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

NCT03731754 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2018-11-09

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Traditional Closure

Primary closure discontinuously the perineal wound of APR

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.

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER
  • First Affiliated Hospital of Jinan University

    collaborator OTHER
  • The First Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER
  • Second Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER
  • Southern Medical University, China

    collaborator OTHER
  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    collaborator OTHER
  • Guangzhou First People's Hospital

    collaborator OTHER
  • Affiliated Hospital of Guangdong Medical University

    collaborator OTHER
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    collaborator OTHER
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER
  • Meizhou People's Hospital

    collaborator OTHER
  • Jieyang People's Hospital

    collaborator OTHER
  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Lei Wang, MD, PhD · Sixth Affiliated Hospital, Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2020-11-20
Completion
2020-12-20

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03731754 on ClinicalTrials.gov