NCT03731754

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
346

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

November 20, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

November 9, 2018

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

October 26, 2018

Last Update Submit

November 7, 2018

Conditions

Rectal CancerAnal Canal Cancer

Keywords

Traditional closure"Cross" closureRectal cancerAnal canal cancerAbdominoperineal resection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Primary wound healing rate

    Within 30 days after operation

  • CTCAE grade for complications of perineal wound

    Within 30 days after surgery

  • The incidence of each complication of perineal wound

    Within 30 days after surgery

  • The rate of reoperation

    Within 30 days after surgery

  • The volumes of presacral drainage

    Within 3, 5, 7 days after surgery

  • +6 more secondary outcomes

Study Arms (2)

Traditional Closure

ACTIVE COMPARATOR

Patients receive primary closure discontinuously for reconstruction of APR perineal wound

Procedure: Traditional Closure

"Cross" Closure

EXPERIMENTAL

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

Procedure: "Cross" closure

Interventions

Traditional ClosurePROCEDURE

Primary closure discontinuously the perineal wound of APR

Traditional Closure
"Cross" closurePROCEDURE

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.

"Cross" Closure

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-75 years old;
  • ECOG performance status: 0-2;
  • Histologically confirmed rectal cancer or anal canal cancer;
  • Completely resected the primary tumor;
  • No evidence of distant metastasis;
  • Tolerable general anesthesia;
  • Total radiation dose of 45-50 Gy needed if the patient needs to receive routine segmental radiotherapy;
  • Provision of written informed consent.

You may not qualify if:

  • Emergency surgery required when the patients combined with acute ileus, perforation and hemorrhage;
  • Extralevator abdominoperineal resection needed;
  • American Society of Anesthesiologists (ASA) IV or V;
  • Combined with other tumors;
  • Severe mental illness;
  • (7)Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease; (8)Expectation of lateral lymph node dissection preoperatively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal NeoplasmsAnal Canal Carcinoma

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Lei Wang, MD, PhD

    Sixth Affiliated Hospital, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Wang, MD, PhD

CONTACT

86-20-38254052leiwangyinhu@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2018

First Posted

November 6, 2018

Study Start

November 20, 2018

Primary Completion

November 20, 2020

Study Completion

December 20, 2020

Last Updated

November 9, 2018

Record last verified: 2018-10