"Cross" Closure for Reconstructing the Perineal Wound of Abdominoperineal Resection

NCT ID: NCT03731754

Last Updated: 2018-11-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-20
• Study Completion Date: 2020-12-20

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.

Conditions

Rectal Cancer; Anal Canal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Traditional Closure

Patients receive primary closure discontinuously for reconstruction of APR perineal wound

Group Type: ACTIVE_COMPARATOR

Traditional Closure

Intervention Type: PROCEDURE

Primary closure discontinuously the perineal wound of APR

"Cross" Closure

Patients receive "cross" closure for reconstruction of APR perineal wound

Group Type: EXPERIMENTAL

"Cross" closure

Intervention Type: PROCEDURE

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.

Interventions

Traditional Closure

Primary closure discontinuously the perineal wound of APR

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Jinan University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Southern Medical University, China

OTHER

Sponsor Role: collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Guangzhou First People's Hospital

OTHER

Sponsor Role: collaborator

Affiliated Hospital of Guangdong Medical University

OTHER

Sponsor Role: collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Meizhou People's Hospital

OTHER

Sponsor Role: collaborator

Jieyang People's Hospital

OTHER

Sponsor Role: collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lei Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Central Contacts

Lei Wang, MD, PhD

Role: CONTACT

leiwangyinhu@126.com

86-20-38254052

Other Identifiers

CCRPWAR

Identifier Type: -

Identifier Source: org_study_id