 days after surgery

  3. The incidence of each complication of perineal wound [ Time Frame: Within 30 days after surgery ]
    The incidence of each complication of perineal wound within 30 days after surgery

  4. The rate of reoperation [ Time Frame: Within 30 days after surgery ]
    The rate of reoperation within 30 days after surgery

  5. The volumes of presacral drainage [ Time Frame: Within 3, 5, 7 days after surgery ]
    The volumes of presacral drainage within 3, 5, 7 days after surgery

  6. The volumes of presacral residual cavity hydrops [ Time Frame: 3 and 7 days postoperatively ]
    The volumes of presacral residual cavity hydrops within 3 and 7 days postoperatively

  7. The times of dressing change of perineal wound [ Time Frame: Within 3, 5, 7 days after surgery ]
    The times of dressing change of perineal wound within 3, 5, 7 days after surgery

  8. Removal time of presacral drainage tube [ Time Frame: Within 30 days after surgery ]
    Removal time of presacral drainage tube within 30 days after surgery

  9. Scar scores for perineal wound and evaluation of patients' overall satisfaction [ Time Frame: Within 30 days after surgery ]
    Scar scores for perineal wound and evaluation of patients' overall satisfaction within 30 days after surgery

  10. Hospital stay after surgery [ Time Frame: Within 30 days after surgery ]
    Hospital stay after surgery within 30 days after surgery

  11. The operation time [ Time Frame: Intraoperatively ]
    The operation time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731754


Contacts
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Contact: Lei Wang, MD, PhD 86-20-38254052 leiwangyinhu@126.com

Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University
First Affiliated Hospital of Jinan University
The First Affiliated Hospital of Guangzhou Medical University
Second Affiliated Hospital of Guangzhou Medical University
Southern Medical University, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou First People's Hospital
The Affiliated Hospital of Guangdong Medical College
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Meizhou People's Hospital
Jieyang People's Hospital
Investigators
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Principal Investigator: Lei Wang, MD, PhD Sixth Affiliated Hospital, Sun Yat-sen University

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Responsible Party: Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03731754     History of Changes
Other Study ID Numbers: CCRPWAR
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sixth Affiliated Hospital, Sun Yat-sen University:
Traditional closure
"Cross" closure
Rectal cancer
Anal canal cancer
Abdominoperineal resection

Additional relevant MeSH terms:
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Anus Diseases
Rectal Neoplasms
Anus Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases