Clinical trial NCT04817150: 3D vs 2D-laparoscopy for Rectocele and Rectal Prolapse Correction: a Prospective, Randomized, Single Center Study
Official title: LARC Study: Three-dimensional Versus Conventional 2D-laparoscopy for Rectocele and Rectal Prolapse Repair: a Prospective, Randomized, Single Center Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectocele; Female
Rectocele and Incomplete Uterine Prolapse
Rectocele and Complete Uterovaginal Prolapse
Rectal Prolapse
Lead sponsor: Private Healthcare Institution Clinical Hospital RGD-Medicine
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a prospective randomized comparative study in parallel groups
Primary purpose: TREATMENT

Brief summary: The aim is to compare proximate and remote results of 3D and conventional 2D laparoscopic interventions in terms of efficacy and safety in treatment of symptomatic rectocele and rectal prolapse.

This is a prospective randomized comparative study in parallel groups conducted in single Colorectal unit. Inclusion criteria: female patients with stage 3 rectocele (3-4 POP-Q \[pelvic organ prolapse quantification\] grade) and/or full-thickness rectal prolapse.

Intervention - laparoscopic ventral rectopexy. The primary outcome is objective cure rate of pelvic prolapse. Secondary outcomes include obstructive defecation and incontinence symptoms according to Wexner and Cleveland Clinic scales, and satisfaction according to Patient Global Impression of Improvement questionnaire. Operative times, intraoperative blood loss, length of hospital stay, postop pain severity, urinary incontinence, as well as surgical and mesh complications are also assessed.

The specific point of interest in this study is surgeon's tiredness after the operation assessed with Profile of Mood States questionnaire.


Eligibility criteria: Inclusion Criteria:

* stage 3 rectocele (3-4 POP-Q grade) and/or full-thickness rectal prolapse
* age 18-70 y.o.

Exclusion Criteria:

* severe concomitants chronic diseases (American Society of Anesthesiologists class III - IV),
* ongoing oncological diseases,
* ongoing hematological diseases,
* ongoing inflammatory diseases of the colon and pelvic organs,
* pregnancy

Primary outcomes:
measure: objective cure rate
timeFrame: 12 months postop
Secondary outcomes:
measure: obstructive defecation cure
timeFrame: 12 months postop
measure: incontinence cure
timeFrame: 12 months postop
measure: patient's satisfaction
timeFrame: 12 months postop
Other outcomes:
measure: intraoperative blood loss
timeFrame: intraoperatively
measure: length of hospital stay
timeFrame: through study completion, an average of 1 year
measure: postop pain severity
timeFrame: 24 hours postop
measure: postop stress urinary incontinence
timeFrame: 12 months
measure: complications rate
timeFrame: 12 months
measure: surgeon's tiredness
timeFrame: 1 hour after the surgery
measure: postoperative seroma/hematoma volume
timeFrame: 3 weeks
measure: postop pain syndrom duration
timeFrame: through study completion, an average of 1 year
Locations:
city: Rostov-on-Don
country: Russian Federation
facility: Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"
Study officials:
References: