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Completed

NCT Number: NCT04757103

Surgical Approach for Retrorectal Tumors Cohort

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

Completed

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resection of the retrorectal tumor

Procedure

Surgical resection of the retrorectal mass

Primary outcomes

  1. Postoperative morbidity rate

    Time frame: 90 days

    Postoperative morbidity according to Clavien Dindo

Secondary outcomes

  1. Mortality rate

    Time frame: 90 days

    Mortality rate

  2. Reoperation rate

    Time frame: 90 days

    Any reoperation linked to surgical resection of the retrorectal tumor

  3. Quality of surgical resection

    Time frame: 90 days

    Evaluation of surgical margins according to pathological examination

  4. Conversion to open approach

    Time frame: 90 days

    Conversion to laparotomy in case of mini-invasive approach

  5. Rate of functional outcomes

    Time frame: 90 days

    Evaluation of fecal

  6. Rate of functional outcomes

    Time frame: 90 days

    Evaluation urinary functions

  7. Functional outcomes

    Time frame: 90 days

    Evaluation of sexual functions

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Centre Hospitalier Universitaire de Nīmes
  • Université Montpellier

Registry information

Official study title

Surgical Approach for Retro-rectal Tumors: a Retrospective Bicentric Cohort (SART Cohort)

Acronym: SART cohort

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2021
Registry last updated
Nov 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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