Surgical Approach for Retrorectal Tumors Cohort

Completed

• Conditions: Malignant Tumor
• Interventions: Procedure: Resection of the retrorectal tumor

• Registration Number: NCT04757103
• Lead Sponsor: University Hospital, Montpellier

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

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 Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-01-30
• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-17
• Study Completion: 2021-05-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Above S3	Resection of the retrorectal tumor	Lesion located above the third sacral vertebra
Below S3	Resection of the retrorectal tumor	Lesion located below the third sacral vertebra

Primary Outcome Measures

Name	Time	Method
Postoperative morbidity rate	90 days	Postoperative morbidity according to Clavien Dindo

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France