Surgical Approach for Retrorectal Tumors Cohort (SART cohort)

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

Study Overview

• Status: Completed
• Conditions: Malignant Tumor
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting a retrorectal tumor who underwent surgical excision

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative morbidity rate	Postoperative morbidity according to Clavien Dindo	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate	Mortality rate	90 days
Reoperation rate	Any reoperation linked to surgical resection of the retrorectal tumor	90 days
Quality of surgical resection	Evaluation of surgical margins according to pathological examination	90 days
Conversion to open approach	Conversion to laparotomy in case of mini-invasive approach	90 days
Rate of functional outcomes	Evaluation of fecal	90 days
Rate of functional outcomes	Evaluation urinary functions	90 days
Functional outcomes	Evaluation of sexual functions	90 days

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Centre Hospitalier Universitaire de Nīmes; Université Montpellier
• Investigators: Study Director: Thomas Bardol, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Retrorectal tumor; Tail gut cyst; Benign tumor; Mini-invasive approach; Open approach; Perineal approach
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: RECHMPL21_0093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No