3D vs 2D-laparoscopy for Rectocele and Rectal Prolapse Correction: a Prospective, Randomized, Single Center Study

Rectal Prolapse Clinical Trial

— LARC  

Official title:

LARC Study: Three-dimensional Versus Conventional 2D-laparoscopy for Rectocele and Rectal Prolapse Repair: a Prospective, Randomized, Single Center Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04817150
• Other study ID #: LARC1
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: July 2022

Study information

• Verified date: March 2021
• Source: Private Healthcare Institution Clinical Hospital RGD-Medicine
• Contact: Anastasiya Golovina
• Phone: +79518319720
• Email: a_anastacia[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Prolapse
• Rectal Prolapse
• Rectocele
• Rectocele and Complete Uterovaginal Prolapse
• Rectocele and Incomplete Uterine Prolapse
• Rectocele; Female
• Uterine Prolapse

Intervention

Procedure:
• Laparoscopic ventral mesh rectopexy
Conventional laparoscopic ventral mesh rectopexy, as first described by D'Hoore

Locations

Country	Name	City	State
Russian Federation	Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"	Rostov-on-Don

Sponsors (1)

Lead Sponsor	Collaborator
Alexander Khitaryan

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	intraoperative blood loss	intraoperative blood loss (ml)	intraoperatively
Other	length of hospital stay	length of hospital stay (days)	through study completion, an average of 1 year
Other	postop pain severity	VAS (Visual Analog Scale)	24 hours postop
Other	postop stress urinary incontinence	Valsalva test (positive - urinary incontinence presents, negative - no stress urinary incontinence)	12 months
Other	complications rate	early and remote complications	12 months
Other	surgeon's tiredness	Profile of Mood States Questionnaire	1 hour after the surgery
Other	postoperative seroma/hematoma volume	size of liquid cavity surrounding mesh on 2-3 postoperative day and on 2-3 postoperative week (ml)	3 weeks
Other	postop pain syndrom duration	pain medications consumption	through study completion, an average of 1 year
Primary	objective cure rate	objective cure rate according to clinical POP-Q assesment	12 months postop
Secondary	obstructive defecation cure	according to Wexner scale score (Cleveland Clinic Constipation Scoring System, scale of 0-30, with 0 = minimum, healthy individual and 30 = maximum, severe obstructive defecation)	12 months postop
Secondary	incontinence cure	according to Cleveland Clinic scale score (Cleveland Clinic Incontinence Scoring System, scale of 0-20, with 0 = minimum, perfect continence and 20 = maximum, complete incontinence)	12 months postop
Secondary	patient's satisfaction	according to PGII (Patient Global Impression of Improvement) questionnaire	12 months postop