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

"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

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.

Study Overview

• Status: Unknown
• Conditions: Rectal Cancer; Anal Canal Cancer
• Intervention / Treatment: Procedure: Traditional Closure; Procedure: "Cross" closure

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 Type: Interventional
• Enrollment (Anticipated): 346
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lei Wang, MD, PhD; Phone Number: 86-20-38254052; Email: leiwangyinhu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 20, 2018
• Primary Completion (ANTICIPATED): November 20, 2020
• Study Completion (ANTICIPATED): December 20, 2020

Study Registration Dates

• First Submitted: October 26, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (ACTUAL): November 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2018
• Last Update Submitted That Met QC Criteria: November 7, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Rectal cancer; Abdominoperineal resection; Traditional closure; "Cross" closure; Anal canal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: CCRPWAR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No