SART cohort: Surgical Approach for Retrorectal Tumors Cohort

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04757103
Collaborator
Université Montpellier (Other), Centre Hospitalier Universitaire de Nīmes (Other)
21
1
3.9
5.3

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Resection of the retrorectal tumor

Detailed Description

Retro-rectal tumors are a group of heterogeneous and rare lesions. The actual incidence has been estimated to be approximately one case per 40,000 admissions. It is most often a benign tumor that affects young women and the origin is congenital in 60% of cases. The most common benign lesion is a tailgut cyst. Chordoma is the most common malignant lesion. They are mostly asymptomatic or pauci-symptomatic. This is why their diagnosis is regularly accidentaly after a morphological examination such as an abdominal ultrasound or a CT scan. MRI is the gold standard for determining the structure of the lesion, its origin, its topography, its extension in relation to adjacent organs, parameters that are essential to define the type of surgery and its approach.

When a retro-rectal tumor is diagnosed, the standard treatment is surgical resection. A biopsy is not helpful if there is no suspicion of a degenerate lesion. Usually, lesions located under the third sacral vertebra (S3) are approached by dorsal transsacrococcygeal, perineal or combined approach (abdominal and perineal approach) while those located above S3 the approach is abdominal (laparotomy or laparoscopy). As these lesions are, in the majority of cases, benign, the functional impact of surgery is essential. Based on our experience in minimally invasive surgery and in particular in retro-rectal tumors, laparoscopy has become our first-line approach regardless of the location of the lesion compared to S3. Our hypothesis is that the minimally invasive approach is reliable, safe and allows satisfactory histological results to be obtained while limiting postoperative pain and functional sequelae.

Study Design

Study Type:
Observational
Actual Enrollment :
21 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Surgical Approach for Retro-rectal Tumors: a Retrospective Bicentric Cohort (SART Cohort)
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Jan 30, 2021
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Above S3

Lesion located above the third sacral vertebra

Procedure: Resection of the retrorectal tumor
Surgical resection of the retrorectal mass

Below S3

Lesion located below the third sacral vertebra

Procedure: Resection of the retrorectal tumor
Surgical resection of the retrorectal mass

Outcome Measures

Primary Outcome Measures

  1. Postoperative morbidity rate [90 days]

    Postoperative morbidity according to Clavien Dindo

Secondary Outcome Measures

  1. Mortality rate [90 days]

    Mortality rate

  2. Reoperation rate [90 days]

    Any reoperation linked to surgical resection of the retrorectal tumor

  3. Quality of surgical resection [90 days]

    Evaluation of surgical margins according to pathological examination

  4. Conversion to open approach [90 days]

    Conversion to laparotomy in case of mini-invasive approach

  5. Rate of functional outcomes [90 days]

    Evaluation of fecal

  6. Rate of functional outcomes [90 days]

    Evaluation urinary functions

  7. Functional outcomes [90 days]

    Evaluation of sexual functions

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
  • Patient presenting a retrorectal tumor

  • Surgical procedure between 01/01/2005 and 31/12/2020

Exclusion criteria:
  • age < 18 years old

  • Patients presenting a rectal tumor

  • Patients presenting a rectal duplication

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uhmontpellier Montpellier France 34295

Sponsors and Collaborators

  • University Hospital, Montpellier
  • Université Montpellier
  • Centre Hospitalier Universitaire de Nīmes

Investigators

  • Study Director: Thomas Bardol, University Hospital, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT04757103
Other Study ID Numbers:
  • RECHMPL21_0093
First Posted:
Feb 17, 2021
Last Update Posted:
Nov 15, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2021