NCT04757103

Brief Summary

Aim of the study : To evaluate postoperative outcomes of all surgical approach for retrorectal tumors. Methods : From 2005 to 2020, all consecutive patients who underwent surgery for a retrorectal tumor in two referral tertiary center were prospectively collected. Considering our exlusion criterias, data from XX patients were analyzed. The cohort was separated into 2 groups according to tumor localization regarding the third sacral vertebra. Short and longterm outcomes were compared between the two groups. Primary outcome : 90 days postoperative morbidity rate

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2021

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

29 days

First QC Date

February 10, 2021

Last Update Submit

November 12, 2021

Conditions

Malignant Tumor

Keywords

Retrorectal tumorTail gut cystBenign tumorMini-invasive approachOpen approachPerineal approach

Outcome Measures

Primary Outcomes (1)

  • Postoperative morbidity rate

    Postoperative morbidity according to Clavien Dindo

    90 days

Secondary Outcomes (7)

  • Mortality rate

    90 days

  • Reoperation rate

    90 days

  • Quality of surgical resection

    90 days

  • Conversion to open approach

    90 days

  • Rate of functional outcomes

    90 days

  • +2 more secondary outcomes

Study Arms (2)

Above S3

Lesion located above the third sacral vertebra

Procedure: Resection of the retrorectal tumor

Below S3

Lesion located below the third sacral vertebra

Procedure: Resection of the retrorectal tumor

Interventions

Resection of the retrorectal tumorPROCEDURE

Surgical resection of the retrorectal mass

Above S3Below S3

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting a retrorectal tumor who underwent surgical excision

You may qualify if:

  • Patient presenting a retrorectal tumor
  • Surgical procedure between 01/01/2005 and 31/12/2020

You may not qualify if:

  • age \< 18 years old
  • Patients presenting a rectal tumor
  • Patients presenting a rectal duplication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Thomas Bardol

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 17, 2021

Study Start

January 1, 2021

Primary Completion

January 30, 2021

Study Completion

May 1, 2021

Last Updated

November 15, 2021

Record last verified: 2021-11

Locations

FR(1)